NCT02578680 · ADVERSE EVENTS

Adverse events

Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189) · Source last updated 2024-09-20

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 88 months
Other-event reporting threshold: 5%

Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease 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+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)	233 / 405	395 / 405	330 / 410
Control Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)	102 / 202	196 / 202	113 / 206
Control Switched Over to Pembrolizumab Monotherapy Qualified participants who received saline placebo with pemetrexed and platinum chemotherapy followed by placebo and pemetrexed, and who experienced disease progression, were switched over to receive pembrolizumab monotherapy 200 mg IV on Day 1 Q3W for up to 2 years.	29 / 84	64 / 84	74 / 84
Control Switched Over to Pembrolizumab Monotherapy (Second Course) Participants who were switched from saline placebo to receive pembrolizumab monotherapy, and met certain criteria, received a second course of pembrolizumab monotherapy at 200 mg IV Q3W for up to 1 additional year.	0 / 2	2 / 2	1 / 2
Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed (Second Course) Participants who received pembrolizumab PLUS pemetrexed and platinum chemotherapy followed by pembrolizumab PLUS pemetrexed during the initial treatment but experienced disease progression, and met certain criteria, received a second course of pembrolizumab monotherapy at 200 mg IV Q3W for up to 1 additional year.	2 / 9	9 / 9	4 / 9

Group identifiers: EG000: Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed · EG001: Control · EG002: Control Switched Over to Pembrolizumab Monotherapy · EG003: Control Switched Over to Pembrolizumab Monotherapy (Second Course) · EG004: Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed (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 26.0
stats
group Id
EG000
num Affected
13
num At Risk
405
num Events
14
group Id
EG001
num Affected
11
num At Risk
202
num Events
12
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
405
num Events
0
group Id
EG001
num Affected
1
num At Risk
202
num Events
1
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
25
num At Risk
405
num Events
26
group Id
EG001
num Affected
4
num At Risk
202
num Events
4
group Id
EG002
num Affected
1
num At Risk
84
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
3
num At Risk
405
num Events
3
group Id
EG001
num Affected
1
num At Risk
202
num Events
1
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
405
num Events
1
group Id
EG001
num Affected
0
num At Risk
202
num Events
0
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
11
num At Risk
405
num Events
11
group Id
EG001
num Affected
1
num At Risk
202
num Events
1
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
4
num At Risk
405
num Events
4
group Id
EG001
num Affected
2
num At Risk
202
num Events
2
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
13
num At Risk
405
num Events
14
group Id
EG001
num Affected
6
num At Risk
202
num Events
6
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
405
num Events
3
group Id
EG001
num Affected
0
num At Risk
202
num Events
0
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
405
num Events
1
group Id
EG001
num Affected
3
num At Risk
202
num Events
3
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
405
num Events
0
group Id
EG001
num Affected
2
num At Risk
202
num Events
2
group Id
EG002
num Affected
1
num At Risk
84
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
405
num Events
2
group Id
EG001
num Affected
0
num At Risk
202
num Events
0
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Cardiac arrest

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 26.0
stats
group Id
EG000
num Affected
186
num At Risk
405
num Events
253
group Id
EG001
num Affected
91
num At Risk
202
num Events
114
group Id
EG002
num Affected
6
num At Risk
84
num Events
8
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
26
num At Risk
405
num Events
44
group Id
EG001
num Affected
13
num At Risk
202
num Events
18
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
108
num At Risk
405
num Events
213
group Id
EG001
num Affected
49
num At Risk
202
num Events
92
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
68
num At Risk
405
num Events
108
group Id
EG001
num Affected
25
num At Risk
202
num Events
37
group Id
EG002
num Affected
1
num At Risk
84
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
3
num At Risk
405
num Events
3
group Id
EG001
num Affected
1
num At Risk
202
num Events
1
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
term
Ear discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
405
num Events
0
group Id
EG001
num Affected
0
num At Risk
202
num Events
0
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
term
Otorrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
14
num At Risk
405
num Events
19
group Id
EG001
num Affected
11
num At Risk
202
num Events
12
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
17
num At Risk
405
num Events
21
group Id
EG001
num Affected
4
num At Risk
202
num Events
7
group Id
EG002
num Affected
1
num At Risk
84
num Events
2
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
31
num At Risk
405
num Events
38
group Id
EG001
num Affected
5
num At Risk
202
num Events
7
group Id
EG002
num Affected
6
num At Risk
84
num Events
6
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
21
num At Risk
405
num Events
23
group Id
EG001
num Affected
5
num At Risk
202
num Events
5
group Id
EG002
num Affected
2
num At Risk
84
num Events
2
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
75
num At Risk
405
num Events
87
group Id
EG001
num Affected
22
num At Risk
202
num Events
24
group Id
EG002
num Affected
1
num At Risk
84
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
39
num At Risk
405
num Events
49
group Id
EG001
num Affected
13
num At Risk
202
num Events
14
group Id
EG002
num Affected
7
num At Risk
84
num Events
7
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
9
num Events
2
term
Abdominal pain

