Document text
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
16-55 C4591001
1011
10111215 1 19OCT2020 Product
administration
error DOSE NOT
CHANGED N N 19OCT2020 N N
C4591001
1012
10121103 2 22SEP2020 Product
administration
error DOSE NOT
CHANGED N N 22SEP2020 Y N
C4591001
1024
10241002 2 01SEP2020 Product storage
error DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1024
10241004 2 02SEP2020 Product storage
error DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1024
10241006 2 02SEP2020 Product storage
error DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1024
10241014 2 01SEP2020 Product storage
error DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1024
10241023 2 02SEP2020 Product storage
error DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1024
10241032 1 17AUG2020 Product storage
error DOSE NOT
CHANGED N N 17AUG2020 N N
C4591001
1024
10241033 1 18AUG2020 Product storage
error DOSE NOT
CHANGED N N 18AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 1
FDA-CBER-2021-5683-1007514
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1024
10241039 1 18AUG2020 Product storage
error DOSE NOT
CHANGED N N 18AUG2020 N N
C4591001
1024
10241040 1 18AUG2020 Product storage
error DOSE NOT
CHANGED N N 18AUG2020 N N
C4591001
1024
10241042 1 19AUG2020 Product storage
error DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1024
10241044 1 19AUG2020 Product storage
error DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1024
10241046 1 19AUG2020 Product storage
error DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1024
10241054 1 20AUG2020 Product storage
error DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1024
10241055 1 20AUG2020 Product storage
error DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1024
10241061 1 21AUG2020 Product storage
error DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1024
10241066 1 24AUG2020 Product storage
error DOSE NOT
CHANGED N N 24AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 2
FDA-CBER-2021-5683-1007515
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1024
10241067 1 24AUG2020 Product storage
error DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1024
10241071 1 24AUG2020 Product storage
error DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1024
10241072 1 25AUG2020 Product storage
error DOSE NOT
CHANGED N N 25AUG2020 N N
C4591001
1024
10241074 1 25AUG2020 Product storage
error DOSE NOT
CHANGED N N 25AUG2020 N N
C4591001
1024
10241078 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1024
10241084 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1024
10241085 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1024
10241091 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1024
10241094 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 3
FDA-CBER-2021-5683-1007516
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1024
10241100 1 31AUG2020 Product storage
error DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1024
10241102 1 31AUG2020 Product storage
error DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1024
10241104 1 01SEP2020 Product storage
error DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1024
10241108 1 02SEP2020 Product storage
error DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1044
10441001 2 02SEP2020 Product
temperature
excursion issue DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1044
10441015 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1044
10441028
24AUG2020 Product storage
error DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1044
10441029 1 25AUG2020 Product storage
error DOSE NOT
CHANGED N N 25AUG2020 N N
C4591001
1044
10441031 1 25AUG2020 Product storage
error DOSE NOT
CHANGED N N 25AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 4
FDA-CBER-2021-5683-1007517
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1044
10441034 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1044
10441037 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1044
10441045 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1044
10441048
27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1044
10441050 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1044
10441052 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1044
10441054 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1044
10441060 1 31AUG2020 Product storage
error DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1044
10441063 1 01SEP2020 Product storage
error DOSE NOT
CHANGED N N 01SEP2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 5
FDA-CBER-2021-5683-1007518
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1044
10441068 1 01SEP2020 Product storage
error DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1044
10441071 1 02SEP2020 Product storage
error DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1044
10441076 1 03SEP2020 Product storage
error DOSE NOT
CHANGED N N 03SEP2020 N N
C4591001
1044
10441079 1 04SEP2020 Product storage
error DOSE NOT
CHANGED N N 04SEP2020 N N
C4591001
1044
10441088 1 06SEP2020 Product storage
error DOSE NOT
CHANGED N N 06SEP2020 N N
C4591001
1044
10441089 1 06SEP2020 Product storage
error DOSE NOT
CHANGED N N 06SEP2020 N N
C4591001
1068
10681002 1 18AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 18AUG2020 N N
C4591001
1068
10681003 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681006 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 6
FDA-CBER-2021-5683-1007519
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1068
10681010 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681011 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681012 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1068
10681013 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1068
10681016 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1068
10681017 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
4 08JAN2021 Product
administration
error DOSE NOT
CHANGED N N 08JAN2021 N N
C4591001
1068
10681018 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1068
10681021 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 7
FDA-CBER-2021-5683-1007520
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1068
10681024 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1068
10681025 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1068
10681026 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1068
10681027 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1068
10681028 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681031 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681034 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681035 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681036 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 8
FDA-CBER-2021-5683-1007521
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
4 08JAN2021 Product
administration
error DOSE NOT
CHANGED N N 08JAN2021 N N
C4591001
1068
10681037 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681038 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681042 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681046 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681047 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681052 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681053 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681058 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 9
FDA-CBER-2021-5683-1007522
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1068
10681060 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681061 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681064 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681066 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681071 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681072 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681073 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681074 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681076 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 10
FDA-CBER-2021-5683-1007523
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1068
10681077 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681080 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681081 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681083 1 01SEP2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1079
10791039 1 03AUG2020 Product
administration
error DOSE NOT
CHANGED N N 03AUG2020 N N
C4591001
1079
10791130 1 17AUG2020 Wrong product
administered DRUG
WITHDRAWN N N 17AUG2020 N N
C4591001
1079
10791170 3 25FEB2021 Product
administration
error DOSE NOT
CHANGED N N 25FEB2021 N N
C4591001
1079
10791206 1 28AUG2020 Product
administration
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1088
10881077 2 11SEP2020 Wrong product
administered DOSE NOT
CHANGED N N 11SEP2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 11
FDA-CBER-2021-5683-1007524
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1090
10901334 1 03SEP2020 Wrong product
administered DOSE NOT
CHANGED N N 03SEP2020 N N
C4591001
1091
10911005 1 30JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 30JUL2020 N N
C4591001
1091
10911008 1 31JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1091
10911014 1 31JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1091
10911015 1 31JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1096
10961011 3 26FEB2021 Product storage
error DOSE NOT
CHANGED N N 26FEB2021 N N
C4591001
1096
10961027 3 26FEB2021 Product storage
error DOSE NOT
CHANGED N N 26FEB2021 N N
C4591001
1096
10961059 4 26FEB2021 Product storage
error DOSE NOT
CHANGED N N 26FEB2021 N N
C4591001
1096
10961195 2 21SEP2020 Product
administration
error DOSE NOT
CHANGED N N 21SEP2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 12
FDA-CBER-2021-5683-1007525
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1096
10961197 2 21SEP2020 Product
administration
error DOSE NOT
CHANGED N N 21SEP2020 N N
C4591001
1096
10961209 4 26FEB2021 Product storage
error DOSE NOT
CHANGED N N 26FEB2021 N N
C4591001
1096
10961245 4 26FEB2021 Product storage
error DOSE NOT
CHANGED N N 26FEB2021 N N
C4591001
1096
10961246 4 26FEB2021 Product storage
error DOSE NOT
CHANGED N N 26FEB2021 N N
C4591001
1101
11011024 3 28DEC2020 Expired product
administered DOSE NOT
CHANGED N N 28DEC2020 N N
C4591001
1116
11161226 1 11SEP2020 Wrong product
administered DOSE NOT
CHANGED N N 11SEP2020 N N
C4591001
1126
11261053 1 20AUG2020 Expired product
administered DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1129
11291129 2 08SEP2020 Product
administration
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1136
11361027 4 25FEB2021 Incorrect dose
administered DOSE NOT
CHANGED N N 25FEB2021 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 13
FDA-CBER-2021-5683-1007526
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1136
11361039 4 24FEB2021 Incorrect dose
administered DOSE NOT
CHANGED N N 24FEB2021 N N
C4591001
1136
11361083 4 24FEB2021 Incorrect dose
administered DOSE NOT
CHANGED N N 24FEB2021 N N
C4591001
1136
11361084 4 25FEB2021 Incorrect dose
administered DOSE NOT
CHANGED N N 25FEB2021 N N
C4591001
1136
11361109 4 24FEB2021 Incorrect dose
administered DOSE NOT
CHANGED N N 24FEB2021 N N
C4591001
1141
11411011 2 21AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1141
11411014 1 03AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 03AUG2020 N N
C4591001
1141
11411023 2 25AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 25AUG2020 N N
C4591001
1141
11411065 1 12AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 12AUG2020 N N
C4591001
1141
11411068 1 12AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 12AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 14
FDA-CBER-2021-5683-1007527
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1141
11411080 1 14AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 14AUG2020 N N
C4591001
1141
11411093 1 18AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 18AUG2020 N N
C4591001
1141
11411139 1 27AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1146
11461196 1 03SEP2020 Product
administration
error DOSE NOT
CHANGED N N 03SEP2020 N N
C4591001
1146
11461338 2 13NOV2020 Product
administration
error DOSE NOT
CHANGED N N 13NOV2020 N N
C4591001
1161
11611010 1 31JUL2020 Product
administration
error DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1161
11611015 1 01AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 01AUG2020 N N
C4591001
1163
11631006 1 31JUL2020 Product
administration
error DRUG
WITHDRAWN N N 31JUL2020 N N
C4591001
1163
11631039 1 06AUG2020 Expired product
administered DOSE NOT
CHANGED N N 06AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 15
FDA-CBER-2021-5683-1007528
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1163
11631064 1 07AUG2020 Expired product
administered DOSE NOT
CHANGED N N 07AUG2020 N N
C4591001
1163
11631096 1 12AUG2020 Product
administration
error DOSE NOT
CHANGED N N 12AUG2020 N N
C4591001
1163
11631117 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1163
11631121 2 09SEP2020 Product storage
error DOSE NOT
CHANGED N N 09SEP2020 N N
C4591001
1163
11631124 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1163
11631127 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1163
11631136 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1163
11631142 2 09SEP2020 Product storage
error DOSE NOT
CHANGED N N 09SEP2020 N N
C4591001
1163
11631145 2 09SEP2020 Product storage
error DOSE NOT
CHANGED N N 09SEP2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 16
FDA-CBER-2021-5683-1007529
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1169
11691033 3 07JAN2021 Underdose DOSE NOT
CHANGED N N 07JAN2021 N N
C4591001
1169
11691049 2 05OCT2020 Product
administration
error DOSE NOT
CHANGED N N 05OCT2020 N N
C4591001
1185
11851017 2 16NOV2020 Product
administration
error DOSE NOT
CHANGED N N 16NOV2020 N N
C4591001
1185
11851037 2 16NOV2020 Product
administration
error DOSE NOT
CHANGED N N 16NOV2020 N N
C4591001
1212
12121005 3 25JAN2021 Product
preparation error DOSE NOT
CHANGED N N 25JAN2021 N N
C4591001
1212
12121008 3 25JAN2021 Product
preparation error DOSE NOT
CHANGED N N 25JAN2021 N N
C4591001
1212
12121013 3 25JAN2021 Product
preparation error DOSE NOT
CHANGED N N 25JAN2021 N N
C4591001
1212
12121022 3 25JAN2021 Product
preparation error DOSE NOT
CHANGED N N 25JAN2021 N N
C4591001
1212
12121031 3 25JAN2021 Product
preparation error DOSE NOT
CHANGED N N 25JAN2021 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 17
FDA-CBER-2021-5683-1007530
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1221
12211079 1 02DEC2020 Expired product
administered DOSE NOT
CHANGED N N 02DEC2020 N N
C4591001
1230
12301157 2 28OCT2020 Product
administration
error DOSE NOT
CHANGED N N 28OCT2020 N N
C4591001
1231
12313428 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313429 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313449 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313456 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313459 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313467 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313469 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 18
FDA-CBER-2021-5683-1007531
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1231
12313479 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313483 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313486 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313487 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313492 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313497 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313498 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313501 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313505 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 19
FDA-CBER-2021-5683-1007532
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1231
12313506 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313508 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313509 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313512 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313514 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313515 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313517 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313518 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313519 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 20
FDA-CBER-2021-5683-1007533
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1231
12313528 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313533 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313534 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313537 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313541 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313542 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313546 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313551 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313553 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 21
FDA-CBER-2021-5683-1007534
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1231
12313554 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313556 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313564 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313567 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1232
12321354 2 13NOV2020 Product storage
error DOSE NOT
CHANGED N N 13NOV2020 N N
C4591001
1232
12321373 2 13NOV2020 Product storage
error DOSE NOT
CHANGED N N 13NOV2020 N N
C4591001
1232
12321382 2 12NOV2020 Product storage
error DOSE NOT
CHANGED N N 12NOV2020 N N
C4591001
1232
12321385 2 13NOV2020 Product storage
error DOSE NOT
CHANGED N N 13NOV2020 N N
C4591001
1232
12321394 2 12NOV2020 Product storage
error DOSE NOT
CHANGED N N 12NOV2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 22
FDA-CBER-2021-5683-1007535
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1232
12321395 2 12NOV2020 Product storage
error DOSE NOT
CHANGED N N 12NOV2020 N N
C4591001
1269
12691004 1 17AUG2020 Product
administration
error DOSE NOT
CHANGED N N 17AUG2020 N N
C4591001
1269
12691011 1 20AUG2020 Product
administration
error DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1269
12691016 1 20AUG2020 Product
administration
error DOSE NOT
CHANGED N N 20AUG2020 N N
>55 C4591001
1003
10031120 1 31JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1011
10111201 1 19OCT2020 Product
administration
error DOSE NOT
CHANGED N N 19OCT2020 N N
C4591001
1024
10241003 2 01SEP2020 Product storage
error DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1024
10241031 1 17AUG2020 Product storage
error DOSE NOT
CHANGED N N 17AUG2020 N N
C4591001
1024
10241037 1 18AUG2020 Product storage
error DOSE NOT
CHANGED N N 18AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 23
FDA-CBER-2021-5683-1007536
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1024
10241041 1 18AUG2020 Product storage
error DOSE NOT
CHANGED N N 18AUG2020 N N
C4591001
1024
10241049 1 20AUG2020 Product storage
error DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1024
10241057 1 21AUG2020 Product storage
error DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1024
10241059 1 21AUG2020 Product storage
error DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1024
10241065 1 24AUG2020 Product storage
error DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1024
10241068 1 24AUG2020 Product storage
error DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1024
10241077 1 25AUG2020 Product storage
error DOSE NOT
CHANGED N N 25AUG2020 N N
C4591001
1024
10241081 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1024
10241083 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 24
FDA-CBER-2021-5683-1007537
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1024
10241087 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1024
10241096 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1024
10241097 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1037
10371356 2 12NOV2020 Expired product
administered DOSE NOT
CHANGED N N 12NOV2020 N N
C4591001
1044
10441002 2 02SEP2020 Product
temperature
excursion issue DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1044
10441004 2 02SEP2020 Product
temperature
excursion issue DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1044
10441007 2 05SEP2020 Product storage
error DOSE NOT
CHANGED N N 05SEP2020 N N
C4591001
1044
10441010 2 06SEP2020 Product storage
error DOSE NOT
CHANGED N N 06SEP2020 N N
C4591001
1044
10441016 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 25
FDA-CBER-2021-5683-1007538
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1044
10441018 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1044
10441032 1 25AUG2020 Product storage
error DOSE NOT
CHANGED N N 25AUG2020 N N
C4591001
1044
10441036 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1044
10441041 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1044
10441047 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1044
10441049 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1044
10441055 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1044
10441062 1 31AUG2020 Product storage
error DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1044
10441067 1 01SEP2020 Product storage
error DOSE NOT
CHANGED N N 01SEP2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 26
FDA-CBER-2021-5683-1007539
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1044
10441073 1 03SEP2020 Product storage
error DOSE NOT
CHANGED N N 03SEP2020 N N
C4591001
1044
10441075 1 03SEP2020 Product storage
error DOSE NOT
CHANGED N N 03SEP2020 N N
C4591001
1044
10441080 1 04SEP2020 Product storage
error DOSE NOT
CHANGED N N 04SEP2020 N N
C4591001
1044
10441083 1 04SEP2020 Product storage
error DOSE NOT
CHANGED N N 04SEP2020 N N
C4591001
1044
10441085 1 05SEP2020 Product storage
error DOSE NOT
CHANGED N N 05SEP2020 N N
C4591001
1044
10441090 1 06SEP2020 Product storage
error DOSE NOT
CHANGED N N 06SEP2020 N N
C4591001
1044
10441092 1 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1044
10441093 1 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1044
10441094 1 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 27
FDA-CBER-2021-5683-1007540
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1054
10541024 2 10OCT2020 Wrong product
administered DOSE NOT
CHANGED N N 10OCT2020 N N
C4591001
1068
10681001 1 18AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 18AUG2020 N N
C4591001
1068
10681004 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681005 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681007 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681008 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681009 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681014 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1068
10681015 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 28
FDA-CBER-2021-5683-1007541
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1068
10681019 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1068
10681020 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1068
10681022 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1068
10681023 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1068
10681029 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681030 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681032 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681033 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681039 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 29
FDA-CBER-2021-5683-1007542
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1068
10681040 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681041 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681043 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681044 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681045 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681050 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681051 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681054 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681055 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 30
FDA-CBER-2021-5683-1007543
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1068
10681056 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681057 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681059 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681062 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681063 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681065 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681068 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681069 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681075 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 31
FDA-CBER-2021-5683-1007544
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1068
10681078 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681079 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681082 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681084 1 01SEP2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1079
10791038 1 03AUG2020 Product
administration
error DOSE NOT
CHANGED N N 03AUG2020 N N
C4591001
1079
10791042 1 03AUG2020 Product
administration
error DOSE NOT
CHANGED N N 03AUG2020 N N
C4591001
1079
10791044 1 03AUG2020 Product
administration
error DOSE NOT
CHANGED N N 03AUG2020 N N
C4591001
1079
10791207 1 28AUG2020 Product
administration
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1081
10811053 2 09SEP2020 Wrong product
administered DOSE NOT
CHANGED N N 09SEP2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 32
FDA-CBER-2021-5683-1007545
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1091
10911001 1 30JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 30JUL2020 N N
C4591001
1091
10911004 1 30JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 30JUL2020 N N
C4591001
1091
10911010 1 31JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1091
10911012 1 31JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1096
10961068 4 26FEB2021 Product storage
error DRUG
WITHDRAWN N N 26FEB2021 N N
C4591001
1096
10961149 4 26FEB2021 Product storage
error DOSE NOT
CHANGED N N 26FEB2021 N N
C4591001
1096
10961247 4 26FEB2021 Product storage
error DOSE NOT
CHANGED N N 26FEB2021 N N
C4591001
1096
10961324 3 26FEB2021 Product storage
error DOSE NOT
CHANGED N N 26FEB2021 N N
C4591001
1121
11211071 1 03SEP2020 Wrong product
administered DOSE NOT
CHANGED N N 03SEP2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 33
FDA-CBER-2021-5683-1007546
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1129
11291091 2 01SEP2020 Wrong product
administered DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1136
11361057 4 25FEB2021 Incorrect dose
administered DOSE NOT
CHANGED N N 25FEB2021 N N
C4591001
1136
11361059 4 25FEB2021 Incorrect dose
administered DOSE NOT
CHANGED N N 25FEB2021 N N
C4591001
1136
11361079 4 24FEB2021 Incorrect dose
administered DOSE NOT
CHANGED N N 24FEB2021 N N
C4591001
1136
11361105 4 25FEB2021 Incorrect dose
administered DOSE NOT
CHANGED N N 25FEB2021 N N
C4591001
1141
11411066 1 12AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 12AUG2020 N N
C4591001
1163
11631003 1 31JUL2020 Product
administration
error DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1163
11631005 1 31JUL2020 Product
administration
error DRUG
WITHDRAWN N N 31JUL2020 N N
C4591001
1163
11631007 1 31JUL2020 Product
administration
error DOSE NOT
CHANGED N N 31JUL2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 34
FDA-CBER-2021-5683-1007547
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1163
11631008 1 31JUL2020 Product
administration
error DRUG
WITHDRAWN N N 31JUL2020 N N
C4591001
1163
11631010 1 03AUG2020 Product
administration
error DOSE NOT
CHANGED N N 03AUG2020 N N
C4591001
1163
11631011 1 03AUG2020 Product
administration
error DOSE NOT
CHANGED N N 03AUG2020 N N
C4591001
1163
11631013 1 03AUG2020 Product
administration
error DOSE NOT
CHANGED N N 03AUG2020 N N
C4591001
1163
11631030 1 05AUG2020 Drug therapy DRUG
WITHDRAWN N N 05AUG2020 N N
C4591001
1163
11631062 1 13AUG2020 Drug therapy DRUG
WITHDRAWN N N 13AUG2020 N N
C4591001
1163
11631092 1 13AUG2020 Drug therapy DOSE NOT
CHANGED N N 13AUG2020 N N
C4591001
1163
11631126 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1163
11631131 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 35
FDA-CBER-2021-5683-1007548
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1163
11631132 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1163
11631133 2 10SEP2020 Product storage
error DOSE NOT
CHANGED N N 10SEP2020 N N
C4591001
1163
11631144 2 09SEP2020 Product storage
error DOSE NOT
CHANGED N N 09SEP2020 N N
C4591001
1163
11631149 2 09SEP2020 Product storage
error DOSE NOT
CHANGED N N 09SEP2020 N N
C4591001
1177
11771089 2 09SEP2020 Wrong product
administered DOSE NOT
CHANGED N N 09SEP2020 N Y
C4591001
1212
12121021† 3 25JAN2021 Product
preparation error DOSE NOT
CHANGED N N 25JAN2021 N N
C4591001
1214
12141002 1 22OCT2020 Product
administration
error DOSE NOT
CHANGED N N 22OCT2020 N N
C4591001
1231
12311057 1 11AUG2020 Product
dispensing error DOSE NOT
CHANGED N N 11AUG2020 N N
C4591001
1231
12313446 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 36
FDA-CBER-2021-5683-1007549
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1231
12313461 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313468 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313478 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313480 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313496 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313503 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313511 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313524 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313530 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 37
FDA-CBER-2021-5683-1007550
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1231
12313536 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313538 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313549 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313562 1 23AUG2020 Wrong dose DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313855 4 24FEB2021 Product
administration
error DOSE NOT
CHANGED N N 24FEB2021 N N
C4591001
1231
12314669 4 24FEB2021 Product
administration
error DOSE NOT
CHANGED N N 24FEB2021 N N
C4591001
1232
12321383 2 12NOV2020 Product storage
error DOSE NOT
CHANGED N N 12NOV2020 N N
C4591001
1232
12321389† 2 12NOV2020 Product storage
error DOSE NOT
CHANGED N N 12NOV2020 N N
C4591001
1232
12321390 2 12NOV2020 Product storage
error DOSE NOT
CHANGED N N 12NOV2020 N N
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 38
FDA-CBER-2021-5683-1007551
16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Nondrug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication
Error–
Associated
AE
(Yes/No)
C4591001
1232
12321398 2 12NOV2020 Product storage
error DOSE NOT
CHANGED N N 12NOV2020 N N
C4591001
1265
12651026 1 31AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1269
12691009 1 19AUG2020 Product
administration
error DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1269
12691019 1 20AUG2020 Product
administration
error DOSE NOT
CHANGED N N 20AUG2020 N N
Note: † = Human immunodeficiency virus (HIV)-positive subject.
