NCT00304031 · ADVERSE EVENTS

Adverse events

Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma · Source last updated 2020-06-09

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: 5%

Eligible participants with adverse event data: concurrent RT and TMZ only arm (not randomized): 285/292; conventional adjuvant TMZ arm: 409/411; dose-dense adjuvant TMZ arm: 420/422.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
No Adjuvant TMZ (Not Randomized) Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.	105 / 285	216 / 285	Not reported / Not reported
Conventional Adjuvant TMZ Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	131 / 409	376 / 409	Not reported / Not reported
Dose-dense Adjuvant TMZ Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.	142 / 420	392 / 420	Not reported / Not reported

Group identifiers: EG000: No Adjuvant TMZ (Not Randomized) · EG001: Conventional Adjuvant TMZ · EG002: Dose-dense Adjuvant TMZ

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
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
285
group Id
EG001
num Affected
2
num At Risk
409
group Id
EG002
num Affected
1
num At Risk
420
term
Blood/bone marrow - Other:
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
285
group Id
EG001
num Affected
1
num At Risk
409
group Id
EG002
num Affected
0
num At Risk
420
term
Bone marrow depression NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
285
group Id
EG001
num Affected
2
num At Risk
409
group Id
EG002
num Affected
1
num At Risk
420
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
285
group Id
EG001
num Affected
0
num At Risk
409
group Id
EG002
num Affected
1
num At Risk
420
term
Haemolysis NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
12
num At Risk
285
group Id
EG001
num Affected
6
num At Risk
409
group Id
EG002
num Affected
5
num At Risk
420
term
Hemoglobin
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
285
group Id
EG001
num Affected
0
num At Risk
409
group Id
EG002
num Affected
1
num At Risk
420
term
Thrombotic microangiopathy NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
285
group Id
EG001
num Affected
3
num At Risk
409
group Id
EG002
num Affected
2
num At Risk
420
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
285
group Id
EG001
num Affected
0
num At Risk
409
group Id
EG002
num Affected
0
num At Risk
420
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
285
group Id
EG001
num Affected
0
num At Risk
409
group Id
EG002
num Affected
1
num At Risk
420
term
Atrial tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
285
group Id
EG001
num Affected
0
num At Risk
409
group Id
EG002
num Affected
0
num At Risk
420
term
Cardiac General - Other:
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
285
group Id
EG001
num Affected
1
num At Risk
409
group Id
EG002
num Affected
0
num At Risk
420
term
Myocardial ischaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
285
group Id
EG001
num Affected
0
num At Risk
409
group Id
EG002
num Affected
0
num At Risk
420
term
Pericardial effusion

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
69
num At Risk
285
group Id
EG001
num Affected
142
num At Risk
409
group Id
EG002
num Affected
171
num At Risk
420
term
Hemoglobin
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
285
group Id
EG001
num Affected
27
num At Risk
409
group Id
EG002
num Affected
20
num At Risk
420
term
Hearing impaired
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
16
num At Risk
285
group Id
EG001
num Affected
37
num At Risk
409
group Id
EG002
num Affected
27
num At Risk
420
term
Ocular/visual - Other:
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
19
num At Risk
285
group Id
EG001
num Affected
48
num At Risk
409
group Id
EG002
num Affected
54
num At Risk
420
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
285
group Id
EG001
num Affected
17
num At Risk
409
group Id
EG002
num Affected
25
num At Risk
420
term
Abdominal pain NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
58
num At Risk
285
group Id
EG001
num Affected
135
num At Risk
409
group Id
EG002
num Affected
129
num At Risk
420
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
12
num At Risk
285
group Id
EG001
num Affected
50
num At Risk
409
group Id
EG002
num Affected
75
num At Risk
420
term
Diarrhoea NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
285
group Id
EG001
num Affected
22
num At Risk
409
group Id
EG002
num Affected
26
num At Risk
420
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
11
num At Risk
285
group Id
EG001
num Affected
30
num At Risk
409
group Id
EG002
num Affected
32
num At Risk
420
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
79
num At Risk
285
group Id
EG001
num Affected
226
num At Risk
409
group Id
EG002
num Affected
228
num At Risk
420
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
9
num At Risk
285
group Id
EG001
num Affected
20
num At Risk
409
group Id
EG002
num Affected
24
num At Risk
420
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
32
num At Risk
285
group Id
EG001
num Affected
114
num At Risk
409
group Id
EG002
num Affected
117
num At Risk
420
term
Vomiting NOS

