NCT00749892 · ADVERSE EVENTS

Adverse events

Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer · Source last updated 2020-09-10

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: Evaluated for 2 months once drug therapy started.
Other-event reporting threshold: 5%

Toxicities were measured at weekly visit while on therapy using the NCI CTCAE v3.0.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pre-surgical Erlotinib Treatment Erlotinib 150 mg by mouth daily for 3 weeks followed by cystectomy within 24 hours of the last dose.	5 / 31	19 / 31	0 / 31

Group identifiers: EG000: Pre-surgical Erlotinib Treatment

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
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Decreased Neutrophils/Grabulocytes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Infection-wound
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Decreased Leukocytes (Total WBD)

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
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
15
num At Risk
31
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
6
num At Risk
31
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
5
num At Risk
31
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Decreased Neutrophils/Grabulocytes

Complete source fields

description

Toxicities were measured at weekly visit while on therapy using the NCI CTCAE v3.0.

event Groups

deaths Num Affected
0
deaths Num At Risk
31
description
Erlotinib 150 mg by mouth daily for 3 weeks followed by cystectomy within 24 hours of the last dose.
id
EG000
other Num Affected
19
other Num At Risk
31
serious Num Affected
5
serious Num At Risk
31
title
Pre-surgical Erlotinib Treatment

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
15
num At Risk
31
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
6
num At Risk
31
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
5
num At Risk
31
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Decreased Neutrophils/Grabulocytes

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Decreased Neutrophils/Grabulocytes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Infection-wound
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
NCI CTCAE V3.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Decreased Leukocytes (Total WBD)

time Frame

Evaluated for 2 months once drug therapy started.

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

Preserved source evidence · Not medical advice