NCT03582475 · ADVERSE EVENTS

Adverse events

Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate · Source last updated 2025-11-12

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 are collected form consent to 90 days post treatment with a median follow up of 34 months.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV	7 / 7	7 / 7	3 / 7
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.	7 / 8	6 / 8	3 / 8

Group identifiers: EG000: Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer · EG001: Cohort 2: Small Cell or Neuroendocrine Prostate Cancer

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
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Aspiration pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Artirial Fibrilation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
2
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Electrolyte Toxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
2
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Hydronephrosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Pyelonephritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Seizure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Sepsis due to urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
2
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Urinary tract obstruction

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
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
7
num Events
5
group Id
EG001
num Affected
2
num At Risk
8
num Events
2
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
7
num Events
12
group Id
EG001
num Affected
4
num At Risk
8
num Events
5
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
2
num At Risk
8
num Events
2
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
B-12 deficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
7
num Events
3
group Id
EG001
num Affected
2
num At Risk
8
num Events
2
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Bicep tendon tear
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Body odor
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Breast nodularity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Bronchial thickening
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
2
num At Risk
8
num Events
2
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Chest tightness

Complete source fields

event Groups

deaths Num Affected
3
deaths Num At Risk
7
description
Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV
id
EG000
other Num Affected
7
other Num At Risk
7
serious Num Affected
7
serious Num At Risk
7
title
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer
deaths Num Affected
3
deaths Num At Risk
8
description
Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
6
other Num At Risk
8
serious Num Affected
7
serious Num At Risk
8
title
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
7
num Events
5
group Id
EG001
num Affected
2
num At Risk
8
num Events
2
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
7
num Events
12
group Id
EG001
num Affected
4
num At Risk
8
num Events
5
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
2
num At Risk
8
num Events
2
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
B-12 deficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
7
num Events
3
group Id
EG001
num Affected
2
num At Risk
8
num Events
2
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Bicep tendon tear
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Body odor
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Breast nodularity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Bronchial thickening
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
2
num At Risk
8
num Events
2
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Chest tightness

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Aspiration pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Artirial Fibrilation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
2
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Electrolyte Toxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
2
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Hydronephrosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Pyelonephritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Seizure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Sepsis due to urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
2
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Urinary tract obstruction

time Frame

Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice