Full Text View
Tabular View
Study Results
Related Studies
Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
This study has been completed.
Study NCT00080301   Information provided by Bristol-Myers Squibb
First Received: March 26, 2004   Last Updated: November 16, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Parallel Assignment
Conditions: Breast Cancer
Metastases
Interventions: Drug: Ixabepilone + Capecitabine
Drug: Capecitabine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ixabepilone + Capecitabine Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
Capecitabine Capecitabine 1250 mg/m2 BID x 14 days

Participant Flow:   Overall Study
  Ixabepilone + Capecitabine Capecitabine
STARTED   375     377  
      Never Treated               5                 10  
      Still on Treatment               0                 1  
COMPLETED   370[1]   366[2]
NOT COMPLETED   5     11  
      Randomized but Never Treated               5                 10  
      Still on Treatment as of CSR date               0                 1  
[1] Participants who are off treatment
[2] Participants who are off treatment



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Ixabepilone + Capecitabine Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
Capecitabine Capecitabine 1250 mg/m2 BID x 14 days

Baseline Measures
  Ixabepilone + Capecitabine Capecitabine Total
Number of Participants  
[units: participants]
 		375 377 752
Age, Customized  
[units: participants]
 		     
<65 years 336 322 658
>= 65 years 39 54 93
<50 years 135 145 280
>= 50 years 240 231 471
Unknown 0 1 1
Age  
[units: years]
Median ( Full Range ) 		53.0
( 25.0 to 76.0 )		 52.0
( 25.0 to 79.0 )		 53.0
( 25.0 to 79.0 )
Gender  
[units: participants]
 		     
Female 375 376 751
Male 0 1 1
Race/Ethnicity, Customized  
[units: participants]
 		     
American Indian or Alaska Native 1 0 1
Asian 83 87 170
Black or African American 11 11 22
White 257 247 504
Other 23 32 55
Disease Sites  
[units: participants]
 		     
Ascites 14 14 28
Bone 168 162 330
Breast 61 63 124
Chest Wall 53 53 106
Effusion 57 55 112
Lymph Node 250 249 499
Other 20 18 38
Peritoneum 7 14 21
Pleura 29 35 64
Skin/Soft Tissue 60 62 122
Visceral, Liver 245 228 473
Visceral, Lung 180 174 354
Visceral, Other 34 28 62
Disease Sites at Baseline  
[units: participants]
 		     
Liver ± Lung ± Skin/Soft Tissue ± Bone 245 228 473
Lung ± Skin/Soft Tissue ± Bone 71 87 158
Skin/Soft Tissue ± Bone 49 52 101
Bone 0 3 3
Other 6 5 11
Karnofsky Performance Status[1]
[units: Units on a scale]
 		     
100 108 105 213
90 145 132 277
80 86 102 188
70 33 34 67
<70 0 1 1
Not reported 3 3 6
Menopausal Status  
[units: participants]
 		     
Premenopausal 54 51 105
Perimenopausal 19 23 42
Postmenopausal 288 289 577
Not reported 14 14 28
Number of Disease Sites  
[units: participants]
 		     
1 disease site 39 34 73
2 disease sites 85 98 183
3 disease sites 110 121 231
4 disease sites 79 69 148
≥5 disease sites 58 53 111
Presence of All Lesions  
[units: participants]
 		     
Subjects with at least 1 lesion 371 375 746
Subjects with no lesions 4 2 6
Visceral Disease in Liver and/or Lung  
[units: participants]
 		     
Yes 316 315 631
No 55 60 115
Missing 4 2 6
[1] Karnofsky Performance Scale Index measures a patient's functional impairment: 100-80=Able to carry on normal activity and work, no special care; 70-50=Unable to work; able to live at home and care for most personal needs with assistance; 40-0=Unable to care for self; institutional or hospital care needed. Score reported in multiples of 10.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)   [ based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]
  Show Outcome Measure 1

