NCT00091572 · ADVERSE EVENTS

Adverse events

Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267) · Source last updated 2017-06-06

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%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Temozolomide Not reported	124 / 419	394 / 419	Not reported / Not reported
Dacarbazine Not reported	100 / 421	374 / 421	Not reported / Not reported

Group identifiers: EG000: Temozolomide · EG001: Dacarbazine

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 10.1
stats
group Id
EG000
num Affected
2
num At Risk
419
num Events
6
group Id
EG001
num Affected
0
num At Risk
421
num Events
0
term
ANAEMIA HAEMOLYTIC AUTOIMMUNE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
1
num At Risk
419
num Events
1
group Id
EG001
num Affected
3
num At Risk
421
num Events
3
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
0
num At Risk
419
num Events
0
group Id
EG001
num Affected
1
num At Risk
421
num Events
1
term
LYMPHADENOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
1
num At Risk
419
num Events
1
group Id
EG001
num Affected
0
num At Risk
421
num Events
0
term
NORMOCHROMIC NORMOCYTIC ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
1
num At Risk
419
num Events
1
group Id
EG001
num Affected
1
num At Risk
421
num Events
1
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
1
num At Risk
419
num Events
1
group Id
EG001
num Affected
0
num At Risk
421
num Events
0
term
ACUTE CORONARY SYNDROME
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
1
num At Risk
419
num Events
1
group Id
EG001
num Affected
0
num At Risk
421
num Events
0
term
ANGINA PECTORIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
0
num At Risk
419
num Events
0
group Id
EG001
num Affected
1
num At Risk
421
num Events
1
term
ARRHYTHMIA SUPRAVENTRICULAR
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
3
num At Risk
419
num Events
3
group Id
EG001
num Affected
1
num At Risk
421
num Events
2
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
0
num At Risk
419
num Events
0
group Id
EG001
num Affected
1
num At Risk
421
num Events
1
term
ATRIAL FLUTTER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
0
num At Risk
419
num Events
0
group Id
EG001
num Affected
1
num At Risk
421
num Events
1
term
CARDIAC FAILURE ACUTE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
1
num At Risk
419
num Events
1
group Id
EG001
num Affected
1
num At Risk
421
num Events
1
term
CARDIO-RESPIRATORY ARREST

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
Gastrointestinal disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
43
num At Risk
419
num Events
91
group Id
EG001
num Affected
31
num At Risk
421
num Events
58
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
22
num At Risk
419
num Events
43
group Id
EG001
num Affected
17
num At Risk
421
num Events
33
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
183
num At Risk
419
num Events
563
group Id
EG001
num Affected
111
num At Risk
421
num Events
267
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
79
num At Risk
419
num Events
146
group Id
EG001
num Affected
71
num At Risk
421
num Events
139
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
22
num At Risk
419
num Events
85
group Id
EG001
num Affected
25
num At Risk
421
num Events
47
term
DYSPEPSIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
286
num At Risk
419
num Events
966
group Id
EG001
num Affected
206
num At Risk
421
num Events
535
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
211
num At Risk
419
num Events
456
group Id
EG001
num Affected
103
num At Risk
421
num Events
208
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
253
num At Risk
419
num Events
1102
group Id
EG001
num Affected
240
num At Risk
421
num Events
798
term
FATIGUE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
18
num At Risk
419
num Events
30
group Id
EG001
num Affected
24
num At Risk
421
num Events
37
term
INFLUENZA LIKE ILLNESS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
30
num At Risk
419
num Events
90
group Id
EG001
num Affected
37
num At Risk
421
num Events
136
term
OEDEMA PERIPHERAL
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
49
num At Risk
419
num Events
67
group Id
EG001
num Affected
54
num At Risk
421
num Events
71
term
PYREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
87
num At Risk
419
num Events
380
group Id
EG001
num Affected
45
num At Risk
421
num Events
114
term
WEIGHT DECREASED

Complete source fields

event Groups

id
EG000
other Num Affected
394
other Num At Risk
419
serious Num Affected
124
serious Num At Risk
419
title
Temozolomide
id
EG001
other Num Affected
374
other Num At Risk
421
serious Num Affected
100
serious Num At Risk
421
title
Dacarbazine

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
43
num At Risk
419
num Events
91
group Id
EG001
num Affected
31
num At Risk
421
num Events
58
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
22
num At Risk
419
num Events
43
group Id
EG001
num Affected
17
num At Risk
421
num Events
33
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
183
num At Risk
419
num Events
563
group Id
EG001
num Affected
111
num At Risk
421
num Events
267
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
79
num At Risk
419
num Events
146
group Id
EG001
num Affected
71
num At Risk
421
num Events
139
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
22
num At Risk
419
num Events
85
group Id
EG001
num Affected
25
num At Risk
421
num Events
47
term
DYSPEPSIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
286
num At Risk
419
num Events
966
group Id
EG001
num Affected
206
num At Risk
421
num Events
535
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
211
num At Risk
419
num Events
456
group Id
EG001
num Affected
103
num At Risk
421
num Events
208
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
253
num At Risk
419
num Events
1102
group Id
EG001
num Affected
240
num At Risk
421
num Events
798
term
FATIGUE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
18
num At Risk
419
num Events
30
group Id
EG001
num Affected
24
num At Risk
421
num Events
37
term
INFLUENZA LIKE ILLNESS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
30
num At Risk
419
num Events
90
group Id
EG001
num Affected
37
num At Risk
421
num Events
136
term
OEDEMA PERIPHERAL
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
49
num At Risk
419
num Events
67
group Id
EG001
num Affected
54
num At Risk
421
num Events
71
term
PYREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
87
num At Risk
419
num Events
380
group Id
EG001
num Affected
45
num At Risk
421
num Events
114
term
WEIGHT DECREASED

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
2
num At Risk
419
num Events
6
group Id
EG001
num Affected
0
num At Risk
421
num Events
0
term
ANAEMIA HAEMOLYTIC AUTOIMMUNE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
1
num At Risk
419
num Events
1
group Id
EG001
num Affected
3
num At Risk
421
num Events
3
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
0
num At Risk
419
num Events
0
group Id
EG001
num Affected
1
num At Risk
421
num Events
1
term
LYMPHADENOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
1
num At Risk
419
num Events
1
group Id
EG001
num Affected
0
num At Risk
421
num Events
0
term
NORMOCHROMIC NORMOCYTIC ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
1
num At Risk
419
num Events
1
group Id
EG001
num Affected
1
num At Risk
421
num Events
1
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
1
num At Risk
419
num Events
1
group Id
EG001
num Affected
0
num At Risk
421
num Events
0
term
ACUTE CORONARY SYNDROME
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
1
num At Risk
419
num Events
1
group Id
EG001
num Affected
0
num At Risk
421
num Events
0
term
ANGINA PECTORIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
0
num At Risk
419
num Events
0
group Id
EG001
num Affected
1
num At Risk
421
num Events
1
term
ARRHYTHMIA SUPRAVENTRICULAR
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
3
num At Risk
419
num Events
3
group Id
EG001
num Affected
1
num At Risk
421
num Events
2
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
0
num At Risk
419
num Events
0
group Id
EG001
num Affected
1
num At Risk
421
num Events
1
term
ATRIAL FLUTTER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
0
num At Risk
419
num Events
0
group Id
EG001
num Affected
1
num At Risk
421
num Events
1
term
CARDIAC FAILURE ACUTE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.1
stats
group Id
EG000
num Affected
1
num At Risk
419
num Events
1
group Id
EG001
num Affected
1
num At Risk
421
num Events
1
term
CARDIO-RESPIRATORY ARREST

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