NCT04003636 · ADVERSE EVENTS

Adverse events

Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966) · Source last updated 2026-03-24

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 65 months
Other-event reporting threshold: 5%

All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
First Course: Arm A: Pembrolizumab + Chemotherapy Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.	280 / 529	513 / 529	483 / 533
First Course: Arm B: Placebo + Chemotherapy Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.	264 / 534	522 / 534	505 / 536
Second Course: Arm A: Pembrolizumab + Chemotherapy Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200 mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.	0 / 10	10 / 10	4 / 10

Group identifiers: EG000: First Course: Arm A: Pembrolizumab + Chemotherapy · EG001: First Course: Arm B: Placebo + Chemotherapy · EG002: Second Course: Arm A: Pembrolizumab + Chemotherapy

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 28.0
stats
group Id
EG000
num Affected
13
num At Risk
529
num Events
13
group Id
EG001
num Affected
10
num At Risk
534
num Events
10
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
534
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Coombs negative haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
534
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
1
num At Risk
534
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
7
num At Risk
529
num Events
8
group Id
EG001
num Affected
8
num At Risk
534
num Events
8
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
2
num At Risk
529
num Events
2
group Id
EG001
num Affected
0
num At Risk
534
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
529
num Events
0
group Id
EG001
num Affected
1
num At Risk
534
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
529
num Events
0
group Id
EG001
num Affected
1
num At Risk
534
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Microangiopathic haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
2
num At Risk
529
num Events
2
group Id
EG001
num Affected
1
num At Risk
534
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
534
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
529
num Events
3
group Id
EG001
num Affected
1
num At Risk
534
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
534
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Acute coronary syndrome

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 28.0
stats
group Id
EG000
num Affected
315
num At Risk
529
num Events
530
group Id
EG001
num Affected
307
num At Risk
534
num Events
488
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
46
num At Risk
529
num Events
47
group Id
EG001
num Affected
14
num At Risk
534
num Events
14
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
534
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Blepharitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
37
num At Risk
529
num Events
41
group Id
EG001
num Affected
34
num At Risk
534
num Events
43
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
89
num At Risk
529
num Events
124
group Id
EG001
num Affected
117
num At Risk
534
num Events
155
group Id
EG002
num Affected
2
num At Risk
10
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
40
num At Risk
529
num Events
53
group Id
EG001
num Affected
58
num At Risk
534
num Events
74
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
30
num At Risk
529
num Events
32
group Id
EG001
num Affected
33
num At Risk
534
num Events
34
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
185
num At Risk
529
num Events
227
group Id
EG001
num Affected
189
num At Risk
534
num Events
234
group Id
EG002
num Affected
3
num At Risk
10
num Events
3
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
102
num At Risk
529
num Events
150
group Id
EG001
num Affected
97
num At Risk
534
num Events
155
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
33
num At Risk
529
num Events
38
group Id
EG001
num Affected
56
num At Risk
534
num Events
65
group Id
EG002
num Affected
2
num At Risk
10
num Events
2
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
233
num At Risk
529
num Events
419
group Id
EG001
num Affected
248
num At Risk
534
num Events
425
group Id
EG002
num Affected
3
num At Risk
10
num Events
4
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
2
num At Risk
534
num Events
2
group Id
EG002
num Affected
2
num At Risk
10
num Events
2
term
Oesophagitis

Complete source fields

description

event Groups

deaths Num Affected
483
deaths Num At Risk
533
description
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
id
EG000
other Num Affected
513
other Num At Risk
529
serious Num Affected
280
serious Num At Risk
529
title
First Course: Arm A: Pembrolizumab + Chemotherapy
deaths Num Affected
505
deaths Num At Risk
536
description
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
id
EG001
other Num Affected
522
other Num At Risk
534
serious Num Affected
264
serious Num At Risk
534
title
First Course: Arm B: Placebo + Chemotherapy
deaths Num Affected
4
deaths Num At Risk
10
description
Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200 mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
id
EG002
other Num Affected
10
other Num At Risk
10
serious Num Affected
0
serious Num At Risk
10
title
Second Course: Arm A: Pembrolizumab + Chemotherapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
315
num At Risk
529
num Events
530
group Id
EG001
num Affected
307
num At Risk
534
num Events
488
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
46
num At Risk
529
num Events
47
group Id
EG001
num Affected
14
num At Risk
534
num Events
14
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
534
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Blepharitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
37
num At Risk
529
num Events
41
group Id
EG001
num Affected
34
num At Risk
534
num Events
43
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
89
num At Risk
529
num Events
124
group Id
EG001
num Affected
117
num At Risk
534
num Events
155
group Id
EG002
num Affected
2
num At Risk
10
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
40
num At Risk
529
num Events
53
group Id
EG001
num Affected
58
num At Risk
534
num Events
74
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
30
num At Risk
529
num Events
32
group Id
EG001
num Affected
33
num At Risk
534
num Events
34
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
185
num At Risk
529
num Events
227
group Id
EG001
num Affected
189
num At Risk
534
num Events
234
group Id
EG002
num Affected
3
num At Risk
10
num Events
3
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
102
num At Risk
529
num Events
150
group Id
EG001
num Affected
97
num At Risk
534
num Events
155
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
33
num At Risk
529
num Events
38
group Id
EG001
num Affected
56
num At Risk
534
num Events
65
group Id
EG002
num Affected
2
num At Risk
10
num Events
2
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
233
num At Risk
529
num Events
419
group Id
EG001
num Affected
248
num At Risk
534
num Events
425
group Id
EG002
num Affected
3
num At Risk
10
num Events
4
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
2
num At Risk
534
num Events
2
group Id
EG002
num Affected
2
num At Risk
10
num Events
2
term
Oesophagitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
13
num At Risk
529
num Events
13
group Id
EG001
num Affected
10
num At Risk
534
num Events
10
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
534
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Coombs negative haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
534
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
1
num At Risk
534
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
7
num At Risk
529
num Events
8
group Id
EG001
num Affected
8
num At Risk
534
num Events
8
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
2
num At Risk
529
num Events
2
group Id
EG001
num Affected
0
num At Risk
534
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
529
num Events
0
group Id
EG001
num Affected
1
num At Risk
534
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
529
num Events
0
group Id
EG001
num Affected
1
num At Risk
534
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Microangiopathic haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
2
num At Risk
529
num Events
2
group Id
EG001
num Affected
1
num At Risk
534
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
534
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
529
num Events
3
group Id
EG001
num Affected
1
num At Risk
534
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
529
num Events
1
group Id
EG001
num Affected
0
num At Risk
534
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Acute coronary syndrome

time Frame

Up to approximately 65 months

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

Preserved source evidence · Not medical advice