NCT02853305 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361) · Source last updated 2023-09-08

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 70 months
Other-event reporting threshold: 5%

All-Cause Mortality reported for all randomized participants by course. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pembrolizumab + ST Chemotherapy (Pembro Combo) First Course Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for a maximum of 35 doses PLUS ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.	189 / 349	345 / 349	283 / 351
Pembrolizumab (Pembro) First Course Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for a maximum of 35 doses.	145 / 302	275 / 302	244 / 307
ST Chemotherapy (Chemo) First Course Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.	138 / 342	337 / 342	300 / 352
Pembrolizumab + ST Chemotherapy (Pembro Combo) Second Course Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments \[approximately 2 years\]) administered in combination with ST chemotherapy, and experienced Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).	0 / 14	0 / 14	4 / 14
Pembrolizumab (Pembro) Second Course Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments \[approximately 2 years\]) with SD or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).	0 / 15	1 / 15	8 / 15

Group identifiers: EG000: Pembrolizumab + ST Chemotherapy (Pembro Combo) First Course · EG001: Pembrolizumab (Pembro) First Course · EG002: ST Chemotherapy (Chemo) First Course · EG003: Pembrolizumab + ST Chemotherapy (Pembro Combo) Second Course · EG004: Pembrolizumab (Pembro) 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 25.0
stats
group Id
EG000
num Affected
15
num At Risk
349
num Events
15
group Id
EG001
num Affected
6
num At Risk
302
num Events
8
group Id
EG002
num Affected
19
num At Risk
342
num Events
19
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
349
num Events
0
group Id
EG001
num Affected
1
num At Risk
302
num Events
1
group Id
EG002
num Affected
0
num At Risk
342
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
9
num At Risk
349
num Events
9
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
11
num At Risk
342
num Events
11
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
349
num Events
0
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
1
num At Risk
342
num Events
1
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Haematotoxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
349
num Events
2
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
0
num At Risk
342
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
349
num Events
2
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
3
num At Risk
342
num Events
3
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
10
num At Risk
349
num Events
10
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
2
num At Risk
342
num Events
2
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
12
num At Risk
349
num Events
15
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
10
num At Risk
342
num Events
11
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
349
num Events
1
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
0
num At Risk
342
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
349
num Events
1
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
0
num At Risk
342
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
349
num Events
0
group Id
EG001
num Affected
1
num At Risk
302
num Events
1
group Id
EG002
num Affected
0
num At Risk
342
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
349
num Events
0
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
1
num At Risk
342
num Events
1
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Angina pectoris

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 25.0
stats
group Id
EG000
num Affected
227
num At Risk
349
num Events
334
group Id
EG001
num Affected
75
num At Risk
302
num Events
103
group Id
EG002
num Affected
210
num At Risk
342
num Events
303
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
31
num At Risk
349
num Events
60
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
25
num At Risk
342
num Events
55
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
126
num At Risk
349
num Events
274
group Id
EG001
num Affected
2
num At Risk
302
num Events
2
group Id
EG002
num Affected
129
num At Risk
342
num Events
281
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
86
num At Risk
349
num Events
175
group Id
EG001
num Affected
2
num At Risk
302
num Events
2
group Id
EG002
num Affected
89
num At Risk
342
num Events
180
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
34
num At Risk
349
num Events
43
group Id
EG001
num Affected
30
num At Risk
302
num Events
33
group Id
EG002
num Affected
1
num At Risk
342
num Events
1
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
41
num At Risk
349
num Events
51
group Id
EG001
num Affected
29
num At Risk
302
num Events
35
group Id
EG002
num Affected
29
num At Risk
342
num Events
31
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
12
num At Risk
349
num Events
15
group Id
EG001
num Affected
9
num At Risk
302
num Events
11
group Id
EG002
num Affected
26
num At Risk
342
num Events
26
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
124
num At Risk
349
num Events
155
group Id
EG001
num Affected
56
num At Risk
302
num Events
70
group Id
EG002
num Affected
107
num At Risk
342
num Events
140
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
102
num At Risk
349
num Events
136
group Id
EG001
num Affected
58
num At Risk
302
num Events
81
group Id
EG002
num Affected
73
num At Risk
342
num Events
91
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
14
num At Risk
349
num Events
16
group Id
EG001
num Affected
6
num At Risk
302
num Events
6
group Id
EG002
num Affected
22
num At Risk
342
num Events
27
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
19
num At Risk
349
num Events
20
group Id
EG001
num Affected
1
num At Risk
302
num Events
1
group Id
EG002
num Affected
6
num At Risk
342
num Events
7
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
180
num At Risk
349
num Events
279
group Id
EG001
num Affected
43
num At Risk
302
num Events
53
group Id
EG002
num Affected
154
num At Risk
342
num Events
247
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Nausea

