NCT02142738 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024) · Source last updated 2022-06-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Up to approximately 80 months.
Other-event reporting threshold: 5%

All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pembrolizumab First Course Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation.	79 / 154	140 / 154	103 / 154
SOC Chemotherapy First Course Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).	70 / 150	142 / 150	60 / 151
SOC Chemotherapy Switched Over to Pembrolizumab First Course Qualified participants who received the SOC chemotherapy first course but continued to experience disease progression, at the investigator's discretion, initiated a course of pembrolizumab IV 200 mg, every cycle (three weeks) for up to 35 cycles up to \~2 years.	27 / 83	72 / 83	62 / 83
Pembrolizumab Second Course Qualified participants who received the pembrolizumab first course and achieved CR, PR, or stable disease, and progressed after discontinuation, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to 17 cycles (approximately 1 additional year).	2 / 12	10 / 12	4 / 12
SOC Switched Over to Pembrolizumab Second Course One qualified participant received SOC chemotherapy first course, but continued to experience disease progression and at investigator's discretion switched to a course of pembrolizumab IV 200 mg, every cycle (three weeks) for up to 35 cycles up to \~2 years. The participant then initiated a second course of pembrolizumab at the same dose and schedule for up to \~1 additional year until documented PD or participant discontinuation.	0 / 1	0 / 1	1 / 1

Group identifiers: EG000: Pembrolizumab First Course · EG001: SOC Chemotherapy First Course · EG002: SOC Chemotherapy Switched Over to Pembrolizumab First Course · EG003: Pembrolizumab Second Course · EG004: SOC Switched Over to Pembrolizumab Second Course

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
154
num Events
3
group Id
EG001
num Affected
5
num At Risk
150
num Events
6
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
154
num Events
0
group Id
EG001
num Affected
3
num At Risk
150
num Events
3
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
154
num Events
0
group Id
EG001
num Affected
1
num At Risk
150
num Events
1
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
154
num Events
0
group Id
EG001
num Affected
3
num At Risk
150
num Events
3
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
154
num Events
0
group Id
EG001
num Affected
3
num At Risk
150
num Events
3
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
154
num Events
0
group Id
EG001
num Affected
1
num At Risk
150
num Events
1
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
154
num Events
1
group Id
EG001
num Affected
0
num At Risk
150
num Events
0
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
154
num Events
0
group Id
EG001
num Affected
1
num At Risk
150
num Events
1
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
154
num Events
1
group Id
EG001
num Affected
2
num At Risk
150
num Events
2
group Id
EG002
num Affected
1
num At Risk
83
num Events
1
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
154
num Events
0
group Id
EG001
num Affected
1
num At Risk
150
num Events
1
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
154
num Events
2
group Id
EG001
num Affected
1
num At Risk
150
num Events
1
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
154
num Events
1
group Id
EG001
num Affected
2
num At Risk
150
num Events
2
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Cardiac failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
24
num At Risk
154
num Events
28
group Id
EG001
num Affected
77
num At Risk
150
num Events
98
group Id
EG002
num Affected
4
num At Risk
83
num Events
4
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
154
num Events
1
group Id
EG001
num Affected
10
num At Risk
150
num Events
17
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
154
num Events
4
group Id
EG001
num Affected
35
num At Risk
150
num Events
67
group Id
EG002
num Affected
1
num At Risk
83
num Events
1
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
154
num Events
2
group Id
EG001
num Affected
18
num At Risk
150
num Events
32
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
154
num Events
1
group Id
EG001
num Affected
1
num At Risk
150
num Events
1
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
10
num At Risk
154
num Events
11
group Id
EG001
num Affected
2
num At Risk
150
num Events
3
group Id
EG002
num Affected
5
num At Risk
83
num Events
7
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
16
num At Risk
154
num Events
16
group Id
EG001
num Affected
3
num At Risk
150
num Events
3
group Id
EG002
num Affected
8
num At Risk
83
num Events
8
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
154
num Events
1
group Id
EG001
num Affected
0
num At Risk
150
num Events
0
group Id
EG002
num Affected
1
num At Risk
83
num Events
1
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Conjunctivitis allergic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
14
num At Risk
154
num Events
17
group Id
EG001
num Affected
10
num At Risk
150
num Events
10
group Id
EG002
num Affected
7
num At Risk
83
num Events
7
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
7
num At Risk
154
num Events
9
group Id
EG001
num Affected
7
num At Risk
150
num Events
13
group Id
EG002
num Affected
2
num At Risk
83
num Events
2
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
35
num At Risk
154
num Events
43
group Id
EG001
num Affected
33
num At Risk
150
num Events
54
group Id
EG002
num Affected
7
num At Risk
83
num Events
7
group Id
EG003
num Affected
2
num At Risk
12
num Events
2
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
41
num At Risk
154
num Events
65
group Id
EG001
num Affected
33
num At Risk
150
num Events
43
group Id
EG002
num Affected
18
num At Risk
83
num Events
22
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Diarrhoea

