NCT00553150 · ADVERSE EVENTS

Adverse events

Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma · Source last updated 2020-02-13

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 assessed weekly during Cycle 1, at the end of RT, prior to cycles 3-8, and during treatment with everolimus only until progression (Cycles ≥9). Only patients who had completed one cycle of treatment and completed an adverse event form were included in this adverse event table; Up to 5 years.
Other-event reporting threshold: 0%

CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until September 30, 2010. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning October 1, 2010. All appropriate treatment areas should have access to a copy of the CTCAE v4.0.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I Cycle 1: Everolimus (either: 30, 50, or 70 mg) days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus (either: 30, 50, or 70 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.	5 / 18	18 / 18	Not reported / Not reported
Phase II Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.	32 / 101	99 / 101	Not reported / Not reported

Group identifiers: EG000: Phase I · EG001: Phase II

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 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
101
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
2
group Id
EG001
num Affected
3
num At Risk
101
num Events
3
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
101
num Events
2
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Colonic perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
101
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
101
num Events
2
term
Ear, nose and throat examination abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
101
num Events
2
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
3
num At Risk
101
num Events
5
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Oral pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
2
term
Vomiting

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 9
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
group Id
EG001
num Affected
9
num At Risk
101
num Events
17
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Hearing loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Middle ear inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Cushingoid
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
3
num At Risk
101
num Events
3
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
2
term
Watering eyes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
group Id
EG001
num Affected
5
num At Risk
101
num Events
5
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
7
num At Risk
18
num Events
11
group Id
EG001
num Affected
35
num At Risk
101
num Events
79
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
101
num Events
2
term
Dyspepsia

Complete source fields

description

event Groups

description
Cycle 1: Everolimus (either: 30, 50, or 70 mg) days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus (either: 30, 50, or 70 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
id
EG000
other Num Affected
18
other Num At Risk
18
serious Num Affected
5
serious Num At Risk
18
title
Phase I
description
Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
id
EG001
other Num Affected
99
other Num At Risk
101
serious Num Affected
32
serious Num At Risk
101
title
Phase II

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
group Id
EG001
num Affected
9
num At Risk
101
num Events
17
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Hearing loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Middle ear inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Cushingoid
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
3
num At Risk
101
num Events
3
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
2
term
Watering eyes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
group Id
EG001
num Affected
5
num At Risk
101
num Events
5
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
7
num At Risk
18
num Events
11
group Id
EG001
num Affected
35
num At Risk
101
num Events
79
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
101
num Events
2
term
Dyspepsia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
101
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
2
group Id
EG001
num Affected
3
num At Risk
101
num Events
3
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
101
num Events
2
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Colonic perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
101
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
101
num Events
2
term
Ear, nose and throat examination abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
101
num Events
2
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
3
num At Risk
101
num Events
5
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
1
term
Oral pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
101
num Events
2
term
Vomiting

time Frame

Adverse events were assessed weekly during Cycle 1, at the end of RT, prior to cycles 3-8, and during treatment with everolimus only until progression (Cycles ≥9). Only patients who had completed one cycle of treatment and completed an adverse event form were included in this adverse event table; Up to 5 years.

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