a. Dose No. = the vaccination vis it at which the medication error occurred.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (20:15) Source Data: adae Table Generation: 27MAR2021 (01:37)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 BLA/adae l002 meallp3
090177e196af71fe\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 39
FDA-CBER-2021-5683-1007552
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
16-55 C4591001 1001
10011004^ Immune system disorders Seasonal allergy 01JUN2010 Y
Investi gations Human papilloma virus test positive 01JUN2006 31DEC2006 N
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Squamous cell carcinoma of skin 01JUN2014 01JUN2014 N
Skin and subcutaneous tissue disorders Eczema 01JUN2010 Y
C4591001 1001
10011005^ Gastrointestinal disorders Haemorrhoids 01JAN2007 Y
Infections and infestations Tooth abscess 01MAR2016 31MAR2016 N
Investi gations Smear cervix abnormal 01JAN2018 31MAR2019 N
Psychiatric disorders Anxiet y 01JAN1998 Y
Depression 01JAN1998 Y
Insomnia 01JAN1986 Y
Skin and subcutaneous tissue disorders Dry skin 01JAN2018 Y
C4591001 1001
10011008^ Gastrointestinal disorders Aphthous ulcer 01JAN1998 Y
Diarrhoea 01JAN2003 Y
Immune s ystem disorders Seasonal aller gy 01MAR1999 Y
Psychiatric disorders Anxiet y 01JAN2012 Y
Attention deficit h yperactivit y disorde r 01JAN2004 Y
Depression 01JAN2012 Y
C4591001 1001
10011009^ Infections and infestations Upper respiratory tract infection 25APR2020 05MAY2020 N
C4591001 1001
10011011^ Psychiatric disorders Anxiety 01JAN2016 Y
C4591001 1001
10011012^ General disorders and administration
site conditionsSwelling face 01JAN2005 31DEC2005 N
Surgical and medical procedures Cyst removal 01JAN2005 31DEC2005 N
C4591001 1001
10011013^ Immune system disorders Allergy to animal 05MAY2018 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 40
FDA-CBER-2021-5683-1007553
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
18JUN2019 Y
Seasonal aller gy 01JAN2019 Y
Skin and subcutaneous tissue disorders Acne 01JAN2013 Y
Eczema 01JAN2017 Y
C4591001 1001
10011015^ Gastrointestinal disorders Dyspepsia 01JAN2011 Y
C4591001 1001
10011017^ Infections and infestations Appendicitis 01JAN2002 31DEC2002 N
Onychom ycosis 01JAN2008 Y
Injury, poisoning and procedural
complicationsJoint injury 01AUG2013 31DEC2018 N
Investi gations Biops y colon 19SEP2018 19SEP2018 N
Colonoscop y 01APR2009 31DEC2009 N
Musculoskeletal and connective tissue
disordersBack pain 19NOV2012 Y
Nervous s ystem disorders Piriformis s yndrome 01DEC2012 31JAN2013 N
Renal and urinar y disorders Nephrolithiasis 01NOV2012 31DEC2012 N
Skin and subcutaneous tissue disorders Rosacea 01JAN2010 Y
Transient acanthol ytic dermatosis 01JAN2019 28FEB2019 N
Surgical and medical procedures Appendicectom y 01JAN2002 31DEC2002 N
Varicose vein operation 01JUL2005 29FEB2008 N
C4591001 1001
10011019^ Skin and subcutaneous tissue disorders Dry skin 01NOV2019 Y
C4591001 1001
10011024^ Psychiatric disorders Anxiety 01JAN2018 31DEC2020 N
C4591001 1001
10011026^ Gastrointestinal disorders Irritable bowel syndrome 30JUN2008 Y
Immune s ystem disorders Seasonal aller gy 30JUN2010 Y
Injury, poisoning and procedural
complicationsAnkle fracture 01FEB2003 28FEB2003 N
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 41
FDA-CBER-2021-5683-1007554
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Road traffic acciden t 01FEB2003 28FEB2003 N
Skin and subcutaneous tissue disorders Urticaria Y
Surgical and medical procedures Tendon operation 30JUN2003 30JUN2003 N
Wound closure 30JUN1996 30JUN1996 N
C4591001 1001
10011028^ Investigations Arthroscopy 01JAN2009 31DEC2009 N
Endoscop y upper gastrointestinal trac t 01FEB2019 28FEB2019 N
Vitamin D decrease d 01JAN2010 Y
Musculoskeletal and connective tissue
disordersOsteoarthritis 01JAN2015 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Benign neoplasm of thyroid gland 01JAN2013 Y
Psychiatric disorders Anxiet y 01JAN2010 Y
Skin and subcutaneous tissue disorders Dermatitis aller gic 01JUN2010 Y
Surgical and medical procedures Caesarean section 30JUN1997 30JUN1997 N
Female sterilisation 01JAN2000 31JAN2000 N
Knee arthroplast y 08JAN2020 08JAN2020 N
Large intestinal pol ypectom y 01FEB2019 28FEB2019 N
C4591001 1001
10011030^ Injury, poisoning and procedural
complicationsLigament rupture 01APR1996 15JUN1996 N
Skin and subcutaneous tissue disorders Acne 30JUN2000 Y
Surgical and medical procedures Ligament operation 15JUN1996 15JUN1996 N
C4591001 1001
10011032^ Immune system disorders Drug hypersensitivity 01JUN2018 Y
Vascular disorders Hypertension 01JAN2012 31DEC2013 N
C4591001 1001
10011034^ Nervous system disorders Sciatica 01OCT2015 Y
Surgical and medical procedures Intervertebral disc operation 18NOV2016 18NOV2016 N
26FEB2016 26FEB2016 N
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 42
FDA-CBER-2021-5683-1007555
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1001
10011066^ Blood and lymphatic system disorders Iron deficiency anaemia 01OCT2019 Y
Gastrointestinal disorders Diarrhoea 01JAN2019 Y
Haemorrhoids 01AUG2019 31MAR2020 N
01JAN2020 31JAN2020 N
Musculoskeletal and connective tissue
disordersScoliosis 01AUG2008 Y
Surgical and medical procedures Spinal fusion sur gery 01JUN2009 30JUN2009 N
C4591001 1001
10011067^ Ear and labyrinth disorders Excessive cerumen production 30JUN2010 Y
Immune s ystem disorders Seasonal aller gy 01JAN2010 Y
Infections and infestations Papilloma viral infection 01JAN2017 31DEC2018 N
Investi gations Smear cervix abnormal 01JAN2016 31DEC2017 N
Skin and subcutaneous tissue disorders Eczema 01JAN1981 Y
Surgical and medical procedures Hernia repai r 01JAN1981 31DEC1981 N
C4591001 1001
10011068^ Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2015 Y
Immune s ystem disorders Seasonal aller gy 01JAN1973 Y
Infections and infestations Sinusitis 01JAN2016 31DEC2016 N
Renal and urinar y disorders Nephrolithiasis 01JAN2001 Y
Surgical and medical procedures Lithotrips y 01JAN2001 Y
Tonsillectom y N
C4591001 1001
10011069^ Immune system disorders Allergy to animal 01JAN1994 Y
Infections and infestations Chlam ydial infection 01JAN2005 31DEC2005 N
Injury, poisoning and procedural
complicationsUpper limb fracture 01JAN1995 31DEC1995 N
Investi gations Smear cervix abnormal 16JAN2014 31DEC2014 N
Reproductive system and breast
disordersUterine haemorrhage 01JAN2016 31DEC2016 N
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 43
FDA-CBER-2021-5683-1007556
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Surgical and medical procedures Varicose vein operation 01JAN2018 31DEC2018 N
Vascular disorders Varicose vein 01JAN2016 31DEC2016 N
C4591001 1001
10011070^ Injury, poisoning and procedural
complicationsCartilage injury 01JAN2016 31DEC2016 N
Meniscus in jury 01JAN2017 31DEC2017 N
Skeletal in jury 01JAN2016 31DEC2016 N
Psychiatric disorders Anxiet y 01JAN2015 Y
Attention deficit h yperactivit y disorde r 01JAN2010 Y
Insomnia 01JAN2015 Y
Respiratory, thoraci c and mediastinal
disordersNasal septum deviation 01JAN1990 31DEC2007 N
Skin and subcutaneous tissue disorders Andro genetic alopecia 01JAN2010 Y
Surgical and medical procedures Appendicectom y 01JAN2008 31DEC2008 N
Nasal septal operation 01JAN2007 31DEC2007 N
Shoulder operation 01JAN2016 31DEC2016 N
Vascular disorders Deep vein thrombosis 14JUN2019 17JUN2019 N
C4591001 1001
10011071^ Eye disorders Astigmatism 01JAN2015 31DEC2019 N
Infections and infestations Pilonidal c yst 01JAN2015 31DEC2015 N
Neoplasms benign, malignant and
unspecified (incl c ysts and polyps)Hair follicle tumour benign 01JAN2002 31DEC2015 N
Psychiatric disorders Anxiet y 01JAN1993 Y
Surgical and medical procedures Keratomileusis 01JAN2019 31DEC2019 N
C4591001 1001
10011076^ Respiratory, thoraci c and mediastinal
disordersUpper respiratory tract congestion 01JAN1999 31DEC1999 N
Surgical and medical procedures Fracture treatmen t 01JAN2002 31DEC2002 N
C4591001 1001
10011083 Immune system disorders Seasonal allergy 01JAN2010 Y
Infections and infestations Oral herpes 01JAN2011 Y
Psychiatric disorders Anxiet y 01JAN1990 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 44
FDA-CBER-2021-5683-1007557
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1001
10011085 Immune system disorders Seasonal allergy 01JAN2002 Y
Injury, poisoning and procedural
complicationsUpper limb fracture 01JAN2002 31DEC2002 N
Metabolism and nutrition disorders Vitamin D deficienc y 01JAN2019 Y
Reproductive system and breast
disordersAmenorrhoea 01FEB2019 Y
Skin and subcutaneous tissue disorders Eczema 01JAN2018 Y
C4591001 1001
10011086 Gastrointestinal disorders Large intestine polyp 01JAN2018 31DEC2018 N
Musculoskeletal and connective tissue
disordersRotator cuff syndrome 01JAN2011 31DEC2011 N
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Testis cancer 01SEP1992 31DEC1992 N
Skin and subcutaneous tissue disorders Eczema 01JAN2010 Y
C4591001 1001
10011087 Gastrointestinal disorders Reflux gastritis 01JAN2020 Y
General disorders and administration
site conditionsChronic fatigue syndrome 01JAN2016 Y
Immune s ystem disorders Seasonal aller gy 01JAN2015 Y
Metabolism and nutrition disorders Hyperlipidaemia 01JAN2014 Y
Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN1993 Y
Skin and subcutaneous tissue disorders Alopecia 01JAN2000 Y
C4591001 1001
10011088 Gastrointestinal disorders Irritable bowel syndrome 01JAN2006 31DEC2018 N
Vascular disorders White coat h ypertension 01JAN2015 Y
C4591001 1001
10011089 Infections and infestations Fungal skin infection 01JAN2013 Y
Investi gations Cardiac murmu r 01JAN2015 Y
Nervous s ystem disorders Syncope 01JAN1988 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1001
10011091 Immune system disorders Seasonal allergy 01JAN2005 Y
Infections and infestations Tinea pedis 01JAN1988 Y
Musculoskeletal and connective tissue
disordersBack pain 01JAN2016 Y
Intervertebral disc de generation 26MAY2016 Y
Spond ylolisthesis 29JUL2016 Y
Reproductive system and breast
disordersErectile dysfunction 01JAN2015 Y
Vascular disorders Hypertension 01JAN2006 Y
C4591001 1001
10011092 Infections and infestations Gastroenteritis 01JAN1989 31DEC1989 N
Skin and subcutaneous tissue disorders Alopecia 01JAN2010 Y
C4591001 1001
10011102 Psychiatric disorders Anxiety 01JAN2018 Y
Depression 01JAN2012 Y
C4591001 1001
10011105 Endocrine disorders Autoimmune thyroiditis 01JAN2018 Y
Investi gations Blood bilirubin increase d 01JAN2018 Y
Musculoskeletal and connective tissue
disordersArthralgia 01APR2020 Y
C4591001 1001
10011106 Immune system disorders Seasonal allergy 01JAN1990 Y
Injury, poisoning and procedural
complicationsBack injury 01JAN1994 31DEC2015 N
Musculoskeletal and connective tissue
disordersArthritis 01JAN1990 Y
Nervous s ystem disorders Epileps y 01JAN1980 31DEC1991 N
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN1990 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1001
10011107 Infections and infestations Chronic sinusitis 01JAN2015 31JAN2020 N
C4591001 1001
10011113 Nervous system disorders Migraine with aura 01JAN2013 Y
Psychiatric disorders Insomnia 01MAR2020 Y
C4591001 1001
10011126 General disorders and administration
site conditionsOedema peripheral 01APR2020 30APR2020 N
Skin and subcutaneous tissue disorders Actinic keratosis 01APR2020 Y
Vascular disorders Collateral circulation 01JAN2015 Y
May-Thurner s yndrome 01JAN2015 Y
C4591001 1001
10011129 General disorders and administration
site conditionsChest pain 01JAN2012 31DEC2012 N
Infections and infestations Localised infection 04SEP2015 11SEP2015 N
Metabolism and nutrition disorders Dyslipidaemia 01JUN2012 Y
C4591001 1001
10011130 Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Lipoma 01JAN2016 Y
C4591001 1001
10011131 Psychiatric disorders Anxiety 01JAN2019 Y
C4591001 1001
10011132 Immune system disorders Allergy to animal 01JUL2020 Y
Seasonal aller gy 01JAN1990 Y
Vascular disorders Hypertension 01JAN2015 Y
C4591001 1001
10011136 Endocrine disorders Hypothyroidism 01JAN2016 Y
General disorders and administration
site conditionsHernia 01JAN2013 31DEC2013 N
Immune s ystem disorders Seasonal aller gy 01JAN2015 Y
Surgical and medical procedures Incisional hernia repai r 01JAN2013 31DEC2013 N
C4591001 1001
10011138 Immune system disorders Seasonal allergy 01JAN2000 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Musculoskeletal and connective tissue
disordersArthralgia 01JUL2020 Y
Skin and subcutaneous tissue disorders Hand dermatitis 01JAN2005 Y
C4591001 1001
10011143 Eye disorders Glaucoma 01JAN2014 Y
C4591001 1001
10011145 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2016 Y
Psychiatric disorders Aerophobia 01JAN2017 Y
Panic disorde r 01JAN2017 Y
C4591001 1001
10011146 Immune system disorders Seasonal allergy 01JAN1987 Y
C4591001 1001
10011149 Skin and subcutaneous tissue disorders Acne 01JAN2015 Y
C4591001 1002
10021003^ Eye disorders Myopia 01JAN2003 Y
Immune s ystem disorders Food aller gy 01JAN2003 Y
01JAN2007 Y
Seasonal aller gy 01JAN2007 Y
Nervous s ystem disorders Headache 01JAN2006 Y
C4591001 1002
10021004^ Eye disorders Myopia 01JAN1998 Y
Injury, poisoning and procedural
complicationsUpper limb fracture 01JAN1995 31DEC1995 N
Reproductive system and breast
disordersDysmenorrhoea 01DEC2003 Y
C4591001 1002
10021005^ Cardiac disorders Bradycardia 01APR2000 Y
Immune s ystem disorders Seasonal aller gy 01JAN1976 Y
Surgical and medical procedures Cardiac pacemaker insertion 09MAY2000 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1002
10021006^ Congenital, familial and genetic
disordersCongenital hypothyroidism 01JAN1997 Y
Eye disorders Hypermetropia 01JAN1996 Y
Myopia 01JAN1996 Y
Immune s ystem disorders Seasonal aller gy 01JAN2019 Y
Infections and infestations Hepatitis A 01JAN1997 30JUL1997 N
C4591001 1002
10021007^ Immune system disorders Seasonal allergy 01JUN2012 Y
Infections and infestations Herpes simplex 01SEP2012 Y
Injury, poisoning and procedural
complicationsCartilage injury 01AUG2010 30SEP2010 N
Skin and subcutaneous tissue disorders Acne 01APR2019 Y
Surgical and medical procedures Chondroplast y 01SEP2010 30SEP2010 N
C4591001 1002
10021009^ Eye disorders Dacryostenosis acquired 01JAN1996 31DEC1996 N
Myopia 01SEP2008 Y
Immune s ystem disorders Aller gy to animal 01JAN2001 Y
Seasonal aller gy 01JAN1999 Y
Infections and infestations Urinar y tract infection 01DEC2019 31DEC2019 N
Surgical and medical procedures Lacrimal duct procedure 01JAN1996 31DEC1996 N
C4591001 1002
10021011^ Eye disorders Myopia 01MAR2010 Y
Immune s ystem disorders Food aller gy 01JAN2017 Y
Seasonal aller gy 01MAR2019 Y
C4591001 1002
10021012^ Immune system disorders Allergy to animal 01JAN1999 Y
Drug hypersensitivit y 01JAN1995 Y
01JAN2010 Y
Seasonal aller gy 01JAN2010 Y
Nervous s ystem disorders Tension headache 01JAN2015 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Psychiatric disorders Anxiet y 01JAN2017 Y
Skin and subcutaneous tissue disorders Perioral dermatitis 01JAN2015 Y
C4591001 1002
10021013^ Eye disorders Myopia 01JAN2005 Y
Immune s ystem disorders Food aller gy 01JAN2010 Y
Seasonal aller gy 01APR2013 Y
Psychiatric disorders Anxiet y 08JAN2020 Y
C4591001 1002
10021014^ Eye disorders Myopia 01JAN1996 Y
Immune s ystem disorders Seasonal aller gy 01JAN2006 Y
Injury, poisoning and procedural
complicationsFacial bones fracture 05DEC2009 05DEC2009 N
Psychiatric disorders Anxiet y 01JAN1996 Y
Depression 01JAN1996 Y
C4591001 1002
10021015^ Eye disorders Myopia 01JAN1988 Y
Social circumstances Menopause 01JAN2016 Y
C4591001 1002
10021017^ Reproductive system and breast
disordersPolycystic ovaries 01JUN2000 Y
Skin and subcutaneous tissue disorders Acne 01JAN1993 Y
C4591001 1002
10021018^ Eye disorders Myopia 01JAN1975 Y
Hepatobiliar y disorders Hepatic c yst 01JAN2005 Y
Immune s ystem disorders Drug hypersensitivit y 01MAR2020 Y
Hypersensitivit y 01JAN1997 Y
Perfume sensitivit y 01MAR2020 Y
Reaction to colourin g 01MAR2020 Y
Rubber sensitivit y 01JAN2000 Y
Seasonal aller gy 01JAN1997 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Injury, poisoning and procedural
complicationsConcussion 01JAN2017 31DEC2017 N
Muscle strain 20APR2020 Y
Musculoskeletal and connective tissue
disordersArthralgia 01JAN1999 Y
Reproductive system and breast
disordersDysmenorrhoea 01JAN1982 Y
C4591001 1002
10021020^ Immune system disorders Drug hypersensitivity 01JAN1995 Y
C4591001 1002
10021021^ Eye disorders Myopia 01JAN1991 Y
Immune s ystem disorders Aller gy to animal 01JAN2014 Y
Cockroach aller gy 01JAN2014 Y
C4591001 1002
10021022^ Investigations Blood cholesterol increased 01JAN2005 Y
Nervous s ystem disorders Tension headache 01JAN2000 Y
Skin and subcutaneous tissue disorders Eczema 01JAN1996 Y
C4591001 1002
10021023^ Immune system disorders Allergy to animal 01JAN2010 Y
Drug hypersensitivit y 01JAN2017 Y
Dust aller gy 01JAN2010 Y
Mycotic aller gy 01JAN2010 Y
Seasonal aller gy 01JAN2010 Y
Psychiatric disorders Anxiet y 01JAN2014 Y
Respiratory, thoraci c and mediastinal
disordersAsthma exercise induced 01JAN2010 30NOV2016 N
Surgical and medical procedures Appendicectom y 10NOV2009 11NOV2009 N
C4591001 1002
10021024^ Eye disorders Myopia 01SEP1984 Y