Complete source fields

description

event Groups

deaths Num Affected
103
deaths Num At Risk
154
description
Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation.
id
EG000
other Num Affected
140
other Num At Risk
154
serious Num Affected
79
serious Num At Risk
154
title
Pembrolizumab First Course
deaths Num Affected
60
deaths Num At Risk
151
description
Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
id
EG001
other Num Affected
142
other Num At Risk
150
serious Num Affected
70
serious Num At Risk
150
title
SOC Chemotherapy First Course
deaths Num Affected
62
deaths Num At Risk
83
description
Qualified participants who received the SOC chemotherapy first course but continued to experience disease progression, at the investigator's discretion, initiated a course of pembrolizumab IV 200 mg, every cycle (three weeks) for up to 35 cycles up to \~2 years.
id
EG002
other Num Affected
72
other Num At Risk
83
serious Num Affected
27
serious Num At Risk
83
title
SOC Chemotherapy Switched Over to Pembrolizumab First Course
deaths Num Affected
4
deaths Num At Risk
12
description
Qualified participants who received the pembrolizumab first course and achieved CR, PR, or stable disease, and progressed after discontinuation, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to 17 cycles (approximately 1 additional year).
id
EG003
other Num Affected
10
other Num At Risk
12
serious Num Affected
2
serious Num At Risk
12
title
Pembrolizumab Second Course
deaths Num Affected
1
deaths Num At Risk
1
description
One qualified participant received SOC chemotherapy first course, but continued to experience disease progression and at investigator's discretion switched to a course of pembrolizumab IV 200 mg, every cycle (three weeks) for up to 35 cycles up to \~2 years. The participant then initiated a second course of pembrolizumab at the same dose and schedule for up to \~1 additional year until documented PD or participant discontinuation.
id
EG004
other Num Affected
0
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
SOC Switched Over to Pembrolizumab Second Course

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
24
num At Risk
154
num Events
28
group Id
EG001
num Affected
77
num At Risk
150
num Events
98
group Id
EG002
num Affected
4
num At Risk
83
num Events
4
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
154
num Events
1
group Id
EG001
num Affected
10
num At Risk
150
num Events
17
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
154
num Events
4
group Id
EG001
num Affected
35
num At Risk
150
num Events
67
group Id
EG002
num Affected
1
num At Risk
83
num Events
1
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
154
num Events
2
group Id
EG001
num Affected
18
num At Risk
150
num Events
32
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
154
num Events
1
group Id
EG001
num Affected
1
num At Risk
150
num Events
1
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
10
num At Risk
154
num Events
11
group Id
EG001
num Affected
2
num At Risk
150
num Events
3
group Id
EG002
num Affected
5
num At Risk
83
num Events
7
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
16
num At Risk
154
num Events
16
group Id
EG001
num Affected
3
num At Risk
150
num Events
3
group Id
EG002
num Affected
8
num At Risk
83
num Events
8
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
154
num Events
1
group Id
EG001
num Affected
0
num At Risk
150
num Events
0
group Id
EG002
num Affected
1
num At Risk
83
num Events
1
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Conjunctivitis allergic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
14
num At Risk
154
num Events
17
group Id
EG001
num Affected
10
num At Risk
150
num Events
10
group Id
EG002
num Affected
7
num At Risk
83
num Events
7
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
7
num At Risk
154
num Events
9
group Id
EG001
num Affected
7
num At Risk
150
num Events
13
group Id
EG002
num Affected
2
num At Risk
83
num Events
2
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
35
num At Risk
154
num Events
43
group Id
EG001
num Affected
33
num At Risk
150
num Events
54
group Id
EG002
num Affected
7
num At Risk
83
num Events
7
group Id
EG003
num Affected
2
num At Risk
12
num Events
2
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
41
num At Risk
154
num Events
65
group Id
EG001
num Affected
33
num At Risk
150
num Events
43
group Id
EG002
num Affected
18
num At Risk
83
num Events
22
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Diarrhoea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
154
num Events
3
group Id
EG001
num Affected
5
num At Risk
150
num Events
6
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
154
num Events
0
group Id
EG001
num Affected
3
num At Risk
150
num Events
3
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
154
num Events
0
group Id
EG001
num Affected
1
num At Risk
150
num Events
1
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
154
num Events
0
group Id
EG001
num Affected
3
num At Risk
150
num Events
3
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
154
num Events
0
group Id
EG001
num Affected
3
num At Risk
150
num Events
3
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
154
num Events
0
group Id
EG001
num Affected
1
num At Risk
150
num Events
1
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
154
num Events
1
group Id
EG001
num Affected
0
num At Risk
150
num Events
0
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
154
num Events
0
group Id
EG001
num Affected
1
num At Risk
150
num Events
1
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
154
num Events
1
group Id
EG001
num Affected
2
num At Risk
150
num Events
2
group Id
EG002
num Affected
1
num At Risk
83
num Events
1
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
154
num Events
0
group Id
EG001
num Affected
1
num At Risk
150
num Events
1
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
154
num Events
2
group Id
EG001
num Affected
1
num At Risk
150
num Events
1
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
154
num Events
1
group Id
EG001
num Affected
2
num At Risk
150
num Events
2
group Id
EG002
num Affected
0
num At Risk
83
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
term
Cardiac failure

time Frame

Up to approximately 80 months.

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Preserved source evidence · Not medical advice