NCT04221945 · ADVERSE EVENTS

Adverse events

Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047) · Source last updated 2026-02-20

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: All-cause mortality (ACM): from allocation up to a maximum of 55 months. Adverse events (AEs): from start of treatment up to a maximum of 55 months.
Other-event reporting threshold: 5%

The ACM population were allocated participants; the AE population were treated participants. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pembrolizumab + CCRT Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).	175 / 528	528 / 528	107 / 529
Placebo + CCRT Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).	153 / 530	525 / 530	140 / 531

Group identifiers: EG000: Pembrolizumab + CCRT · EG001: Placebo + CCRT

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 27.1
stats
group Id
EG000
num Affected
16
num At Risk
528
num Events
20
group Id
EG001
num Affected
13
num At Risk
530
num Events
13
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
528
num Events
0
group Id
EG001
num Affected
1
num At Risk
530
num Events
1
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
5
num At Risk
528
num Events
5
group Id
EG001
num Affected
4
num At Risk
530
num Events
4
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
528
num Events
0
group Id
EG001
num Affected
1
num At Risk
530
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
528
num Events
0
group Id
EG001
num Affected
2
num At Risk
530
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
528
num Events
2
group Id
EG001
num Affected
0
num At Risk
530
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
528
num Events
1
group Id
EG001
num Affected
1
num At Risk
530
num Events
1
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
528
num Events
2
group Id
EG001
num Affected
0
num At Risk
530
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
528
num Events
0
group Id
EG001
num Affected
1
num At Risk
530
num Events
1
term
Glucocorticoid deficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
528
num Events
1
group Id
EG001
num Affected
0
num At Risk
530
num Events
0
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
528
num Events
2
group Id
EG001
num Affected
0
num At Risk
530
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
528
num Events
1
group Id
EG001
num Affected
0
num At Risk
530
num Events
0
term
Secondary adrenocortical insufficiency

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 27.1
stats
group Id
EG000
num Affected
356
num At Risk
528
num Events
549
group Id
EG001
num Affected
342
num At Risk
530
num Events
489
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
129
num At Risk
528
num Events
216
group Id
EG001
num Affected
97
num At Risk
530
num Events
160
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
52
num At Risk
528
num Events
77
group Id
EG001
num Affected
56
num At Risk
530
num Events
80
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
124
num At Risk
528
num Events
200
group Id
EG001
num Affected
107
num At Risk
530
num Events
161
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
80
num At Risk
528
num Events
89
group Id
EG001
num Affected
69
num At Risk
530
num Events
86
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
31
num At Risk
528
num Events
32
group Id
EG001
num Affected
35
num At Risk
530
num Events
39
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
62
num At Risk
528
num Events
70
group Id
EG001
num Affected
15
num At Risk
530
num Events
15
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
119
num At Risk
528
num Events
146
group Id
EG001
num Affected
39
num At Risk
530
num Events
48
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
78
num At Risk
528
num Events
94
group Id
EG001
num Affected
78
num At Risk
530
num Events
102
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
35
num At Risk
528
num Events
39
group Id
EG001
num Affected
35
num At Risk
530
num Events
39
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
118
num At Risk
528
num Events
139
group Id
EG001
num Affected
122
num At Risk
530
num Events
151
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
297
num At Risk
528
num Events
479
group Id
EG001
num Affected
296
num At Risk
530
num Events
421
term
Diarrhoea

Complete source fields

description

event Groups

deaths Num Affected
107
deaths Num At Risk
529
description
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
id
EG000
other Num Affected
528
other Num At Risk
528
serious Num Affected
175
serious Num At Risk
528
title
Pembrolizumab + CCRT
deaths Num Affected
140
deaths Num At Risk
531
description
Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
id
EG001
other Num Affected
525
other Num At Risk
530
serious Num Affected
153
serious Num At Risk
530
title
Placebo + CCRT

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
356
num At Risk
528
num Events
549
group Id
EG001
num Affected
342
num At Risk
530
num Events
489
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
129
num At Risk
528
num Events
216
group Id
EG001
num Affected
97
num At Risk
530
num Events
160
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
52
num At Risk
528
num Events
77
group Id
EG001
num Affected
56
num At Risk
530
num Events
80
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
124
num At Risk
528
num Events
200
group Id
EG001
num Affected
107
num At Risk
530
num Events
161
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
80
num At Risk
528
num Events
89
group Id
EG001
num Affected
69
num At Risk
530
num Events
86
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
31
num At Risk
528
num Events
32
group Id
EG001
num Affected
35
num At Risk
530
num Events
39
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
62
num At Risk
528
num Events
70
group Id
EG001
num Affected
15
num At Risk
530
num Events
15
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
119
num At Risk
528
num Events
146
group Id
EG001
num Affected
39
num At Risk
530
num Events
48
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
78
num At Risk
528
num Events
94
group Id
EG001
num Affected
78
num At Risk
530
num Events
102
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
35
num At Risk
528
num Events
39
group Id
EG001
num Affected
35
num At Risk
530
num Events
39
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
118
num At Risk
528
num Events
139
group Id
EG001
num Affected
122
num At Risk
530
num Events
151
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
297
num At Risk
528
num Events
479
group Id
EG001
num Affected
296
num At Risk
530
num Events
421
term
Diarrhoea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
16
num At Risk
528
num Events
20
group Id
EG001
num Affected
13
num At Risk
530
num Events
13
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
528
num Events
0
group Id
EG001
num Affected
1
num At Risk
530
num Events
1
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
5
num At Risk
528
num Events
5
group Id
EG001
num Affected
4
num At Risk
530
num Events
4
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
528
num Events
0
group Id
EG001
num Affected
1
num At Risk
530
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
528
num Events
0
group Id
EG001
num Affected
2
num At Risk
530
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
528
num Events
2
group Id
EG001
num Affected
0
num At Risk
530
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
528
num Events
1
group Id
EG001
num Affected
1
num At Risk
530
num Events
1
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
528
num Events
2
group Id
EG001
num Affected
0
num At Risk
530
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
528
num Events
0
group Id
EG001
num Affected
1
num At Risk
530
num Events
1
term
Glucocorticoid deficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
528
num Events
1
group Id
EG001
num Affected
0
num At Risk
530
num Events
0
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
528
num Events
2
group Id
EG001
num Affected
0
num At Risk
530
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
528
num Events
1
group Id
EG001
num Affected
0
num At Risk
530
num Events
0
term
Secondary adrenocortical insufficiency

time Frame

All-cause mortality (ACM): from allocation up to a maximum of 55 months. Adverse events (AEs): from start of treatment up to a maximum of 55 months.

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