NCT02426125 · ADVERSE EVENTS

Adverse events

A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer · Source last updated 2023-08-21

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 64.7 Months
Other-event reporting threshold: 0%

All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ramucirumab + Docetaxel Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	111 / 258	241 / 258	193 / 258
Placebo+Docetaxel Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	107 / 265	251 / 265	209 / 265

Group identifiers: EG000: Ramucirumab + Docetaxel · EG001: Placebo+Docetaxel

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 26.0
stats
group Id
EG000
num Affected
0
num At Risk
258
num Events
0
group Id
EG001
num Affected
4
num At Risk
265
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
17
num At Risk
258
num Events
20
group Id
EG001
num Affected
13
num At Risk
265
num Events
14
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
258
num Events
0
group Id
EG001
num Affected
2
num At Risk
265
num Events
3
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
4
num At Risk
258
num Events
5
group Id
EG001
num Affected
2
num At Risk
265
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
258
num Events
0
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Arteriospasm coronary
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
258
num Events
0
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Intracardiac thrombus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
258
num Events
2
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Myocardial infarction

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 26.0
stats
group Id
EG000
num Affected
50
num At Risk
258
num Events
87
group Id
EG001
num Affected
76
num At Risk
265
num Events
140
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
9
num At Risk
258
num Events
9
group Id
EG001
num Affected
5
num At Risk
265
num Events
5
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
3
num At Risk
265
num Events
3
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
8
num At Risk
258
num Events
25
group Id
EG001
num Affected
5
num At Risk
265
num Events
9
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
258
num Events
0
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
258
num Events
7
group Id
EG001
num Affected
2
num At Risk
265
num Events
2
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
18
num At Risk
258
num Events
36
group Id
EG001
num Affected
14
num At Risk
265
num Events
14
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
6
num At Risk
258
num Events
13
group Id
EG001
num Affected
3
num At Risk
265
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
258
num Events
0
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Thrombocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
258
num Events
0
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Arrhythmia

Complete source fields

description

event Groups

deaths Num Affected
193
deaths Num At Risk
258
description
Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
id
EG000
other Num Affected
241
other Num At Risk
258
serious Num Affected
111
serious Num At Risk
258
title
Ramucirumab + Docetaxel
deaths Num Affected
209
deaths Num At Risk
265
description
Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
id
EG001
other Num Affected
251
other Num At Risk
265
serious Num Affected
107
serious Num At Risk
265
title
Placebo+Docetaxel

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
50
num At Risk
258
num Events
87
group Id
EG001
num Affected
76
num At Risk
265
num Events
140
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
9
num At Risk
258
num Events
9
group Id
EG001
num Affected
5
num At Risk
265
num Events
5
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
3
num At Risk
265
num Events
3
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
8
num At Risk
258
num Events
25
group Id
EG001
num Affected
5
num At Risk
265
num Events
9
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
258
num Events
0
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
258
num Events
7
group Id
EG001
num Affected
2
num At Risk
265
num Events
2
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
18
num At Risk
258
num Events
36
group Id
EG001
num Affected
14
num At Risk
265
num Events
14
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
6
num At Risk
258
num Events
13
group Id
EG001
num Affected
3
num At Risk
265
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
258
num Events
0
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Thrombocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
258
num Events
0
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Arrhythmia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
258
num Events
0
group Id
EG001
num Affected
4
num At Risk
265
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
17
num At Risk
258
num Events
20
group Id
EG001
num Affected
13
num At Risk
265
num Events
14
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
258
num Events
0
group Id
EG001
num Affected
2
num At Risk
265
num Events
3
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
4
num At Risk
258
num Events
5
group Id
EG001
num Affected
2
num At Risk
265
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
258
num Events
0
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Arteriospasm coronary
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
258
num Events
1
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
258
num Events
0
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Intracardiac thrombus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
258
num Events
2
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Myocardial infarction

time Frame

Up to 64.7 Months

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Preserved source evidence · Not medical advice