Trial Outcomes & Findings for Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267) (NCT NCT00091572)
NCT ID: NCT00091572
Last Updated: 2017-06-06
Results Overview
Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
859 participants
Primary outcome timeframe
The final analysis was to be performed when at least 616 deaths had occurred.
Results posted on
2017-06-06
Participant Flow
Participant milestones
| Measure |
Temozolomide
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
|
Dacarbazine
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
429
|
430
|
|
Overall Study
COMPLETED
|
334
|
348
|
|
Overall Study
NOT COMPLETED
|
95
|
82
|
Reasons for withdrawal
| Measure |
Temozolomide
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
|
Dacarbazine
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Subject's Refusal unrelated to toxicity
|
14
|
22
|
|
Overall Study
Death not due to malignancy/toxicity
|
1
|
3
|
|
Overall Study
Medical Decision unrelated toxicity/PD
|
10
|
22
|
|
Overall Study
Other Reason
|
6
|
13
|
|
Overall Study
Ongoing (still on treatment)
|
8
|
12
|
|
Overall Study
Major Protocol Violation
|
2
|
0
|
|
Overall Study
Toxicity (Related AE)
|
53
|
9
|
Baseline Characteristics
Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)
Baseline characteristics by cohort
| Measure |
Temozolomide
n=429 Participants
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
|
Dacarbazine
n=430 Participants
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
|
Total
n=859 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
276 Participants
n=5 Participants
|
261 Participants
n=7 Participants
|
537 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
153 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
322 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
179 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
356 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
250 Participants
n=5 Participants
|
253 Participants
n=7 Participants
|
503 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The final analysis was to be performed when at least 616 deaths had occurred.Population: Intent to Treat Population
Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
Outcome measures
| Measure |
Temozolomide
n=429 Participants
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
|
Dacarbazine
n=430 Participants
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
|
|---|---|---|
|
Overall Survival
|
9.13 Months
Interval 8.11 to 9.89
|
9.36 Months
Interval 8.21 to 10.28
|
SECONDARY outcome
Timeframe: Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.Population: Intent to Treat Population
Progression free survival was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause.
Outcome measures
| Measure |
Temozolomide
n=429 Participants
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
|
Dacarbazine
n=430 Participants
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
|
|---|---|---|
|
Progression Free Survival
|
2.30 Months
Interval 2.23 to 2.43
|
2.17 Months
Interval 2.14 to 2.27
|
SECONDARY outcome
Timeframe: Treatment continued until disease progression or unacceptable toxicity.Population: Intent to treat population with measurable disease at Baseline.
Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter.
Outcome measures
| Measure |
Temozolomide
n=401 Participants
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
|
Dacarbazine
n=388 Participants
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
|
|---|---|---|
|
Objective Response Rate in Subjects With Measurable Lesions
|
0.14 Ratio
Interval 0.1 to 0.17
|
0.10 Ratio
Interval 0.07 to 0.12
|
SECONDARY outcome
Timeframe: Treatment continued until disease progression or unacceptable toxicity.Population: All responders
Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented.
Outcome measures
| Measure |
Temozolomide
n=55 Participants
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
|
Dacarbazine
n=37 Participants
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
|
|---|---|---|
|
Duration of Objective Response
|
4.34 Months
Interval 4.17 to 6.18
|
8.31 Months
Interval 6.08 to 19.25
|
Adverse Events
Temozolomide
Serious events: 124 serious events
Other events: 394 other events
Deaths: 0 deaths
Dacarbazine
Serious events: 100 serious events
Other events: 374 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Temozolomide
n=419 participants at risk
|
Dacarbazine
n=421 participants at risk
|
|---|---|---|
|
Vascular disorders
HYPOTENSION
|
0.24%
1/419 • Number of events 1
|
0.71%
3/421 • Number of events 4
|
|
Vascular disorders
THROMBOSIS
|
0.24%
1/419 • Number of events 2
|
0.48%
2/421 • Number of events 2
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Eye disorders
GLAUCOMA
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Eye disorders
KERATITIS
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Eye disorders
PHOTOPHOBIA
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Eye disorders
UVEITIS
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Eye disorders
VISION BLURRED
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Eye disorders
VITREOUS HAEMORRHAGE
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.4%
6/419 • Number of events 9
|
1.9%
8/421 • Number of events 8
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/419
|
0.24%
1/421 • Number of events 3
|
|
Gastrointestinal disorders
COLONIC FISTULA
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Gastrointestinal disorders
COLONIC OBSTRUCTION
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.4%
6/419 • Number of events 10
|
0.48%
2/421 • Number of events 2
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/419
|
0.95%
4/421 • Number of events 4
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.48%
2/419 • Number of events 2
|
0.00%
0/421
|
|
Gastrointestinal disorders
INTRA-ABDOMINAL HAEMORRHAGE
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
2.6%
11/419 • Number of events 14
|
2.4%
10/421 • Number of events 12
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Gastrointestinal disorders
SMALL INTESTINAL HAEMORRHAGE
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.24%
1/419 • Number of events 1
|
0.24%
1/421 • Number of events 1
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Gastrointestinal disorders
VOMITING
|
3.6%
15/419 • Number of events 21
|
2.1%
9/421 • Number of events 11
|
|
General disorders
CHEST PAIN
|
0.24%
1/419 • Number of events 2
|
0.48%
2/421 • Number of events 2
|
|
General disorders
CHILLS
|
0.24%
1/419 • Number of events 1
|
0.48%
2/421 • Number of events 3
|
|
General disorders
FATIGUE
|
1.7%
7/419 • Number of events 9
|
1.2%
5/421 • Number of events 6
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.95%
4/419 • Number of events 4
|
0.71%
3/421 • Number of events 3
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.24%
1/419 • Number of events 1
|
0.24%
1/421 • Number of events 1
|
|
General disorders
PERFORMANCE STATUS DECREASED
|
0.24%
1/419 • Number of events 1
|
0.24%
1/421 • Number of events 2
|
|
General disorders
PYREXIA
|
0.72%
3/419 • Number of events 3
|
1.9%
8/421 • Number of events 9
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.24%
1/419 • Number of events 2
|
0.00%
0/421
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.24%
1/419 • Number of events 2
|
0.00%
0/421
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.24%
1/419 • Number of events 2
|
0.00%
0/421
|
|
Hepatobiliary disorders
HEPATIC PAIN
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/419
|
0.48%
2/421 • Number of events 2
|
|
Infections and infestations
ABSCESS INTESTINAL
|
0.24%
1/419 • Number of events 1
|
0.24%
1/421 • Number of events 1
|
|
Infections and infestations
APPENDICITIS
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Infections and infestations
BRONCHITIS
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/419
|
0.48%
2/421 • Number of events 2
|
|
Infections and infestations
ENDOCARDITIS
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Infections and infestations
HAEMOPHILUS INFECTION
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Infections and infestations
HERPES ZOSTER
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Infections and infestations
INFECTION
|
0.24%
1/419 • Number of events 1
|
0.24%
1/421 • Number of events 1
|
|
Infections and infestations
INFECTIVE MYOSITIS
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/419
|
0.48%
2/421 • Number of events 3
|
|
Infections and infestations
PNEUMONIA
|
0.95%
4/419 • Number of events 4
|
0.24%
1/421 • Number of events 1
|
|
Infections and infestations
RHINITIS
|
0.24%
1/419 • Number of events 2
|
0.00%
0/421
|
|
Infections and infestations
SALPINGITIS
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Infections and infestations
SEPSIS
|
0.95%
4/419 • Number of events 4
|
0.24%
1/421 • Number of events 1
|
|
Infections and infestations
SEPTIC SHOCK
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Infections and infestations
SERRATIA INFECTION
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/419
|
0.48%
2/421 • Number of events 2
|
|
Infections and infestations
WOUND INFECTION
|
0.48%
2/419 • Number of events 3
|
0.24%
1/421 • Number of events 1
|
|
Injury, poisoning and procedural complications
AORTIC INJURY
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.24%
1/419 • Number of events 3
|
0.00%
0/421
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.24%
1/419 • Number of events 1
|
0.24%
1/421 • Number of events 3
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.24%
1/419 • Number of events 1
|
0.24%
1/421 • Number of events 3
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.24%
1/419 • Number of events 1
|
0.24%
1/421 • Number of events 1
|
|
Investigations
BLOOD CALCIUM INCREASED
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Investigations
BLOOD GLUCOSE DECREASED
|
0.00%
0/419
|
0.48%
2/421 • Number of events 2
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
0.48%
2/419 • Number of events 6
|
0.00%
0/421
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.72%
3/419 • Number of events 5
|
1.7%
7/421 • Number of events 9
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.72%
3/419 • Number of events 5
|
0.00%
0/421
|
|
Investigations
MINI MENTAL STATUS EXAMINATION ABNORMAL
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
2.1%
9/419 • Number of events 14
|
0.71%
3/421 • Number of events 4
|
|
Investigations
PLATELET COUNT DECREASED
|
5.0%
21/419 • Number of events 34
|
0.71%
3/421 • Number of events 4
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
1.2%
5/419 • Number of events 7
|
0.48%
2/421 • Number of events 4
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.24%
1/419 • Number of events 2
|
0.00%
0/421
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.48%
2/419 • Number of events 2
|
0.71%
3/421 • Number of events 3
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.48%
2/419 • Number of events 2
|
0.00%
0/421
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.24%
1/419 • Number of events 1
|
0.95%
4/421 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.24%
1/419 • Number of events 1
|
0.24%
1/421 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
OSTEOLYSIS
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/419
|
0.71%
3/421 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
SOFT TISSUE NECROSIS
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.00%
0/419
|
0.24%
1/421 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID CANCER
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR HAEMORRHAGE
|
0.24%
1/419 • Number of events 1
|
0.95%
4/421 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.24%
1/419 • Number of events 1
|
0.48%
2/421 • Number of events 2
|
|
Nervous system disorders
ATAXIA
|
0.72%
3/419 • Number of events 3
|
0.24%
1/421 • Number of events 1
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Nervous system disorders
CONUS MEDULLARIS SYNDROME
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Nervous system disorders
CONVULSION
|
0.48%
2/419 • Number of events 2
|
0.48%
2/421 • Number of events 2
|
|
Nervous system disorders
DIZZINESS
|
0.72%
3/419 • Number of events 5
|
0.48%
2/421 • Number of events 3
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.24%
1/419 • Number of events 1
|
0.48%
2/421 • Number of events 2
|
|
Nervous system disorders
HEADACHE
|
1.2%
5/419 • Number of events 5
|
0.48%
2/421 • Number of events 2
|
|
Nervous system disorders
HEMIPLEGIA
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Nervous system disorders
INTRACRANIAL PRESSURE INCREASED
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Nervous system disorders
NEURALGIA
|
0.24%
1/419 • Number of events 1
|
0.24%
1/421 • Number of events 1
|
|
Nervous system disorders
NEUROLOGICAL SYMPTOM
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
0.00%
0/419
|
0.48%
2/421 • Number of events 2
|
|
Nervous system disorders
SOMNOLENCE
|
0.24%
1/419 • Number of events 1
|
0.24%
1/421 • Number of events 1
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Nervous system disorders
SYNCOPE
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Nervous system disorders
SYNCOPE VASOVAGAL
|
0.00%
0/419
|
0.48%
2/421 • Number of events 2
|
|
Psychiatric disorders
ANXIETY
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.24%
1/419 • Number of events 1
|
0.48%
2/421 • Number of events 2
|
|
Psychiatric disorders
DEPRESSION
|
0.48%
2/419 • Number of events 2
|
0.24%
1/421 • Number of events 1
|
|
Psychiatric disorders
DRUG DEPENDENCE
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Renal and urinary disorders
HAEMORRHAGE URINARY TRACT
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.48%
2/419 • Number of events 5
|
0.00%
0/421
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.24%
1/419 • Number of events 2
|
0.00%
0/421
|
|
Renal and urinary disorders
URETERIC OBSTRUCTION
|
0.72%
3/419 • Number of events 5
|
0.00%
0/421
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.24%
1/419 • Number of events 1
|
0.24%
1/421 • Number of events 1
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.24%
1/419 • Number of events 2
|
0.00%
0/421
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.24%
1/419 • Number of events 2
|
0.00%
0/421
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.7%
7/419 • Number of events 8
|
0.95%
4/421 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.48%
2/419 • Number of events 2
|
0.48%
2/421 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL FIBROSIS
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.24%
1/419 • Number of events 2
|
0.48%
2/421 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Skin and subcutaneous tissue disorders
EXFOLIATIVE RASH
|
1.2%
5/419 • Number of events 12
|
0.00%
0/421
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Surgical and medical procedures
ABDOMINAL CAVITY DRAINAGE
|
0.24%
1/419 • Number of events 3
|
0.00%
0/421
|
|
Surgical and medical procedures
LYMPHADENECTOMY
|
0.48%
2/419 • Number of events 2
|
0.24%
1/421 • Number of events 1
|
|
Surgical and medical procedures
MALIGNANT TUMOUR EXCISION
|
0.48%
2/419 • Number of events 3
|
0.00%
0/421
|
|
Surgical and medical procedures
MASTECTOMY
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Surgical and medical procedures
PLEURODESIS
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Surgical and medical procedures
SKIN LESION EXCISION
|
0.24%
1/419 • Number of events 2
|
0.24%
1/421 • Number of events 1
|
|
Surgical and medical procedures
THORACIC CAVITY DRAINAGE
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Vascular disorders
HAEMATOMA
|
0.24%
1/419 • Number of events 4
|
0.00%
0/421
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/419
|
0.48%
2/421 • Number of events 2
|
|
Blood and lymphatic system disorders
ANAEMIA HAEMOLYTIC AUTOIMMUNE
|
0.48%
2/419 • Number of events 6
|
0.00%
0/421
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.24%
1/419 • Number of events 1
|
0.71%
3/421 • Number of events 3
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Blood and lymphatic system disorders
NORMOCHROMIC NORMOCYTIC ANAEMIA
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.24%
1/419 • Number of events 1
|
0.24%
1/421 • Number of events 1
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
|
Cardiac disorders
ARRHYTHMIA SUPRAVENTRICULAR
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.72%
3/419 • Number of events 3
|
0.24%
1/421 • Number of events 2
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.24%
1/419 • Number of events 1
|
0.24%
1/421 • Number of events 1
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Cardiac disorders
NODAL ARRHYTHMIA
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.24%
1/419 • Number of events 1
|
0.24%
1/421 • Number of events 1
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/419
|
0.24%
1/421 • Number of events 1
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.24%
1/419 • Number of events 1
|
0.00%
0/421
|
Other adverse events
| Measure |
Temozolomide
n=419 participants at risk
|
Dacarbazine
n=421 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
10.3%
43/419 • Number of events 91
|
7.4%
31/421 • Number of events 58
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.3%
22/419 • Number of events 43
|
4.0%
17/421 • Number of events 33
|
|
Gastrointestinal disorders
CONSTIPATION
|
43.7%
183/419 • Number of events 563
|
26.4%
111/421 • Number of events 267
|
|
Gastrointestinal disorders
DIARRHOEA
|
18.9%
79/419 • Number of events 146
|
16.9%
71/421 • Number of events 139
|
|
Gastrointestinal disorders
DYSPEPSIA
|
5.3%
22/419 • Number of events 85
|
5.9%
25/421 • Number of events 47
|
|
Gastrointestinal disorders
NAUSEA
|
68.3%
286/419 • Number of events 966
|
48.9%
206/421 • Number of events 535
|
|
Gastrointestinal disorders
VOMITING
|
50.4%
211/419 • Number of events 456
|
24.5%
103/421 • Number of events 208
|
|
General disorders
FATIGUE
|
60.4%
253/419 • Number of events 1102
|
57.0%
240/421 • Number of events 798
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
4.3%
18/419 • Number of events 30
|
5.7%
24/421 • Number of events 37
|
|
General disorders
OEDEMA PERIPHERAL
|
7.2%
30/419 • Number of events 90
|
8.8%
37/421 • Number of events 136
|
|
General disorders
PYREXIA
|
11.7%
49/419 • Number of events 67
|
12.8%
54/421 • Number of events 71
|
|
Investigations
WEIGHT DECREASED
|
20.8%
87/419 • Number of events 380
|
10.7%
45/421 • Number of events 114
|
|
Investigations
WEIGHT INCREASED
|
3.8%
16/419 • Number of events 90
|
9.5%
40/421 • Number of events 209
|
|
Metabolism and nutrition disorders
ANOREXIA
|
28.2%
118/419 • Number of events 384
|
18.8%
79/421 • Number of events 157
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
4.8%
20/419 • Number of events 66
|
5.5%
23/421 • Number of events 79
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
8.4%
35/419 • Number of events 88
|
11.2%
47/421 • Number of events 102
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
8.4%
35/419 • Number of events 120
|
7.4%
31/421 • Number of events 54
|
|
Nervous system disorders
DIZZINESS
|
12.2%
51/419 • Number of events 135
|
10.7%
45/421 • Number of events 77
|
|
Nervous system disorders
DYSGEUSIA
|
5.3%
22/419 • Number of events 77
|
4.0%
17/421 • Number of events 35
|
|
Nervous system disorders
HEADACHE
|
22.0%
92/419 • Number of events 206
|
13.3%
56/421 • Number of events 115
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
6.7%
28/419 • Number of events 75
|
6.9%
29/421 • Number of events 77
|
|
Psychiatric disorders
DEPRESSION
|
6.0%
25/419 • Number of events 81
|
4.5%
19/421 • Number of events 49
|
|
Psychiatric disorders
INSOMNIA
|
6.0%
25/419 • Number of events 66
|
4.0%
17/421 • Number of events 42
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.9%
71/419 • Number of events 193
|
12.1%
51/421 • Number of events 91
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.7%
45/419 • Number of events 109
|
11.4%
48/421 • Number of events 105
|
|
Skin and subcutaneous tissue disorders
EXFOLIATIVE RASH
|
12.2%
51/419 • Number of events 156
|
5.5%
23/421 • Number of events 45
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
17.9%
75/419 • Number of events 214
|
6.9%
29/421 • Number of events 67
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER