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Trial record 60 of 519 for:    melanoma phase III

Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00091572
Recruitment Status : Completed
First Posted : September 14, 2004
Results First Posted : March 12, 2009
Last Update Posted : June 6, 2017
Sponsor:
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Interventions Drug: Temozolomide
Drug: Dacarbazine
Enrollment 859
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Temozolomide Dacarbazine
Hide Arm/Group Description temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously) dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
Period Title: Overall Study
Started 429 [1] 430 [2]
Completed 334 [3] 348 [3]
Not Completed 95 82
Reason Not Completed
Lost to Follow-up             1             1
Subject's Refusal unrelated to toxicity             14             22
Death not due to malignancy/toxicity             1             3
Medical Decision unrelated toxicity/PD             10             22
Other Reason             6             13
Ongoing (still on treatment)             8             12
Major Protocol Violation             2             0
Toxicity (Related AE)             53             9
[1]
10 subjects in temozolomide group not treated.
[2]
9 subjects in dacarbazine group not treated.
[3]
Progressive disease/relapse/death due to progressive disease
Arm/Group Title Temozolomide Dacarbazine Total
Hide Arm/Group Description temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously) dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks Total of all reporting groups
Overall Number of Baseline Participants 429 430 859
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 429 participants 430 participants 859 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
276
  64.3%
261
  60.7%
537
  62.5%
>=65 years
153
  35.7%
169
  39.3%
322
  37.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 429 participants 430 participants 859 participants
Female
179
  41.7%
177
  41.2%
356
  41.4%
Male
250
  58.3%
253
  58.8%
503
  58.6%
1.Primary Outcome
Title Overall Survival
Hide Description Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
Time Frame The final analysis was to be performed when at least 616 deaths had occurred.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Temozolomide Dacarbazine
Hide Arm/Group Description:
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
Overall Number of Participants Analyzed 429 430
Median (95% Confidence Interval)
Unit of Measure: Months
9.13
(8.11 to 9.89)
9.36
(8.21 to 10.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Temozolomide, Dacarbazine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9999
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.00
Confidence Interval 95%
0.86 to 1.17
Estimation Comments Temozolomide events (deaths) = 320. Dacarbazine events (deaths) = 325.
2.Secondary Outcome
Title Progression Free Survival
Hide Description 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.
Time Frame Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Temozolomide Dacarbazine
Hide Arm/Group Description:
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
Overall Number of Participants Analyzed 429 430
Median (95% Confidence Interval)
Unit of Measure: Months
2.30
(2.23 to 2.43)
2.17
(2.14 to 2.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Temozolomide, Dacarbazine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2663
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval 95%
0.80 to 1.06
Estimation Comments Temozolomide events (progressions/deaths) = 401. Dacarbazine events (progressions/deaths) = 398.
3.Secondary Outcome
Title Objective Response Rate in Subjects With Measurable Lesions
Hide Description 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.
Time Frame Treatment continued until disease progression or unacceptable toxicity.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population with measurable disease at Baseline.
Arm/Group Title Temozolomide Dacarbazine
Hide Arm/Group Description:
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
Overall Number of Participants Analyzed 401 388
Median (95% Confidence Interval)
Unit of Measure: Ratio
0.14
(0.10 to 0.17)
0.10
(0.07 to 0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Temozolomide, Dacarbazine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0718
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.43
Confidence Interval 95%
0.97 to 2.12
Estimation Comments Temozolomide numerator (responders) = 55. Dacarbazine numerator (responders) = 37.
4.Secondary Outcome
Title Duration of Objective Response
Hide Description 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.
Time Frame Treatment continued until disease progression or unacceptable toxicity.
