NCT03914612 · ADVERSE EVENTS

Adverse events

Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer · Source last updated 2026-07-31

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: Adverse Events monitored/assessed up to 28.39 months; the interquartile range was (0.79 months, 3.42 months). All-Cause Mortality monitored/assessed up to 37.85 months; the interquartile range was (6.37 months, 30.62 months).
Other-event reporting threshold: 0%

Assessed by Common Terminology Criteria for Adverse Events (CTCAE). All Enrolled participants monitored/assessed for All-Cause Mortality; participants that received intervention (safety population) monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
(dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.	50 / 106	105 / 106	16 / 113
(dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.	66 / 109	107 / 109	7 / 112
(pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.	125 / 274	256 / 274	47 / 295
(pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.	152 / 276	258 / 276	42 / 293

Group identifiers: EG000: (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) · EG001: (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) · EG002: (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) · EG003: (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
10
num At Risk
106
group Id
EG001
num Affected
20
num At Risk
109
group Id
EG002
num Affected
25
num At Risk
274
group Id
EG003
num Affected
38
num At Risk
276
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
109
group Id
EG002
num Affected
2
num At Risk
274
group Id
EG003
num Affected
0
num At Risk
276
term
Blood and lymphatic system disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
5
num At Risk
109
group Id
EG002
num Affected
4
num At Risk
274
group Id
EG003
num Affected
9
num At Risk
276
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
1
num At Risk
276
term
Hemolysis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
1
num At Risk
274
group Id
EG003
num Affected
0
num At Risk
276
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
106
group Id
EG001
num Affected
2
num At Risk
109
group Id
EG002
num Affected
1
num At Risk
274
group Id
EG003
num Affected
2
num At Risk
276
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
1
num At Risk
274
group Id
EG003
num Affected
2
num At Risk
276
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
2
num At Risk
276
term
Chest pain - cardiac
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
0
num At Risk
276
term
Heart failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
1
num At Risk
274
group Id
EG003
num Affected
1
num At Risk
276
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
0
num At Risk
276
term
Myocarditis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
1
num At Risk
276
term
Palpitations

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
58
num At Risk
106
group Id
EG001
num Affected
63
num At Risk
109
group Id
EG002
num Affected
144
num At Risk
274
group Id
EG003
num Affected
152
num At Risk
276
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
2
num At Risk
109
group Id
EG002
num Affected
7
num At Risk
274
group Id
EG003
num Affected
5
num At Risk
276
term
Blood and lymphatic system disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
2
num At Risk
274
group Id
EG003
num Affected
4
num At Risk
276
term
Eosinophilia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
5
num At Risk
109
group Id
EG002
num Affected
4
num At Risk
274
group Id
EG003
num Affected
9
num At Risk
276
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
1
num At Risk
276
term
Hemolysis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
106
group Id
EG001
num Affected
2
num At Risk
109
group Id
EG002
num Affected
1
num At Risk
274
group Id
EG003
num Affected
0
num At Risk
276
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
1
num At Risk
276
term
Lymph node pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
106
group Id
EG001
num Affected
4
num At Risk
109
group Id
EG002
num Affected
2
num At Risk
274
group Id
EG003
num Affected
3
num At Risk
276
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
1
num At Risk
274
group Id
EG003
num Affected
2
num At Risk
276
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
2
num At Risk
109
group Id
EG002
num Affected
2
num At Risk
274
group Id
EG003
num Affected
1
num At Risk
276
term
Cardiac disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
2
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
5
num At Risk
276
term
Chest pain - cardiac
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
1
num At Risk
276
term
Heart failure

Complete source fields

description

event Groups

deaths Num Affected
16
deaths Num At Risk
113
description
COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
105
other Num At Risk
106
serious Num Affected
50
serious Num At Risk
106
title
(dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
deaths Num Affected
7
deaths Num At Risk
112
description
COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
107
other Num At Risk
109
serious Num Affected
66
serious Num At Risk
109
title
(dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
deaths Num Affected
47
deaths Num At Risk
295
description
COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
id
EG002
other Num Affected
256
other Num At Risk
274
serious Num Affected
125
serious Num At Risk
274
title
(pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
deaths Num Affected
42
deaths Num At Risk
293
description
COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
id
EG003
other Num Affected
258
other Num At Risk
276
serious Num Affected
152
serious Num At Risk
276
title
(pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
58
num At Risk
106
group Id
EG001
num Affected
63
num At Risk
109
group Id
EG002
num Affected
144
num At Risk
274
group Id
EG003
num Affected
152
num At Risk
276
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
2
num At Risk
109
group Id
EG002
num Affected
7
num At Risk
274
group Id
EG003
num Affected
5
num At Risk
276
term
Blood and lymphatic system disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
2
num At Risk
274
group Id
EG003
num Affected
4
num At Risk
276
term
Eosinophilia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
5
num At Risk
109
group Id
EG002
num Affected
4
num At Risk
274
group Id
EG003
num Affected
9
num At Risk
276
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
1
num At Risk
276
term
Hemolysis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
106
group Id
EG001
num Affected
2
num At Risk
109
group Id
EG002
num Affected
1
num At Risk
274
group Id
EG003
num Affected
0
num At Risk
276
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
1
num At Risk
276
term
Lymph node pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
106
group Id
EG001
num Affected
4
num At Risk
109
group Id
EG002
num Affected
2
num At Risk
274
group Id
EG003
num Affected
3
num At Risk
276
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
1
num At Risk
274
group Id
EG003
num Affected
2
num At Risk
276
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
2
num At Risk
109
group Id
EG002
num Affected
2
num At Risk
274
group Id
EG003
num Affected
1
num At Risk
276
term
Cardiac disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
2
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
5
num At Risk
276
term
Chest pain - cardiac
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
1
num At Risk
276
term
Heart failure

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
10
num At Risk
106
group Id
EG001
num Affected
20
num At Risk
109
group Id
EG002
num Affected
25
num At Risk
274
group Id
EG003
num Affected
38
num At Risk
276
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
109
group Id
EG002
num Affected
2
num At Risk
274
group Id
EG003
num Affected
0
num At Risk
276
term
Blood and lymphatic system disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
5
num At Risk
109
group Id
EG002
num Affected
4
num At Risk
274
group Id
EG003
num Affected
9
num At Risk
276
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
1
num At Risk
276
term
Hemolysis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
1
num At Risk
274
group Id
EG003
num Affected
0
num At Risk
276
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
106
group Id
EG001
num Affected
2
num At Risk
109
group Id
EG002
num Affected
1
num At Risk
274
group Id
EG003
num Affected
2
num At Risk
276
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
1
num At Risk
274
group Id
EG003
num Affected
2
num At Risk
276
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
2
num At Risk
276
term
Chest pain - cardiac
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
0
num At Risk
276
term
Heart failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
1
num At Risk
274
group Id
EG003
num Affected
1
num At Risk
276
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
0
num At Risk
276
term
Myocarditis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
109
group Id
EG002
num Affected
0
num At Risk
274
group Id
EG003
num Affected
1
num At Risk
276
term
Palpitations

time Frame

Adverse Events monitored/assessed up to 28.39 months; the interquartile range was (0.79 months, 3.42 months). All-Cause Mortality monitored/assessed up to 37.85 months; the interquartile range was (6.37 months, 30.62 months).

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

Preserved source evidence · Not medical advice