Immune s ystem disorders Seasonal aller gy 01SEP1983 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Respiratory, thoraci c and mediastinal
disordersAsthma 01SEP1983 31MAY1993 N
C4591001 1002
10021027^ Eye disorders Myopia 01JAN2005 Y
C4591001 1002
10021034^ Immune system disorders Seasonal allergy 01JAN2003 Y
C4591001 1002
10021035^ Immune system disorders Seasonal allergy 01JAN1980 Y
Metabolism and nutrition disorders Hypercholesterolaemia 01JAN2015 Y
Surgical and medical procedures Vasectom y 01JAN2015 31DEC2015 N
C4591001 1002
10021036^ Endocrine disorders Hypothyroidism 01DEC2006 Y
Immune s ystem disorders Rubber sensitivit y 01JAN2000 Y
Psychiatric disorders Depression 01DEC2006 Y
C4591001 1002
10021038^ Eye disorders Hypermetropia 01JAN2013 Y
Immune s ystem disorders Seasonal aller gy 01APR2010 Y
Surgical and medical procedures Caesarean section 15APR2003 15APR2003 N
23APR2007 23APR2007 N
C4591001 1002
10021041^ Immune system disorders Seasonal allergy 01JAN2008 Y
Infections and infestations Osteom yelitis 01APR2013 31MAY2013 N
Surgical and medical procedures Sinuplast y 01OCT2019 31OCT2019 N
C4591001 1002
10021079^ Immune system disorders Drug hypersensitivity 01JAN2000 Y
Food aller gy 01JAN1999 Y
Milk aller gy 01JAN1999 Y
Seasonal aller gy 01JAN1994 Y
Infections and infestations Genital herpes 01JAN2008 Y
Psychiatric disorders Depression 01JAN1992 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1002
10021080^ Cardiac disorders Bundle branch block left 01JAN2000 Y
Immune s ystem disorders Food aller gy 01JAN1987 Y
Milk aller gy 01JAN1987 Y
Seasonal aller gy 01JAN1987 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Basal cell carcinoma 01MAY2012 30JUN2012 N
Reproductive system and breast
disordersOligospermia 01JAN2010 Y
C4591001 1002
10021081^ Injury, poisoning and procedural
complicationsMuscle strain 01JUL2020 18JUL2020 N
Psychiatric disorders Anxiet y 01JAN2008 Y
Skin and subcutaneous tissue disorders Rash 01OCT2019 Y
C4591001 1002
10021082^ Immune system disorders Rubber sensitivity 01JAN1988 Y
Seasonal aller gy 01JAN2010 Y
Injury, poisoning and procedural
complicationsCartilage injury 01JAN1978 Y
Metabolism and nutrition disorders Hypercholesterolaemia 01JAN2005 Y
Vitamin D deficienc y 01JAN2010 Y
Nervous s ystem disorders Migraine 01JAN1985 Y
Skin and subcutaneous tissue disorders Keratosis pilaris 01JAN1972 Y
Surgical and medical procedures Female sterilisation 01OCT1990 31OCT1990 N
C4591001 1002
10021083^ Psychiatric disorders Depression 01JAN2014 Y
Skin and subcutaneous tissue disorders Dermal c yst 01JAN2011 31DEC2015 N
Surgical and medical procedures Shoulder operation 01JAN2015 31DEC2015 N
C4591001 1002
10021084^ Eye disorders Myopia 01JAN1985 Y
Gastrointestinal disorders Dyspepsia 01JAN2015 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Immune s ystem disorders Seasonal aller gy 01JAN2000 Y
Musculoskeletal and connective tissue
disordersMyalgia 01JAN1985 Y
Nervous s ystem disorders Headache 01JAN1985 Y
Surgical and medical procedures Varicose vein operation 01NOV2019 30NOV2019 N
Vascular disorders Varicose vein 01JAN2016 30NOV2019 N
C4591001 1002
10021087^ Endocrine disorders Hypothyroidism 01JAN2010 Y
Immune s ystem disorders Seasonal aller gy 01JAN2010 Y
Surgical and medical procedures Vasectom y 06JUN2006 06JUN2006 N
C4591001 1003
10031016^ Infections and infestations Appendicitis 01JAN2012 31DEC2012 N
Psychiatric disorders Anxiet y 01JAN2017 Y
Skin and subcutaneous tissue disorders Acne 01JAN2017 Y
Surgical and medical procedures Appendicectom y 01JAN2012 31DEC2012 N
C4591001 1003
10031017^ Immune system disorders Seasonal allergy 01JAN1981 Y
C4591001 1003
10031018^ Social circumstances Postmenopause 01JAN2018 Y
C4591001 1003
10031019^ Immune system disorders Food allergy 01JAN2005 Y
C4591001 1003
10031020^ Musculoskeletal and connective tissue
disordersArthritis 01JAN1995 Y
Nervous s ystem disorders Sinus headache 01JAN1994 Y
Psychiatric disorders Anxiet y 01JAN2018 Y
C4591001 1003
10031021^ Immune system disorders Allergy to animal 01JAN2013 Y
C4591001 1003
10031022^ Surgical and medical procedures Turbinectomy 01JAN2015 31DEC2015 N
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1003
10031024^ Immune system disorders Seasonal allergy 01JAN1990 Y
Injury, poisoning and procedural
complicationsLigament rupture 01JAN2015 31DEC2016 N
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Malignant melanoma in situ 01JAN2015 31DEC2015 N
Surgical and medical procedures Ligament operation 01JAN2016 31DEC2016 N
C4591001 1003
10031026^ Immune system disorders Seasonal allergy 01JAN2010 Y
C4591001 1003
10031027^ Injury, poisoning and procedural
complicationsArthropod bite 25MAY2020 25MAY2020 N
Skin and subcutaneous tissue disorders Dermatitis contact 01JAN1982 Y
Social circumstances Corrective lens use r 01JAN1981 Y
C4591001 1003
10031028^ Immune system disorders Seasonal allergy 01JAN2020 Y
Musculoskeletal and connective tissue
disordersScoliosis 01MAY2020 Y
Skin and subcutaneous tissue disorders Miliaria 01JAN2010 Y
Social circumstances Corrective lens use r 01JAN2020 Y
C4591001 1003
10031029^ Immune system disorders Seasonal allergy 01JAN2016 Y
Psychiatric disorders Anxiet y 01OCT2018 Y
Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
C4591001 1003
10031030^ Musculoskeletal and connective tissue
disordersScoliosis 01JAN2009 Y
Skin and subcutaneous tissue disorders Hand dermatitis 01JAN2012 Y
Social circumstances Corrective lens use r 01JAN2009 Y
C4591001 1003
10031032^ Immune system disorders Drug hypersensitivity 01JAN1987 Y
Seasonal aller gy 01JAN2017 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1003
10031034^ Blood and lymphatic system disorders Anaemia 01JAN2019 Y
Gastrointestinal disorders Irritable bowel s yndrome 01JAN2000 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN2000 Y
Infections and infestations Herpes simplex 01JAN2014 Y
Social circumstances Corrective lens use r 01JAN2016 Y
C4591001 1003
10031038^ General disorders and administration
site conditionsHernia 01JAN2017 31DEC2017 N
Immune s ystem disorders Drug hypersensitivit y 01JAN1972 Y
Investi gations Blood cholesterol increase d 01JAN2014 Y
Musculoskeletal and connective tissue
disordersBack pain 01JAN2018 Y
Groin pain 01JAN2018 Y
Surgical and medical procedures Hernia repai r 01JAN2017 31DEC2017 N
C4591001 1003
10031050^ Gastrointestinal disorders Irritable bowel syndrome 01JAN1996 Y
Immune s ystem disorders Seasonal aller gy 01JAN1998 Y
C4591001 1003
10031057^ Immune system disorders Seasonal allergy 01JAN2019 Y
Infections and infestations Helicobacter infection 06JUN2020 Y
C4591001 1003
10031059^ Immune system disorders Drug hypersensitivity 24JUN1975 Y
C4591001 1003
10031061^ Musculoskeletal and connective tissue
disordersBursitis 01JAN2008 Y
Psychiatric disorders Seasonal affective disorde r 01JAN2015 Y
C4591001 1003
10031065^ Social circumstances Corrective lens user 01JAN1982 Y
Surgical and medical procedures Nasal septal operation 01JAN2010 31DEC2010 N
C4591001 1003
10031066^ Endocrine disorders Hypothyroidism 01JAN2010 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Immune s ystem disorders Aller gy to animal 01JAN1976 Y
Seasonal aller gy 01JAN1976 Y
Injury, poisoning and procedural
complicationsUpper limb fracture 01JAN2015 31DEC2016 N
Musculoskeletal and connective tissue
disordersIntervertebral disc protrusion 01JAN2020 31DEC2020 N
Nervous s ystem disorders Migraine 01JAN2010 Y
Skin and subcutaneous tissue disorders Dermatitis contact 01JAN2015 Y
Surgical and medical procedures Uterine operation 01JAN2013 31DEC2013 N
C4591001 1003
10031070^ Immune system disorders Seasonal allergy 01JAN2000 Y
Social circumstances Corrective lens use r 01JAN2012 Y
C4591001 1003
10031072^ Nervous system disorders Nystagmus 01JAN1981 Y
Surgical and medical procedures Mastectom y 01JAN2016 31DEC2016 N
C4591001 1003
10031088 Eye disorders Myopia 01JAN2003 Y
Immune s ystem disorders Aller gy to animal 01JAN2005 Y
Drug hypersensitivit y 01JAN1994 Y
Seasonal aller gy 01JAN1999 Y
Psychiatric disorders Anxiet y 01JAN2014 Y
Depression 01JAN2014 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN1999 Y
Social circumstances Corrective lens use r 01JAN2003 Y
Surgical and medical procedures Intra-uterine contraceptive device insertion 01MAY2019 Y
C4591001 1003
10031090 Cardiac disorders Palpitations 01JAN2013 Y
Gastrointestinal disorders Gastrooesopha geal reflux disease 01JAN2000 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN1980 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Investi gations Blood cholesterol increase d 01JAN2000 Y
Psychiatric disorders Anxiet y 01JAN2016 Y
Surgical and medical procedures Hysterectom y 01FEB2020 29FEB2020 N
Vascular disorders Hypertension 01JAN2000 Y
C4591001 1003
10031094 Immune system disorders Seasonal allergy 01JAN2000 Y
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 01JAN2014 Y
Social circumstances Corrective lens use r 01JAN1989 Y
Surgical and medical procedures Adenoidectom y 01JAN1983 31DEC1983 N
Ear tube removal 01JAN1983 31DEC1983 N
Sinus operation 01MAR2017 31MAR2017 N
C4591001 1003
10031096 Eye disorders Myopia 01JAN2007 Y
Immune s ystem disorders Aller gy to animal 01JAN2010 Y
Infections and infestations Tuberculosis 01JAN2006 31DEC2006 N
Social circumstances Corrective lens use r 01JAN2007 Y
C4591001 1003
10031100 Cardiac disorders Arrhythmia 01JAN2008 Y
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 01JAN2015 Y
Vascular disorders Hypertension 01JAN2008 Y
C4591001 1003
10031101 Congenital, familial and genetic
disordersCorneal dystrophy 01JAN2015 Y
Eye disorders Astigmatis m 01JAN2015 Y
Immune s ystem disorders Aller gy to animal 01JAN2019 Y
Dust aller gy 01JAN2019 Y
Mycotic aller gy 01JAN2019 Y
Seasonal aller gy 01JAN2019 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Musculoskeletal and connective tissue
disordersIntervertebral disc protrusion 01JAN2007 31DEC2007 N
Social circumstances Corrective lens use r 01JAN2015 Y
Surgical and medical procedures Ear tube removal 01JAN1986 31DEC1986 N
Tonsillectom y 01JAN2009 31DEC2009 N
C4591001 1003
10031104 Immune system disorders Seasonal allergy 01JAN2010 Y
Investi gations Blood testosterone decrease d 01JAN2015 Y
Surgical and medical procedures Vasectom y 01JAN2013 31DEC2013 N
C4591001 1003
10031111 Immune system disorders Seasonal allergy 01JAN2010 Y
Nervous s ystem disorders Migraine 01JAN2005 31DEC2007 N
C4591001 1003
10031115 Eye disorders Hypermetropia 01JAN2000 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN2015 Y
Metabolism and nutrition disorders Lactose intolerance 01JAN2013 Y
Skin and subcutaneous tissue disorders Acne 01JAN2005 Y
Social circumstances Corrective lens use r 01JAN2000 Y
Surgical and medical procedures External fixatio n of fracture 01DEC2019 31DEC2019 N
Fracture treatmen t 01DEC2016 31DEC2019 N
C4591001 1003
10031116 Endocrine disorders Hypothyroidism 01JAN2015 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN2001 Y
Musculoskeletal and connective tissue
disordersOsteoarthritis 01JAN2019 31MAY2019 N
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Cervix carcinoma 01JAN2008 31DEC2009 N
Nervous s ystem disorders Migraine 01JAN1988 Y
Surgical and medical procedures Hip sur gery 01MAY2019 31MAY2019 N
Hysterectom y 01JAN2009 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1003
10031122 Immune system disorders Seasonal allergy 01JAN1977 Y
Metabolism and nutrition disorders Type 2 diabetes mellitus 01JAN2019 Y
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 01JAN2018 Y
Social circumstances Corrective lens use r 01JAN1982 Y
01JAN2017 Y
C4591001 1003
10031125 Immune system disorders Seasonal allergy 01JAN2018 Y
Psychiatric disorders Depression 01JAN2013 Y
C4591001 1003
10031137 Cardiac disorders Sinus tachycardia 01JAN2020 Y
Congenital, familial and genetic
disordersFactor V Leiden mutation 1978 Y
Psychiatric disorders Insomnia 01JAN2020 Y
Respiratory, thoraci c and mediastinal
disordersBronchial hyperreactivity 01JAN2015 Y
C4591001 1003
10031138 Gastrointestinal disorders Colitis ulcerative 01JAN2012 31DEC2012 N
Metabolism and nutrition disorders Hypercholesterolaemia 01JAN2018 Y
Surgical and medical procedures Cholec ystectom y 01JAN2017 31DEC2017 N
Colectom y 01JAN2012 31DEC2012 N
Hysterectom y 01JAN2016 31DEC2016 N
Vascular disorders Hypertension 01JAN2005 Y
C4591001 1003
10031141 Eye disorders Myopia 01JAN2010 Y
C4591001 1003
10031144 Nervous system disorders Migraine 01JAN2005 31DEC2005 N
C4591001 1003
10031146 Vascular disorders Hypertension 01JAN2010 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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(b) (6)
FDA-CBER-2021-5683-1007573
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1003
10031147 Endocrine disorders Hypothyroidism 01JAN2013 Y
Investi gations Haemo globin decrease d 01JAN2013 Y
Psychiatric disorders Anxiet y 01JAN1997 Y
Social circumstances Tobacco use r 01JAN2000 Y
Surgical and medical procedures Cholec ystectom y 01JAN2015 31DEC2015 N
Gastrectom y 01JAN2018 31DEC2018 N
Vascular disorders Hypertension 01JAN2014 Y
C4591001 1003
10031151 Metabolism and nutrition disorders Lactose intolerance 01JAN2005 Y
Vascular disorders Hypertension 01JAN2015 Y
C4591001 1003
10031155 Eye disorders Hypermetropia 01JAN1997 Y
Investi gations Blood cholesterol increase d 01NOV2019 Y
Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN1998 Y
Social circumstances Corrective lens use r 01JAN1997 Y
Tobacco use r 01JAN2009 Y
Surgical and medical procedures Decompressive craniectom y 01JAN2003 31DEC2003 N
Ligament operation 01JAN2007 31DEC2007 N
01JAN2010 31DEC2010 N
C4591001 1003
10031156 Endocrine disorders Hypothyroidism 01JAN2005 Y
Nervous s ystem disorders Migraine 01JAN1991 Y
Psychiatric disorders Anxiet y 01JAN2005 Y
Social circumstances Menopause 01JAN2020 Y
C4591001 1003
10031158 Musculoskeletal and connective tissue
disordersArthritis 01JAN1989 Y
Spond ylitis 01JAN2006 Y
Social circumstances Corrective lens use r 01JAN2018 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Surgical and medical procedures Brain tumour operation 01JAN2006 31DEC2006 N
Carpal tunnel decompression 01JAN2009 31DEC2009 N
Knee operation 01JAN1985 31DEC1985 N
Shoulder operation 01JAN2017 31DEC2017 N
C4591001 1003
10031160 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2010 Y
Irritable bowel s yndrome 01JAN2014 Y
Metabolism and nutrition disorders Lactose intolerance 01JAN2010 Y
Skin and subcutaneous tissue disorders Urticaria thermal 01JAN2018 Y
C4591001 1003
10031161 Metabolism and nutrition disorders Type 2 diabetes mellitus 01JAN2016 Y
Musculoskeletal and connective tissue
disordersOsteoarthritis 01JAN2019 31DEC2019 N
Surgical and medical procedures Hip arthroplast y 01JAN2019 31DEC2019 N
Hysterectom y 01JAN2006 31DEC2006 N
Vascular disorders Hypertension 01JAN2016 Y
C4591001 1003
10031162 Ear and labyrinth disorders Deafness 01JAN2005 Y
Endocrine disorders Hypothyroidism 01JAN2000 Y
Gastrointestinal disorders Gastrooesopha geal reflux disease 01JAN2016 Y
Immune s ystem disorders Seasonal aller gy 01JAN2005 Y
Metabolism and nutrition disorders Hypercholesterolaemia 01JAN2000 31DEC2000 N
Reproductive system and breast
disordersPelvic pain 01JAN2010 31DEC2010 N
Respiratory, thoraci c and mediastinal
disordersAsthma exercise induced 01JAN2012 Y
Surgical and medical procedures Hysterectom y 01JAN2010 31DEC2010 N
Vascular disorders Hypertension 01JAN2014 Y
C4591001 1003
10031166 Gastrointestinal disorders Diverticulum 01JAN2018 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Gastrooesopha geal reflux disease 01JAN2010 Y
Immune s ystem disorders Rubber sensitivit y 01JAN2005 Y
Musculoskeletal and connective tissue
disordersArthritis 01JAN1998 Y
Plantar fasciitis 01JAN2013 31DEC2013 N
Nervous s ystem disorders Cluster headache 01JAN2013 31DEC2013 N
Psychiatric disorders Post-traumatic stress disorde r 01JAN1994 31DEC1997 N
Renal and urinar y disorders Nephrolithiasis 01JAN2015 31DEC2015 N
01JAN2019 31DEC2019 N
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 01JAN2010 31DEC2010 N
Surgical and medical procedures Knee operation 01JAN1983 31DEC1983 N
01JAN2000 31DEC2000 N
Shoulder operation 01JAN2018 31DEC2018 N
Vascular disorders Hypertension 01JAN2018 Y
C4591001 1003
10031170 Pregnancy, puerperium and perinatal
conditionsGestational hypertension 01JAN2019 31DEC2019 N
Reproductive system and breast
disordersUterine haemorrhage 01JAN2019 31DEC2019 N
Social circumstances Corrective lens use r 01JAN2002 Y
C4591001 1003
10031174 Eye disorders Glaucoma 01JAN2016 Y
Immune s ystem disorders Aller gy to animal 01JAN1990 Y
Aller gy to plants 01JAN1990 Y
Seasonal aller gy 01JAN1990 Y
Respiratory, thoraci c and mediastinal
disordersChildhood asthma 01JAN1990 31DEC2000 N
Surgical and medical procedures Ear tube removal 01JAN1991 31DEC1991 N
Inguinal hernia repai r 01JAN2006 31DEC2006 N
Trabeculectom y 01JAN2017 31DEC2017 N
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1003
10031175 Immune system disorders Food allergy 01JAN1979 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN1974 Y
Social circumstances Menopause 01JAN1998 Y
Vascular disorders Hypertension 01JAN2018 Y
C4591001 1003