Hide Outcome Measure Data
Hide Analysis Population Description
All responders
Arm/Group Title Temozolomide Dacarbazine
Hide Arm/Group Description:
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
Overall Number of Participants Analyzed 55 37
Median (95% Confidence Interval)
Unit of Measure: Months
4.34
(4.17 to 6.18)
8.31
(6.08 to 19.25)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Temozolomide Dacarbazine
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Temozolomide Dacarbazine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Temozolomide Dacarbazine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   124/419 (29.59%)      100/421 (23.75%)    
Blood and lymphatic system disorders     
ANAEMIA HAEMOLYTIC AUTOIMMUNE  1  2/419 (0.48%)  6 0/421 (0.00%)  0
FEBRILE NEUTROPENIA  1  1/419 (0.24%)  1 3/421 (0.71%)  3
LYMPHADENOPATHY  1  0/419 (0.00%)  0 1/421 (0.24%)  1
NORMOCHROMIC NORMOCYTIC ANAEMIA  1  1/419 (0.24%)  1 0/421 (0.00%)  0
PANCYTOPENIA  1  1/419 (0.24%)  1 1/421 (0.24%)  1
Cardiac disorders     
ACUTE CORONARY SYNDROME  1  1/419 (0.24%)  1 0/421 (0.00%)  0
ANGINA PECTORIS  1  1/419 (0.24%)  1 0/421 (0.00%)  0
ARRHYTHMIA SUPRAVENTRICULAR  1  0/419 (0.00%)  0 1/421 (0.24%)  1
ATRIAL FIBRILLATION  1  3/419 (0.72%)  3 1/421 (0.24%)  2
ATRIAL FLUTTER  1  0/419 (0.00%)  0 1/421 (0.24%)  1
CARDIAC FAILURE ACUTE  1  0/419 (0.00%)  0 1/421 (0.24%)  1
CARDIO-RESPIRATORY ARREST  1  1/419 (0.24%)  1 1/421 (0.24%)  1
MYOCARDIAL ISCHAEMIA  1  0/419 (0.00%)  0 1/421 (0.24%)  1
NODAL ARRHYTHMIA  1  0/419 (0.00%)  0 1/421 (0.24%)  1
PERICARDIAL EFFUSION  1  1/419 (0.24%)  1 1/421 (0.24%)  1
SINUS TACHYCARDIA  1  0/419 (0.00%)  0 1/421 (0.24%)  1
SUPRAVENTRICULAR TACHYCARDIA  1  1/419 (0.24%)  1 0/421 (0.00%)  0
VENTRICULAR EXTRASYSTOLES  1  0/419 (0.00%)  0 1/421 (0.24%)  1
VENTRICULAR TACHYCARDIA  1  1/419 (0.24%)  1 0/421 (0.00%)  0
Eye disorders     
GLAUCOMA  1  0/419 (0.00%)  0 1/421 (0.24%)  1
KERATITIS  1  1/419 (0.24%)  1 0/421 (0.00%)  0
PHOTOPHOBIA  1  1/419 (0.24%)  1 0/421 (0.00%)  0
UVEITIS  1  0/419 (0.00%)  0 1/421 (0.24%)  1
VISION BLURRED  1  1/419 (0.24%)  1 0/421 (0.00%)  0
VITREOUS HAEMORRHAGE  1  1/419 (0.24%)  1 0/421 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL PAIN  1  6/419 (1.43%)  9 8/421 (1.90%)  8
ABDOMINAL PAIN LOWER  1  0/419 (0.00%)  0 1/421 (0.24%)  1
ABDOMINAL PAIN UPPER  1  0/419 (0.00%)  0 1/421 (0.24%)  1
ASCITES  1  0/419 (0.00%)  0 1/421 (0.24%)  3
COLONIC FISTULA  1  0/419 (0.00%)  0 1/421 (0.24%)  1
COLONIC OBSTRUCTION  1  0/419 (0.00%)  0 1/421 (0.24%)  1
