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Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00103844
Recruitment Status : Completed
First Posted : February 16, 2005
Results First Posted : January 7, 2010
Last Update Posted : August 10, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Myeloid Leukemia
Philadelphia-Positive Myeloid Leukemia
Interventions Drug: Dasatinib
Drug: Imatinib
Enrollment 150
Recruitment Details  
Pre-assignment Details 166 subjects enrolled; 16 failed screening and were not treated (2 subjects were double-randomizations, 13 subjects failed inclusion criteria, 1 subject withdrew consent during screening.)
Arm/Group Title Dasatinib First Imatinib First
Hide Arm/Group Description Dasatinib 70 mg twice a day (BID) in the first intervention period and, if intolerance to dasatinib or progression, imatinib 400 mg BID in the second intervention period (after washout period). Imatinib 400 mg BID in the first intervention period and, if intolerance to imatinib or progression or lack of efficacy, dasatinib 70 mg BID in the second intervention period (after washout period).
Period Title: Overall Study
Started 101 49
Crossed Over 22 [1] 40 [2]
Completed 101 [3] 49 [3]
Not Completed 0 0
[1]
22 participants from the dasatinib arm crossed over to imatinib
[2]
40 participants from the imatinib arm crossed over the dasatinib
[3]
Completed=no longer on treatment.Treatment continued until disease progression/intolerable toxicity.
Arm/Group Title Dasatinib Imatinib Total
Hide Arm/Group Description Dasatinib 70 mg twice a day (BID) Imatinib 400 mg BID Total of all reporting groups
Overall Number of Baseline Participants 101 49 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 49 participants 150 participants
Between 21 and 45 years 36 15 51
Between 46 and 65 years 48 28 76
Between 66 and 75 years 13 5 18
>75 years 4 1 5
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 49 participants 150 participants
51  (13.6) 50  (13.6) 51  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 49 participants 150 participants
Female
48
  47.5%
27
  55.1%
75
  50.0%
Male
53
  52.5%
22
  44.9%
75
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 49 participants 150 participants
Asian 6 3 9
Black or African American 2 1 3
White 87 43 130
Other 6 2 8
Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 49 participants 150 participants
Score=0 (fully active) 71 34 105
Score=1 (ambulatory, light/sedentary work) 27 12 39
Score=2 (ambulatory, all selfcare, unable to work) 0 0 0
Score=3 (limited selfcare, some bed confinement) 0 0 0
Score=4 (completely disabled) 0 0 0
Score=5 (dead) 0 0 0
Not Reported 3 3 6
[1]
Measure Description: ECOG PS: a 6-item scale to assess disease progression, daily functioning, and appropriate treatment and prognosis. Scale: 0-5, with 0=fully active, able to carry on all pre-disease performance without restriction and 5=death.
1.Primary Outcome
Title Number of Participants With Major Cytogenetic Response (MCyR) at Week 12
Hide Description Cytogenetic response was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (CCyR; 0% Ph+ cells in metaphase in bone marrow) or Partial CyR (PCyR; >0% to 35% Ph+ cells in metaphase in bone marrow).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects
Arm/Group Title Dasatinib Imatinib
Hide Arm/Group Description:
Dasatinib 70 mg twice a day (BID)
Imatinib 400 mg BID
Overall Number of Participants Analyzed 101 49
Measure Type: Number
Unit of Measure: Participants
36 14
2.Secondary Outcome
Title MCyR at Any Time Prior to Crossover
Hide Description Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as CCyR (0% Ph+ cells in metaphase in bone marrow) or PCyR (>0% to 35% Ph+ cells in metaphase in bone marrow).
Time Frame Baseline (within 4 weeks of Day 1), every 12 weeks until crossover or off-study timepoints. Restricted to precrossover measurements.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib Imatinib
Hide Arm/Group Description:
Dasatinib 70 mg twice a day (BID)
Imatinib 400 mg BID
Overall Number of Participants Analyzed 101 49
Measure Type: Number
Unit of Measure: Participants
MCyR (CCyR + PCyR) 54 16
CCyR (0% Ph+ cells) 44 9
PCyR (>0% to 35% Ph+ cells) 10 7
3.Secondary Outcome
Title Duration of MCyR at 12 Months and 18 Months
Hide Description Percentage of participants who achieved MCyR and did not progress at 12 and 18 months.
