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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Open Label, Active Control, Parallel Assignment |
| Conditions: |
Cancer Breast Cancer |
| Interventions: |
Drug: Ixabepilone + Capecitabine Drug: Capecitabine |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| PLEASE NOTE: Completed=number of participants completing ≥18 cycles of treatment; not completed=number of subjects coming off study treatment prior to completing at least 18 cycles, with specified reasons for coming off study treatment. Participants continued to be followed for overall survival. |
| Description | |
|---|---|
| Ixabepilone + Capecitabine | Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest. |
| Capecitabine | Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest. |
| Ixabepilone + Capecitabine | Capecitabine | |
|---|---|---|
| STARTED | 609 | 612 |
| COMPLETED | 15[1] | 15[2] |
| NOT COMPLETED | 594 | 597 |
| Adverse Event | 12 | 17 |
| Death | 8 | 18 |
| Disease Progression/Relapse | 270 | 388 |
| Physician Decision | 50 | 61 |
| Lost to Follow-up | 1 | 2 |
| Study Drug Toxicity | 179 | 66 |
| Withdrawal by Subject | 55 | 30 |
| Still On Treatment | 2 | 1 |
| Not Treated | 12 | 11 |
| Ineligible | 2 | 1 |
| Noncompliance | 2 | 1 |
| New primary cancer | 1 | 0 |
| Impending surgery | 0 | 1 |
| [1] | Participants who received 18 or more cycles of treatment. |
|---|---|
| [2] | Participants who received 18 or more cycles of treatment. |
Baseline Characteristics
| Description | |
|---|---|
| Ixabepilone + Capecitabine | Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest. |
| Capecitabine | Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest. |
| Ixabepilone + Capecitabine | Capecitabine | Total | |
|---|---|---|---|
|
Number of Participants [units: participants] |
609 | 612 | 1221 |
|
Age, Customized [units: participants] |
|||
| <65 years | 532 | 531 | 1063 |
| ≥65 years | 77 | 81 | 158 |
| <50 years | 225 | 235 | 460 |
| ≥50 years | 384 | 377 | 761 |
|
Age [units: years] Median ( Full Range ) |
53.0 ( 23.0 to 78.0 ) |
53.0 ( 24.0 to 81.0 ) |
53.0 ( 23.0 to 81.0 ) |
|
Gender [units: participants] |
|||
| Female | 609 | 612 | 1221 |
| Male | 0 | 0 | 0 |
|
Race/Ethnicity, Customized [units: participants] |
|||
| American Indian or Alaska Native | 1 | 2 | 3 |
| Asian | 90 | 69 | 159 |
| Black or African American | 25 | 21 | 46 |
| White | 480 | 502 | 982 |
| Unknown or Not Reported | 13 | 18 | 31 |
|
Karnofsky performance Status[1] [units: units on a scale] |
|||
| 100 | 219 | 265 | 484 |
| 90 | 187 | 188 | 375 |
| 80 | 151 | 130 | 281 |
| 70 | 44 | 26 | 70 |
| <70 | 2 | 2 | 4 |
| not reported | 6 | 1 | 7 |
|
Menopausal Status [units: participants] |
|||
| Premenopausal | 93 | 90 | 183 |
| Perimenopausal | 32 | 32 | 64 |
| Postmenopausal | 475 | 481 | 956 |
| Not Reported | 9 | 9 | 18 |
|
Organ Sites [units: participants] |
|||
| Ascites | 13 | 16 | 29 |
| Bone | 283 | 287 | 570 |
| Brain | 0 | 1 | 1 |
| Breast | 41 | 54 | 95 |
| Chest Wall Mass | 47 | 38 | 85 |
| CNS | 1 | 0 | 1 |
| Cutaneous | 64 | 57 | 121 |
| Effusion | 7 | 7 | 14 |
| Intestine | 1 | 1 | 2 |
| Lymph Node | 236 | 233 | 469 |
| Mediastinum | 54 | 52 | 106 |
| Other | 17 | 30 | 47 |
| Pleura | 86 | 84 | 170 |
| Subcutaneous | 23 | 24 | 47 |
| Visceral, Liver | 273 | 276 | 549 |
| Visceral, Lung | 221 | 217 | 438 |
| Visceral, Other | 24 | 26 | 50 |
|
Presence with at least 1 lesion [units: participants] |
606 | 612 | 1218 |
| [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=unable to care for self; requires institutional or hospital care. Score reported in multiples of 10. |
|---|
Outcome Measures
| 1. Primary: | Overall Survival (OS) [ from date of randomization until death ] |
| 2. Secondary: | Progression-Free Survival (PFS) [ every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] |
| 3. Secondary: | Response Rate (RR) [ every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] |
| 4. Secondary: | Duration of Response [ every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] |
| 5. Secondary: | Time to Response [ every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] |
| 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. ] |
| 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 ] |
Serious Adverse Events| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
| Description | |
|---|---|
| Capecitabine | No text entered. |
| Ixabepilone + Capecitabine | No text entered. |
| Capecitabine | Ixabepilone + Capecitabine | |
|---|---|---|
| Total, serious adverse events | ||
| # participants affected / at risk | 192/603 (31.84%) | 205/595 (34.45%) |
| Blood and lymphatic system disorders | ||
| ANAEMIA † A # participants affected / at risk |