CONSTIPATION  1  6/419 (1.43%)  10 2/421 (0.48%)  2
DIARRHOEA  1  0/419 (0.00%)  0 4/421 (0.95%)  4
HAEMATEMESIS  1  2/419 (0.48%)  2 0/421 (0.00%)  0
INTRA-ABDOMINAL HAEMORRHAGE  1  0/419 (0.00%)  0 1/421 (0.24%)  1
NAUSEA  1  11/419 (2.63%)  14 10/421 (2.38%)  12
PANCREATITIS  1  1/419 (0.24%)  1 0/421 (0.00%)  0
SMALL INTESTINAL HAEMORRHAGE  1  0/419 (0.00%)  0 1/421 (0.24%)  1
SMALL INTESTINAL OBSTRUCTION  1  1/419 (0.24%)  1 1/421 (0.24%)  1
UPPER GASTROINTESTINAL HAEMORRHAGE  1  1/419 (0.24%)  1 0/421 (0.00%)  0
VOMITING  1  15/419 (3.58%)  21 9/421 (2.14%)  11
General disorders     
CHEST PAIN  1  1/419 (0.24%)  2 2/421 (0.48%)  2
CHILLS  1  1/419 (0.24%)  1 2/421 (0.48%)  3
FATIGUE  1  7/419 (1.67%)  9 5/421 (1.19%)  6
GENERAL PHYSICAL HEALTH DETERIORATION  1  4/419 (0.95%)  4 3/421 (0.71%)  3
MULTI-ORGAN FAILURE  1  1/419 (0.24%)  1 1/421 (0.24%)  1
PERFORMANCE STATUS DECREASED  1  1/419 (0.24%)  1 1/421 (0.24%)  2
PYREXIA  1  3/419 (0.72%)  3 8/421 (1.90%)  9
Hepatobiliary disorders     
CHOLANGITIS  1  1/419 (0.24%)  1 0/421 (0.00%)  0
CHOLECYSTITIS  1  1/419 (0.24%)  2 0/421 (0.00%)  0
CHOLELITHIASIS  1  1/419 (0.24%)  2 0/421 (0.00%)  0
HEPATIC FAILURE  1  1/419 (0.24%)  2 0/421 (0.00%)  0
HEPATIC PAIN  1  1/419 (0.24%)  1 0/421 (0.00%)  0
Immune system disorders     
HYPERSENSITIVITY  1  0/419 (0.00%)  0 2/421 (0.48%)  2
Infections and infestations     
ABSCESS INTESTINAL  1  1/419 (0.24%)  1 1/421 (0.24%)  1
APPENDICITIS  1  1/419 (0.24%)  1 0/421 (0.00%)  0
BRONCHITIS  1  1/419 (0.24%)  1 0/421 (0.00%)  0
CYSTITIS  1  0/419 (0.00%)  0 1/421 (0.24%)  1
DIVERTICULITIS  1  0/419 (0.00%)  0 2/421 (0.48%)  2
ENDOCARDITIS  1  1/419 (0.24%)  1 0/421 (0.00%)  0
ERYSIPELAS  1  0/419 (0.00%)  0 1/421 (0.24%)  1
GASTROINTESTINAL INFECTION  1  1/419 (0.24%)  1 0/421 (0.00%)  0
HAEMOPHILUS INFECTION  1  0/419 (0.00%)  0 1/421 (0.24%)  1
HERPES ZOSTER  1  1/419 (0.24%)  1 0/421 (0.00%)  0
INFECTION  1  1/419 (0.24%)  1 1/421 (0.24%)  1
INFECTIVE MYOSITIS  1  0/419 (0.00%)  0 1/421 (0.24%)  1
LOWER RESPIRATORY TRACT INFECTION  1  1/419 (0.24%)  1 0/421 (0.00%)  0
LUNG INFECTION  1  0/419 (0.00%)  0 2/421 (0.48%)  3
PNEUMONIA  1  4/419 (0.95%)  4 1/421 (0.24%)  1
RHINITIS  1  1/419 (0.24%)  2 0/421 (0.00%)  0
SALPINGITIS  1  1/419 (0.24%)  1 0/421 (0.00%)  0
SEPSIS  1  4/419 (0.95%)  4 1/421 (0.24%)  1
SEPTIC SHOCK  1  1/419 (0.24%)  1 0/421 (0.00%)  0
SERRATIA INFECTION  1  1/419 (0.24%)  1 0/421 (0.00%)  0
SKIN INFECTION  1  0/419 (0.00%)  0 1/421 (0.24%)  1
SUBCUTANEOUS ABSCESS  1  1/419 (0.24%)  1 0/421 (0.00%)  0
TOOTH ABSCESS  1  0/419 (0.00%)  0 1/421 (0.24%)  1
URINARY TRACT INFECTION  1  0/419 (0.00%)  0 2/421 (0.48%)  2
WOUND INFECTION  1  2/419 (0.48%)  3 1/421 (0.24%)  1
Injury, poisoning and procedural complications     
AORTIC INJURY  1  0/419 (0.00%)  0 1/421 (0.24%)  1
CONTUSION  1  1/419 (0.24%)  1 0/421 (0.00%)  0
POST PROCEDURAL HAEMORRHAGE  1  1/419 (0.24%)  3 0/421 (0.00%)  0
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  1/419 (0.24%)  1 1/421 (0.24%)  3
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/419 (0.24%)  1 1/421 (0.24%)  3
BLOOD BILIRUBIN INCREASED  1  1/419 (0.24%)  1 1/421 (0.24%)  1
BLOOD CALCIUM INCREASED  1  1/419 (0.24%)  1 0/421 (0.00%)  0
BLOOD GLUCOSE DECREASED  1  0/419 (0.00%)  0 2/421 (0.48%)  2
BLOOD LACTATE DEHYDROGENASE INCREASED  1  2/419 (0.48%)  6 0/421 (0.00%)  0
BLOOD POTASSIUM DECREASED  1  1/419 (0.24%)  1 0/421 (0.00%)  0
HAEMOGLOBIN DECREASED  1  3/419 (0.72%)  5 7/421 (1.66%)  9
LYMPHOCYTE COUNT DECREASED  1  3/419 (0.72%)  5 0/421 (0.00%)  0
MINI MENTAL STATUS EXAMINATION ABNORMAL  1  0/419 (0.00%)  0 1/421 (0.24%)  1
NEUTROPHIL COUNT DECREASED  1  9/419 (2.15%)  14 3/421 (0.71%)  4
PLATELET COUNT DECREASED  1  21/419 (5.01%)  34 3/421 (0.71%)  4
WHITE BLOOD CELL COUNT DECREASED  1  5/419 (1.19%)  7 2/421 (0.48%)  4
Metabolism and nutrition disorders     
ANOREXIA  1  1/419 (0.24%)  2 0/421 (0.00%)  0
DEHYDRATION  1  2/419 (0.48%)  2 3/421 (0.71%)  3
DIABETES MELLITUS  1  2/419 (0.48%)  2 0/421 (0.00%)  0
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  0/419 (0.00%)  0 1/421 (0.24%)  1
BACK PAIN  1  1/419 (0.24%)  1 4/421 (0.95%)  6
MUSCULAR WEAKNESS  1  0/419 (0.00%)  0 1/421 (0.24%)  1
MUSCULOSKELETAL CHEST PAIN  1  1/419 (0.24%)  1 1/421 (0.24%)  1
OSTEOLYSIS  1  1/419 (0.24%)  1 0/421 (0.00%)  0
PAIN IN EXTREMITY  1  0/419 (0.00%)  0 3/421 (0.71%)  4
SOFT TISSUE NECROSIS  1  0/419 (0.00%)  0 1/421 (0.24%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
MALIGNANT MELANOMA  1  0/419 (0.00%)  0 1/421 (0.24%)  2
THYROID CANCER  1  0/419 (0.00%)  0 1/421 (0.24%)  1
TUMOUR HAEMORRHAGE  1  1/419 (0.24%)  1 4/421 (0.95%)  4
TUMOUR PAIN  1  1/419 (0.24%)  1 2/421 (0.48%)  2
Nervous system disorders     
ATAXIA  1  3/419 (0.72%)  3 1/421 (0.24%)  1
CEREBRAL ISCHAEMIA  1  0/419 (0.00%)  0 1/421 (0.24%)  1
CEREBROVASCULAR ACCIDENT  1  1/419 (0.24%)  1 0/421 (0.00%)  0
COGNITIVE DISORDER  1  1/419 (0.24%)  1 0/421 (0.00%)  0
CONUS MEDULLARIS SYNDROME  1  1/419 (0.24%)  1 0/421 (0.00%)  0
CONVULSION  1  2/419 (0.48%)  2 2/421 (0.48%)  2
DIZZINESS  1  3/419 (0.72%)  5 2/421 (0.48%)  3