2.  Secondary:   Overall Response Rate (ORR) Per IRRC   [ based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]
  Show Outcome Measure 2

3.  Secondary:   Duration of Response Per IRRC   [ based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]
  Show Outcome Measure 3

4.  Secondary:   Time to Response Per IRRC   [ based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]
  Show Outcome Measure 4

5.  Secondary:   Overall Survival (OS)   [ from date of randomization until death ]
  Show Outcome Measure 5

6.  Secondary:   Treatment-related Safety Summary   [ safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible. ]
  Show Outcome Measure 6

7.  Secondary:   Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)   [ Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment. ]
  Show Outcome Measure 7


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Capecitabine No text entered.
Ixabepilone + Capecitabine No text entered.

Serious Adverse Events
  Capecitabine Ixabepilone + Capecitabine
Total, serious adverse events    
# participants affected / at risk 127/368 (34.51%)   151/369 (40.92%)  
Blood and lymphatic system disorders    
ANAEMIA   † A
      # participants affected / at risk
3/368 (0.82%)  
11/369 (2.98%)  
LEUKOPENIA   † A
      # participants affected / at risk
0/368 (0.00%)  
6/369 (1.63%)  
NEUTROPENIA   † A
      # participants affected / at risk
0/368 (0.00%)  
18/369 (4.88%)  
COAGULOPATHY   † A
      # participants affected / at risk
3/368 (0.82%)  
0/369 (0.00%)  
LYMPHADENOPATHY   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
THROMBOCYTOPENIA   † A
      # participants affected / at risk
2/368 (0.54%)  
7/369 (1.90%)  
BONE MARROW FAILURE   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
FEBRILE NEUTROPENIA   † A
      # participants affected / at risk
4/368 (1.09%)  
15/369 (4.07%)  
DISSEMINATED INTRAVASCULAR COAGULATION   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
Cardiac disorders    
ATRIAL FLUTTER   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
CARDIAC ARREST   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
CARDIOMYOPATHY   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
ANGINA PECTORIS   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
CARDIAC FAILURE   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
ATRIAL FIBRILLATION   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
MYOCARDIAL ISCHAEMIA   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
PERICARDIAL EFFUSION   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
MYOCARDIAL INFARCTION   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
CARDIOPULMONARY FAILURE   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
VENTRICULAR DYSFUNCTION   † A
      # participants affected / at risk
0/368 (0.00%)  
3/369 (0.81%)  
CARDIO-RESPIRATORY ARREST   † A
      # participants affected / at risk
2/368 (0.54%)  
1/369 (0.27%)  
ACUTE MYOCARDIAL INFARCTION   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
ARRHYTHMIA SUPRAVENTRICULAR   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
Gastrointestinal disorders    
ILEUS   † A
      # participants affected / at risk
1/368 (0.27%)  
3/369 (0.81%)  
NAUSEA   † A
      # participants affected / at risk
5/368 (1.36%)  
8/369 (2.17%)  
ASCITES   † A
      # participants affected / at risk
2/368 (0.54%)  
1/369 (0.27%)  
COLITIS   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
MELAENA   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
VOMITING   † A
      # participants affected / at risk
8/368 (2.17%)  
12/369 (3.25%)  
CHEILITIS   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
DIARRHOEA   † A
      # participants affected / at risk
15/368 (4.08%)  
14/369 (3.79%)  
DYSPEPSIA   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
ENTERITIS   † A
      # participants affected / at risk
2/368 (0.54%)  
0/369 (0.00%)  
GASTRITIS   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
STOMATITIS   † A
      # participants affected / at risk
1/368 (0.27%)  
3/369 (0.81%)  
CONSTIPATION   † A
      # participants affected / at risk
2/368 (0.54%)  
1/369 (0.27%)  
HAEMATEMESIS   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
OESOPHAGITIS   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
PANCREATITIS   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
PEPTIC ULCER   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
ABDOMINAL PAIN   † A
      # participants affected / at risk
4/368 (1.09%)  
4/369 (1.08%)  
ABDOMINAL PAIN UPPER   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
EROSIVE OESOPHAGITIS   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
GASTROINTESTINAL ULCER   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
GASTROINTESTINAL HAEMORRHAGE   † A
      # participants affected / at risk
2/368 (0.54%)  
0/369 (0.00%)  
GASTROINTESTINAL OBSTRUCTION   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
LARGE INTESTINAL OBSTRUCTION   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
LOWER GASTROINTESTINAL HAEMORRHAGE   † A
      # participants affected / at risk
0/368 (0.00%)  
2/369 (0.54%)  
General disorders    
PAIN   † A
      # participants affected / at risk
0/368 (0.00%)  
2/369 (0.54%)  
DEATH   † A
      # participants affected / at risk
1/368 (0.27%)  
2/369 (0.54%)  
CHILLS   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
FATIGUE   † A
      # participants affected / at risk
1/368 (0.27%)  
3/369 (0.81%)  
PYREXIA   † A
      # participants affected / at risk
3/368 (0.82%)  
9/369 (2.44%)  
ASTHENIA   † A
      # participants affected / at risk
2/368 (0.54%)  
3/369 (0.81%)  
CHEST PAIN   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
SUDDEN DEATH   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
GENERALISED OEDEMA   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
MUCOSAL INFLAMMATION   † A
      # participants affected / at risk
3/368 (0.82%)  
4/369 (1.08%)  
PERFORMANCE STATUS DECREASED   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
GENERAL PHYSICAL HEALTH DETERIORATION   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
Hepatobiliary disorders    
HEPATIC FAILURE   † A
      # participants affected / at risk
4/368 (1.09%)  
1/369 (0.27%)  
ACUTE HEPATIC FAILURE   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
HEPATOCELLULAR DAMAGE   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
Immune system disorders    
HYPERSENSITIVITY   † A
      # participants affected / at risk
0/368 (0.00%)  
2/369 (0.54%)  
TYPE IV HYPERSENSITIVITY REACTION   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
Infections and infestations    
SEPSIS   † A
      # participants affected / at risk
0/368 (0.00%)  
5/369 (1.36%)  
MYIASIS   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
CYSTITIS   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
INFECTION   † A
      # participants affected / at risk
2/368 (0.54%)  
1/369 (0.27%)  
PNEUMONIA   † A
      # participants affected / at risk
3/368 (0.82%)  
17/369 (4.61%)  
CELLULITIS   † A
      # participants affected / at risk
0/368 (0.00%)  
3/369 (0.81%)  
ERYSIPELAS   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
LARYNGITIS   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
PARONYCHIA   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
BACTERAEMIA   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
SEPTIC SHOCK   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
HERPES ZOSTER   † A
      # participants affected / at risk
2/368 (0.54%)  
2/369 (0.54%)  
GASTROENTERITIS   † A
      # participants affected / at risk
1/368 (0.27%)  
2/369 (0.54%)  
LOBAR PNEUMONIA   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
PERITONEAL INFECTION   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
NEUTROPENIC INFECTION   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
ENTEROCOLITIS INFECTIOUS   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
PNEUMONIA STAPHYLOCOCCAL   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
GASTROINTESTINAL INFECTION   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
RESPIRATORY TRACT INFECTION   † A
      # participants affected / at risk
1/368 (0.27%)  
2/369 (0.54%)  
GENITOURINARY TRACT INFECTION   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
LOWER RESPIRATORY TRACT INFECTION   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
Injury, poisoning and procedural complications    
FALL   † A
      # participants affected / at risk
0/368 (0.00%)  
2/369 (0.54%)  
OVERDOSE   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
HIP FRACTURE   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
ANKLE FRACTURE   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
FEMUR FRACTURE   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
VASCULAR ACCESS COMPLICATION   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
POST LUMBAR PUNCTURE SYNDROME   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
Investigations    
HAEMOGLOBIN DECREASED   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
GRIP STRENGTH DECREASED   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
PLATELET COUNT DECREASED   † A
      # participants affected / at risk
2/368 (0.54%)  
2/369 (0.54%)  
NEUTROPHIL COUNT DECREASED   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
GRANULOCYTE COUNT DECREASED   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
WHITE BLOOD CELL COUNT DECREASED   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
Metabolism and nutrition disorders    
ANOREXIA   † A
      # participants affected / at risk
2/368 (0.54%)  
2/369 (0.54%)  
DEHYDRATION   † A
      # participants affected / at risk
3/368 (0.82%)  
8/369 (2.17%)  
HYPOKALAEMIA   † A
      # participants affected / at risk
0/368 (0.00%)  
3/369 (0.81%)  
HYPOVOLAEMIA   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
HYPOCALCAEMIA   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
HYPOGLYCAEMIA   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
HYPONATRAEMIA   † A
      # participants affected / at risk
0/368 (0.00%)  
3/369 (0.81%)  
HYPERCALCAEMIA   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
HYPERGLYCAEMIA   † A
      # participants affected / at risk
0/368 (0.00%)  
2/369 (0.54%)  
METABOLIC ACIDOSIS   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
DIABETIC KETOACIDOSIS   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
Musculoskeletal and connective tissue disorders    
MYALGIA   † A
      # participants affected / at risk
0/368 (0.00%)  
3/369 (0.81%)  
TRISMUS   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
BACK PAIN   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
BONE PAIN   † A
      # participants affected / at risk
3/368 (0.82%)  
1/369 (0.27%)  
ARTHRALGIA   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
MUSCLE SPASMS   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
PAIN IN EXTREMITY   † A
      # participants affected / at risk
1/368 (0.27%)  
2/369 (0.54%)  
MUSCULOSKELETAL PAIN   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
PATHOLOGICAL FRACTURE   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
MUSCULOSKELETAL CHEST PAIN   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
CANCER PAIN   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
BREAST CANCER   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
METASTATIC PAIN   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
CERVIX CARCINOMA   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
INFECTED NEOPLASM   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
MALIGNANT ASCITES   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
METASTASES TO BONE   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
NEOPLASM MALIGNANT   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
METASTASES TO LIVER   † A
      # participants affected / at risk
2/368 (0.54%)  
0/369 (0.00%)  
METASTASES TO MENINGES   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
MALIGNANT PLEURAL EFFUSION   † A
      # participants affected / at risk
2/368 (0.54%)  
2/369 (0.54%)  
MALIGNANT NEOPLASM PROGRESSION   † A
      # participants affected / at risk
36/368 (9.78%)  
19/369 (5.15%)  
PERICARDIAL EFFUSION MALIGNANT   † A
      # participants affected / at risk
4/368 (1.09%)  
0/369 (0.00%)  
METASTASES TO CENTRAL NERVOUS SYSTEM   † A
      # participants affected / at risk
8/368 (2.17%)  
7/369 (1.90%)  
RENAL CELL CARCINOMA STAGE UNSPECIFIED   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
Nervous system disorders    
APHASIA   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
SYNCOPE   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
HEADACHE   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
LETHARGY   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
DIZZINESS   † A
      # participants affected / at risk
0/368 (0.00%)  
4/369 (1.08%)  
NEURALGIA   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
CONVULSION   † A
      # participants affected / at risk
2/368 (0.54%)  
0/369 (0.00%)  
SOMNOLENCE   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
PARAESTHESIA   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
HYPOAESTHESIA   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
MENTAL IMPAIRMENT   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
CEREBRAL ISCHAEMIA   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
COGNITIVE DISORDER   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
CEREBRAL HAEMORRHAGE   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
COORDINATION ABNORMAL   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
INTERCOSTAL NEURALGIA   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
LOSS OF CONSCIOUSNESS   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
NEUROPATHY PERIPHERAL   † A
      # participants affected / at risk
0/368 (0.00%)  
2/369 (0.54%)  
PARESIS CRANIAL NERVE   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
SPINAL CORD COMPRESSION   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
MARCHIAFAVA-BIGNAMI DISEASE   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
PERIPHERAL MOTOR NEUROPATHY   † A
      # participants affected / at risk
1/368 (0.27%)  
3/369 (0.81%)  
PERIPHERAL SENSORY NEUROPATHY   † A
      # participants affected / at risk
0/368 (0.00%)  
5/369 (1.36%)  
Psychiatric disorders    
ANXIETY   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
DEPRESSION   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
DISORIENTATION   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
CONFUSIONAL STATE   † A
      # participants affected / at risk
2/368 (0.54%)  
2/369 (0.54%)  
Renal and urinary disorders    
HAEMATURIA   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
RENAL FAILURE   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
RENAL IMPAIRMENT   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
URINARY RETENTION   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
RENAL FAILURE ACUTE   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
Reproductive system and breast disorders    
UTERINE HAEMORRHAGE   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
Respiratory, thoracic and mediastinal disorders    
HYPOXIA   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
DYSPNOEA   † A
      # participants affected / at risk
7/368 (1.90%)  
14/369 (3.79%)  
DYSPHONIA   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
HYDROTHORAX   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
PNEUMONITIS   † A
      # participants affected / at risk
4/368 (1.09%)  
0/369 (0.00%)  
PNEUMOTHORAX   † A
      # participants affected / at risk
1/368 (0.27%)  
2/369 (0.54%)  
LUNG DISORDER   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
PLEURITIC PAIN   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
PLEURAL EFFUSION   † A
      # participants affected / at risk
9/368 (2.45%)  
6/369 (1.63%)  
HYDROPNEUMOTHORAX   † A
      # participants affected / at risk
1/368 (0.27%)  
1/369 (0.27%)  
PULMONARY EMBOLISM   † A
      # participants affected / at risk
1/368 (0.27%)  
2/369 (0.54%)  
RESPIRATORY FAILURE   † A
      # participants affected / at risk
1/368 (0.27%)  
4/369 (1.08%)  
PULMONARY HAEMORRHAGE   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
ACUTE PULMONARY OEDEMA   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
PHARYNGOLARYNGEAL PAIN   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
ACUTE RESPIRATORY DISTRESS SYNDROME   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
Skin and subcutaneous tissue disorders    
RASH   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
SKIN ULCER   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
ERYTHEMA MULTIFORME   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME   † A
      # participants affected / at risk
1/368 (0.27%)  
5/369 (1.36%)  
Vascular disorders    
THROMBOSIS   † A
      # participants affected / at risk
0/368 (0.00%)  
3/369 (0.81%)  
VASCULITIS   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
HYPOTENSION   † A
      # participants affected / at risk
2/368 (0.54%)  
3/369 (0.81%)  
LYMPHOEDEMA   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
HYPERTENSION   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
THROMBOPHLEBITIS   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
HYPOVOLAEMIC SHOCK   † A
      # participants affected / at risk
0/368 (0.00%)  
1/369 (0.27%)  
POOR VENOUS ACCESS   † A
      # participants affected / at risk
1/368 (0.27%)  
2/369 (0.54%)  
DEEP VEIN THROMBOSIS   † A
      # participants affected / at risk
4/368 (1.09%)  
0/369 (0.00%)  
JUGULAR VEIN THROMBOSIS   † A
      # participants affected / at risk
1/368 (0.27%)  
0/369 (0.00%)  
† Indicates events were collected by systematic assessment.
A Term from vocabulary, MedDRA 9.1


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: CA163-046
Study First Received: March 26, 2004
Results First Received: May 1, 2009
Last Updated: November 16, 2009
ClinicalTrials.gov Identifier: NCT00080301     History of Changes
Health Authority: United States: Food and Drug Administration





Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services