NCT00112736 · ADVERSE EVENTS

Adverse events

Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma · Source last updated 2015-06-15

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: Adverse Events were collected weekly for the first cycle and then at the start of each cycle while on treatment and at time of off study.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I (Erlotinib & Temsirolimus) PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity. erlotinib: Given orally temsirolimus: Given IV pharmacological study: Correlative studies	3 / 21	21 / 21	Not reported / Not reported
Phase II (Erlotinib & Erlotinib) Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity. PHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I. therapeutic conventional surgery: Undergo surgical resection laboratory biomarker analysis: Correlative studies	2 / 59	37 / 59	Not reported / Not reported

Group identifiers: EG000: Phase I (Erlotinib & Temsirolimus) · EG001: Phase II (Erlotinib & 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
NON_SYSTEMATIC_ASSESSMENT
notes
Cardiac ischemia
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
term
generalized muscle weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
normal ANC
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
Upper respiratory infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
term
retinopathy

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
notes
Leukopenia
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
White blood Cells
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Thrombocytopenia
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
21
num Events
4
group Id
EG001
num Affected
2
num At Risk
59
num Events
2
term
Platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
21
num Events
3
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
2
num At Risk
59
num Events
2
term
fatigue
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
21
num Events
1
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
term
hypercholesterolemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
term
hypertriglyceridemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
term
hypocalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
21
num Events
5
group Id
EG001
num Affected
4
num At Risk
59
num Events
4
term
hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
Mucosal infection

Complete source fields

event Groups

description
PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity. erlotinib: Given orally temsirolimus: Given IV pharmacological study: Correlative studies
id
EG000
other Num Affected
21
other Num At Risk
21
serious Num Affected
3
serious Num At Risk
21
title
Phase I (Erlotinib & Temsirolimus)
description
Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity. PHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I. therapeutic conventional surgery: Undergo surgical resection laboratory biomarker analysis: Correlative studies
id
EG001
other Num Affected
37
other Num At Risk
59
serious Num Affected
2
serious Num At Risk
59
title
Phase II (Erlotinib & Erlotinib)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Leukopenia
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
White blood Cells
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Thrombocytopenia
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
21
num Events
4
group Id
EG001
num Affected
2
num At Risk
59
num Events
2
term
Platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
21
num Events
3
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
2
num At Risk
59
num Events
2
term
fatigue
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
21
num Events
1
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
term
hypercholesterolemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
term
hypertriglyceridemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
term
hypocalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
21
num Events
5
group Id
EG001
num Affected
4
num At Risk
59
num Events
4
term
hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
Mucosal infection

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Cardiac ischemia
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
term
generalized muscle weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
normal ANC
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
59
num Events
0
term
Upper respiratory infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
59
num Events
1
term
retinopathy

time Frame

Adverse Events were collected weekly for the first cycle and then at the start of each cycle while on treatment and at time of off study.

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Preserved source evidence · Not medical advice