NCT04223856 · ADVERSE EVENTS

Adverse events

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer · Source last updated 2026-05-29

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: From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Other-event reporting threshold: 5%

Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Enfortumab Vedotin + Pembrolizumab Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.	220 / 440	435 / 440	133 / 442
Standard of Care Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.	169 / 433	418 / 433	226 / 444

Group identifiers: EG000: Enfortumab Vedotin + Pembrolizumab · EG001: Standard of Care

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 v26.0
stats
group Id
EG000
num Affected
3
num At Risk
440
num Events
4
group Id
EG001
num Affected
17
num At Risk
433
num Events
18
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
440
num Events
1
group Id
EG001
num Affected
0
num At Risk
433
num Events
0
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
4
num At Risk
440
num Events
4
group Id
EG001
num Affected
12
num At Risk
433
num Events
12
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
440
num Events
1
group Id
EG001
num Affected
0
num At Risk
433
num Events
0
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
440
num Events
1
group Id
EG001
num Affected
0
num At Risk
433
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
440
num Events
1
group Id
EG001
num Affected
7
num At Risk
433
num Events
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
440
num Events
0
group Id
EG001
num Affected
3
num At Risk
433
num Events
3
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
440
num Events
0
group Id
EG001
num Affected
13
num At Risk
433
num Events
13
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
440
num Events
1
group Id
EG001
num Affected
0
num At Risk
433
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
2
num At Risk
440
num Events
2
group Id
EG001
num Affected
2
num At Risk
433
num Events
2
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
440
num Events
0
group Id
EG001
num Affected
1
num At Risk
433
num Events
1
term
Acute right ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
440
num Events
0
group Id
EG001
num Affected
2
num At Risk
433
num Events
2
term
Angina pectoris

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 v26.0
stats
group Id
EG000
num Affected
106
num At Risk
440
num Events
168
group Id
EG001
num Affected
255
num At Risk
433
num Events
362
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
16
num At Risk
440
num Events
25
group Id
EG001
num Affected
47
num At Risk
433
num Events
91
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
43
num At Risk
440
num Events
70
group Id
EG001
num Affected
178
num At Risk
433
num Events
360
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
19
num At Risk
440
num Events
21
group Id
EG001
num Affected
147
num At Risk
433
num Events
266
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
6
num At Risk
440
num Events
6
group Id
EG001
num Affected
29
num At Risk
433
num Events
31
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
45
num At Risk
440
num Events
47
group Id
EG001
num Affected
3
num At Risk
433
num Events
3
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
22
num At Risk
440
num Events
23
group Id
EG001
num Affected
1
num At Risk
433
num Events
1
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
50
num At Risk
440
num Events
52
group Id
EG001
num Affected
5
num At Risk
433
num Events
5
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
36
num At Risk
440
num Events
42
group Id
EG001
num Affected
2
num At Risk
433
num Events
2
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
26
num At Risk
440
num Events
28
group Id
EG001
num Affected
5
num At Risk
433
num Events
5
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
44
num At Risk
440
num Events
52
group Id
EG001
num Affected
25
num At Risk
433
num Events
30
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
116
num At Risk
440
num Events
136
group Id
EG001
num Affected
146
num At Risk
433
num Events
168
term
Constipation

Complete source fields

description

event Groups

deaths Num Affected
133
deaths Num At Risk
442
description
Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.
id
EG000
other Num Affected
435
other Num At Risk
440
serious Num Affected
220
serious Num At Risk
440
title
Enfortumab Vedotin + Pembrolizumab
deaths Num Affected
226
deaths Num At Risk
444
description
Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.
id
EG001
other Num Affected
418
other Num At Risk
433
serious Num Affected
169
serious Num At Risk
433
title
Standard of Care

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
106
num At Risk
440
num Events
168
group Id
EG001
num Affected
255
num At Risk
433
num Events
362
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
16
num At Risk
440
num Events
25
group Id
EG001
num Affected
47
num At Risk
433
num Events
91
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
43
num At Risk
440
num Events
70
group Id
EG001
num Affected
178
num At Risk
433
num Events
360
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
19
num At Risk
440
num Events
21
group Id
EG001
num Affected
147
num At Risk
433
num Events
266
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
6
num At Risk
440
num Events
6
group Id
EG001
num Affected
29
num At Risk
433
num Events
31
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
45
num At Risk
440
num Events
47
group Id
EG001
num Affected
3
num At Risk
433
num Events
3
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
22
num At Risk
440
num Events
23
group Id
EG001
num Affected
1
num At Risk
433
num Events
1
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
50
num At Risk
440
num Events
52
group Id
EG001
num Affected
5
num At Risk
433
num Events
5
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
36
num At Risk
440
num Events
42
group Id
EG001
num Affected
2
num At Risk
433
num Events
2
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
26
num At Risk
440
num Events
28
group Id
EG001
num Affected
5
num At Risk
433
num Events
5
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
44
num At Risk
440
num Events
52
group Id
EG001
num Affected
25
num At Risk
433
num Events
30
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
116
num At Risk
440
num Events
136
group Id
EG001
num Affected
146
num At Risk
433
num Events
168
term
Constipation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
3
num At Risk
440
num Events
4
group Id
EG001
num Affected
17
num At Risk
433
num Events
18
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
440
num Events
1
group Id
EG001
num Affected
0
num At Risk
433
num Events
0
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
4
num At Risk
440
num Events
4
group Id
EG001
num Affected
12
num At Risk
433
num Events
12
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
440
num Events
1
group Id
EG001
num Affected
0
num At Risk
433
num Events
0
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
440
num Events
1
group Id
EG001
num Affected
0
num At Risk
433
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
440
num Events
1
group Id
EG001
num Affected
7
num At Risk
433
num Events
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
440
num Events
0
group Id
EG001
num Affected
3
num At Risk
433
num Events
3
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
440
num Events
0
group Id
EG001
num Affected
13
num At Risk
433
num Events
13
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
440
num Events
1
group Id
EG001
num Affected
0
num At Risk
433
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
2
num At Risk
440
num Events
2
group Id
EG001
num Affected
2
num At Risk
433
num Events
2
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
440
num Events
0
group Id
EG001
num Affected
1
num At Risk
433
num Events
1
term
Acute right ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
440
num Events
0
group Id
EG001
num Affected
2
num At Risk
433
num Events
2
term
Angina pectoris

time Frame

From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)

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