HAEMORRHAGE INTRACRANIAL  1  1/419 (0.24%)  1 2/421 (0.48%)  2
HEADACHE  1  5/419 (1.19%)  5 2/421 (0.48%)  2
HEMIPLEGIA  1  0/419 (0.00%)  0 1/421 (0.24%)  1
INTRACRANIAL PRESSURE INCREASED  1  0/419 (0.00%)  0 1/421 (0.24%)  1
MEMORY IMPAIRMENT  1  0/419 (0.00%)  0 1/421 (0.24%)  1
NEURALGIA  1  1/419 (0.24%)  1 1/421 (0.24%)  1
NEUROLOGICAL SYMPTOM  1  0/419 (0.00%)  0 1/421 (0.24%)  1
PERIPHERAL MOTOR NEUROPATHY  1  0/419 (0.00%)  0 2/421 (0.48%)  2
SOMNOLENCE  1  1/419 (0.24%)  1 1/421 (0.24%)  1
SPINAL CORD COMPRESSION  1  0/419 (0.00%)  0 1/421 (0.24%)  1
SYNCOPE  1  1/419 (0.24%)  1 0/421 (0.00%)  0
SYNCOPE VASOVAGAL  1  0/419 (0.00%)  0 2/421 (0.48%)  2
Psychiatric disorders     
ANXIETY  1  1/419 (0.24%)  1 0/421 (0.00%)  0
CONFUSIONAL STATE  1  1/419 (0.24%)  1 2/421 (0.48%)  2
DEPRESSION  1  2/419 (0.48%)  2 1/421 (0.24%)  1
DRUG DEPENDENCE  1  0/419 (0.00%)  0 1/421 (0.24%)  1
Renal and urinary disorders     
HAEMORRHAGE URINARY TRACT  1  0/419 (0.00%)  0 1/421 (0.24%)  1
NEPHROLITHIASIS  1  0/419 (0.00%)  0 1/421 (0.24%)  1
RENAL FAILURE  1  2/419 (0.48%)  5 0/421 (0.00%)  0
RENAL FAILURE ACUTE  1  1/419 (0.24%)  2 0/421 (0.00%)  0
URETERIC OBSTRUCTION  1  3/419 (0.72%)  5 0/421 (0.00%)  0
URINARY RETENTION  1  1/419 (0.24%)  1 1/421 (0.24%)  1
Reproductive system and breast disorders     
MENORRHAGIA  1  1/419 (0.24%)  2 0/421 (0.00%)  0
PELVIC PAIN  1  1/419 (0.24%)  1 0/421 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
ACUTE RESPIRATORY DISTRESS SYNDROME  1  1/419 (0.24%)  1 0/421 (0.00%)  0
COUGH  1  1/419 (0.24%)  2 0/421 (0.00%)  0
DYSPHONIA  1  0/419 (0.00%)  0 1/421 (0.24%)  1
DYSPNOEA  1  7/419 (1.67%)  8 4/421 (0.95%)  5
EPISTAXIS  1  1/419 (0.24%)  1 0/421 (0.00%)  0
PLEURAL EFFUSION  1  2/419 (0.48%)  2 2/421 (0.48%)  2
PLEURAL FIBROSIS  1  0/419 (0.00%)  0 1/421 (0.24%)  1
PNEUMOTHORAX  1  1/419 (0.24%)  1 0/421 (0.00%)  0
PULMONARY EMBOLISM  1  1/419 (0.24%)  2 2/421 (0.48%)  2
PULMONARY OEDEMA  1  1/419 (0.24%)  1 0/421 (0.00%)  0
Skin and subcutaneous tissue disorders     
EXFOLIATIVE RASH  1  5/419 (1.19%)  12 0/421 (0.00%)  0
URTICARIA  1  1/419 (0.24%)  1 0/421 (0.00%)  0
Surgical and medical procedures     
ABDOMINAL CAVITY DRAINAGE  1  1/419 (0.24%)  3 0/421 (0.00%)  0
LYMPHADENECTOMY  1  2/419 (0.48%)  2 1/421 (0.24%)  1
MALIGNANT TUMOUR EXCISION  1  2/419 (0.48%)  3 0/421 (0.00%)  0
MASTECTOMY  1  1/419 (0.24%)  1 0/421 (0.00%)  0
PLEURODESIS  1  1/419 (0.24%)  1 0/421 (0.00%)  0
SKIN LESION EXCISION  1  1/419 (0.24%)  2 1/421 (0.24%)  1
THORACIC CAVITY DRAINAGE  1  1/419 (0.24%)  1 0/421 (0.00%)  0