10031177 Endocrine disorders Hypothyroidism 01JAN2010 Y
Eye disorders Myopia 01JAN1990 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN2000 Y
Psychiatric disorders Depression 01JAN2018 Y
Social circumstances Corrective lens use r 01JAN1990 Y
C4591001 1003
10031179 Immune system disorders Drug hypersensitivity 01JAN1980 Y
Seasonal aller gy 01JAN1986 Y
Infections and infestations Folliculitis 01DEC1995 Y
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 01JAN2017 Y
Skin and subcutaneous tissue disorders Photodermatosis 01JAN2018 Y
C4591001 1003
10031180 Cardiac disorders Tachycardia 01JAN1985 31DEC1997 N
Eye disorders Myopia 01JAN1990 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN1986 Y
Nervous s ystem disorders Migraine 01JAN1982 Y
Reproductive system and breast
disordersInfertility 01JAN1997 Y
Respiratory, thoraci c and mediastinal
disordersAsthma exercise induced 01JAN1986 Y
C4591001 1003
10031183 Immune system disorders Seasonal allergy 01JAN1993 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Injury, poisoning and procedural
complicationsLigament rupture 01JAN2015 31DEC2015 N
Surgical and medical procedures Ligament operation 01JAN2015 31DEC2015 N
01JAN2017 31DEC2017 N
C4591001 1003
10031184 Cardiac disorders Ventricular tachycardia 01JAN2010 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN2003 Y
C4591001 1003
10031186 Endocrine disorders Hypothyroidism 01JAN2009 Y
Metabolism and nutrition disorders Obesit y 01JAN2020 Y
Nervous s ystem disorders Narcoleps y 01JAN2010 Y
C4591001 1003
10031187 Eye disorders Myopia 01JAN2000 Y
Immune s ystem disorders Seasonal aller gy 01JAN2019 Y
Social circumstances Corrective lens use r 01JAN2000 Y
C4591001 1003
10031190 Surgical and medical procedures Vasectomy 01JAN2012 31DEC2012 N
C4591001 1003
10031191 Endocrine disorders Hypothyroidism 01JAN2015 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2005 Y
Skin and subcutaneous tissue disorders Acne 01FEB2020 Y
C4591001 1003
10031194 Surgical and medical procedures Spinal operation 01JAN2016 31DEC2016 N
C4591001 1003
10031196 Immune system disorders Drug hypersensitivity 01JAN1982 Y
C4591001 1003
10031198 Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Basal cell carcinoma 01JAN2019 31DEC2019 N
Social circumstances Postmenopause 01JAN2018 Y
Surgical and medical procedures Skin neoplasm excision 01JAN2019 31DEC2019 N
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1003
10031199 Endocrine disorders Autoimmune thyroiditis 01JAN2012 Y
Eye disorders Myopia 01JAN2000 Y
Metabolism and nutrition disorders Hypercholesterolaemia 01JAN2013 31DEC2019 N
Latent autoimmune diabetes in adults 01JAN2016 Y
Nervous s ystem disorders Migraine 01JAN2000 Y
Pregnancy, puerperium and perinatal
conditionsGestational diabetes 01JAN2016 31DEC2016 N
Reproductive system and breast
disordersPolycystic ovaries 01JAN2012 Y
Surgical and medical procedures Salpin gectom y 01JAN2017 31DEC2017 N
C4591001 1003
10031201 Endocrine disorders Hypothyroidism 01JAN1999 Y
Metabolism and nutrition disorders Type 2 diabetes mellitus 01JAN2020 Y
Musculoskeletal and connective tissue
disordersFibromyalgia 01JAN2015 Y
Psychiatric disorders Depression 01JAN1995 Y
Surgical and medical procedures Hysterectom y 01JAN2003 Y
Vascular disorders Hypertension 01JAN2010 Y
C4591001 1003
10031203 Eye disorders Myopia 01JAN1986 Y
Gastrointestinal disorders Duodeno gastric reflux 01JAN2010 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN2012 Y
Metabolism and nutrition disorders Hypercholesterolaemia 01JAN2017 Y
Musculoskeletal and connective tissue
disordersArthritis 01JAN2018 Y
Skin and subcutaneous tissue disorders Granuloma annulare 01JAN2019 Y
Surgical and medical procedures Cholec ystectom y 01JAN2005 31DEC2005 N
Oophorectom y bilateral 01JAN2017 31DEC2017 N
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1003
10031204 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2017 Y
Immune s ystem disorders Hypersensitivit y 01JAN2000 Y
Metabolism and nutrition disorders Lactose intolerance 01JAN2000 Y
Nervous s ystem disorders Migraine 01JAN1995 Y
Psychiatric disorders Anxiet y 01JAN2016 Y
Surgical and medical procedures Hysterectom y 01JAN2013 31DEC2013 N
C4591001 1003
10031205 Musculoskeletal and connective tissue
disordersArthralgia 01JAN2019 Y
Renal and urinar y disorders Stress urinar y incontinence 01JAN2018 Y
Social circumstances Postmenopause 01JAN2018 Y
Vascular disorders Hypertension 01JAN2019 Y
C4591001 1003
10031206 Eye disorders Myopia 01JAN1985 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN1990 Y
Skin and subcutaneous tissue disorders Psoriasis 01JAN2003 Y
Surgical and medical procedures Vasectom y 01JAN2018 31DEC2018 N
Vascular disorders Hypertension 01JAN2019 Y
C4591001 1003
10031207 Surgical and medical procedures Hip arthroplasty 01JAN2018 Y
C4591001 1005
10051002 Nervous system disorders Migraine 01JAN2001 Y
Surgical and medical procedures Tonsillectom y 01JAN1990 31DEC1990 N
C4591001 1005
10051003 Immune system disorders Drug hypersensitivity 01JAN1996 Y
C4591001 1005
10051004 Surgical and medical procedures Hernia repair 01JAN2001 31DEC2001 N
C4591001 1005
10051007 Immune system disorders Hypersensitivity 01JAN1970 Y
Psychiatric disorders Insomnia 01JAN2018 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Social circumstances Menopause 01JAN2018 Y
Surgical and medical procedures Caesarean section 01JAN1995 31DEC1995 N
C4591001 1005
10051008 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2009 01JAN2011 N
Immune s ystem disorders Hypersensitivit y 01JAN2005 Y
Investi gations Laparoscop y 01JAN2007 31DEC2007 N
Metabolism and nutrition disorders Obesit y 01JAN1980 Y
Reproductive system and breast
disordersEndometriosis 01JAN2007 31DEC2007 N
Surgical and medical procedures Mammoplast y 01JAN1997 31DEC1997 N
C4591001 1005
10051015 Immune system disorders Hypersensitivity 01JAN2018 Y
Surgical and medical procedures Rotator cuff repai r 01JAN2018 31DEC2018 N
C4591001 1005
10051016 Immune system disorders Seasonal allergy 01JAN1977 Y
C4591001 1005
10051017 Immune system disorders Hypersensitivity 01JAN2019 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2005 Y
Surgical and medical procedures Caesarean section 01JAN2011 31DEC2011 N
C4591001 1005
10051024 Surgical and medical procedures Appendicectomy 01JAN2008 31DEC2008 N
C4591001 1005
10051026 Immune system disorders Hypersensitivity 01JAN1979 Y
Psychiatric disorders Anxiet y 01JAN1995 Y
Renal and urinar y disorders Nephrolithiasis 01JAN2011 31DEC2016 N
Surgical and medical procedures Renal stone removal 01JAN2012 31DEC2012 N
C4591001 1005
10051027 Eye disorders Glaucoma 01JAN2019 Y
Nervous s ystem disorders Tension headache 01JAN2000 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Vascular disorders Hypertension 01JAN2017 Y
C4591001 1005
10051028 Gastrointestinal disorders Irritable bowel syndrome 01JAN2010 Y
Musculoskeletal and connective tissue
disordersBack pain 01JAN1999 Y
Nervous s ystem disorders Migraine 01JAN2009 Y
Tension headache 01JAN2000 Y
Social circumstances Postmenopause 01JAN2017 31DEC2017 N
Surgical and medical procedures Spinal laminectom y 01JAN1999 31DEC1999 N
C4591001 1005
10051029 Musculoskeletal and connective tissue
disordersBack pain 01JAN1998 Y
Surgical and medical procedures Spinal laminectom y 01JAN1998 31DEC1998 N
01JAN2008 31DEC2008 N
C4591001 1005
10051030 Nervous system disorders Migraine 01JAN1977 Y
Surgical and medical procedures Rotator cuff repai r 01JAN2006 31DEC2006 N
C4591001 1005
10051031 Immune system disorders Drug hypersensitivity 01JAN1985 Y
01JAN1988 Y
Surgical and medical procedures Tonsillectom y 01JAN2013 12AUG2020 N
Vascular disorders Hypertension 01JAN2018 Y
C4591001 1005
10051035 Congenital, familial and genetic
disordersFactor V Leiden mutation 01JAN1990 Y
Immune s ystem disorders Seasonal aller gy 01JAN1990 Y
Injury, poisoning and procedural
complicationsHead injury 01JAN2010 31DEC2010 N
Metabolism and nutrition disorders Overwei ght 01JAN2010 Y
Surgical and medical procedures Suture insertion 01JAN2010 31DEC2010 N
C4591001 1005
10051036 Immune system disorders Hypersensitivity 01FEB2008 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Metabolism and nutrition disorders Overwei ght 01JAN2005 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01FEB2008 Y
Surgical and medical procedures Orchidectom y 01JAN1998 31DEC1998 N
C4591001 1005
10051041 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2010 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN2009 Y
Hypersensitivit y 01JAN1993 Y
Metabolism and nutrition disorders Overwei ght 01JAN1984 Y
Surgical and medical procedures Caesarean section 01JAN2009 31DEC2009 N
Urinar y bladder suspension 01JAN2010 31DEC2010 N
C4591001 1005
10051048 Cardiac disorders Arrhythmia 01JAN2005 Y
Gastrointestinal disorders Gastrooesopha geal reflux disease 01JAN2019 31DEC2020 N
Immune s ystem disorders Drug hypersensitivit y 01JAN1983 Y
01JAN2019 Y
Psychiatric disorders Anxiet y 01JAN2016 Y
Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
Surgical and medical procedures Salpin gectom y 01JAN2019 31DEC2019 N
C4591001 1005
10051051 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN1986 Y
Immune s ystem disorders Hypersensitivit y 01JAN1975 Y
Investi gations Blood cholesterol increase d 01JAN2009 Y
Musculoskeletal and connective tissue
disordersBack pain 01JAN2000 Y
Psychiatric disorders Anxiet y 01JAN1978 Y
Depression 01JAN1980 Y
Obsessive-compulsive disorde r 01JAN1975 Y
Reproductive system and breast
disordersProstatomegaly 01JAN2019 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2006 Y
Vascular disorders White coat h ypertension 01JAN2016 Y
C4591001 1005
10051052 Immune system disorders Hypersensitivity 01JAN2003 Y
Psychiatric disorders Anxiet y 01JAN2003 Y
Depression 01JAN2003 Y
Surgical and medical procedures Appendicectom y 01JAN2019 31DEC2019 N
C4591001 1005
10051054 Immune system disorders Drug hypersensitivity 01JAN1985 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Uterine leiomyoma 01JAN2008 31DEC2008 N
Psychiatric disorders Anxiet y 01JAN2004 Y
Depression 01JAN1985 Y
Social circumstances Menopause 01JAN2017 Y
Surgical and medical procedures Hysterectom y 01JAN2008 31DEC2008 N
Vascular disorders Hypertension 01JAN1980 Y
C4591001 1005
10051055 Metabolism and nutrition disorders Overweight 01JAN1998 Y
C4591001 1005
10051057 Investigations Blood triglycerides increased 01JAN2001 Y
Metabolism and nutrition disorders Overwei ght 01JAN1995 Y
Surgical and medical procedures Caesarean section 01JAN2014 31DEC2014 N
01JAN2016 31DEC2016 N
Vascular disorders Hypertension 01JAN2006 Y
C4591001 1005
10051059 Metabolism and nutrition disorders Overweight 01JAN2000 Y
Psychiatric disorders Insomnia 01JAN2010 Y
Skin and subcutaneous tissue disorders Eczema 01JAN2015 Y
Rosacea 01JAN2015 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Surgical and medical procedures Carpal tunnel decompression 01JAN2016 31DEC2016 N
Mammoplast y 01JAN2000 31DEC2000 N
C4591001 1005
10051066 Endocrine disorders Hypothyroidism 01JAN2008 Y
Hepatobiliar y disorders Cholelithiasis 01JAN2015 31DEC2015 N
Surgical and medical procedures Caesarean section 01JAN2018 31DEC2018 N
Cholec ystectom y 01JAN2015 31DEC2015 N
C4591001 1005
10051067 Metabolism and nutrition disorders Obesity 01JAN2017 31DEC2017 N
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 01JAN1995 Y
Surgical and medical procedures Metabolic sur gery 01JAN2017 31DEC2017 N
C4591001 1005
10051070 Hepatobiliary disorders Nonalcoholic fatty liver disease 01JAN2013 Y
Immune s ystem disorders Hypersensitivit y 01JAN1990 Y
C4591001 1005
10051073 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2005 Y
Metabolism and nutrition disorders Overwei ght 01JAN2016 Y
Psychiatric disorders Insomnia 01JAN1997 Y
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 01JAN1997 Y
C4591001 1005
10051075 Immune system disorders Drug hypersensitivity 01JAN1995 Y
Metabolism and nutrition disorders Overwei ght 01JAN2010 Y
C4591001 1005
10051076 Vascular disorders Hypertension 01JAN2008 31DEC2010 N
C4591001 1005
10051077 Immune system disorders Drug hypersensitivity 01JAN2012 Y
Psychiatric disorders Anxiet y 01JAN2007 31DEC2017 N
Surgical and medical procedures Salpin gectom y 01JAN2015 31DEC2015 N
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1005
10051079 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2019 Y
Metabolism and nutrition disorders Overwei ght 01JAN2015 Y
Surgical and medical procedures Knee arthroplast y 01JUN2020 01JUN2020 N
C4591001 1005
10051081 Cardiac disorders Mitral valve prolapse 01JAN1986 Y
Ear and lab yrinth disorders Verti go 01JAN2008 Y
Endocrine disorders Hypothyroidism 01JAN2019 Y
Gastrointestinal disorders Gastrooesopha geal reflux disease 01JAN2019 Y
Immune s ystem disorders Hypersensitivit y 01JAN2001 Y
Infections and infestations Candida infection 01JAN2010 Y
Investi gations Blood cholesterol increase d 01JAN2019 Y
Blood tri glycerides increase d 01JAN2019 Y
Psychiatric disorders Anxiet y 01JAN2011 Y
C4591001 1005
10051082 Nervous system disorders Migraine without aura 01JAN2014 Y
Tension headache 01JAN2014 Y
Psychiatric disorders Anxiet y 01JAN2006 Y
Depression 01JAN2004 Y
Insomnia 01JAN2015 Y
C4591001 1005
10051084 Immune system disorders Hypersensitivity 01JAN2005 Y
Metabolism and nutrition disorders Overwei ght 01JAN2016 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2010 Y
Vascular disorders Hypertension 01JAN2010 Y
C4591001 1005
10051085 Injury, poisoning and procedural
complicationsCartilage injury 01JAN2012 31DEC2012 N
Metabolism and nutrition disorders Overwei ght 01JAN2000 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Musculoskeletal and connective tissue
disordersBack pain 01JAN2000 Y
Psychiatric disorders Anxiet y 01JAN2016 Y
Surgical and medical procedures Caesarean section 01JAN2010 31DEC2010 N
Female sterilisation 01JAN2012 31DEC2012 N
Shoulder operation 01JAN2012 31DEC2012 N
Vascular disorders Hypertension 01JAN2016 Y
C4591001 1005
10051087 Immune system disorders Allergy to metals 01JAN2010 Y
Nervous s ystem disorders Migraine without aura 01JAN2018 Y
Reproductive system and breast
disordersMenstruation irregular 01JAN2016 Y
Surgical and medical procedures Caesarean section 01JAN2013 31DEC2013 N
01JAN2016 31DEC2016 N
01JAN2017 31DEC2017 N
C4591001 1005
10051093 Congenital, familial and genetic
disordersCongenital hypothyroidism 01JAN1985 Y
Infections and infestations Urinar y tract infection 01JAN1995 Y
Surgical and medical procedures Mammoplast y 01JAN2008 Y
C4591001 1005
10051094 Psychiatric disorders Anxiety 01JAN2008 Y
Surgical and medical procedures Salpin gectom y 30JUN2019 30JUN2019 N
C4591001 1005
10051100 Immune system disorders Drug hypersensitivity 01JAN1984 Y
Hypersensitivit y 01JAN1988 Y
Infections and infestations Oral herpes 01JAN1988 Y
Metabolism and nutrition disorders Overwei ght 01JAN2001 Y
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 01JAN2014 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1005
10051101 Immune system disorders Drug hypersensitivity 01JAN1993 Y
Hypersensitivit y 01JAN2000 Y
Psychiatric disorders Anxiet y 01JAN2019 Y
C4591001 1005
10051105 Endocrine disorders Hypothyroidism 01JAN1985 Y
Musculoskeletal and connective tissue
disordersArthralgia 01JAN2012 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Benign neoplasm 01JAN2013 31DEC2013 N
Nervous s ystem disorders Headache 01JAN1987 Y
Migraine without aura 01MAR2020 Y
Psychiatric disorders Anxiet y 01MAR2020 Y
Surgical and medical procedures Hysterectom y 01JAN2013 31DEC2013 N
C4591001 1005
10051106 Immune system disorders Hypersensitivity 01JAN1997 Y
Metabolism and nutrition disorders Overwei ght 01JAN2009 Y
Psychiatric disorders Anxiet y 01JAN1999 Y
Depression 01JAN1999 Y
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 01JAN2016 Y
Vascular disorders Venous thrombosis 01JAN2015 Y
C4591001 1005
10051108 Ear and labyrinth disorders Deafness 01JAN2011 Y
Tinnitus 01JAN2011 Y
Immune s ystem disorders Hypersensitivit y 01JAN1980 Y
Investi gations Blood cholesterol increase d 01JAN1995 Y
Metabolism and nutrition disorders Overwei ght 01JAN2017 Y
Nervous s ystem disorders Migraine without aura 01JAN2018 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Reproductive system and breast
disordersSexual dysfunction 01JAN2015 Y
C4591001 1005
10051115 Nervous system disorders Headache 01JAN2019 Y
Psychiatric disorders Anxiet y 01APR2019 Y
C4591001 1005
10051117 Immune system disorders Drug hypersensitivity 01JAN2015 Y
Hypersensitivit y 01JAN2000 Y
Metabolism and nutrition disorders Overwei ght 01JAN2016 Y
Psychiatric disorders Anxiet y 01JAN2012 Y
Depression 01JAN2012 Y
Reproductive system and breast
disordersMenstruation irregular 01JAN1996 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN1999 Y
Surgical and medical procedures Appendicectom y 01JAN1992 31DEC1992 N
C4591001 1005
10051118 Immune system disorders Hypersensitivity 01JAN1969 Y
Metabolism and nutrition disorders Overwei ght 01JAN2006 Y
C4591001 1005
10051119 Psychiatric disorders Anxiety 01JAN2014 Y
Depression 01JAN2014 Y
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 01JAN2019 Y
