NCT00476476 · ADVERSE EVENTS

Adverse events

Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar · Source last updated 2015-05-07

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: Assessed from time of first dose, weekly during treatment and through 30 days post-treatment.
Other-event reporting threshold: 0%

Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Erlotinib Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.	19 / 41	40 / 41	Not reported / Not reported

Group identifiers: EG000: Erlotinib

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
notes
Organ System N/A
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
term
Death - disease progression NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
term
Hearing w/w-o audiogr in monitor prg
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
41
term
Diarrhea w/o prior colostomy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
41
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Infection-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Bilirubin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Creatinine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Anorexia

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 (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Erythema multiforme
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Skin breakdown/decubitus ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
41
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Hematologic-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Endocrine-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Dry eye syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Eyelid dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Tearing
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
term
Ocular-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
41
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
23
num At Risk
41
term
Diarrhea w/o prior colostomy

Complete source fields

description

Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.

event Groups

description
Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
id
EG000
other Num Affected
40
other Num At Risk
41
serious Num Affected
19
serious Num At Risk
41
title
Erlotinib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Erythema multiforme
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Skin breakdown/decubitus ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
41
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Hematologic-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Endocrine-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Dry eye syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Eyelid dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Tearing
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
term
Ocular-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
41
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
23
num At Risk
41
term
Diarrhea w/o prior colostomy

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Organ System N/A
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
term
Death - disease progression NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
term
Hearing w/w-o audiogr in monitor prg
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
41
term
Diarrhea w/o prior colostomy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
41
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Infection-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Bilirubin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Creatinine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Anorexia

time Frame

Assessed from time of first dose, weekly during treatment and through 30 days post-treatment.

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Preserved source evidence · Not medical advice