Vascular disorders     
HAEMATOMA  1  1/419 (0.24%)  4 0/421 (0.00%)  0
HYPERTENSION  1  0/419 (0.00%)  0 2/421 (0.48%)  2
HYPOTENSION  1  1/419 (0.24%)  1 3/421 (0.71%)  4
THROMBOSIS  1  1/419 (0.24%)  2 2/421 (0.48%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Temozolomide Dacarbazine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   394/419 (94.03%)      374/421 (88.84%)    
Gastrointestinal disorders     
ABDOMINAL PAIN  1  43/419 (10.26%)  91 31/421 (7.36%)  58
ABDOMINAL PAIN UPPER  1  22/419 (5.25%)  43 17/421 (4.04%)  33
CONSTIPATION  1  183/419 (43.68%)  563 111/421 (26.37%)  267
DIARRHOEA  1  79/419 (18.85%)  146 71/421 (16.86%)  139
DYSPEPSIA  1  22/419 (5.25%)  85 25/421 (5.94%)  47
NAUSEA  1  286/419 (68.26%)  966 206/421 (48.93%)  535
VOMITING  1  211/419 (50.36%)  456 103/421 (24.47%)  208
General disorders     
FATIGUE  1  253/419 (60.38%)  1102 240/421 (57.01%)  798
INFLUENZA LIKE ILLNESS  1  18/419 (4.30%)  30 24/421 (5.70%)  37
OEDEMA PERIPHERAL  1  30/419 (7.16%)  90 37/421 (8.79%)  136
PYREXIA  1  49/419 (11.69%)  67 54/421 (12.83%)  71
Investigations     
WEIGHT DECREASED  1  87/419 (20.76%)  380 45/421 (10.69%)  114
WEIGHT INCREASED  1  16/419 (3.82%)  90 40/421 (9.50%)  209
Metabolism and nutrition disorders     
ANOREXIA  1  118/419 (28.16%)  384 79/421 (18.76%)  157
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  20/419 (4.77%)  66 23/421 (5.46%)  79
BACK PAIN  1  35/419 (8.35%)  88 47/421 (11.16%)  102
PAIN IN EXTREMITY  1  35/419 (8.35%)  120 31/421 (7.36%)  54
Nervous system disorders     
DIZZINESS  1  51/419 (12.17%)  135 45/421 (10.69%)  77
DYSGEUSIA  1  22/419 (5.25%)  77 17/421 (4.04%)  35
HEADACHE  1  92/419 (21.96%)  206 56/421 (13.30%)  115
PERIPHERAL SENSORY NEUROPATHY  1  28/419 (6.68%)  75 29/421 (6.89%)  77
Psychiatric disorders     
DEPRESSION  1  25/419 (5.97%)  81 19/421 (4.51%)  49
INSOMNIA  1  25/419 (5.97%)  66 17/421 (4.04%)  42
Respiratory, thoracic and mediastinal disorders     
COUGH  1  71/419 (16.95%)  193 51/421 (12.11%)  91
DYSPNOEA  1  45/419 (10.74%)  109 48/421 (11.40%)  105
Skin and subcutaneous tissue disorders     
EXFOLIATIVE RASH  1  51/419 (12.17%)  156 23/421 (5.46%)  45
PRURITUS  1  75/419 (17.90%)  214 29/421 (6.89%)  67
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00091572     History of Changes
Obsolete Identifiers: NCT00101218
Other Study ID Numbers: P03267
First Submitted: September 10, 2004
First Posted: September 14, 2004
Results First Submitted: December 19, 2008
Results First Posted: March 12, 2009
Last Update Posted: June 6, 2017