Complete source fields

description

event Groups

deaths Num Affected
283
deaths Num At Risk
351
description
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for a maximum of 35 doses PLUS ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
id
EG000
other Num Affected
345
other Num At Risk
349
serious Num Affected
189
serious Num At Risk
349
title
Pembrolizumab + ST Chemotherapy (Pembro Combo) First Course
deaths Num Affected
244
deaths Num At Risk
307
description
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for a maximum of 35 doses.
id
EG001
other Num Affected
275
other Num At Risk
302
serious Num Affected
145
serious Num At Risk
302
title
Pembrolizumab (Pembro) First Course
deaths Num Affected
300
deaths Num At Risk
352
description
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
id
EG002
other Num Affected
337
other Num At Risk
342
serious Num Affected
138
serious Num At Risk
342
title
ST Chemotherapy (Chemo) First Course
deaths Num Affected
4
deaths Num At Risk
14
description
Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments \[approximately 2 years\]) administered in combination with ST chemotherapy, and experienced Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).
id
EG003
other Num Affected
0
other Num At Risk
14
serious Num Affected
0
serious Num At Risk
14
title
Pembrolizumab + ST Chemotherapy (Pembro Combo) Second Course
deaths Num Affected
8
deaths Num At Risk
15
description
Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments \[approximately 2 years\]) with SD or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).
id
EG004
other Num Affected
1
other Num At Risk
15
serious Num Affected
0
serious Num At Risk
15
title
Pembrolizumab (Pembro) Second Course

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
227
num At Risk
349
num Events
334
group Id
EG001
num Affected
75
num At Risk
302
num Events
103
group Id
EG002
num Affected
210
num At Risk
342
num Events
303
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
31
num At Risk
349
num Events
60
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
25
num At Risk
342
num Events
55
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
126
num At Risk
349
num Events
274
group Id
EG001
num Affected
2
num At Risk
302
num Events
2
group Id
EG002
num Affected
129
num At Risk
342
num Events
281
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
86
num At Risk
349
num Events
175
group Id
EG001
num Affected
2
num At Risk
302
num Events
2
group Id
EG002
num Affected
89
num At Risk
342
num Events
180
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
34
num At Risk
349
num Events
43
group Id
EG001
num Affected
30
num At Risk
302
num Events
33
group Id
EG002
num Affected
1
num At Risk
342
num Events
1
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
41
num At Risk
349
num Events
51
group Id
EG001
num Affected
29
num At Risk
302
num Events
35
group Id
EG002
num Affected
29
num At Risk
342
num Events
31
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
12
num At Risk
349
num Events
15
group Id
EG001
num Affected
9
num At Risk
302
num Events
11
group Id
EG002
num Affected
26
num At Risk
342
num Events
26
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
124
num At Risk
349
num Events
155
group Id
EG001
num Affected
56
num At Risk
302
num Events
70
group Id
EG002
num Affected
107
num At Risk
342
num Events
140
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
102
num At Risk
349
num Events
136
group Id
EG001
num Affected
58
num At Risk
302
num Events
81
group Id
EG002
num Affected
73
num At Risk
342
num Events
91
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
14
num At Risk
349
num Events
16
group Id
EG001
num Affected
6
num At Risk
302
num Events
6
group Id
EG002
num Affected
22
num At Risk
342
num Events
27
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
19
num At Risk
349
num Events
20
group Id
EG001
num Affected
1
num At Risk
302
num Events
1
group Id
EG002
num Affected
6
num At Risk
342
num Events
7
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
180
num At Risk
349
num Events
279
group Id
EG001
num Affected
43
num At Risk
302
num Events
53
group Id
EG002
num Affected
154
num At Risk
342
num Events
247
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
15
num At Risk
349
num Events
15
group Id
EG001
num Affected
6
num At Risk
302
num Events
8
group Id
EG002
num Affected
19
num At Risk
342
num Events
19
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
349
num Events
0
group Id
EG001
num Affected
1
num At Risk
302
num Events
1
group Id
EG002
num Affected
0
num At Risk
342
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
9
num At Risk
349
num Events
9
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
11
num At Risk
342
num Events
11
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
349
num Events
0
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
1
num At Risk
342
num Events
1
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Haematotoxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
349
num Events
2
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
0
num At Risk
342
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
349
num Events
2
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
3
num At Risk
342
num Events
3
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
10
num At Risk
349
num Events
10
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
2
num At Risk
342
num Events
2
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
12
num At Risk
349
num Events
15
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
10
num At Risk
342
num Events
11
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
349
num Events
1
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
0
num At Risk
342
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
349
num Events
1
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
0
num At Risk
342
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
349
num Events
0
group Id
EG001
num Affected
1
num At Risk
302
num Events
1
group Id
EG002
num Affected
0
num At Risk
342
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
349
num Events
0
group Id
EG001
num Affected
0
num At Risk
302
num Events
0
group Id
EG002
num Affected
1
num At Risk
342
num Events
1
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
15
num Events
0
term
Angina pectoris

time Frame

Up to approximately 70 months

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

Preserved source evidence · Not medical advice