Time Frame 12 months, 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib Imatinib
Hide Arm/Group Description:
Dasatinib 70 mg twice a day (BID)
Imatinib 400 mg BID
Overall Number of Participants Analyzed 101 49
Measure Type: Number
Unit of Measure: percentage of participants.
12 months 92 74
18 months 90 74
4.Secondary Outcome
Title Duration of MCyR at 24 Months
Hide Description Percentage of participants who achieved MCyR and did not progress at 24 months.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
In the imatinib group, the 24 months timepoint was beyond the maximum observed time.
Arm/Group Title Dasatinib Imatinib
Hide Arm/Group Description:
Dasatinib 70 mg twice a day (BID)
Imatinib 400 mg BID
Overall Number of Participants Analyzed 101 0
Measure Type: Number
Unit of Measure: Percentage of Participants
90
5.Secondary Outcome
Title Time to MCyR Prior to Crossover
Hide Description Median time from first dosing date to date of MCyR
Time Frame Baseline (within 4 weeks of Day 1), every 12 weeks, at crossover or off-study timepoints; restricted to precrossover measurements.
Hide Outcome Measure Data
Hide Analysis Population Description
Population consists of the number of responders in each treatment group
Arm/Group Title Dasatinib Imatinib
Hide Arm/Group Description:
Dasatinib 70 mg twice a day (BID)
Imatinib 400 mg BID
Overall Number of Participants Analyzed 54 16
Median (Full Range)
Unit of Measure: months
2.8
(0.7 to 19.3)
2.8
(2.4 to 5.7)
6.Secondary Outcome
Title Complete Hematologic Response (CHR) at Any Time Prior to Crossover
Hide Description Participants achieving CHR prior to crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Time Frame Baseline (within 4 weeks of Day 1), weekly until Week 12 and then every 12 weeks until crossover or off-study; restricted to precrossover measurements.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib Imatinib
Hide Arm/Group Description:
Dasatinib 70 mg twice a day (BID)
Imatinib 400 mg BID
Overall Number of Participants Analyzed 101 49
Measure Type: Number
Unit of Measure: Participants
94 40
7.Secondary Outcome
Title Duration of Complete Hematologic Response (CHR)
Hide Description Percentage of participants who achieved CHR and did not progress at specified time points. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Time Frame 12 months, 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants achieving CHR in each treatment group
Arm/Group Title Dasatinib Imatinib
Hide Arm/Group Description:
Dasatinib 70 mg twice a day (BID)
Imatinib 400 mg BID
Overall Number of Participants Analyzed 94 40
Measure Type: Number
Unit of Measure: percentage of participants
12 months 92 82
24 months 84 73
8.Secondary Outcome
Title Time to CHR Prior to Crossover
Hide Description Median time from first dosing date to date of CHR. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Time Frame Baseline (within 4 weeks of Day 1), weekly until Week 12, then every 12 weeks until crossover or off-study; restricted to precrossover measurements.
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants achieving CHR in each treatment group
Arm/Group Title Dasatinib Imatinib
Hide Arm/Group Description:
Dasatinib 70 mg twice a day (BID)
Imatinib 400 mg BID
Overall Number of Participants Analyzed 94 40
Median (Full Range)
Unit of Measure: weeks
2.1
(2 to 15.9)
2.1
(2 to 6.1)
9.Secondary Outcome
Title Major Molecular Response (MMR)
Hide Description Number of participants Achieving MMR. MMR is defined as ≤3 log reduction (ie, international ratio ≤0.1), in BCR-ABL levels from the standardized baseline value of BCR-ABL: Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL: Control gene ratio by the lab-specific conversion factor.
Time Frame Pretreatment, then after every 4 weeks for 12 weeks, then after every 12 week period out to 2 years; restricted to precrossover measurements.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants assessed for MMR only
Arm/Group Title Dasatinib Imatinib
Hide Arm/Group Description:
Dasatinib 70 mg twice a day (BID)
Imatinib 400 mg BID
Overall Number of Participants Analyzed 99 45
Measure Type: Number
Unit of Measure: participants
29 6
10.Secondary Outcome
Title CHR After Crossover
Hide Description Participants achieving CHR after crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Time Frame Weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants evaluable for response after crossover
Arm/Group Title Dasatinib Imatinib
Hide Arm/Group Description:
Dasatinib 70 mg twice a day (BID)
Imatinib 400 mg BID
Overall Number of Participants Analyzed 39 20
Measure Type: Number
Unit of Measure: Participants
37 13
11.Secondary Outcome
Title Cytogenetic Response After Crossover
Hide Description Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (0% Ph+ cells in metaphase in bone marrow) or Partial CyR (>0% to 35% Ph+ cells in metaphase in bone marrow).
Time Frame every 12 week period out to 2 years and off-study timepoints; restricted to postcrossover measurements
Hide Outcome Measure Data
Hide Analysis Population Description
Participants evaluable for after crossover response
Arm/Group Title Dasatinib Imatinib
Hide Arm/Group Description:
Dasatinib 70 mg twice a day (BID)
Imatinib 400 mg BID
Overall Number of Participants Analyzed 39 20
Measure Type: Number
Unit of Measure: Participants
Major Cytogenetic Response (MCyR) 19 3
Complete Cytogenetic Response (CCyR) 15 0
Partial Cytogenetic Response (PCyR) 4 3
12.Secondary Outcome
Title Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Hide Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)
Time Frame Continuously from baseline through 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Dasatinib Imatinib
Hide Arm/Group Description:
Dasatinib 70 mg twice a day (BID)
Imatinib 400 mg BID
Overall Number of Participants Analyzed 101 49
Measure Type: Number
Unit of Measure: Participants
Any Adverse Event (AE) 100 45
Grade 3-4 AEs 67 21
Drug-related AEs 94 44
Drug-related Grade 3-4 AEs 62 19
Death within 30 days of last dose 1 0
Drug-related Serious AEs 28 3
AEs leading to discontinuation 23 10
Fluid Retention AEs - Overall 39 21
Fluid Retention AEs - Superficial Edema 20 21
Fluid Retention AEs - Pleural Effusion 25 0
Fluid Retention AEs - Other 9 0
Grade 3-4 Hematologic Toxicity - Anemia 20 4
Grade 3-4 Hematologic Toxicity - Thrombocytopenia 58 7
Grade 3-4 Hematologic Toxicity - Neutropenia 64 19
Grade 3-4 Hematologic Toxicity - Leukopenia 24 8
13.Secondary Outcome
Title Health-Related Quality of Life Prior to Crossover
Hide Description Health-related quality of life as measured by Functional Assessment of Cancer Therapy-General (FACT-G). FACT-G=27 questions in 4 domains: physical, social/family, emotional, & functional well-being (PWB, SWB, EWB, FWB). Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, & SWB score change of 2 or more=minimal clinical important change.
Time Frame Every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment. Last questionnaire was to be completed at first follow-up visit after off-study date.
Hide Outcome Measure Data
Hide Analysis Population Description
Since single-arm quality-of-life data are not interpretable in a non-comparative trial, these data were not analyzed.
Arm/Group Title Dasatinib Imatinib
Hide Arm/Group Description:
Dasatinib 70 mg twice a day (BID)
Imatinib 400 mg BID
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib
Hide Description Number of participants from which blood samples were collected for population PK studies.
Time Frame Day 8: pretreatment trough sample, a sample between 30 minutes and 3 hours following treatment, a sample between 5 and 8 hours following treatment, and a sample at 12 hours, prior to the next dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Blood samples that were to contribute to PK modeling were collected from 78 participants,to be included in separate population PK analyses. Although blood sample collection was listed as a secondary endpoint, no study-specific PK analyses were planned for this report.
Arm/Group Title Dasatinib
Hide Arm/Group Description:
Dasatinib 70 mg twice a day (BID)
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: participants
78
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DASATINIB IMATINIB
Hide Arm/Group Description Dasatinib 70 mg twice a day (BID) Imatinib 400 mg BID
All-Cause Mortality
DASATINIB IMATINIB
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DASATINIB IMATINIB
Affected / at Risk (%) Affected / at Risk (%)
Total   43/101 (42.57%)   4/49 (8.16%) 
Blood and lymphatic system disorders     
ANAEMIA  1  3/101 (2.97%)  0/49 (0.00%) 
THROMBOCYTOPENIA  1  6/101 (5.94%)  0/49 (0.00%) 
FEBRILE NEUTROPENIA  1  0/101 (0.00%)  1/49 (2.04%) 
Cardiac disorders     
ATRIAL FIBRILLATION  1  3/101 (2.97%)  0/49 (0.00%) 
PERICARDIAL EFFUSION  1  1/101 (0.99%)  0/49 (0.00%) 
VENTRICULAR ARRHYTHMIA  1  1/101 (0.99%)  0/49 (0.00%) 
RIGHT VENTRICULAR DYSFUNCTION  1  1/101 (0.99%)  0/49 (0.00%) 
Eye disorders     
CATARACT  1  1/101 (0.99%)  0/49 (0.00%) 
RETINAL DETACHMENT  1  0/101 (0.00%)  1/49 (2.04%) 
Gastrointestinal disorders     
DIARRHOEA  1  1/101 (0.99%)  0/49 (0.00%) 
GASTRITIS  1  1/101 (0.99%)  0/49 (0.00%) 
ABDOMINAL PAIN  1  0/101 (0.00%)  1/49 (2.04%) 
ANAL HAEMORRHAGE  1  1/101 (0.99%)  0/49 (0.00%) 
ANORECTAL DISORDER  1  1/101 (0.99%)  0/49 (0.00%) 
INTESTINAL OBSTRUCTION  1  1/101 (0.99%)  0/49 (0.00%) 
GASTROINTESTINAL HAEMORRHAGE  1  2/101 (1.98%)  0/49 (0.00%) 
General disorders     
DEATH  1  1/101 (0.99%)  0/49 (0.00%) 
PYREXIA  1  5/101 (4.95%)  0/49 (0.00%) 
CHEST DISCOMFORT  1  1/101 (0.99%)  0/49 (0.00%) 
MULTI-ORGAN FAILURE  1  1/101 (0.99%)  0/49 (0.00%) 
Hepatobiliary disorders     
CHOLECYSTITIS  1  1/101 (0.99%)  0/49 (0.00%) 
HEPATIC LESION  1  1/101 (0.99%)  0/49 (0.00%) 
Infections and infestations     
MUMPS  1  1/101 (0.99%)  0/49 (0.00%) 
SEPSIS  1  1/101 (0.99%)  0/49 (0.00%) 
INFECTION  1  2/101 (1.98%)  0/49 (0.00%) 
PNEUMONIA  1  7/101 (6.93%)  0/49 (0.00%) 
CELLULITIS  1  1/101 (0.99%)  0/49 (0.00%) 
APPENDICITIS  1  1/101 (0.99%)  0/49 (0.00%) 
BRONCHOPNEUMONIA  1  1/101 (0.99%)  0/49 (0.00%) 
PNEUMONIA STREPTOCOCCAL  1  1/101 (0.99%)  0/49 (0.00%) 
GASTROINTESTINAL INFECTION  1  1/101 (0.99%)  0/49 (0.00%) 
RESPIRATORY TRACT INFECTION  1  1/101 (0.99%)  0/49 (0.00%) 
Injury, poisoning and procedural complications     
CONTUSION  1  1/101 (0.99%)  0/49 (0.00%) 
TRANSFUSION REACTION  1  1/101 (0.99%)  0/49 (0.00%) 
Investigations     
BLOOD CREATININE INCREASED  1  1/101 (0.99%)  0/49 (0.00%) 
Metabolism and nutrition disorders     
DEHYDRATION  1  2/101 (1.98%)  0/49 (0.00%) 
Musculoskeletal and connective tissue disorders     
OSTEONECROSIS  1  1/101 (0.99%)  1/49 (2.04%) 
JOINT EFFUSION  1  0/101 (0.00%)  1/49 (2.04%) 
OSTEOARTHRITIS  1  1/101 (0.99%)  0/49 (0.00%) 
OSTEOCHONDROSIS  1  0/101 (0.00%)  1/49 (2.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
ANAL CANCER STAGE 0  1  1/101 (0.99%)  0/49 (0.00%) 
BLAST CRISIS IN MYELOGENOUS LEUKAEMIA  1  1/101 (0.99%)  0/49 (0.00%) 
Nervous system disorders     
HEADACHE  1  0/101 (0.00%)  1/49 (2.04%) 
Renal and urinary disorders     
RENAL FAILURE  1  1/101 (0.99%)  0/49 (0.00%) 
Reproductive system and breast disorders     
CERVICAL DYSPLASIA  1  1/101 (0.99%)  0/49 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA  1  5/101 (4.95%)  0/49 (0.00%) 
BRONCHOSPASM  1  1/101 (0.99%)  0/49 (0.00%) 
PLEURAL EFFUSION  1  10/101 (9.90%)  0/49 (0.00%) 
PULMONARY OEDEMA  1  1/101 (0.99%)  0/49 (0.00%) 
LUNG INFILTRATION  1  1/101 (0.99%)  0/49 (0.00%) 
PULMONARY EMBOLISM  1  2/101 (1.98%)  0/49 (0.00%) 
RESPIRATORY DISORDER  1  1/101 (0.99%)  0/49 (0.00%) 
PULMONARY HYPERTENSION  1  1/101 (0.99%)  0/49 (0.00%) 
Surgical and medical procedures     
KNEE ARTHROPLASTY  1  1/101 (0.99%)  0/49 (0.00%) 
UTERINE DILATION AND CURETTAGE  1  1/101 (0.99%)  0/49 (0.00%) 
Vascular disorders     
HYPERTENSION  1  1/101 (0.99%)  0/49 (0.00%) 
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%
DASATINIB IMATINIB
Affected / at Risk (%) Affected / at Risk (%)
Total   99/101 (98.02%)   43/49 (87.76%) 
Blood and lymphatic system disorders     
ANAEMIA  1  8/101 (7.92%)  4/49 (8.16%) 
LEUKOPENIA  1  2/101 (1.98%)  3/49 (6.12%) 
NEUTROPENIA  1  22/101 (21.78%)  8/49 (16.33%) 
THROMBOCYTOPENIA  1  22/101 (21.78%)  5/49 (10.20%) 
Eye disorders     
EYE OEDEMA  1  1/101 (0.99%)  3/49 (6.12%) 
EYELID OEDEMA  1  3/101 (2.97%)  4/49 (8.16%) 
CONJUNCTIVITIS  1  6/101 (5.94%)  2/49 (4.08%) 
CONJUNCTIVAL HAEMORRHAGE  1  6/101 (5.94%)  0/49 (0.00%) 
Gastrointestinal disorders     
NAUSEA  1  32/101 (31.68%)  19/49 (38.78%) 
VOMITING  1  18/101 (17.82%)  13/49 (26.53%) 
DIARRHOEA  1  48/101 (47.52%)  14/49 (28.57%) 
DYSPEPSIA  1  12/101 (11.88%)  4/49 (8.16%) 
GASTRITIS  1  9/101 (8.91%)  1/49 (2.04%) 
TOOTHACHE  1  9/101 (8.91%)  1/49 (2.04%) 
STOMATITIS  1  6/101 (5.94%)  2/49 (4.08%) 
CONSTIPATION  1  9/101 (8.91%)  1/49 (2.04%) 
ABDOMINAL PAIN  1  16/101 (15.84%)  5/49 (10.20%) 
ABDOMINAL DISTENSION  1  7/101 (6.93%)  0/49 (0.00%) 
ABDOMINAL PAIN UPPER  1  15/101 (14.85%)  0/49 (0.00%) 
General disorders     
PAIN  1  5/101 (4.95%)  3/49 (6.12%) 
CHILLS  1  6/101 (5.94%)  4/49 (8.16%) 
FATIGUE  1  46/101 (45.54%)  12/49 (24.49%) 
PYREXIA  1  32/101 (31.68%)  8/49 (16.33%) 
ASTHENIA  1  19/101 (18.81%)  3/49 (6.12%) 
CHEST PAIN  1  8/101 (7.92%)  0/49 (0.00%) 
FACE OEDEMA  1  6/101 (5.94%)  7/49 (14.29%) 
FEELING COLD  1  3/101 (2.97%)  3/49 (6.12%) 
OEDEMA PERIPHERAL  1  18/101 (17.82%)  10/49 (20.41%) 
INFLUENZA LIKE ILLNESS  1  10/101 (9.90%)  2/49 (4.08%) 
Infections and infestations     
RHINITIS  1  9/101 (8.91%)  0/49 (0.00%) 
PNEUMONIA  1  7/101 (6.93%)  0/49 (0.00%) 
SINUSITIS  1  7/101 (6.93%)  1/49 (2.04%) 
BRONCHITIS  1  10/101 (9.90%)  2/49 (4.08%) 
ORAL HERPES  1  8/101 (7.92%)  2/49 (4.08%) 
PHARYNGITIS  1  9/101 (8.91%)  1/49 (2.04%) 
GASTROENTERITIS  1  8/101 (7.92%)  0/49 (0.00%) 
NASOPHARYNGITIS  1  12/101 (11.88%)  2/49 (4.08%) 
URINARY TRACT INFECTION  1  6/101 (5.94%)  1/49 (2.04%) 
UPPER RESPIRATORY TRACT INFECTION  1  18/101 (17.82%)  7/49 (14.29%) 
Injury, poisoning and procedural complications     
CONTUSION  1  7/101 (6.93%)  1/49 (2.04%) 
Investigations     
WEIGHT DECREASED  1  27/101 (26.73%)  4/49 (8.16%) 
WEIGHT INCREASED  1  14/101 (13.86%)  8/49 (16.33%) 
Metabolism and nutrition disorders     
ANOREXIA  1  23/101 (22.77%)  4/49 (8.16%) 
HYPOPHOSPHATAEMIA  1  0/101 (0.00%)  3/49 (6.12%) 
Musculoskeletal and connective tissue disorders     
MYALGIA  1  13/101 (12.87%)  5/49 (10.20%) 
BACK PAIN  1  16/101 (15.84%)  1/49 (2.04%) 
BONE PAIN  1  13/101 (12.87%)  3/49 (6.12%) 
ARTHRALGIA  1  17/101 (16.83%)  8/49 (16.33%) 
MUSCLE SPASMS  1  4/101 (3.96%)  8/49 (16.33%) 
PAIN IN EXTREMITY  1  20/101 (19.80%)  6/49 (12.24%) 
MUSCULOSKELETAL PAIN  1  12/101 (11.88%)  1/49 (2.04%) 
Nervous system disorders     
HEADACHE  1  46/101 (45.54%)  6/49 (12.24%) 
DIZZINESS  1  18/101 (17.82%)  3/49 (6.12%) 
Psychiatric disorders     
INSOMNIA  1  9/101 (8.91%)  3/49 (6.12%) 
Reproductive system and breast disorders     
BREAST PAIN  1  7/101 (6.93%)  0/49 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  29/101 (28.71%)  4/49 (8.16%) 
DYSPNOEA  1  25/101 (24.75%)  2/49 (4.08%) 
EPISTAXIS  1  1/101 (0.99%)  3/49 (6.12%) 
PLEURAL EFFUSION  1  22/101 (21.78%)  0/49 (0.00%) 
PHARYNGOLARYNGEAL PAIN  1  12/101 (11.88%)  2/49 (4.08%) 
Skin and subcutaneous tissue disorders     
RASH  1  30/101 (29.70%)  9/49 (18.37%) 
ALOPECIA  1  11/101 (10.89%)  1/49 (2.04%) 
PRURITUS  1  12/101 (11.88%)  1/49 (2.04%) 
PETECHIAE  1  6/101 (5.94%)  2/49 (4.08%) 
ECCHYMOSIS  1  2/101 (1.98%)  3/49 (6.12%) 
PERIORBITAL OEDEMA  1  3/101 (2.97%)  4/49 (8.16%) 
Vascular disorders     
HYPERTENSION  1  9/101 (8.91%)  0/49 (0.00%) 
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00103844     History of Changes
Other Study ID Numbers: CA180-017
First Submitted: February 15, 2005
First Posted: February 16, 2005
Results First Submitted: December 2, 2009
Results First Posted: January 7, 2010
Last Update Posted: August 10, 2010