NCT03653507 · ADVERSE EVENTS

Adverse events

A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW). · Source last updated 2026-07-16

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: All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
Other-event reporting threshold: 5%

SAF. Participants may have repeated in the arm groups.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Zolbetuximab Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.	123 / 254	249 / 254	180 / 254
Capecitabine Participants received capecitabine orally at 1000 mg/m\^2 (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.	249 / 503	481 / 503	387 / 503
Oxaliplatin Participants received an IV infusion of oxaliplatin 130 mg/m\^2 on day 1 of each cycle over 2 hours for a maximum of 8 treatments. Each cycle was approximately 21 days.	249 / 503	481 / 503	387 / 503
Placebo Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.	126 / 249	232 / 249	207 / 249

Group identifiers: EG000: Zolbetuximab · EG001: Capecitabine · EG002: Oxaliplatin · EG003: Placebo

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 v25
stats
group Id
EG000
num Affected
1
num At Risk
254
num Events
1
group Id
EG001
num Affected
1
num At Risk
503
num Events
1
group Id
EG002
num Affected
1
num At Risk
503
num Events
1
group Id
EG003
num Affected
0
num At Risk
249
num Events
0
term
Agranulocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
5
num At Risk
254
num Events
6
group Id
EG001
num Affected
11
num At Risk
503
num Events
15
group Id
EG002
num Affected
11
num At Risk
503
num Events
15
group Id
EG003
num Affected
6
num At Risk
249
num Events
9
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
0
num At Risk
254
num Events
0
group Id
EG001
num Affected
1
num At Risk
503
num Events
1
group Id
EG002
num Affected
1
num At Risk
503
num Events
1
group Id
EG003
num Affected
1
num At Risk
249
num Events
1
term
Bone marrow infiltration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
1
num At Risk
254
num Events
2
group Id
EG001
num Affected
2
num At Risk
503
num Events
3
group Id
EG002
num Affected
2
num At Risk
503
num Events
3
group Id
EG003
num Affected
1
num At Risk
249
num Events
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
0
num At Risk
254
num Events
0
group Id
EG001
num Affected
3
num At Risk
503
num Events
4
group Id
EG002
num Affected
3
num At Risk
503
num Events
4
group Id
EG003
num Affected
3
num At Risk
249
num Events
4
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
0
num At Risk
254
num Events
0
group Id
EG001
num Affected
1
num At Risk
503
num Events
1
group Id
EG002
num Affected
1
num At Risk
503
num Events
1
group Id
EG003
num Affected
1
num At Risk
249
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
0
num At Risk
254
num Events
0
group Id
EG001
num Affected
1
num At Risk
503
num Events
1
group Id
EG002
num Affected
1
num At Risk
503
num Events
1
group Id
EG003
num Affected
1
num At Risk
249
num Events
1
term
Microangiopathic haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
4
num At Risk
254
num Events
4
group Id
EG001
num Affected
6
num At Risk
503
num Events
7
group Id
EG002
num Affected
6
num At Risk
503
num Events
7
group Id
EG003
num Affected
2
num At Risk
249
num Events
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
3
num At Risk
254
num Events
3
group Id
EG001
num Affected
5
num At Risk
503
num Events
5
group Id
EG002
num Affected
5
num At Risk
503
num Events
5
group Id
EG003
num Affected
2
num At Risk
249
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
1
num At Risk
254
num Events
1
group Id
EG001
num Affected
1
num At Risk
503
num Events
1
group Id
EG002
num Affected
1
num At Risk
503
num Events
1
group Id
EG003
num Affected
0
num At Risk
249
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
1
num At Risk
254
num Events
1
group Id
EG001
num Affected
1
num At Risk
503
num Events
1
group Id
EG002
num Affected
1
num At Risk
503
num Events
1
group Id
EG003
num Affected
0
num At Risk
249
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
0
num At Risk
254
num Events
0
group Id
EG001
num Affected
1
num At Risk
503
num Events
1
group Id
EG002
num Affected
1
num At Risk
503
num Events
1
group Id
EG003
num Affected
1
num At Risk
249
num Events
1
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 v25
stats
group Id
EG000
num Affected
90
num At Risk
254
num Events
255
group Id
EG001
num Affected
179
num At Risk
503
num Events
480
group Id
EG002
num Affected
179
num At Risk
503
num Events
480
group Id
EG003
num Affected
89
num At Risk
249
num Events
225
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
17
num At Risk
254
num Events
41
group Id
EG001
num Affected
25
num At Risk
503
num Events
63
group Id
EG002
num Affected
25
num At Risk
503
num Events
63
group Id
EG003
num Affected
8
num At Risk
249
num Events
22
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
48
num At Risk
254
num Events
131
group Id
EG001
num Affected
82
num At Risk
503
num Events
212
group Id
EG002
num Affected
82
num At Risk
503
num Events
212
group Id
EG003
num Affected
34
num At Risk
249
num Events
81
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
27
num At Risk
254
num Events
68
group Id
EG001
num Affected
56
num At Risk
503
num Events
133
group Id
EG002
num Affected
56
num At Risk
503
num Events
133
group Id
EG003
num Affected
29
num At Risk
249
num Events
65
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
15
num At Risk
254
num Events
21
group Id
EG001
num Affected
29
num At Risk
503
num Events
36
group Id
EG002
num Affected
29
num At Risk
503
num Events
36
group Id
EG003
num Affected
14
num At Risk
249
num Events
15
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
40
num At Risk
254
num Events
54
group Id
EG001
num Affected
91
num At Risk
503
num Events
120
group Id
EG002
num Affected
91
num At Risk
503
num Events
120
group Id
EG003
num Affected
51
num At Risk
249
num Events
66
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
24
num At Risk
254
num Events
37
group Id
EG001
num Affected
37
num At Risk
503
num Events
57
group Id
EG002
num Affected
37
num At Risk
503
num Events
57
group Id
EG003
num Affected
13
num At Risk
249
num Events
20
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
40
num At Risk
254
num Events
53
group Id
EG001
num Affected
93
num At Risk
503
num Events
121
group Id
EG002
num Affected
93
num At Risk
503
num Events
121
group Id
EG003
num Affected
53
num At Risk
249
num Events
68
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
79
num At Risk
254
num Events
134
group Id
EG001
num Affected
162
num At Risk
503
num Events
322
group Id
EG002
num Affected
162
num At Risk
503
num Events
322
group Id
EG003
num Affected
83
num At Risk
249
num Events
188
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
174
num At Risk
254
num Events
503
group Id
EG001
num Affected
297
num At Risk
503
num Events
786
group Id
EG002
num Affected
297
num At Risk
503
num Events
786
group Id
EG003
num Affected
123
num At Risk
249
num Events
283
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
164
num At Risk
254
num Events
463
group Id
EG001
num Affected
236
num At Risk
503
num Events
616
group Id
EG002
num Affected
236
num At Risk
503
num Events
616
group Id
EG003
num Affected
72
num At Risk
249
num Events
153
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
34
num At Risk
254
num Events
67
group Id
EG001
num Affected
65
num At Risk
503
num Events
122
group Id
EG002
num Affected
65
num At Risk
503
num Events
122
group Id
EG003
num Affected
31
num At Risk
249
num Events
55
term
Asthenia