Complete source fields

description

event Groups

deaths Num Affected
330
deaths Num At Risk
410
description
Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)
id
EG000
other Num Affected
395
other Num At Risk
405
serious Num Affected
233
serious Num At Risk
405
title
Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed
deaths Num Affected
113
deaths Num At Risk
206
description
Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
id
EG001
other Num Affected
196
other Num At Risk
202
serious Num Affected
102
serious Num At Risk
202
title
Control
deaths Num Affected
74
deaths Num At Risk
84
description
Qualified participants who received saline placebo with pemetrexed and platinum chemotherapy followed by placebo and pemetrexed, and who experienced disease progression, were switched over to receive pembrolizumab monotherapy 200 mg IV on Day 1 Q3W for up to 2 years.
id
EG002
other Num Affected
64
other Num At Risk
84
serious Num Affected
29
serious Num At Risk
84
title
Control Switched Over to Pembrolizumab Monotherapy
deaths Num Affected
1
deaths Num At Risk
2
description
Participants who were switched from saline placebo to receive pembrolizumab monotherapy, and met certain criteria, received a second course of pembrolizumab monotherapy at 200 mg IV Q3W for up to 1 additional year.
id
EG003
other Num Affected
2
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Control Switched Over to Pembrolizumab Monotherapy (Second Course)
deaths Num Affected
4
deaths Num At Risk
9
description
Participants who received pembrolizumab PLUS pemetrexed and platinum chemotherapy followed by pembrolizumab PLUS pemetrexed during the initial treatment but experienced disease progression, and met certain criteria, received a second course of pembrolizumab monotherapy at 200 mg IV Q3W for up to 1 additional year.
id
EG004
other Num Affected
9
other Num At Risk
9
serious Num Affected
2
serious Num At Risk
9
title
Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed (Second Course)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
186
num At Risk
405
num Events
253
group Id
EG001
num Affected
91
num At Risk
202
num Events
114
group Id
EG002
num Affected
6
num At Risk
84
num Events
8
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
26
num At Risk
405
num Events
44
group Id
EG001
num Affected
13
num At Risk
202
num Events
18
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
108
num At Risk
405
num Events
213
group Id
EG001
num Affected
49
num At Risk
202
num Events
92
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
68
num At Risk
405
num Events
108
group Id
EG001
num Affected
25
num At Risk
202
num Events
37
group Id
EG002
num Affected
1
num At Risk
84
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
3
num At Risk
405
num Events
3
group Id
EG001
num Affected
1
num At Risk
202
num Events
1
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
term
Ear discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
405
num Events
0
group Id
EG001
num Affected
0
num At Risk
202
num Events
0
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
term
Otorrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
14
num At Risk
405
num Events
19
group Id
EG001
num Affected
11
num At Risk
202
num Events
12
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
17
num At Risk
405
num Events
21
group Id
EG001
num Affected
4
num At Risk
202
num Events
7
group Id
EG002
num Affected
1
num At Risk
84
num Events
2
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
31
num At Risk
405
num Events
38
group Id
EG001
num Affected
5
num At Risk
202
num Events
7
group Id
EG002
num Affected
6
num At Risk
84
num Events
6
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
21
num At Risk
405
num Events
23
group Id
EG001
num Affected
5
num At Risk
202
num Events
5
group Id
EG002
num Affected
2
num At Risk
84
num Events
2
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
75
num At Risk
405
num Events
87
group Id
EG001
num Affected
22
num At Risk
202
num Events
24
group Id
EG002
num Affected
1
num At Risk
84
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
39
num At Risk
405
num Events
49
group Id
EG001
num Affected
13
num At Risk
202
num Events
14
group Id
EG002
num Affected
7
num At Risk
84
num Events
7
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
9
num Events
2
term
Abdominal pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
13
num At Risk
405
num Events
14
group Id
EG001
num Affected
11
num At Risk
202
num Events
12
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
405
num Events
0
group Id
EG001
num Affected
1
num At Risk
202
num Events
1
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
25
num At Risk
405
num Events
26
group Id
EG001
num Affected
4
num At Risk
202
num Events
4
group Id
EG002
num Affected
1
num At Risk
84
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
3
num At Risk
405
num Events
3
group Id
EG001
num Affected
1
num At Risk
202
num Events
1
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
405
num Events
1
group Id
EG001
num Affected
0
num At Risk
202
num Events
0
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
11
num At Risk
405
num Events
11
group Id
EG001
num Affected
1
num At Risk
202
num Events
1
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
4
num At Risk
405
num Events
4
group Id
EG001
num Affected
2
num At Risk
202
num Events
2
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
13
num At Risk
405
num Events
14
group Id
EG001
num Affected
6
num At Risk
202
num Events
6
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
405
num Events
3
group Id
EG001
num Affected
0
num At Risk
202
num Events
0
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
405
num Events
1
group Id
EG001
num Affected
3
num At Risk
202
num Events
3
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
405
num Events
0
group Id
EG001
num Affected
2
num At Risk
202
num Events
2
group Id
EG002
num Affected
1
num At Risk
84
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
405
num Events
2
group Id
EG001
num Affected
0
num At Risk
202
num Events
0
group Id
EG002
num Affected
0
num At Risk
84
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
term
Cardiac arrest

time Frame

Up to approximately 88 months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice