NCT03474107 · ADVERSE EVENTS

Adverse events

A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) · Source last updated 2026-01-09

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 first dose up to 30 days after last dose (Median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group)
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Enfortumab Vedotin Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.	138 / 296	284 / 296	130 / 296
Chemotherapy Participants received either 75 mg/m\^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.	128 / 291	266 / 291	161 / 291

Group identifiers: EG000: Enfortumab Vedotin · EG001: 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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
4
num At Risk
296
num Events
4
group Id
EG001
num Affected
6
num At Risk
291
num Events
7
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
296
num Events
0
group Id
EG001
num Affected
2
num At Risk
291
num Events
4
term
Bone marrow failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
4
num At Risk
296
num Events
4
group Id
EG001
num Affected
16
num At Risk
291
num Events
16
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
296
num Events
0
group Id
EG001
num Affected
1
num At Risk
291
num Events
1
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
4
num At Risk
296
num Events
4
group Id
EG001
num Affected
8
num At Risk
291
num Events
9
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
296
num Events
0
group Id
EG001
num Affected
1
num At Risk
291
num Events
1
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
2
num At Risk
296
num Events
2
group Id
EG001
num Affected
0
num At Risk
291
num Events
0
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
296
num Events
0
group Id
EG001
num Affected
1
num At Risk
291
num Events
1
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
5
num At Risk
296
num Events
5
group Id
EG001
num Affected
1
num At Risk
291
num Events
1
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
296
num Events
0
group Id
EG001
num Affected
1
num At Risk
291
num Events
1
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
296
num Events
1
group Id
EG001
num Affected
1
num At Risk
291
num Events
1
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
296
num Events
0
group Id
EG001
num Affected
2
num At Risk
291
num Events
2
term
Cardiac arrest

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
MedDRA v23.0
stats
group Id
EG000
num Affected
57
num At Risk
296
num Events
98
group Id
EG001
num Affected
83
num At Risk
291
num Events
136
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
16
num At Risk
296
num Events
30
group Id
EG001
num Affected
20
num At Risk
291
num Events
37
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
19
num At Risk
296
num Events
24
group Id
EG001
num Affected
3
num At Risk
291
num Events
3
term
Dry eye
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
30
num At Risk
296
num Events
37
group Id
EG001
num Affected
12
num At Risk
291
num Events
15
term
Lacrimation increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
16
num At Risk
296
num Events
20
group Id
EG001
num Affected
5
num At Risk
291
num Events
5
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
37
num At Risk
296
num Events
52
group Id
EG001
num Affected
24
num At Risk
291
num Events
33
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
81
num At Risk
296
num Events
116
group Id
EG001
num Affected
72
num At Risk
291
num Events
105
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
98
num At Risk
296
num Events
171
group Id
EG001
num Affected
64
num At Risk
291
num Events
89
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
24
num At Risk
296
num Events
26
group Id
EG001
num Affected
7
num At Risk
291
num Events
7
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
19
num At Risk
296
num Events
22
group Id
EG001
num Affected
9
num At Risk
291
num Events
10
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
89
num At Risk
296
num Events
119
group Id
EG001
num Affected
73
num At Risk
291
num Events
92
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
27
num At Risk
296
num Events
35
group Id
EG001
num Affected
19
num At Risk
291
num Events
27
term
Stomatitis

Complete source fields

event Groups

deaths Num Affected
130
deaths Num At Risk
296
description
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
id
EG000
other Num Affected
284
other Num At Risk
296
serious Num Affected
138
serious Num At Risk
296
title
Enfortumab Vedotin
deaths Num Affected
161
deaths Num At Risk
291
description
Participants received either 75 mg/m\^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
id
EG001
other Num Affected
266
other Num At Risk
291
serious Num Affected
128
serious Num At Risk
291
title
Chemotherapy

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
57
num At Risk
296
num Events
98
group Id
EG001
num Affected
83
num At Risk
291
num Events
136
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
16
num At Risk
296
num Events
30
group Id
EG001
num Affected
20
num At Risk
291
num Events
37
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
19
num At Risk
296
num Events
24
group Id
EG001
num Affected
3
num At Risk
291
num Events
3
term
Dry eye
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
30
num At Risk
296
num Events
37
group Id
EG001
num Affected
12
num At Risk
291
num Events
15
term
Lacrimation increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
16
num At Risk
296
num Events
20
group Id
EG001
num Affected
5
num At Risk
291
num Events
5
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
37
num At Risk
296
num Events
52
group Id
EG001
num Affected
24
num At Risk
291
num Events
33
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
81
num At Risk
296
num Events
116
group Id
EG001
num Affected
72
num At Risk
291
num Events
105
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
98
num At Risk
296
num Events
171
group Id
EG001
num Affected
64
num At Risk
291
num Events
89
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
24
num At Risk
296
num Events
26
group Id
EG001
num Affected
7
num At Risk
291
num Events
7
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
19
num At Risk
296
num Events
22
group Id
EG001
num Affected
9
num At Risk
291
num Events
10
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
89
num At Risk
296
num Events
119
group Id
EG001
num Affected
73
num At Risk
291
num Events
92
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
27
num At Risk
296
num Events
35
group Id
EG001
num Affected
19
num At Risk
291
num Events
27
term
Stomatitis

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
4
num At Risk
296
num Events
4
group Id
EG001
num Affected
6
num At Risk
291
num Events
7
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
296
num Events
0
group Id
EG001
num Affected
2
num At Risk
291
num Events
4
term
Bone marrow failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
4
num At Risk
296
num Events
4
group Id
EG001
num Affected
16
num At Risk
291
num Events
16
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
296
num Events
0
group Id
EG001
num Affected
1
num At Risk
291
num Events
1
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
4
num At Risk
296
num Events
4
group Id
EG001
num Affected
8
num At Risk
291
num Events
9
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
296
num Events
0
group Id
EG001
num Affected
1
num At Risk
291
num Events
1
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
2
num At Risk
296
num Events
2
group Id
EG001
num Affected
0
num At Risk
291
num Events
0
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
296
num Events
0
group Id
EG001
num Affected
1
num At Risk
291
num Events
1
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
5
num At Risk
296
num Events
5
group Id
EG001
num Affected
1
num At Risk
291
num Events
1
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
296
num Events
0
group Id
EG001
num Affected
1
num At Risk
291
num Events
1
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
296
num Events
1
group Id
EG001
num Affected
1
num At Risk
291
num Events
1
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
296
num Events
0
group Id
EG001
num Affected
2
num At Risk
291
num Events
2
term
Cardiac arrest

time Frame

From first dose up to 30 days after last dose (Median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group)

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