C4591001 1005
10051123 Immune system disorders Hypersensitivity 01JAN2000 Y
Metabolism and nutrition disorders Overwei ght 01JAN2003 Y
Vascular disorders White coat h ypertension 01JAN2003 Y
C4591001 1005
10051125 Blood and lymphatic system disorders Iron deficiency anaemia 01MAR2020 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Infections and infestations Herpes zoste r 01JUL2018 30SEP2018 N
Psychiatric disorders Anxiet y 01JAN2000 Y
Depression 01JAN2000 Y
C4591001 1005
10051129 Cardiac disorders Arrhythmia 01JAN1982 Y
Ear and lab yrinth disorders Tinnitus 01JAN2018 Y
Gastrointestinal disorders Gastrooesopha geal reflux disease 01JAN2010 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN2000 Y
Hypersensitivit y 01JAN1996 Y
Musculoskeletal and connective tissue
disordersBack pain 01JAN2007 Y
Nervous s ystem disorders Migraine without aura 01JAN2000 Y
Renal and urinar y disorders Haematuria 01JAN2015 Y
Stress urinar y incontinence 01JAN2015 Y
Social circumstances Menopause 01JAN2013 Y
C4591001 1005
10051134 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2018 Y
Immune s ystem disorders Hypersensitivit y 01JAN2001 Y
Infections and infestations Oral herpes 01JAN2011 Y
Metabolism and nutrition disorders Overwei ght 01JAN2017 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Uterine leiomyoma 01MAR2020 31MAR2020 N
Psychiatric disorders Anxiet y 01JAN2016 Y
Insomnia 01JAN2010 Y
Surgical and medical procedures Hysterectom y 01MAR2020 Y
C4591001 1005
10051142 Infections and infestations Oral herpes 01JAN2002 Y
Psychiatric disorders Anxiet y 01JAN2014 Y
Reproductive system and breast
disordersErectile dysfunction 01JAN2017 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1005
10051144 General disorders and administration
site conditionsOedema 01JAN2016 Y
Metabolism and nutrition disorders Overwei ght 01JAN1999 Y
Vascular disorders Hypertension 01JAN1999 Y
C4591001 1005
10051145 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2010 Y
Immune s ystem disorders Seasonal aller gy 01JAN2010 Y
Infections and infestations Oral herpes 01JAN1993 Y
Musculoskeletal and connective tissue
disordersBack pain 01JAN2018 Y
Skin and subcutaneous tissue disorders Rosacea 01JAN2011 Y
Vascular disorders Hypertension 01JAN2011 Y
C4591001 1005
10051146 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2020 Y
Skin and subcutaneous tissue disorders Alopecia 01JAN2005 Y
C4591001 1005
10051147 Psychiatric disorders Depression 01JAN2017 Y
C4591001 1005
10051148 Investigations Blood cholesterol increased 01JAN2014 Y
Metabolism and nutrition disorders Overwei ght 01JAN1986 Y
Type 2 diabetes mellitus 01JAN2015 Y
Nervous s ystem disorders Neuropath y peripheral 01JAN2015 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN1991 Y
Surgical and medical procedures Vasectom y 01JAN1998 31DEC1998 N
Vascular disorders Hypertension 01JAN2014 Y
C4591001 1005
10051150 Eye disorders Glaucoma 01JAN2000 Y
Gastrointestinal disorders Gastrooesopha geal reflux disease 01JAN1995 Y
Immune s ystem disorders Seasonal aller gy 01JAN1975 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Investi gations Blood cholesterol increase d 01JAN2010 Y
Metabolism and nutrition disorders Overwei ght 01JAN1975 Y
Type 2 diabetes mellitus 01JAN2018 Y
Nervous s ystem disorders Tarsal tunnel s yndrome 01JAN2017 Y
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 01JAN2006 Y
Surgical and medical procedures Small intestinal resection 01JAN2017 31DEC2017 N
C4591001 1005
10051151 Infections and infestations Oral herpes 01JAN1973 Y
Metabolism and nutrition disorders Overwei ght 01JAN2015 Y
Nervous s ystem disorders Migraine without aura 01JAN2000 Y
Psychiatric disorders Anxiet y 01JAN2010 Y
Attention deficit h yperactivit y disorde r 01JAN2018 Y
Surgical and medical procedures Appendicectom y 01JAN2015 31DEC2015 N
Caesarean section 01JAN2004 31DEC2004 N
01JAN2006 31DEC2006 N
Cholec ystectom y 01JAN1996 31DEC1996 N
C4591001 1005
10051153 Immune system disorders Hypersensitivity 01JAN2000 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2000 Y
Surgical and medical procedures Caesarean section 01JAN2011 31DEC2011 N
01JAN2015 Y
C4591001 1005
10051164 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2010 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN1991 Y
Hypersensitivit y 01JAN1980 Y
Musculoskeletal and connective tissue
disordersOsteoarthritis 01JAN2019 Y
Spinal osteoarthritis 01JAN2019 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN1985 Y
Surgical and medical procedures Inguinal hernia repai r 07AUG2020 07AUG2020 N
Vascular disorders Hypertension 01JAN2012 Y
C4591001 1005
10051165 Immune system disorders Hypersensitivity 01JAN1971 Y
Psychiatric disorders Depression 01JAN2005 Y
Surgical and medical procedures Orchidopex y 01JAN1979 31DEC1979 N
Vascular disorders Hypertension 01JAN2012 Y
C4591001 1005
10051166 Ear and labyrinth disorders Deafness 01JAN2003 Y
Tinnitus 01JAN2003 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN1994 Y
Hypersensitivit y 01JAN2001 Y
Infections and infestations Oral herpes 01JAN1999 Y
Metabolism and nutrition disorders Overwei ght 01JAN2015 Y
Musculoskeletal and connective tissue
disordersBack pain 01JAN2009 Y
Psychiatric disorders Anxiet y 01MAY2020 Y
Insomnia 01JAN2011 Y
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 01JAN2015 Y
Skin and subcutaneous tissue disorders Rosacea 01JAN2004 Y
Surgical and medical procedures Spinal laminectom y 01JAN2011 31DEC2011 N
C4591001 1005
10051167 Immune system disorders Hypersensitivity 01JAN2000 Y
Investi gations Blood cholesterol increase d 01JAN2017 31DEC2019 N
Metabolism and nutrition disorders Overwei ght 01JAN2017 31DEC2020 N
Nervous s ystem disorders Migraine without aura 01JAN1990 Y
Tension headache 01JAN1990 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Psychiatric disorders Insomnia 01JAN2019 Y
Skin and subcutaneous tissue disorders Rosacea 01JAN1990 Y
Surgical and medical procedures Bunion operation 01JAN1996 31DEC1996 N
Laser therap y 01JAN2020 31DEC2020 N
C4591001 1005
10051168 Psychiatric disorders Depression 01JAN2010 Y
C4591001 1005
10051169 Immune system disorders Hypersensitivity 01JAN1999 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN1999 Y
C4591001 1005
10051170 Surgical and medical procedures Appendicectomy 01JAN2018 31DEC2018 N
C4591001 1005
10051171 Gastrointestinal disorders Constipation 01JAN2018 Y
Nervous s ystem disorders Migraine without aura 01JAN2018 Y
Psychiatric disorders Anxiet y 01JAN2018 Y
Insomnia 01JAN2018 Y
C4591001 1005
10051175 Immune system disorders Drug hypersensitivity 01JAN1983 Y
Hypersensitivit y 01JAN2000 Y
Nervous s ystem disorders Migraine without aura 01JAN2000 Y
C4591001 1005
10051178 Surgical and medical procedures Vasectomy 01JAN2008 31DEC2008 N
C4591001 1005
10051179 Immune system disorders Drug hypersensitivity 01JAN1972 Y
Infections and infestations Oral herpes 01JAN1995 Y
Metabolism and nutrition disorders Overwei ght 01JAN1993 Y
Nervous s ystem disorders Headache 01JAN2010 Y
Psychiatric disorders Insomnia 01JAN2010 Y
Skin and subcutaneous tissue disorders Psoriasis 01JAN2007 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Vascular disorders Hypertension 01JAN2019 Y
C4591001 1005
10051181 Social circumstances Menopause 01JAN2013 Y
C4591001 1005
10051183 Immune system disorders Seasonal allergy 01JAN1998 Y
Metabolism and nutrition disorders Overwei ght 01JAN1989 Y
Reproductive system and breast
disordersProstatomegaly 01JAN2016 Y
Surgical and medical procedures Gastric bandin g 01JAN2013 31DEC2013 N
Vascular disorders Hypertension 01JAN1987 Y
C4591001 1005
10051187 Hepatobiliary disorders Cholelithiasis 01JAN2009 31DEC2009 N
Immune s ystem disorders Drug hypersensitivit y 01JAN2007 Y
Hypersensitivit y 01JAN1980 Y
Metabolism and nutrition disorders Overwei ght 01JAN2003 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Benign neoplasm of thyroid gland 01JAN2014 31DEC2014 N
Surgical and medical procedures Caesarean section 01JAN2007 31DEC2007 N
01JAN2012 31DEC2012 N
Cholec ystectom y 01JAN2009 31DEC2009 N
Thyroidectom y 01JAN2014 31DEC2014 N
C4591001 1005
10051188 Endocrine disorders Hypothyroidism 01JAN2012 Y
Immune s ystem disorders Hypersensitivit y 01JAN1970 Y
Vascular disorders Hypertension 01JAN2006 Y
C4591001 1005
10051189 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2010 Y
Hepatobiliar y disorders Cholelithiasis 01JAN1999 31DEC1999 N
Immune s ystem disorders Drug hypersensitivit y 01JAN1968 Y
Hypersensitivit y 01JAN1990 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Infections and infestations Oral herpes 01JAN1991 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Benign neoplasm of thyroid gland 01JAN2008 Y
Skin and subcutaneous tissue disorders Acne 01JAN2015 Y
Surgical and medical procedures Appendicectom y 01JAN2010 31DEC2010 N
Caesarean section 01JAN2000 31DEC2000 N
01JAN2003 31DEC2003 N
Carpal tunnel decompression 01JAN2010 31DEC2010 N
Cholec ystectom y 01JAN1999 31DEC1999 N
C4591001 1005
10051192 Immune system disorders Hypersensitivity 01JAN1993 Y
Metabolism and nutrition disorders Overwei ght 01JAN2016 Y
Musculoskeletal and connective tissue
disordersBack pain 01JAN2017 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Benign neoplasm of thyroid gland 01JAN2010 Y
Lipoma 01JAN2019 31DEC2019 N
Psychiatric disorders Anxiet y 01JAN2007 Y
Respiratory, thoraci c and mediastinal
disordersAsthma exercise induced 01JAN1995 Y
Sleep apnoea s yndrome 01JAN2020 Y
Skin and subcutaneous tissue disorders Idiopathic urticaria 01JAN1986 Y
Surgical and medical procedures Caesarean section 01JAN2007 31DEC2007 N
Salpin goplast y 01JAN2018 31DEC2018 N
Wisdom teeth removal 01JAN2001 31DEC2001 N
C4591001 1005
10051198 Skin and subcutaneous tissue disorders Acne 01JAN2016 Y
C4591001 1005
10051199 Hepatobiliary disorders Cholelithiasis 01JAN2016 31DEC2016 N
Surgical and medical procedures Cholec ystectom y 01JAN2016 31DEC2016 N
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1005
10051200 Immune system disorders Hypersensitivity 01JAN1990 Y
C4591001 1005
10051203 Psychiatric disorders Anxiety 01JAN2006 Y
Depression 01JAN2006 Y
C4591001 1005
10051210 Immune system disorders Hypersensitivity 01JAN1995 Y
Psychiatric disorders Anxiet y 01JAN2010 Y
C4591001 1005
10051212 Psychiatric disorders Depression 01JAN2016 Y
C4591001 1005
10051215 Investigations Blood cholesterol increased 01JAN2015 Y
Nervous s ystem disorders Migraine without aura 01JAN2000 Y
Psychiatric disorders Depression 01JAN2010 Y
C4591001 1005
10051216 Nervous system disorders Migraine without aura 01JAN2006 Y
Vascular disorders Hypertension 01AUG2020 Y
C4591001 1005
10051217 Immune system disorders Hypersensitivity 01JAN2010 Y
Metabolism and nutrition disorders Overwei ght 01JAN2018 Y
Psychiatric disorders Anxiet y 01JAN2019 Y
C4591001 1005
10051220 Immune system disorders Hypersensitivity 01JAN2017 Y
Metabolism and nutrition disorders Overwei ght 01JAN2018 Y
Psychiatric disorders Anxiet y 01JAN2004 31DEC2010 N
C4591001 1005
10051222 Infections and infestations Oral herpes 01JAN2000 Y
Injury, poisoning and procedural
complicationsJoint dislocation 14FEB2014 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Musculoskeletal and connective tissue
disordersBack pain 01FEB2014 Y
Vascular disorders Hot flush 01JAN2020 Y
C4591001 1005
10051223 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2011 Y
Immune s ystem disorders Hypersensitivit y 01JUN2020 Y
C4591001 1005
10051224 Infections and infestations Bronchitis 24SEP2020 29SEP2020 N
Injury, poisoning and procedural
complicationsEpicondylitis 01JAN2019 Y
C4591001 1005
10051226 Immune system disorders Hypersensitivity 01JAN1995 Y
Nervous s ystem disorders Migraine without aura 01JAN1998 Y
Psychiatric disorders Anxiet y 01JAN2018 Y
C4591001 1005
10051228 Immune system disorders Allergy to plants 05JAN2012 Y
Nervous s ystem disorders Seizure 01SEP2009 Y
C4591001 1005
10051232 Infections and infestations Oral herpes 24JAN1985 Y
Injury, poisoning and procedural
complicationsCartilage injury 04OCT2018 04OCT2018 N
Investi gations Arthroscop y 04OCT2018 04OCT2018 N
Metabolism and nutrition disorders Overwei ght 17APR2019 Y
Musculoskeletal and connective tissue
disordersArthralgia 19OCT2018 Y
C4591001 1005
10051233 Ear and labyrinth disorders Tinnitus 01JAN2010 Y
Immune s ystem disorders Mite aller gy 01JAN1987 Y
Infections and infestations Oral herpes 01FEB2013 Y
Renal and urinar y disorders Nephrolithiasis 06MAY2020 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1005
10051235 Investigations Arthroscopy 13MAY2004 13MAY2004 N
Musculoskeletal and connective tissue
disordersFoot deformity 22FEB2014 Y
Reproductive system and breast
disordersMenstruation irregular 01JAN2018 Y
Social circumstances Menopause 01OCT2018 Y
Surgical and medical procedures Mammoplast y 20MAY1993 20MAY1993 N
C4591001 1005
10051236 Immune system disorders Hypersensitivity 01JAN2000 Y
Surgical and medical procedures Tonsillectom y 01JAN2014 31DEC2014 N
C4591001 1005
10051237 Skin and subcutaneous tissue disorders Dermatitis atopic 01JAN2010 Y
C4591001 1005
10051238 Immune system disorders Hypersensitivity 01JAN2010 Y
Injury, poisoning and procedural
complicationsCartilage injury 01MAR2020 31MAR2020 N
Investi gations Arthroscop y 01MAR2020 31MAR2020 N
Nervous s ystem disorders Migraine without aura 01JAN2018 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2016 Y
C4591001 1005
10051240 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2008 Y
Musculoskeletal and connective tissue
disordersBack pain 01JAN2008 Y
C4591001 1005
10051241 Endocrine disorders Hypothyroidism 01JAN2000 Y
Gastrointestinal disorders Gastrooesopha geal reflux disease 01JAN2000 Y
Immune s ystem disorders Hypersensitivit y 01JAN1970 Y
Musculoskeletal and connective tissue
disordersSacroiliac joint dysfunction 01JAN2016 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Renal and urinar y disorders Bladder spas m 01JAN2000 Y
Social circumstances Menopause 01JAN2018 Y
Surgical and medical procedures Appendicectom y 01JAN1990 31DEC1990 N
Cholec ystectom y 01JAN2010 31DEC2010 N
Gastric b ypass 01JAN2013 31DEC2013 N
Thyroidectom y 01JAN2000 31DEC2000 N
C4591001 1005
10051242 Immune system disorders Hypersensitivity 01JAN1993 Y
Surgical and medical procedures Vasectom y 01JAN2002 Y
C4591001 1005
10051243 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN1998 Y
Investi gations Blood cholesterol increase d 01JAN1998 Y
Metabolism and nutrition disorders Type 2 diabetes mellitus 01JAN1998 Y
Surgical and medical procedures Appendicectom y 01JAN1973 31DEC1973 N
Vasectom y 01JAN2002 31DEC2002 N
Vascular disorders Hypertension 01JAN1998 Y
C4591001 1005
10051244 Gastrointestinal disorders Gastrooesophageal reflux disease 01APR2020 Y
Nervous s ystem disorders Migraine without aura 01JAN2004 Y
Surgical and medical procedures Tonsillectom y 01JAN1996 31DEC1996 N
C4591001 1005
10051245 Musculoskeletal and connective tissue
disordersArthralgia 01JAN2006 Y
Vascular disorders White coat h ypertension 01JAN2000 Y
C4591001 1005
10051246 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2016 Y
Nervous s ystem disorders Migraine with aura 01JAN1980 Y
Surgical and medical procedures Inguinal hernia repai r 01JAN2016 31DEC2016 N
01JAN2018 31DEC2018 N
Ligament operation 01JAN1996 31DEC1996 N
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1005
10051248 Psychiatric disorders Depression 01JAN2001 Y
Surgical and medical procedures Keratomileusis 01JAN2004 31DEC2004 N
C4591001 1005
10051251 Endocrine disorders Goitre 01JAN2009 Y
Immune s ystem disorders Hypersensitivit y 01JAN1996 Y
Investi gations Endoscop y 01JAN2012 Y
Surgical and medical procedures Tonsillectom y 01JAN1997 Y
C4591001 1005
10051254 Immune system disorders Hypersensitivity 01JAN2018 Y
Nervous s ystem disorders Headache 01JAN2010 Y
Surgical and medical procedures Wisdom teeth removal 01JAN1999 31DEC1999 N
C4591001 1005
10051257 Blood and lymphatic system disorders Anaemia 01JAN2016 Y
Ear and lab yrinth disorders Tinnitus 01JAN2019 Y
Gastrointestinal disorders Constipation 01JAN2018 Y
Gastrooesopha geal reflux disease 01JAN2015 Y
Immune s ystem disorders Hypersensitivit y 01JAN1970 Y
Infections and infestations Oral herpes 01JAN1980 Y
Musculoskeletal and connective tissue
disordersOsteopenia 01JAN2014 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Benign neoplasm of thyroid gland 01JAN2000 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN1970 Y
Surgical and medical procedures Bunion operation 01JAN2002 31DEC2002 N
Female sterilisation 01JAN1993 31DEC1993 N
Haemorrhoid operation 01JAN2016 31DEC2016 N
Inguinal hernia repai r 01JAN2011 31DEC2011 N
01JAN2013 31DEC2013 N
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Oophorectom y bilateral 01JAN2018 31DEC2018 N
Rhinoplast y 01JAN1983 31DEC1983 N
C4591001 1005
10051259 Social circumstances Menopause 01JAN2018 Y
Surgical and medical procedures Female sterilisation 01JAN1992 31DEC1992 N
Sterilisation reversal 01JAN1992 31DEC1992 N
C4591001 1005
10051260 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2017 Y
Investi gations Laparoscop y 01JAN2003 31DEC2003 N