5/603 (0.83%) |
7/595 (1.18%) |
| LEUKOPENIA † A # participants affected / at risk |
1/603 (0.17%) |
8/595 (1.34%) |
| NEUTROPENIA † A # participants affected / at risk |
8/603 (1.33%) |
18/595 (3.03%) |
| LYMPH NODE PAIN † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| THROMBOCYTOPENIA † A # participants affected / at risk |
3/603 (0.50%) |
4/595 (0.67%) |
| FEBRILE NEUTROPENIA † A # participants affected / at risk |
5/603 (0.83%) |
34/595 (5.71%) |
| Cardiac disorders | ||
| PERICARDITIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| ANGINA UNSTABLE † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| CARDIAC FAILURE † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| SINUS TACHYCARDIA † A # participants affected / at risk |
0/603 (0.00%) |
2/595 (0.34%) |
| ATRIAL FIBRILLATION † A # participants affected / at risk |
2/603 (0.33%) |
0/595 (0.00%) |
| PERICARDIAL EFFUSION † A # participants affected / at risk |
4/603 (0.66%) |
0/595 (0.00%) |
| ACUTE CORONARY SYNDROME † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| CARDIO-RESPIRATORY ARREST † A # participants affected / at risk |
1/603 (0.17%) |
1/595 (0.17%) |
| VENTRICULAR EXTRASYSTOLES † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| CARDIAC FAILURE CONGESTIVE † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| Ear and labyrinth disorders | ||
| VERTIGO † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| Eye disorders | ||
| EYE PAIN † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| ECTROPION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| EYELID PTOSIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| VISUAL DISTURBANCE † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| BLINDNESS UNILATERAL † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| ULCERATIVE KERATITIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| Gastrointestinal disorders | ||
| ILEUS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| NAUSEA † A # participants affected / at risk |
7/603 (1.16%) |
12/595 (2.02%) |
| ASCITES † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| COLITIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| VOMITING † A # participants affected / at risk |
17/603 (2.82%) |
24/595 (4.03%) |
| DIARRHOEA † A # participants affected / at risk |
33/603 (5.47%) |
23/595 (3.87%) |
| GASTRITIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| STOMATITIS † A # participants affected / at risk |
2/603 (0.33%) |
5/595 (0.84%) |
| CONSTIPATION † A # participants affected / at risk |
2/603 (0.33%) |
6/595 (1.01%) |
| HAEMORRHOIDS † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| OESOPHAGITIS † A # participants affected / at risk |
0/603 (0.00%) |
2/595 (0.34%) |
| ABDOMINAL PAIN † A # participants affected / at risk |
3/603 (0.50%) |
7/595 (1.18%) |
| PANCREATIC CYST † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| MOUTH ULCERATION † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| GASTRITIS EROSIVE † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| ABDOMINAL PAIN UPPER † A # participants affected / at risk |
1/603 (0.17%) |
1/595 (0.17%) |
| GASTROINTESTINAL PAIN † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| INTESTINAL OBSTRUCTION † A # participants affected / at risk |
2/603 (0.33%) |
0/595 (0.00%) |
| UPPER GASTROINTESTINAL HAEMORRHAGE † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| General disorders | ||
| PAIN † A # participants affected / at risk |
2/603 (0.33%) |
3/595 (0.50%) |
| FATIGUE † A # participants affected / at risk |
6/603 (1.00%) |
8/595 (1.34%) |
| PYREXIA † A # participants affected / at risk |
8/603 (1.33%) |
6/595 (1.01%) |
| ASTHENIA † A # participants affected / at risk |
2/603 (0.33%) |
1/595 (0.17%) |
| CHEST PAIN † A # participants affected / at risk |
2/603 (0.33%) |
1/595 (0.17%) |
| HYPOTHERMIA † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| SUDDEN DEATH † A # participants affected / at risk |
1/603 (0.17%) |
1/595 (0.17%) |
| EXTRAVASATION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| CATHETER THROMBOSIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| MULTI-ORGAN FAILURE † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| CATHETER SITE OEDEMA † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| MUCOSAL INFLAMMATION † A # participants affected / at risk |
4/603 (0.66%) |
6/595 (1.01%) |
| INJECTION SITE EXTRAVASATION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| PERFORMANCE STATUS DECREASED † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| GENERAL PHYSICAL HEALTH DETERIORATION † A # participants affected / at risk |
4/603 (0.66%) |
5/595 (0.84%) |
| Hepatobiliary disorders | ||
| CHOLANGITIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| HEPATIC PAIN † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| CHOLELITHIASIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| HEPATIC FAILURE † A # participants affected / at risk |
3/603 (0.50%) |
2/595 (0.34%) |
| CHOLECYSTITIS ACUTE † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| HYPERBILIRUBINAEMIA † A # participants affected / at risk |
2/603 (0.33%) |
0/595 (0.00%) |
| PORTAL VEIN THROMBOSIS † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| Immune system disorders | ||
| HYPERSENSITIVITY † A # participants affected / at risk |
0/603 (0.00%) |
4/595 (0.67%) |
| Infections and infestations | ||
| SEPSIS † A # participants affected / at risk |
3/603 (0.50%) |
6/595 (1.01%) |
| EMPYEMA † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| CYSTITIS † A # participants affected / at risk |
1/603 (0.17%) |
1/595 (0.17%) |
| INFECTION † A # participants affected / at risk |
4/603 (0.66%) |
4/595 (0.67%) |
| PNEUMONIA † A # participants affected / at risk |
5/603 (0.83%) |
6/595 (1.01%) |
| CELLULITIS † A # participants affected / at risk |
1/603 (0.17%) |
3/595 (0.50%) |
| ERYSIPELAS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| MENINGITIS † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| PARONYCHIA † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| ABSCESS LIMB † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| LYMPHANGITIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| SEPTIC SHOCK † A # participants affected / at risk |
1/603 (0.17%) |
2/595 (0.34%) |
| TUBERCULOSIS † A # participants affected / at risk |
1/603 (0.17%) |
1/595 (0.17%) |
| FUNGAL SEPSIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| NAIL INFECTION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| GASTROENTERITIS † A # participants affected / at risk |
2/603 (0.33%) |
1/595 (0.17%) |
| LOBAR PNEUMONIA † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| WOUND INFECTION † A # participants affected / at risk |
3/603 (0.50%) |
1/595 (0.17%) |
| BRONCHOPNEUMONIA † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| NEUTROPENIC SEPSIS † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| VAGINAL CELLULITIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| ABDOMINAL INFECTION † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| ANORECTAL INFECTION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| BACTERIAL INFECTION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| LOCALISED INFECTION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| NEUTROPENIC INFECTION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| PNEUMONIA STREPTOCOCCAL † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| URINARY TRACT INFECTION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| CATHETER RELATED INFECTION † A # participants affected / at risk |
3/603 (0.50%) |
4/595 (0.67%) |
| GASTROINTESTINAL INFECTION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| RESPIRATORY TRACT INFECTION † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| GASTROENTERITIS NORWALK VIRUS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| LOWER RESPIRATORY TRACT INFECTION † A # participants affected / at risk |
1/603 (0.17%) |
2/595 (0.34%) |
| UPPER RESPIRATORY TRACT INFECTION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| Injury, poisoning and procedural complications | ||
| FRACTURE † A # participants affected / at risk |
1/603 (0.17%) |
4/595 (0.67%) |
| OVERDOSE † A # participants affected / at risk |
1/603 (0.17%) |
7/595 (1.18%) |
| DRUG TOXICITY † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| ANKLE FRACTURE † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| FEMUR FRACTURE † A # participants affected / at risk |
0/603 (0.00%) |
3/595 (0.50%) |
| TIBIA FRACTURE † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| WRIST FRACTURE † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| FIBULA FRACTURE † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| PELVIC FRACTURE † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| INCISIONAL HERNIA † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| LOWER LIMB FRACTURE † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| PUBIC RAMI FRACTURE † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| TRACHEAL OBSTRUCTION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| TRANSFUSION REACTION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| FEMORAL NECK FRACTURE † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| PROCEDURAL COMPLICATION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| LUMBAR VERTEBRAL FRACTURE † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| Investigations | ||