Complete source fields

description

Eligible participants with adverse event data: concurrent RT and TMZ only arm (not randomized): 285/292; conventional adjuvant TMZ arm: 409/411; dose-dense adjuvant TMZ arm: 420/422.

event Groups

description
Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
id
EG000
other Num Affected
216
other Num At Risk
285
serious Num Affected
105
serious Num At Risk
285
title
No Adjuvant TMZ (Not Randomized)
description
Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
id
EG001
other Num Affected
376
other Num At Risk
409
serious Num Affected
131
serious Num At Risk
409
title
Conventional Adjuvant TMZ
description
Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
id
EG002
other Num Affected
392
other Num At Risk
420
serious Num Affected
142
serious Num At Risk
420
title
Dose-dense Adjuvant TMZ

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
69
num At Risk
285
group Id
EG001
num Affected
142
num At Risk
409
group Id
EG002
num Affected
171
num At Risk
420
term
Hemoglobin
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
285
group Id
EG001
num Affected
27
num At Risk
409
group Id
EG002
num Affected
20
num At Risk
420
term
Hearing impaired
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
16
num At Risk
285
group Id
EG001
num Affected
37
num At Risk
409
group Id
EG002
num Affected
27
num At Risk
420
term
Ocular/visual - Other:
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
19
num At Risk
285
group Id
EG001
num Affected
48
num At Risk
409
group Id
EG002
num Affected
54
num At Risk
420
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
285
group Id
EG001
num Affected
17
num At Risk
409
group Id
EG002
num Affected
25
num At Risk
420
term
Abdominal pain NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
58
num At Risk
285
group Id
EG001
num Affected
135
num At Risk
409
group Id
EG002
num Affected
129
num At Risk
420
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
12
num At Risk
285
group Id
EG001
num Affected
50
num At Risk
409
group Id
EG002
num Affected
75
num At Risk
420
term
Diarrhoea NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
285
group Id
EG001
num Affected
22
num At Risk
409
group Id
EG002
num Affected
26
num At Risk
420
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
11
num At Risk
285
group Id
EG001
num Affected
30
num At Risk
409
group Id
EG002
num Affected
32
num At Risk
420
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
79
num At Risk
285
group Id
EG001
num Affected
226
num At Risk
409
group Id
EG002
num Affected
228
num At Risk
420
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
9
num At Risk
285
group Id
EG001
num Affected
20
num At Risk
409
group Id
EG002
num Affected
24
num At Risk
420
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
32
num At Risk
285
group Id
EG001
num Affected
114
num At Risk
409
group Id
EG002
num Affected
117
num At Risk
420
term
Vomiting NOS

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
285
group Id
EG001
num Affected
2
num At Risk
409
group Id
EG002
num Affected
1
num At Risk
420
term
Blood/bone marrow - Other:
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
285
group Id
EG001
num Affected
1
num At Risk
409
group Id
EG002
num Affected
0
num At Risk
420
term
Bone marrow depression NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
285
group Id
EG001
num Affected
2
num At Risk
409
group Id
EG002
num Affected
1
num At Risk
420
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
285
group Id
EG001
num Affected
0
num At Risk
409
group Id
EG002
num Affected
1
num At Risk
420
term
Haemolysis NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
12
num At Risk
285
group Id
EG001
num Affected
6
num At Risk
409
group Id
EG002
num Affected
5
num At Risk
420
term
Hemoglobin
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
285
group Id
EG001
num Affected
0
num At Risk
409
group Id
EG002
num Affected
1
num At Risk
420
term
Thrombotic microangiopathy NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
285
group Id
EG001
num Affected
3
num At Risk
409
group Id
EG002
num Affected
2
num At Risk
420
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
285
group Id
EG001
num Affected
0
num At Risk
409
group Id
EG002
num Affected
0
num At Risk
420
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
285
group Id
EG001
num Affected
0
num At Risk
409
group Id
EG002
num Affected
1
num At Risk
420
term
Atrial tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
285
group Id
EG001
num Affected
0
num At Risk
409
group Id
EG002
num Affected
0
num At Risk
420
term
Cardiac General - Other:
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
285
group Id
EG001
num Affected
1
num At Risk
409
group Id
EG002
num Affected
0
num At Risk
420
term
Myocardial ischaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
285
group Id
EG001
num Affected
0
num At Risk
409
group Id
EG002
num Affected
0
num At Risk
420
term
Pericardial effusion

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