Psychiatric disorders Anxiet y 01JAN2010 Y
Insomnia 01JAN2010 Y
Social circumstances Menopause 01JAN2019 Y
Surgical and medical procedures Mammoplast y 01JAN2008 31DEC2008 N
C4591001 1005
10051264 Surgical and medical procedures Cholecystectomy 01JAN2018 31DEC2018 N
C4591001 1005
10051267 Investigations Arthroscopy 01JAN2003 31DEC2003 N
Blood cholesterol increase d 01JAN2019 Y
Metabolism and nutrition disorders Type 2 diabetes mellitus 01JAN2018 Y
Musculoskeletal and connective tissue
disordersBack pain 01JAN2017 Y
Nervous s ystem disorders Migraine without aura 01JAN2015 Y
Psychiatric disorders Anxiet y 01JAN1999 Y
Bipolar disorde r 01JAN2016 Y
Depression 01JAN2016 Y
Skin and subcutaneous tissue disorders Acne 01JAN2000 Y
Social circumstances Menopause 01JAN2018 Y
Surgical and medical procedures Abdominoplast y 01JUL2020 31JUL2020 N
Open reduction of fracture 01JAN2003 31DEC2003 N
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Spinal decompression 01JAN2018 31DEC2018 N
Vascular disorders Hypertension 01JAN2018 Y
C4591001 1005
10051268 Immune system disorders Hypersensitivity 01JAN1990 Y
Musculoskeletal and connective tissue
disordersRotator cuff syndrome 01JUN2020 Y
Surgical and medical procedures Inguinal hernia repai r 01JAN1984 31DEC1984 N
Muscle operation 01JAN2016 31DEC2016 N
C4591001 1005
10051270 Immune system disorders Hypersensitivity 01JAN2000 Y
C4591001 1005
10051274 Immune system disorders Hypersensitivity 01JAN2018 Y
Metabolism and nutrition disorders Overwei ght 01JAN2000 Y
Psychiatric disorders Anxiet y 01JAN2008 Y
Bipolar disorde r 01JAN2008 Y
Insomnia 01JAN2018 Y
Reproductive system and breast
disordersEndometriosis 01JAN2015 31DEC2015 N
Surgical and medical procedures Caesarean section 01JAN2014 31DEC2014 N
Hysterectom y 01JAN2015 31DEC2015 N
C4591001 1005
10051276 Immune system disorders Hypersensitivity 01JAN2017 Y
Metabolism and nutrition disorders Overwei ght 01JAN1992 Y
Surgical and medical procedures Caesarean section 01JAN1994 31DEC1994 N
Female sterilisation 01JAN1996 31DEC1996 N
Gastrectom y 01FEB2020 31DEC2020 N
Vascular disorders Hypertension 01JAN2016 Y
C4591001 1005
10051277 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN1996 Y
Immune s ystem disorders Hypersensitivit y 01JAN1985 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Infections and infestations Herpes simplex 01JAN2018 Y
Reproductive system and breast
disordersErectile dysfunction 01JAN2010 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN1980 Y
Surgical and medical procedures Vasectom y 01JAN2012 31DEC2012 N
Vascular disorders Hypertension 01JAN2010 Y
C4591001 1005
10051280 Skin and subcutaneous tissue disorders Dermatitis atopic 09OCT2020 Y
C4591001 1005
10051281 Immune system disorders Hypersensitivity 01JAN2010 Y
Musculoskeletal and connective tissue
disordersArthralgia 01JAN2019 Y
Surgical and medical procedures Female sterilisation 01JAN2015 31DEC2015 N
C4591001 1005
10051283 Immune system disorders Hypersensitivity 01JAN2015 Y
Skin and subcutaneous tissue disorders Acne 01JAN2007 Y
C4591001 1005
10051285 Cardiac disorders Palpitations 01JAN2016 Y
Gastrointestinal disorders Gastrooesopha geal reflux disease 01JAN1990 Y
Immune s ystem disorders Hypersensitivit y 01JAN2015 Y
Metabolism and nutrition disorders Overwei ght 01JAN2000 Y
Musculoskeletal and connective tissue
disordersBack pain 01JAN2009 Y
Psychiatric disorders Anxiet y 01JAN2020 Y
Depression 01JAN2000 Y
Insomnia 01JAN2000 Y
Renal and urinar y disorders Nephrolithiasis 01AUG2020 Y
Skin and subcutaneous tissue disorders Acne 01JAN2000 Y
Surgical and medical procedures Cholec ystectom y 01JAN2014 31DEC2014 N
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Chondroplast y 24AUG2020 24AUG2020 N
Renal stone removal 10AUG2020 10AUG2020 N
C4591001 1005
10051288 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2006 Y
Immune s ystem disorders Aller gy to plants 01JAN2013 Y
Contrast media aller gy 01JAN2016 Y
Drug hypersensitivit y 01JAN2016 Y
Hypersensitivit y 01JAN1990 Y
Nervous s ystem disorders Migraine without aura 01JAN2000 Y
Psychiatric disorders Anxiet y 01JAN2000 Y
Depression 01JAN2000 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2000 Y
Skin and subcutaneous tissue disorders Urticaria 01JAN2014 Y
C4591001 1005
10051289 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2015 Y
Immune s ystem disorders Hypersensitivit y 01JAN2000 Y
Metabolism and nutrition disorders Overwei ght 01JAN2000 Y
Musculoskeletal and connective tissue
disordersOsteoarthritis 01JAN2012 Y
Pain in extremit y 01JAN2012 Y
Psychiatric disorders Depression 01JAN1992 Y
Insomnia 01JAN2008 Y
Respiratory, thoraci c and mediastinal
disordersChronic obstructiv e pulmonary disease 01JAN2011 Y
Skin and subcutaneous tissue disorders Cutaneous lupus er ythematosus 01JAN2018 Y
Surgical and medical procedures Appendicectom y 01JAN2015 31DEC2015 N
Hysterectom y 01JAN2000 31DEC2011 N
Intervertebral disc operation 01JAN2002 31DEC2002 N
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Vascular disorders Hypertension 01JAN2010 Y
C4591001 1005
10051290 Ear and labyrinth disorders Vertigo 01JAN2017 Y
Endocrine disorders Hypothyroidism 01JAN2003 Y
Hepatobiliar y disorders Cholelithiasis 01JAN2010 31DEC2010 N
Immune s ystem disorders Hypersensitivit y 01JAN2010 Y
Surgical and medical procedures Cholec ystectom y 01JAN2010 31DEC2010 N
Gastric b ypass 01JAN2016 31DEC2016 N
C4591001 1005
10051292 Immune system disorders Hypersensitivity 01JAN1992 Y
Investi gations Blood cholesterol increase d 01JAN2015 Y
Nervous s ystem disorders Cerebrovascular acciden t 01JAN2015 31DEC2015 N
Surgical and medical procedures Appendicectom y 01JAN1990 31DEC1990 N
Cataract operation 01JAN2000 31DEC2000 N
Vascular disorders Hypertension 01JAN2015 Y
C4591001 1005
10051294 Ear and labyrinth disorders Tinnitus 01JAN2017 Y
Gastrointestinal disorders Gastrooesopha geal reflux disease 01JAN2020 Y
Immune s ystem disorders Hypersensitivit y 01JAN2000 Y
Metabolism and nutrition disorders Overwei ght 01JAN2000 Y
Psychiatric disorders Depression 01JAN2015 Y
Surgical and medical procedures Cholec ystectom y 01JAN2017 31DEC2017 N
C4591001 1005
10051295 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2017 Y
Nervous s ystem disorders Migraine without aura 01JAN2011 Y
Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
Eczema 01JAN2015 Y
Surgical and medical procedures Inguinal hernia repai r 01JAN2012 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-1007606
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1005
10051301 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN1987 Y
Investi gations Blood cholesterol increase d 01JAN2012 Y
Blood tri glycerides increase d 01JAN2012 Y
Metabolism and nutrition disorders Gout 01JAN2003 Y
Overwei ght 01JAN1984 Y
Type 2 diabetes mellitus 01JAN2012 Y
Psychiatric disorders Anxiet y 01JAN2001 Y
Vascular disorders Hypertension 01JAN2012 Y
C4591001 1005
10051302 Endocrine disorders Hypothyroidism 01JAN2000 Y
Metabolism and nutrition disorders Type 2 diabetes mellitus 01JAN2000 Y
Psychiatric disorders Anxiet y 01JAN2000 Y
C4591001 1005
10051308 Metabolism and nutrition disorders Overweight 01JAN2016 Y
Pregnancy, puerperium and perinatal
conditionsGestational diabetes 01JAN2016 30SEP2020 N
Surgical and medical procedures Caesarean section 01JAN2016 31DEC2016 N
24AUG2020 24AUG2020 N
Female sterilisation 24AUG2020 24AUG2020 N
C4591001 1005
10051310 Metabolism and nutrition disorders Hypokalaemia 01JAN2006 Y
Overwei ght 01JAN1980 Y
Musculoskeletal and connective tissue
disordersBack pain 01JAN2000 Y
Social circumstances Menopause 01JAN2018 Y
Surgical and medical procedures Caesarean section 01JAN1994 31DEC1994 N
Cholec ystectom y 01JAN1994 31DEC1994 N
Spinal fusion sur gery 01JAN2019 31DEC2019 N
Spinal nerve stimulator implantation 01JAN2019 31DEC2019 N
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1005
10051311 Surgical and medical procedures Tonsillectomy 01JAN1978 31DEC1978 N
C4591001 1005
10051314 Gastrointestinal disorders Irritable bowel syndrome 01JAN2007 Y
Immune s ystem disorders Hypersensitivit y 01FEB2001 Y
Investi gations Blood tri glycerides increase d 01JAN2008 Y
Metabolism and nutrition disorders Overwei ght 01FEB2005 Y
Musculoskeletal and connective tissue
disordersOsteoarthritis 01JAN2019 Y
Psychiatric disorders Anxiet y 01JAN1996 Y
Depression 01JAN1993 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01FEB2001 Y
Sleep apnoea s yndrome 01JAN2009 Y
Skin and subcutaneous tissue disorders Rosacea 01JAN2018 Y
Surgical and medical procedures Ligament operation 01JAN2000 31DEC2000 N
Urethral repai r 01JAN2009 31DEC2009 N
Vasectom y 01JAN2007 31DEC2007 N
Vascular disorders Hypertension 01JAN2010 Y
C4591001 1005
10051315 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2016 Y
Immune s ystem disorders Hypersensitivit y 01JAN2019 Y
Surgical and medical procedures Vasectom y 01JAN1995 31DEC1995 N
C4591001 1005
10051316 Gastrointestinal disorders Irritable bowel syndrome 01JAN2000 Y
Immune s ystem disorders Hypersensitivit y 01JAN1990 Y
Metabolism and nutrition disorders Overwei ght 01JAN2000 Y
Nervous s ystem disorders Sinus headache 01JAN2010 Y
Psychiatric disorders Anxiet y 01JAN2000 Y
Depression 01JAN2000 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-1007608
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN1995 Y
Sleep apnoea s yndrome 01JAN2014 Y
Skin and subcutaneous tissue disorders Eczema 01JAN1990 Y
Surgical and medical procedures Cholec ystectom y 01JAN2003 31DEC2003 N
Endometrial ablation 01JAN2012 31DEC2012 N
Mammoplast y 01JAN2005 31DEC2005 N
C4591001 1005
10051318 Immune system disorders Hypersensitivity 01JAN2009 Y
Vascular disorders Hypertension 01JAN2015 Y
C4591001 1005
10051323 Cardiac disorders Coronary artery disease 01JAN2007 Y
Myocardial infarction 01JAN2007 31DEC2007 N
Metabolism and nutrition disorders Type 2 diabetes mellitus 01JAN2006 Y
Musculoskeletal and connective tissue
disordersBack pain 01JAN2006 Y
Osteoarthritis 01JAN2006 Y
Psychiatric disorders Anxiet y 01JAN2018 Y
Depression 01JAN2018 Y
Surgical and medical procedures Caesarean section 01JAN1997 31DEC1997 N
Coronar y arterial stent insertion 01JAN2007 31DEC2007 N
Female sterilisation 01JAN1997 31DEC1997 N
Vascular disorders Hypertension 01JAN2007 Y
C4591001 1005
10051326 Psychiatric disorders Anxiety 01JAN2010 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2004 Y
Surgical and medical procedures Tonsillectom y 01MAR2017 31MAR2017 N
C4591001 1005
10051331 Psychiatric disorders Anxiety 01JAN2011 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-1007609
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Depression 01JAN2011 Y
C4591001 1005
10051332 Psychiatric disorders Anxiety 01JUN2008 Y
C4591001 1005
10051335 Immune system disorders Hypersensitivity 01JAN1988 Y
C4591001 1005
10051340 Metabolism and nutrition disorders Overweight 01JAN2000 Y
Psychiatric disorders Anxiet y 01JAN2006 Y
Depression 01JAN2006 Y
Reproductive system and breast
disordersMenstruation irregular 01JAN2013 Y
Surgical and medical procedures Cholec ystectom y 01JAN2015 31DEC2015 N
Vascular disorders Hypertension 01JAN2010 Y
C4591001 1005
10051341 Gastrointestinal disorders Irritable bowel syndrome 01DEC2019 Y
Immune s ystem disorders Hypersensitivit y 01OCT2019 Y
Metabolism and nutrition disorders Overwei ght 01DEC2019 Y
Psychiatric disorders Anxiet y 01JAN2018 Y
Depression 01JAN2018 Y
Surgical and medical procedures Cholec ystectom y 01JAN2013 31DEC2013 N
C4591001 1005
10051343 Musculoskeletal and connective tissue
disordersOsteochondrosis 01JAN2018 31DEC2018 N
Surgical and medical procedures Internal fixation of fracture 01JAN2018 31DEC2018 N
C4591001 1005
10051345 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2015 Y
Immune s ystem disorders Hypersensitivit y 01JAN1983 Y
Musculoskeletal and connective tissue
disordersBack pain 01JAN2000 Y
Psychiatric disorders Anxiet y 01JAN2012 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1005
10051346 Reproductive system and breast
disordersPremenstrual dysphoric disorder 01JAN2013 Y
Surgical and medical procedures Pilonidal sinus repai r 01MAR2020 31MAR2020 N
C4591001 1005
10051349 Endocrine disorders Hypothyroidism 01JAN2018 Y
Gastrointestinal disorders Gastrooesopha geal reflux disease 01JAN2000 Y
Immune s ystem disorders Hypersensitivit y 01JAN2000 Y
Infections and infestations Oral herpes 01JAN2007 Y
Investi gations Mediastinoscop y 01JAN2002 31DEC2002 N
Metabolism and nutrition disorders Vitamin B12 deficienc y 01JAN2018 Y
Respiratory, thoraci c and mediastinal
disordersCystic lung disease 01JAN2002 31DEC2002 N
Surgical and medical procedures Caesarean section 01JAN2008 31DEC2008 N
C4591001 1005
10051350 Endocrine disorders Hypothyroidism 01JAN2017 Y
Psychiatric disorders Anxiet y 01JAN2018 Y
Attention deficit h yperactivit y disorde r 01JAN2018 Y
Surgical and medical procedures Hysterectom y 01JAN2019 31JAN2019 N
C4591001 1005
10051356 Hepatobiliary disorders Hepatic cirrhosis 01DEC2019 Y
Musculoskeletal and connective tissue
disordersRotator cuff syndrome 01AUG2020 Y
Psychiatric disorders Depression 01APR2020 Y
Vascular disorders Hypertension 01JAN2017 Y
C4591001 1005
10051358 Social circumstances Menopause 01JAN2018 Y
Surgical and medical procedures Gastric b ypass 01JUN2019 30JUN2019 N
C4591001 1005
10051361 Gastrointestinal disorders Irritable bowel syndrome 01JAN2017 Y
Psychiatric disorders Anxiet y 01JAN1980 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-1007611
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Depression 01JAN1980 Y
C4591001 1005
10051362 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2015 Y
Immune s ystem disorders Hypersensitivit y 01JAN1990 Y
Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
C4591001 1005
10051363 Musculoskeletal and connective tissue
disordersTendonitis 01JAN2018 Y
Reproductive system and breast
disordersBenign prostatic hyperplasia 01JAN2018 Y
C4591001 1005
10051364 Immune system disorders Hypersensitivity 01JAN1985 Y
Infections and infestations Oral herpes 01JAN1996 Y
Metabolism and nutrition disorders Overwei ght 01JAN2010 Y
Nervous s ystem disorders Migraine with aura 01JAN1993 Y
Psychiatric disorders Anxiet y 01JAN2000 Y
Insomnia 01JAN2000 Y
C4591001 1005
10051366 Immune system disorders Hypersensitivity 01JAN2010 Y
Surgical and medical procedures Vasectom y 01JAN2010 31DEC2010 N
C4591001 1005
10051368 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2005 Y
Injury, poisoning and procedural
complicationsCraniocerebral injury 01JAN1995 31DEC1995 N
Musculoskeletal and connective tissue
disordersBack pain 01JAN1980 Y
Nervous s ystem disorders Cognitive disorde r 01JAN1995 Y
Nerve compression 01JAN2008 Y
Renal and urinar y disorders Urinar y retention 01MAY2019 Y
C4591001 1005
10051369 Metabolism and nutrition disorders Overweight 01JAN2000 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-1007612
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Social circumstances Menopause 01OCT2019 Y
C4591001 1005
10051378 Metabolism and nutrition disorders Overweight 01JAN2000 Y
Musculoskeletal and connective tissue
disordersOsteoarthritis 01JAN2019 Y
Social circumstances Menopause 01JAN2016 Y
C4591001 1005
10051380 Congenital, familial and genetic
disordersHypertrophic cardiomyopathy 01JAN2017 Y
Surgical and medical procedures Implantable defibrillator insertion 01JAN2018 31DEC2018 N
C4591001 1005
10051381 Metabolism and nutrition disorders Overweight 01JAN1975 Y
Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2019 Y
Social circumstances Menopause 01APR2019 Y
C4591001 1005
10051385 Immune system disorders Hypersensitivity 01JAN1996 Y
Nervous s ystem disorders Headache 01JAN1999 Y
Psychiatric disorders Depression 01JAN1997 Y
Insomnia 01JAN2005 Y
Surgical and medical procedures Female sterilisation 01JAN2015 31DEC2015 N
C4591001 1005
10051386 Immune system disorders Hypersensitivity 01JAN1990 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2002 Y
C4591001 1005
10051390 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2009 Y
Metabolism and nutrition disorders Overwei ght 01JAN2000 Y
Psychiatric disorders Anxiet y 01JAN2011 Y
Depression 01JAN2011 Y
C4591001 1005
10051394 Psychiatric disorders Anxiety 01NOV2019 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 100
FDA-CBER-2021-5683-1007613
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Depression 01NOV2019 Y
Insomnia 01OCT2010 Y
Skin and subcutaneous tissue disorders Hyperhidrosis 01JAN2016 Y
C4591001 1005
10051396 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2015 Y
Immune s ystem disorders Hypersensitivit y 01JAN1970 Y
Social circumstances Menopause 01JAN2019 Y
C4591001 1005
10051397 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2016 Y
C4591001 1005
10051398 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2008 Y
C4591001 1005
10051407 Immune system disorders Hypersensitivity 01JAN1975 Y
Respiratory, thoraci c and mediastinal
disordersAsthma exercise induced 01JAN1985 Y
C4591001 1005
10051409 Immune system disorders Drug hypersensitivity 01JAN2005 Y
C4591001 1005
10051411 Congenital, familial and genetic