Complete source fields

description

SAF. Participants may have repeated in the arm groups.

event Groups

deaths Num Affected
180
deaths Num At Risk
254
description
Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
id
EG000
other Num Affected
249
other Num At Risk
254
serious Num Affected
123
serious Num At Risk
254
title
Zolbetuximab
deaths Num Affected
387
deaths Num At Risk
503
description
Participants received capecitabine orally at 1000 mg/m\^2 (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
id
EG001
other Num Affected
481
other Num At Risk
503
serious Num Affected
249
serious Num At Risk
503
title
Capecitabine
deaths Num Affected
387
deaths Num At Risk
503
description
Participants received an IV infusion of oxaliplatin 130 mg/m\^2 on day 1 of each cycle over 2 hours for a maximum of 8 treatments. Each cycle was approximately 21 days.
id
EG002
other Num Affected
481
other Num At Risk
503
serious Num Affected
249
serious Num At Risk
503
title
Oxaliplatin
deaths Num Affected
207
deaths Num At Risk
249
description
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
id
EG003
other Num Affected
232
other Num At Risk
249
serious Num Affected
126
serious Num At Risk
249
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
90
num At Risk
254
num Events
255
group Id
EG001
num Affected
179
num At Risk
503
num Events
480
group Id
EG002
num Affected
179
num At Risk
503
num Events
480
group Id
EG003
num Affected
89
num At Risk
249
num Events
225
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
17
num At Risk
254
num Events
41
group Id
EG001
num Affected
25
num At Risk
503
num Events
63
group Id
EG002
num Affected
25
num At Risk
503
num Events
63
group Id
EG003
num Affected
8
num At Risk
249
num Events
22
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
48
num At Risk
254
num Events
131
group Id
EG001
num Affected
82
num At Risk
503
num Events
212
group Id
EG002
num Affected
82
num At Risk
503
num Events
212
group Id
EG003
num Affected
34
num At Risk
249
num Events
81
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
27
num At Risk
254
num Events
68
group Id
EG001
num Affected
56
num At Risk
503
num Events
133
group Id
EG002
num Affected
56
num At Risk
503
num Events
133
group Id
EG003
num Affected
29
num At Risk
249
num Events
65
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
15
num At Risk
254
num Events
21
group Id
EG001
num Affected
29
num At Risk
503
num Events
36
group Id
EG002
num Affected
29
num At Risk
503
num Events
36
group Id
EG003
num Affected
14
num At Risk
249
num Events
15
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
40
num At Risk
254
num Events
54
group Id
EG001
num Affected
91
num At Risk
503
num Events
120
group Id
EG002
num Affected
91
num At Risk
503
num Events
120
group Id
EG003
num Affected
51
num At Risk
249
num Events
66
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
24
num At Risk
254
num Events
37
group Id
EG001
num Affected
37
num At Risk
503
num Events
57
group Id
EG002
num Affected
37
num At Risk
503
num Events
57
group Id
EG003
num Affected
13
num At Risk
249
num Events
20
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
40
num At Risk
254
num Events
53
group Id
EG001
num Affected
93
num At Risk
503
num Events
121
group Id
EG002
num Affected
93
num At Risk
503
num Events
121
group Id
EG003
num Affected
53
num At Risk
249
num Events
68
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
79
num At Risk
254
num Events
134
group Id
EG001
num Affected
162
num At Risk
503
num Events
322
group Id
EG002
num Affected
162
num At Risk
503
num Events
322
group Id
EG003
num Affected
83
num At Risk
249
num Events
188
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
174
num At Risk
254
num Events
503
group Id
EG001
num Affected
297
num At Risk
503
num Events
786
group Id
EG002
num Affected
297
num At Risk
503
num Events
786
group Id
EG003
num Affected
123
num At Risk
249
num Events
283
