NCT01024946 · ADVERSE EVENTS

Adverse events

Everolimus (RAD001) for the Treatment of Malignant Pleural Mesothelioma With Merlin/NF2 Loss as a Biomarker to Predict Sensitivity · Source last updated 2015-05-12

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Patients Getting Everolimus This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation. everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity	3 / 7	6 / 7	Not reported / Not reported

Group identifiers: EG000: Patients Getting Everolimus

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
Gastrointestinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
2
term
Dyspnea (shortness of breath)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Pneumonitis/pulmonary infiltrates
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Inf norm ANC/gr1/2 neut-Myositis infection(muscle)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Inf norm ANC/gr1/2 neut-Cellulitis(skin)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Hemorrhage/Bleeding, other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Ascites (non-malignant)

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
Metabolism and nutrition disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
4
term
Albumin, low (hypoalbuminemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
ALT, SGPT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Bilirubin (hyperbilirubinemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
4
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Dry skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
7
term
Dyspnea (shortness of breath)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
6
term
Fatigue (asthenia, lethargy, malaise)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
4
term
Glucose, high (hyperglycemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
2
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Insomnia

Complete source fields

event Groups

description
This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation. everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity
id
EG000
other Num Affected
6
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
Patients Getting Everolimus

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
4
term
Albumin, low (hypoalbuminemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
ALT, SGPT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Bilirubin (hyperbilirubinemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
4
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Dry skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
7
term
Dyspnea (shortness of breath)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
6
term
Fatigue (asthenia, lethargy, malaise)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
4
term
Glucose, high (hyperglycemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
2
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Insomnia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
2
term
Dyspnea (shortness of breath)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Pneumonitis/pulmonary infiltrates
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Inf norm ANC/gr1/2 neut-Myositis infection(muscle)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Inf norm ANC/gr1/2 neut-Cellulitis(skin)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Hemorrhage/Bleeding, other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
term
Ascites (non-malignant)

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

Preserved source evidence · Not medical advice