disordersAnal atresia 01JAN2003 31DEC2003 N
Gastrointestinal disorders Constipation 01JAN2013 Y
Shor t-bowel s yndrome 01JAN2003 Y
Volvulus 01JAN2003 31DEC2003 N
Surgical and medical procedures Appendicectom y 01JAN2003 31DEC2003 N
Cholec ystectom y 01JAN2003 31DEC2003 N
Enterostom y 01JAN2003 31DEC2003 N
Intestinal resection 01JAN2003 31DEC2003 N
Stoma closure 01JAN2003 31DEC2003 N
C4591001 1005
10051416 Immune system disorders Hypersensitivity 01JAN2015 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 101
FDA-CBER-2021-5683-1007614
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1005
10051432 Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
C4591001 1005
10051433 Psychiatric disorders Depression 01JAN2019 Y
C4591001 1005
10051435 Blood and lymphatic system disorders Anaemia 01SEP2019 Y
Psychiatric disorders Anxiet y 01JAN2020 Y
Attention deficit h yperactivit y disorde r 01JAN2015 Y
Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
C4591001 1005
10051442 Immune system disorders Hypersensitivity 01JAN2006 Y
Nervous s ystem disorders Headache 01JAN2014 Y
Migraine without aura 01JAN2014 Y
Psychiatric disorders Anxiet y 01JAN2010 Y
Depression 01JAN2010 Y
C4591001 1005
10051446 Psychiatric disorders Anxiety 01JAN2012 Y
Attention deficit h yperactivit y disorde r 01JAN2010 Y
C4591001 1006
10061005 Immune system disorders Drug hypersensitivity 01JAN2004 Y
Seasonal aller gy 01JAN1990 Y
Psychiatric disorders Insomnia 01JUL2018 Y
C4591001 1006
10061007 Endocrine disorders Hypothyroidism 01JAN2011 Y
General disorders and administration
site conditionsDrug intolerance 01JAN2005 Y
Metabolism and nutrition disorders Food intolerance 01JAN1990 Y
Obesit y 01JAN2010 Y
Psychiatric disorders Anxiet y 01JAN2011 Y
Depression 01JAN2011 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 102
FDA-CBER-2021-5683-1007615
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Reproductive system and breast
disordersMenorrhagia 01JAN2012 Y
C4591001 1006
10061008 Immune system disorders Seasonal allergy 01JAN1990 Y
Psychiatric disorders Anxiet y 01JAN2017 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2012 Y
Cough 01JAN2012 Y
Surgical and medical procedures Vasectom y 01JAN2012 31DEC2012 N
Vascular disorders Essential h ypertension 01JAN2012 Y
C4591001 1006
10061009 Ear and labyrinth disorders Cerumen impaction 27FEB2017 Y
Metabolism and nutrition disorders Overwei ght 01JAN2020 Y
Psychiatric disorders Anxiet y 01JAN2010 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2014 Y
C4591001 1006
10061011 Gastrointestinal disorders Gastrooesophageal reflux disease 20JUL2013 Y
General disorders and administration
site conditionsDrug intolerance 04JUN2012 Y
Immune s ystem disorders Drug hypersensitivit y 04JUN2012 Y
10JUL2014 Y
26JUL2011 Y
Musculoskeletal and connective tissue
disordersArthritis 01JAN2013 Y
Nervous s ystem disorders Migraine 01JAN1988 Y
Psychiatric disorders Depression 27JAN2004 Y
Respiratory, thoraci c and mediastinal
disordersRhinitis allergic 27JAN2004 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-1007616
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1006
10061012 Ear and labyrinth disorders Deafness bilateral 01MAY2010 Y
Tinnitus 01JAN2005 Y
Endocrine disorders Basedow's disease 01JAN2015 Y
Hypogonadis m 01JAN2010 Y
Hypothyroidism 01MAR2011 Y
Gastrointestinal disorders Gastrooesopha geal reflux disease 20FEB2009 Y
General disorders and administration
site conditionsDrug intolerance 01JAN2015 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN1990 Y
Metabolism and nutrition disorders Obesit y 01JAN2005 Y
Nervous s ystem disorders Migraine 01JAN2006 Y
Psychiatric disorders Anxiet y 01JAN2007 Y
13MAR2014 Y
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 19DEC2013 Y
C4591001 1006
10061013 Gastrointestinal disorders Constipation 01JAN2015 Y
Gastrooesopha geal reflux disease 01JAN2019 Y
Infections and infestations Urinar y tract infection 01MAY2020 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Colon adenoma 19OCT2019 19OCT2019 N
Nervous s ystem disorders Migraine 01JAN2016 Y
Psychiatric disorders Depression 01JAN2014 Y
Reproductive system and breast
disordersDysmenorrhoea 01JAN2010 Y
Skin and subcutaneous tissue disorders Eczema 01JAN2017 Y
C4591001 1006
10061014 Gastrointestinal disorders Eosinophilic oesophagitis 01JAN2015 Y
Immune s ystem disorders Amyloidosis 05FEB2019 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-1007617
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Drug hypersensitivit y 01JAN1998 Y
Nervous s ystem disorders Migraine 01JAN1987 Y
Skin and subcutaneous tissue disorders Urticaria 01JAN1990 Y
C4591001 1006
10061018 Gastrointestinal disorders Inguinal hernia 17MAY2019 24MAY2019 N
Immune s ystem disorders Seasonal aller gy 01JAN1992 Y
Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN1994 Y
C4591001 1006
10061019 Infections and infestations Genital herpes 26DEC2019 Y
Metabolism and nutrition disorders Hyperlipidaemia 26DEC2019 Y
Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN1990 Y
Vascular disorders Hypertension 26DEC2019 Y
C4591001 1006
10061021 General disorders and administration
site conditionsDrug intolerance 03JUL2019 Y
C4591001 1006
10061022 Gastrointestinal disorders Diverticulum intestinal 27DEC2016 Y
Haemorrhoids 27DEC2016 Y
Immune s ystem disorders Seasonal aller gy 10APR2008 Y
Musculoskeletal and connective tissue
disordersArthralgia 10APR2008 Y
Intervertebral disc protrusion 10AUG2008 Y
Psychiatric disorders Insomnia 01JAN2015 Y
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 30APR2009 Y
Vascular disorders Hypertension 29SEP2017 Y
C4591001 1006
10061023 Endocrine disorders Hypothyroidism 22JUL2019 Y
Thyroid stimulatin g hormone deficienc y 11JUL2019 Y
C4591001 1006
10061024 Immune system disorders Drug hypersensitivity 01JUN1996 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Infections and infestations Urinar y tract infection 01MAR2020 Y
Metabolism and nutrition disorders Gluten sensitivit y 01JAN2012 Y
Musculoskeletal and connective tissue
disordersArthralgia 01DEC2019 Y
01FEB2020 Y
C4591001 1006
10061028 Infections and infestations Papilloma viral infection 01NOV2019 Y
Respiratory, thoraci c and mediastinal
disordersAsthma exercise induced 01JAN2020 Y
C4591001 1006
10061031 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2015 Y
Metabolism and nutrition disorders Obesit y 01JAN2018 Y
Psychiatric disorders Anxiet y disorde r 2000 Y
Attention deficit h yperactivit y disorde r 01JAN2007 Y
Autism spectrum disorde r 2000 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2002 Y
Skin and subcutaneous tissue disorders Acne 01JAN2012 Y
C4591001 1006
10061032 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2003 Y
General disorders and administration
site conditionsDrug intolerance 13FEB2019 Y
Immune s ystem disorders Seasonal aller gy 01JAN2002 Y
Investi gations Blood glucose increase d 01JAN1995 Y
Metabolism and nutrition disorders Obesit y 01JAN1990 Y
Nervous s ystem disorders Migraine 01JAN1986 Y
Psychiatric disorders Anxiet y 01JAN2002 Y
Depression 01JAN2002 Y
Insomnia 01JAN2003 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 106
(b) (6)
(b) (6)
FDA-CBER-2021-5683-1007619
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2008 Y
C4591001 1006
10061033 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2018 Y
Immune s ystem disorders Seasonal aller gy 01JAN2018 Y
Nervous s ystem disorders Migraine 01JAN2016 Y
Psychiatric disorders Anxiet y 01JAN2007 Y
Attention deficit h yperactivit y disorde r 01JAN2007 Y
Autism spectrum disorde r 01JAN2010 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2007 Y
Skin and subcutaneous tissue disorders Drug eruption 01JAN1999 Y
C4591001 1006
10061036 Congenital, familial and genetic
disordersType V hyperlipidaemia 01JAN2014 Y
Immune s ystem disorders Drug hypersensitivit y 07NOV2019 Y
Rubber sensitivit y 02AUG2013 Y
Infections and infestations Oral herpes 12JAN2010 Y
Metabolism and nutrition disorders Obesit y 01JAN2010 Y
Musculoskeletal and connective tissue
disordersBack pain 07NOV2019 Y
Intervertebral disc protrusion 01JAN2002 31DEC2018 N
Psychiatric disorders Anxiet y 09NOV2012 Y
Major depression 01JAN2009 Y
Reproductive system and breast
disordersAnisomastia 01JUL2020 Y
Polycystic ovaries 05JUL2013 Y
Surgical and medical procedures Intervertebral disc operation 01JAN2018 31DEC2018 N
C4591001 1006
10061037 Cardiac disorders Atrioventricular block first degree 08APR2018 Y
Ear and lab yrinth disorders Deafness bilateral 10MAR2020 Y
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Endocrine disorders Hypogonadis m 18MAR2020 Y
Gastrointestinal disorders Diverticulu m 09JUN2017 Y
Metabolism and nutrition disorders Hypercholesterolaemia 28MAY2010 Y
Type 2 diabetes mellitus 07SEP2018 Y
Nervous s ystem disorders Neuropath y peripheral 21SEP2017 Y
Psychiatric disorders Anxiet y 01JAN2010 Y
Depression 01JAN2010 Y
Insomnia 28DEC2009 Y
Reproductive system and breast
disordersErectile dysfunction 10JAN2020 Y
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 09JUN2017 Y
C4591001 1006
10061040 Congenital, familial and genetic
disordersCancer gene carrier 01NOV2018 Y
General disorders and administration
site conditionsDrug intolerance 01JAN2016 Y
Infections and infestations Tonsillitis 01JAN2018 28DEC2020 N
Metabolism and nutrition disorders Obesit y 01JAN2018 Y
Musculoskeletal and connective tissue
disordersBack disorder 16AUG2019 Y
Muscle spasms 23AUG2019 Y
Nervous s ystem disorders Migraine 30AUG2016 Y
Trigeminal nerve disorde r 16AUG2019 Y
Psychiatric disorders Major depression 13JUL2018 Y
C4591001 1006
10061041 Immune system disorders Seasonal allergy 01JAN2000 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2018 Y
C4591001 1006
10061050 Metabolism and nutrition disorders Obesity 01JAN2020 Y
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2012 Y
Insomnia 01JAN2000 Y
Major depression 14APR2020 Y
C4591001 1006
10061052 General disorders and administration
site conditionsDrug intolerance 01JAN2002 Y
Metabolism and nutrition disorders Type 1 diabetes mellitus 01JAN1989 Y
Musculoskeletal and connective tissue
disordersTendonitis 03NOV2018 Y
Reproductive system and breast
disordersErectile dysfunction 01JAN2019 Y
Respiratory, thoraci c and mediastinal
disordersCough 01JAN2014 Y
Skin and subcutaneous tissue disorders Dyshidrotic eczema 01JAN2018 Y
C4591001 1006
10061053 Psychiatric disorders Anxiety 01JAN1994 Y
Insomnia 01JAN2015 Y
C4591001 1006
10061054 Nervous system disorders Migraine 01JAN2000 Y
Psychiatric disorders Insomnia 01JAN2019 Y
Reproductive system and breast
disordersEndometriosis 01JAN1986 31DEC2006 N
Skin and subcutaneous tissue disorders Drug eruption 01JAN1995 Y
Social circumstances Postmenopause 01JAN2006 31DEC2006 N
Surgical and medical procedures Hysterectom y 01JAN2006 31DEC2006 N
C4591001 1006
10061055 Immune system disorders Seasonal allergy 01JAN2018 Y
Psychiatric disorders Anxiet y 01APR2020 Y
Depression 01APR2020 Y
C4591001 1006
10061056 Skin and subcutaneous tissue disorders Hand dermatitis 01JAN2010 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1006
10061057 Metabolism and nutrition disorders Obesity 01JAN2015 Y
C4591001 1006
10061061 Blood and lymphatic system disorders Anaemia 01JAN2019 Y
Immune s ystem disorders Aller gy to arthropod stin g 01JAN1996 Y
Drug hypersensitivit y 01JAN2010 Y
Musculoskeletal and connective tissue
disordersArthralgia 01JAN2000 Y
Back pain 01JAN2000 Y
Muscle spasms 01JAN2000 Y
Psychiatric disorders Anxiet y 01JAN2019 Y
C4591001 1006
10061066 Endocrine disorders Hypothyroidism 01JAN2003 Y
Thyroid mass 01JAN2004 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN2000 Y
Injury, poisoning and procedural
complicationsProcedural pain 01JAN2009 Y
Nervous s ystem disorders Migraine 01JAN2001 Y
Psychiatric disorders Anxiet y 01JAN2017 Y
Depression 01JAN2017 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2003 Y
Surgical and medical procedures Shoulder operation 01JAN2009 31DEC2009 N
C4591001 1006
10061067 Immune system disorders Seasonal allergy 01JAN1998 Y
Metabolism and nutrition disorders Food intolerance 01JAN2018 Y
C4591001 1006
10061068 Investigations Weight increased 15JUN2020 Y
Nervous s ystem disorders Migraine 01JAN2004 Y
Psychiatric disorders Anxiet y 01JAN2002 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Depression 01JAN2002 Y
Respiratory, thoraci c and mediastinal
disordersSleep apnoea syndrome 19JUL2019 Y
Skin and subcutaneous tissue disorders Drug eruption 01JAN2010 Y
C4591001 1006
10061070 Gastrointestinal disorders Gastric ulcer 13APR1998 14JUL1998 N
Gastrooesopha geal reflux disease 13APR1998 14JUL1998 N
Oesopha gitis 13APR1998 14JUL1998 N
Immune s ystem disorders Aller gy to animal 01JAN1988 Y
Seasonal aller gy 01JAN1988 Y
Injury, poisoning and procedural
complicationsFacial bones fracture 01MAY2002 12JUN2002 N
Metabolism and nutrition disorders Obesit y 01JAN2006 Y
Musculoskeletal and connective tissue
disordersBack pain 06SEP2014 Y
Psychiatric disorders Depression 25SEP2019 Y
Insomnia 25SEP2019 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN1988 Y
Sleep apnoea s yndrome 01JAN2010 Y
Skin and subcutaneous tissue disorders Drug eruption 14JUL1998 Y
Surgical and medical procedures Fracture reduction 12JUN2002 12JUN2002 N
Oesopha gogastric fundoplast y 14JUL1998 14JUL1998 N
C4591001 1006
10061071 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2009 Y
C4591001 1006
10061073 Musculoskeletal and connective tissue
disordersArthritis 01FEB2020 Y
C4591001 1006
10061074 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2015 Y
Metabolism and nutrition disorders Obesit y 01JAN2015 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Psychiatric disorders Bipolar II disorde r 01JAN2017 Y
Reproductive system and breast
disordersPolycystic ovaries 01JAN2017 Y
Respiratory, thoraci c and mediastinal
disordersAsthma exercise induced 01JAN2018 Y
C4591001 1006
10061075 Cardiac disorders Palpitations 01JAN2015 Y
Endocrine disorders Thyroid mass 01JAN2015 Y
Eye disorders Dry eye 01JAN2017 Y
Hepatobiliar y disorders Hepatic steatosis 01JAN2018 Y
Immune s ystem disorders Seasonal aller gy 01JAN2004 Y
Metabolism and nutrition disorders Hypercholesterolaemia 01JAN2019 Y
Musculoskeletal and connective tissue
disordersBack pain 01JAN2019 Y
Pain in extremit y 01MAR2020 Y
C4591001 1006
10061078 Immune system disorders Allergy to animal 01JAN1990 Y
Investi gations Blood pressure diastolic increase d 01JAN1995 Y
Mean cell volume increase d 01JAN1995 Y
Psychiatric disorders Anxiet y 01JAN2013 Y
Depression 01JAN2013 Y
C4591001 1006
10061079 Endocrine disorders Hypothyroidism 01JAN2000 Y
Gastrointestinal disorders Large intestine perforation 30AUG2015 30AUG2015 N
General disorders and administration
site conditionsDrug intolerance 01JAN2000 Y
Infections and infestations Appendicitis 30SEP2015 30SEP2015 N
Oral herpes 01JAN2018 Y
Reproductive system and breast
disordersEndometriosis 01JAN1988 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Infertilit y 30AUG2000 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2000 Y
Surgical and medical procedures Appendicectom y 30SEP2015 30SEP2015 N
Colon operation 30AUG2015 30AUG2015 N
Female sterilisation 30SEP2015 30SEP2015 N
C4591001 1006
10061081 Immune system disorders Allergy to animal 01JAN2007 Y
Hypersensitivit y 01JAN2007 Y
Infections and infestations Staph ylococcal infection 01JAN2007 Y
Metabolism and nutrition disorders Obesit y 01JAN2005 Y
C4591001 1006
10061084 Psychiatric disorders Anxiety 01MAR2018 Y
Depression 01MAR2018 Y
C4591001 1006
10061088 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2018 Y
Musculoskeletal and connective tissue
disordersArthralgia 01JAN2013 Y
Nervous s ystem disorders Migraine 01JAN2010 Y
Psychiatric disorders Depression 01JAN2012 Y
Generalised anxiet y disorde r 11SEP2012 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2001 Y
C4591001 1006
10061089 Investigations Mammogram abnormal 03APR2015 Y
Musculoskeletal and connective tissue
disordersArthralgia 05NOV2014 Y
06DEC2014 Y
Back pain 01JAN1993 Y
Intervertebral disc de generation 27NOV2018 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Osteoarthritis 01JAN1990 Y
Pain in extremit y 01JAN2018 Y
Skin and subcutaneous tissue disorders Psoriasis 01JAN1995 Y
Social circumstances Organ dono r 30APR2019 30APR2019 N
Postmenopause 01JAN2018 Y
Surgical and medical procedures Nephrectom y 30APR2019 30APR2019 N
C4591001 1006
10061090 Immune system disorders Seasonal allergy 16AUG2016 Y
Musculoskeletal and connective tissue
disordersArthralgia 01MAY2020 Y
Nervous s ystem disorders Migraine 19JUL2016 Y
Reproductive system and breast
disordersPolycystic ovaries 30MAR2017 Y
C4591001 1006
10061091 Metabolism and nutrition disorders Obesity 25JUL2014 Y
Reproductive system and breast
disordersPolycystic ovaries 01JAN2018 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2006 Y
C4591001 1006
10061092 Immune system disorders Seasonal allergy 01JAN2000 Y
Metabolism and nutrition disorders Obesit y 01JAN2015 Y
Nervous s ystem disorders Migraine 01JAN2010 Y
C4591001 1006
10061094 Cardiac disorders Postural orthostatic tachycardia syndrome 01JAN1986 Y