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
164
num At Risk
254
num Events
463
group Id
EG001
num Affected
236
num At Risk
503
num Events
616
group Id
EG002
num Affected
236
num At Risk
503
num Events
616
group Id
EG003
num Affected
72
num At Risk
249
num Events
153
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
34
num At Risk
254
num Events
67
group Id
EG001
num Affected
65
num At Risk
503
num Events
122
group Id
EG002
num Affected
65
num At Risk
503
num Events
122
group Id
EG003
num Affected
31
num At Risk
249
num Events
55
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
1
num At Risk
254
num Events
1
group Id
EG001
num Affected
1
num At Risk
503
num Events
1
group Id
EG002
num Affected
1
num At Risk
503
num Events
1
group Id
EG003
num Affected
0
num At Risk
249
num Events
0
term
Agranulocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
5
num At Risk
254
num Events
6
group Id
EG001
num Affected
11
num At Risk
503
num Events
15
group Id
EG002
num Affected
11
num At Risk
503
num Events
15
group Id
EG003
num Affected
6
num At Risk
249
num Events
9
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
0
num At Risk
254
num Events
0
group Id
EG001
num Affected
1
num At Risk
503
num Events
1
group Id
EG002
num Affected
1
num At Risk
503
num Events
1
group Id
EG003
num Affected
1
num At Risk
249
num Events
1
term
Bone marrow infiltration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
1
num At Risk
254
num Events
2
group Id
EG001
num Affected
2
num At Risk
503
num Events
3
group Id
EG002
num Affected
2
num At Risk
503
num Events
3
group Id
EG003
num Affected
1
num At Risk
249
num Events
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
0
num At Risk
254
num Events
0
group Id
EG001
num Affected
3
num At Risk
503
num Events
4
group Id
EG002
num Affected
3
num At Risk
503
num Events
4
group Id
EG003
num Affected
3
num At Risk
249
num Events
4
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
0
num At Risk
254
num Events
0
group Id
EG001
num Affected
1
num At Risk
503
num Events
1
group Id
EG002
num Affected
1
num At Risk
503
num Events
1
group Id
EG003
num Affected
1
num At Risk
249
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
0
num At Risk
254
num Events
0
group Id
EG001
num Affected
1
num At Risk
503
num Events
1
group Id
EG002
num Affected
1
num At Risk
503
num Events
1
group Id
EG003
num Affected
1
num At Risk
249
num Events
1
term
Microangiopathic haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
4
num At Risk
254
num Events
4
group Id
EG001
num Affected
6
num At Risk
503
num Events
7
group Id
EG002
num Affected
6
num At Risk
503
num Events
7
group Id
EG003
num Affected
2
num At Risk
249
num Events
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
3
num At Risk
254
num Events
3
group Id
EG001
num Affected
5
num At Risk
503
num Events
5
group Id
EG002
num Affected
5
num At Risk
503
num Events
5
group Id
EG003
num Affected
2
num At Risk
249
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
1
num At Risk
254
num Events
1
group Id
EG001
num Affected
1
num At Risk
503
num Events
1
group Id
EG002
num Affected
1
num At Risk
503
num Events
1
group Id
EG003
num Affected
0
num At Risk
249
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
1
num At Risk
254
num Events
1
group Id
EG001
num Affected
1
num At Risk
503
num Events
1
group Id
EG002
num Affected
1
num At Risk
503
num Events
1
group Id
EG003
num Affected
0
num At Risk
249
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25
stats
group Id
EG000
num Affected
0
num At Risk
254
num Events
0
group Id
EG001
num Affected
1
num At Risk
503
num Events
1
group Id
EG002
num Affected
1
num At Risk
503
num Events
1
group Id
EG003
num Affected
1
num At Risk
249
num Events
1
term
Cardiac arrest

time Frame

All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days

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

Preserved source evidence · Not medical advice