Congenital, familial and genetic
disordersEhlers-Danlos syndrome 01JAN1986 Y
Gastrointestinal disorders Gastrooesopha geal reflux disease 01JAN1986 Y
Oesopha geal spas m 01JAN2015 Y
Immune s ystem disorders Contrast media aller gy 01JAN1990 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-1007627
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Drug hypersensitivit y 01JAN1990 Y
Seasonal aller gy 01JAN1988 Y
Infections and infestations Oral herpes 01JAN1995 Y
Sinusitis 01JAN2010 Y
Investi gations Cardiac murmu r 01JAN2019 Y
Musculoskeletal and connective tissue
disordersMuscle spasms 01JAN2003 Y
Temporomandibular joint s yndrome 01JAN2003 Y
Nervous s ystem disorders Migraine 01JAN2003 Y
Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN1998 Y
Post-traumatic stress disorde r 01JAN1990 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN1990 Y
Nasal septum deviation 01JAN1987 31DEC2004 N
Skin and subcutaneous tissue disorders Acne 01JAN1998 Y
Surgical and medical procedures Nasal septal operation 01JAN2004 31DEC2004 N
Oesopha gogastric fundoplast y 01JAN2009 Y
C4591001 1006
10061095 Immune system disorders Drug hypersensitivity 01JAN2010 Y
Nervous s ystem disorders Migraine 01JAN1996 Y
Psychiatric disorders Anxiet y 01JAN2002 Y
Insomnia 01JAN2004 Y
Perinatal depression 01APR2019 Y
Skin and subcutaneous tissue disorders Acne 01MAY2020 Y
C4591001 1006
10061096 Infections and infestations Cystitis 18JUN2019 31JUL2019 N
Urinar y tract infection 01JAN2015 Y
Nervous s ystem disorders Migraine 22APR2010 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Pregnancy, puerperium and perinatal
conditionsGestational diabetes 14MAY2015 31DEC2016 N
Psychiatric disorders Anxiet y 08JUN2015 Y
Depression 01JAN2018 Y
Generalised anxiet y disorde r 01JAN2018 Y
Reproductive system and breast
disordersDysmenorrhoea 10JAN2013 Y
Menorrha gia 22JUN2016 Y
C4591001 1006
10061099 Cardiac disorders Tachycardia 01JAN2012 Y
Gastrointestinal disorders Gastrooesopha geal reflux disease 01JAN2017 Y
C4591001 1006
10061100 Infections and infestations Oral herpes 01JAN1983 Y
Metabolism and nutrition disorders Obesit y 01JAN2000 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Melanocytic naevus 01JAN1990 Y
Surgical and medical procedures Vasectom y 02MAY2017 Y
C4591001 1006
10061102 Immune system disorders Food allergy 01JAN1986 Y
Seasonal aller gy 29JUN2015 Y
Musculoskeletal and connective tissue
disordersBack pain 13MAY2013 Y
Intervertebral disc protrusion 14MAY2012 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Skin papilloma 27AUG2012 Y
Psychiatric disorders Generalised anxiet y disorde r 19MAY2014 Y
Major depression 06APR2020 Y
Respiratory, thoraci c and mediastinal
disordersNasal septum deviation 30MAY2007 Y
Skin and subcutaneous tissue disorders Chloasma 17AUG2017 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1006
10061103 Immune system disorders Seasonal allergy 01JAN1996 Y
Musculoskeletal and connective tissue
disordersBack pain 03AUG2016 Y
Psychiatric disorders Depression 17DEC2015 Y
Surgical and medical procedures Vasectom y 07AUG2020 Y
C4591001 1006
10061104 Nervous system disorders Migraine 01JAN2018 Y
Psychiatric disorders Anxiet y 01JAN2018 Y
C4591001 1006
10061106 Blood and lymphatic system disorders Iron deficiency anaemia 01JAN2018 Y
Skin and subcutaneous tissue disorders Psoriasis 01JAN2016 Y
C4591001 1006
10061107 Immune system disorders Seasonal allergy 01JAN2015 Y
Metabolism and nutrition disorders Hyperlipidaemia 19APR2018 Y
Psychiatric disorders Anxiet y 01JAN2010 Y
Reproductive system and breast
disordersAnisomastia 10APR2019 Y
Menorrha gia 01JAN2015 Y
C4591001 1006
10061108 Gastrointestinal disorders Haemorrhoids 17OCT2017 Y
Metabolism and nutrition disorders Hypertri glyceridaemia 18APR2019 Y
Psychiatric disorders Anxiet y 01JAN2018 Y
C4591001 1006
10061109 Immune system disorders Seasonal allergy 01JAN1996 Y
C4591001 1006
10061110 Ear and labyrinth disorders Deafness unilateral 01JAN2006 Y
Gastrointestinal disorders Gastric ulce r 01JAN2010 Y
Gastrointestinal disorde r 01JAN2009 Y
Gastrooesopha geal reflux disease 01JAN2000 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
01JAN2010 Y
Hiatus hernia 1989 Y
Immune s ystem disorders Seasonal aller gy 01JAN2010 Y
Injury, poisoning and procedural
complicationsConcussion 01JAN1990 Y
Musculoskeletal and connective tissue
disordersArthralgia 01JAN2010 Y
Back pain 01JAN1998 Y
Neck pain 01JAN1993 30APR2020 N
Vertebral osteoph yte 01JAN1993 30APR2020 N
Nervous s ystem disorders Headache 01JAN1990 Y
Migraine 01JAN1990 Y
Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2015 Y
Surgical and medical procedures Spinal fusion sur gery 01APR2020 30APR2020 N
C4591001 1006
10061112 Immune system disorders Drug hypersensitivity 01JAN2017 Y
Infections and infestations Genital herpes simplex 01JAN2010 Y
Nervous s ystem disorders Migraine 01JAN1978 Y
Reproductive system and breast
disordersDysmenorrhoea 01JAN2015 Y
Surgical and medical procedures Female sterilisation 01JAN2016 Y
C4591001 1006
10061113 Congenital, familial and genetic
disordersBicuspid aortic valve 1989 Y
Infections and infestations Tinea versicolou r 01JAN2010 Y
Nervous s ystem disorders Syncope 06OCT2015 06OCT2015 N
C4591001 1006
10061114 Gastrointestinal disorders Enlarged uvula 01JUN2016 Y
Immune s ystem disorders Aller gy to arthropod stin g 01JAN2000 Y
Seasonal aller gy 01JAN2018 Y
Metabolism and nutrition disorders Hyperlipidaemia 23DEC2015 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 118
(b) (6)
(b) (6)
FDA-CBER-2021-5683-1007631
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Obesit y 01JAN2000 Y
Respiratory, thoraci c and mediastinal
disordersNasal congestion 01JAN2016 Y
Nasal septum deviation 01JUN2016 15DEC2016 N
Nasal turbinate h ypertroph y 01JUN2016 Y
Sleep apnoea s yndrome 01JAN2017 Y
Surgical and medical procedures Nasal septal operation 15DEC2016 15DEC2016 N
Vascular disorders Hypertension 01JAN2018 Y
C4591001 1006
10061116 General disorders and administration
site conditionsDrug intolerance 01JAN2005 Y
Immune s ystem disorders Seasonal aller gy 01JAN2017 Y
Metabolism and nutrition disorders Glucose tolerance impaire d 01JAN2018 Y
Hyperlipidaemia 01JAN2018 Y
Musculoskeletal and connective tissue
disordersArthralgia 01FEB2020 Y
Psychiatric disorders Insomnia 01JAN2018 Y
Major depression 01JAN2017 Y
Surgical and medical procedures Vasectom y 01DEC2001 31DEC2001 N
C4591001 1006
10061117 Psychiatric disorders Bipolar disorder 01JAN2005 Y
C4591001 1006
10061118 Congenital, familial and genetic
disordersTuberous sclerosis complex 01JAN2018 Y
Immune s ystem disorders Aller gy to animal 01JAN1995 Y
Nervous s ystem disorders Restless le gs syndrome 01JAN2008 Y
Psychiatric disorders Anxiet y 01JAN2008 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2000 Y
C4591001 1006
10061122 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2006 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN2010 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Seasonal aller gy 01JAN1996 Y
Nervous s ystem disorders Headache 01JAN2006 Y
Psychiatric disorders Anxiet y 01JAN2007 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2014 Y
Sleep apnoea s yndrome 01JAN2018 Y
Vascular disorders Hypertension 01JAN2000 Y
C4591001 1006
10061124 Skin and subcutaneous tissue disorders Acne 01MAR2020 Y
C4591001 1006
10061128 Endocrine disorders Hypothyroidism 01JAN1998 Y
Immune s ystem disorders Drug hypersensitivit y 01DEC2019 Y
01JAN1977 Y
Rubber sensitivit y 01JAN1977 Y
Pregnancy, puerperium and perinatal
conditionsPlacenta accreta 30NOV1997 30NOV1997 N
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN1977 Y
Social circumstances Menopause 01JAN2018 Y
Surgical and medical procedures Hysterectom y 30NOV1997 30NOV1997 N
Vascular disorders Hot flush 01JAN2018 Y
C4591001 1006
10061129 Immune system disorders Seasonal allergy 01JAN1981 Y
Skin and subcutaneous tissue disorders Acne 28MAY2013 Y
C4591001 1006
10061130 Congenital, familial and genetic
disordersAtrial septal defect 01JAN2017 Y
Immune s ystem disorders Seasonal aller gy 01JAN2010 Y
Nervous s ystem disorders Transient ischaemic attac k 01JAN2017 Y
C4591001 1006
10061131 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2012 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1006
10061133 General disorders and administration
site conditionsFatigue 06JUN2020 01JUL2020 N
Renal and urinar y disorders Pollakiuria 19SEP2017 31MAR2018 N
C4591001 1006
10061134 Gastrointestinal disorders Abdominal pain 01JAN2006 Y
Gastrointestinal pain 01JAN2006 Y
General disorders and administration
site conditionsDrug intolerance 01JAN2006 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Cervix carcinoma 01JAN2006 31DEC2006 N
Nervous s ystem disorders Migraine 01JAN2015 Y
Psychiatric disorders Anxiet y 01JAN1997 Y
Insomnia 01JAN2000 Y
Reproductive system and breast
disordersAtrophic vulvovaginitis 01OCT2019 Y
Social circumstances Postmenopause 01JAN2006 Y
Surgical and medical procedures Radiotherap y 01JAN2006 31DEC2006 N
C4591001 1006
10061136 Gastrointestinal disorders Volvulus 27JUL2015 Y
Immune s ystem disorders Seasonal aller gy 01JAN2013 Y
Metabolism and nutrition disorders Obesit y 01JAN2015 Y
Musculoskeletal and connective tissue
disordersTemporomandibular joint syndrome 01JAN2012 Y
Psychiatric disorders Depression 01JAN2012 Y
C4591001 1006
10061138 Immune system disorders Seasonal allergy 01JAN1995 Y
Psychiatric disorders Major depression 01JAN2000 Y
Tic 01JAN2007 Y
Reproductive system and breast
disordersGynaecomastia 01JAN2000 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1006
10061140 Immune system disorders Seasonal allergy 01JAN1995 Y
C4591001 1006
10061141 Immune system disorders Perennial allergy 01OCT2019 Y
Metabolism and nutrition disorders Underwei ght 01JAN2015 Y
Vascular disorders Hypotension 01JAN2012 Y
C4591001 1006
10061142 Endocrine disorders Hypothyroidism 01JAN2010 Y
Nervous s ystem disorders Complex re gional pain s yndrome 01JAN2007 Y
Social circumstances Postmenopause 01JAN2016 Y
Vascular disorders Hypertension 01JAN2015 Y
C4591001 1006
10061144 General disorders and administration
site conditionsDrug intolerance 01JAN2000 Y
01JAN2010 Y
Immune s ystem disorders Seasonal aller gy 01JAN2015 Y
Injury, poisoning and procedural
complicationsEpicondylitis 01APR2020 Y
01JAN2019 Y
Psychiatric disorders Insomnia 01JAN1986 Y
C4591001 1006
10061148 General disorders and administration
site conditionsFatigue 01FEB2020 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN1990 Y
Injury, poisoning and procedural
complicationsConcussion 01FEB2020 Y
Head in jury 01FEB2020 29FEB2020 N
Musculoskeletal and connective tissue
disordersArthralgia 01JAN2013 Y
01JAN2018 Y
Nervous s ystem disorders Memor y impairmen t 01FEB2020 Y
Mental impairmen t 01FEB2020 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-1007635
16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Psychiatric disorders Anxiet y 07JAN2020 Y
Depression 07JAN2020 Y
Insomnia 01MAR2020 Y
Surgical and medical procedures Endometrial ablation 01MAR2019 Y
Female sterilisation 01MAR2018 31MAR2018 N
C4591001 1006
10061151 Immune system disorders Seasonal allergy 01MAR2020 Y
Metabolism and nutrition disorders Metabolic s yndrome 01FEB2018 Y
Obesit y 01FEB2018 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Basal cell carcinoma 01JAN2018 31DEC2018 N
01MAY2020 31MAY2020 N
Reproductive system and breast
disordersMenorrhagia 01JAN1999 Y
C4591001 1006
10061152 Endocrine disorders Hypothyroidism 01JAN2000 Y
Gastrointestinal disorders Coeliac disease 01JAN2016 Y
Metabolism and nutrition disorders Obesit y 01JAN2010 Y
Musculoskeletal and connective tissue
disordersIntervertebral disc degeneration 12MAR2012 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN1983 Y
Rhinitis aller gic 01JAN1972 Y
Skin and subcutaneous tissue disorders Granuloma annulare 01JAN2011 Y
Vascular disorders Hypertension 21JAN2019 Y
C4591001 1006
10061153 Immune system disorders Seasonal allergy 01JAN2009 Y
Metabolism and nutrition disorders Fructose intolerance 09AUG2010 Y
Psychiatric disorders Anxiet y 26JUL2019 Y
Depression 12SEP2018 Y
090177e196af71ff\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
C4591001 1006
10061154 Ear and labyrinth disorders Deafness unilateral 01JAN2006 Y
Psychiatric disorders Autism spectrum disorde r 01MAR2010 Y
C4591001 1006
10061155 Skin and subcutaneous tissue disorders Acne cystic 02DEC2019 Y
C4591001 1006
10061156 Immune system disorders Drug hypersensitivity 01JAN2007 Y
Seasonal aller gy 01JAN2009 Y
Metabolism and nutrition disorders Lactose intolerance 01JAN2006 Y
Musculoskeletal and connective tissue
disordersArthralgia 01NOV2019 Y
Back pain 01JUL2019 Y
Nervous s ystem disorders Migraine 01JAN2012 Y
Respiratory, thoraci c and mediastinal
disordersRhinitis allergic 01JAN2009 Y
Skin and subcutaneous tissue disorders Eczema 01JAN2006 Y
C4591001 1006
10061159 General disorders and administration
site conditionsDrug intolerance 01JAN2014 Y
Musculoskeletal and connective tissue
disordersConnective tissue disorder 01MAY2018 01JUN2018 N
Femoroacetabular impin gemen t 01APR2019 31MAR2020 N
Surgical and medical procedures Bone operation 01JAN2020 31MAR2020 N
Chondroplast y 01JAN2020 31MAR2020 N
Fascial operation 01JUN2018 01JUN2018 N
C4591001 1006
10061160 Endocrine disorders Hypothyroidism 01JAN2018 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Uterine leiomyoma 01JAN2017 18SEP2017 N
Psychiatric disorders Anxiet y 01JAN2018 Y
Depression 01JAN2018 Y
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Surgical and medical procedures Hysterectom y 18SEP2017 18SEP2017 N
C4591001 1006
10061161 Immune system disorders Drug hypersensitivity 01JAN1991 Y
Rubber sensitivit y 01JAN2003 Y
Infections and infestations Kidne y infection 01JAN2015 Y
Urinar y tract infection 01JAN2015 Y
Skin and subcutaneous tissue disorders Acne 01MAR2020 Y
Surgical and medical procedures Ureteral stent insertion 01JAN2016 Y
C4591001 1006
10061162 Immune system disorders Allergy to animal 01JAN2005 Y
Seasonal aller gy 01JAN2005 Y
Skin and subcutaneous tissue disorders Dermatitis contact 01JAN2005 Y
C4591001 1006
10061163 General disorders and administration
site conditionsFatigue 01JAN2018 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN2005 Y
Metabolism and nutrition disorders Abnormal wei ght gain 01JAN2015 Y
Musculoskeletal and connective tissue
disordersPlantar fasciitis 01JAN2014 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2015 Y
C4591001 1006
10061164 Immune system disorders Allergy to animal 01JAN2017 Y
Hypersensitivit y 01JAN2017 Y
Metabolism and nutrition disorders Lactose intolerance 01JAN2015 Y
C4591001 1006
10061166 Endocrine disorders Hypogonadism 01JAN2005 Y
Hypothyroidism 01JAN2007 Y
Immune s ystem disorders Food aller gy 01JAN1990 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Testis cancer 01JAN2005 31DEC2005 N
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Nervous s ystem disorders Migraine 01JAN1990 Y
Surgical and medical procedures Bilateral orchidectom y 01JAN2005 31DEC2005 N
C4591001 1006
10061167 Blood and lymphatic system disorders Iron deficiency anaemia 26FEB2016 Y
Psychiatric disorders Depression 01JAN2016 Y
Skin and subcutaneous tissue disorders Acne 01JAN2017 Y
C4591001 1006
10061169 Metabolism and nutrition disorders Obesity 01JAN2018 Y
Nervous s ystem disorders Migraine 01JAN2015 Y
Psychiatric disorders Anxiet y 01JAN2014 Y
Attention deficit h yperactivit y disorde r 01JAN2014 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2010 Y
C4591001 1006
10061170 Immune system disorders Perennial allergy 01JAN2018 Y
Neoplasms benign, malignant and
unspecified (incl c ysts and pol yps)Skin papilloma 01JUL2020 Y
Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2007 Y
Autism spectrum disorde r 01JAN2007 Y
C4591001 1006
10061171 Immune system disorders Drug hypersensitivity 01JAN2016 Y
Seasonal aller gy 01JAN2013 Y
Psychiatric disorders Attention deficit h yperactivit y disorde r 03APR2013 Y
C4591001 1006
10061173 Reproductive system and breast
disordersMenstruation irregular 01JAN2016 Y
Skin and subcutaneous tissue disorders Eczema 01JAN2005 Y
C4591001 1006
10061176 Immune system disorders Seasonal allergy 01JAN2011 Y
Nervous s ystem disorders Migraine 01JAN2017 Y
Psychiatric disorders Anxiet y 01JAN2018 Y
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16.2.5.4 Listing of Medical Histo ry – All Subjects ≥16 Years of Age
Age
Group
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
Depression 01JAN2018 Y
Respiratory, thoraci c and mediastinal
disordersAsthma 01JAN2011 Y
C4591001 1006
10061179 Gastrointestinal disorders Constipation 01FEB2020 Y
Immune s ystem disorders Drug hypersensitivit y 01JAN1988 Y
Seasonal aller gy 01JAN1980 Y
Infections and infestations Sinusitis 01JAN1988 Y
Injury, poisoning and procedural
complicationsSpinal cord injury thoracic 19FEB2020 Y
Spinal fracture 19FEB2020 20FEB2020 N
Musculoskeletal and connective tissue
disordersBack pain 19FEB2020 Y
Nervous s ystem disorders Neuropath y peripheral 19FEB2020 Y
Respiratory, thoraci c and mediastinal
disord
…[truncated]