| DIAGNOSTIC PROCEDURE † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| HAEMOGLOBIN DECREASED † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| BLOOD ALBUMIN DECREASED † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| PLATELET COUNT DECREASED † A # participants affected / at risk |
2/603 (0.33%) |
2/595 (0.34%) |
| BLOOD PHOSPHORUS INCREASED † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| NEUTROPHIL COUNT DECREASED † A # participants affected / at risk |
0/603 (0.00%) |
3/595 (0.50%) |
| PROTHROMBIN TIME PROLONGED † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| WHITE BLOOD CELL COUNT DECREASED † A # participants affected / at risk |
0/603 (0.00%) |
3/595 (0.50%) |
| ALANINE AMINOTRANSFERASE INCREASED † A # participants affected / at risk |
2/603 (0.33%) |
0/595 (0.00%) |
| ASPARTATE AMINOTRANSFERASE INCREASED † A # participants affected / at risk |
1/603 (0.17%) |
1/595 (0.17%) |
| Metabolism and nutrition disorders | ||
| ANOREXIA † A # participants affected / at risk |
5/603 (0.83%) |
2/595 (0.34%) |
| DEHYDRATION † A # participants affected / at risk |
7/603 (1.16%) |
7/595 (1.18%) |
| HYPOKALAEMIA † A # participants affected / at risk |
1/603 (0.17%) |
2/595 (0.34%) |
| HYPERKALAEMIA † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| HYPOGLYCAEMIA † A # participants affected / at risk |
1/603 (0.17%) |
1/595 (0.17%) |
| HYPONATRAEMIA † A # participants affected / at risk |
1/603 (0.17%) |
1/595 (0.17%) |
| HYPERCALCAEMIA † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| HYPERGLYCAEMIA † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| Musculoskeletal and connective tissue disorders | ||
| MYALGIA † A # participants affected / at risk |
1/603 (0.17%) |
2/595 (0.34%) |
| BACK PAIN † A # participants affected / at risk |
2/603 (0.33%) |
1/595 (0.17%) |
| BONE PAIN † A # participants affected / at risk |
4/603 (0.66%) |
3/595 (0.50%) |
| ARTHRALGIA † A # participants affected / at risk |
2/603 (0.33%) |
3/595 (0.50%) |
| FLANK PAIN † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| PAIN IN EXTREMITY † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| MUSCULOSKELETAL PAIN † A # participants affected / at risk |
1/603 (0.17%) |
2/595 (0.34%) |
| PATHOLOGICAL FRACTURE † A # participants affected / at risk |
2/603 (0.33%) |
0/595 (0.00%) |
| MUSCULOSKELETAL CHEST PAIN † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| SYSTEMIC LUPUS ERYTHEMATOSUS † A # participants affected / at risk |
0/603 (0.00%) |
2/595 (0.34%) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| TUMOUR PAIN † A # participants affected / at risk |
2/603 (0.33%) |
3/595 (0.50%) |
| COLON CANCER † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| BREAST CANCER † A # participants affected / at risk |
1/603 (0.17%) |
1/595 (0.17%) |
| BREAST NEOPLASM † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| MALIGNANT ASCITES † A # participants affected / at risk |
2/603 (0.33%) |
0/595 (0.00%) |
| MALIGNANT MELANOMA † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| METASTASES TO BONE † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| METASTASES TO LUNG † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| BREAST CANCER METASTATIC † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| MALIGNANT PLEURAL EFFUSION † A # participants affected / at risk |
11/603 (1.82%) |
5/595 (0.84%) |
| MALIGNANT NEOPLASM PROGRESSION † A # participants affected / at risk |
43/603 (7.13%) |
17/595 (2.86%) |
| PERICARDIAL EFFUSION MALIGNANT † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| METASTASES TO CENTRAL NERVOUS SYSTEM † A # participants affected / at risk |
4/603 (0.66%) |
4/595 (0.67%) |
| Nervous system disorders | ||
| ATAXIA † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| SYNCOPE † A # participants affected / at risk |
1/603 (0.17%) |
1/595 (0.17%) |
| DYSTONIA † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| EPILEPSY † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| HEADACHE † A # participants affected / at risk |
3/603 (0.50%) |
2/595 (0.34%) |
| DIZZINESS † A # participants affected / at risk |
6/603 (1.00%) |
0/595 (0.00%) |
| NEURALGIA † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| CONVULSION † A # participants affected / at risk |
0/603 (0.00%) |
2/595 (0.34%) |
| MONOPLEGIA † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| SOMNOLENCE † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| HEMIPARESIS † A # participants affected / at risk |
1/603 (0.17%) |
1/595 (0.17%) |
| PARAESTHESIA † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| HYPOAESTHESIA † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| ENCEPHALOPATHY † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| POLYNEUROPATHY † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| CEREBRAL ISCHAEMIA † A # participants affected / at risk |
1/603 (0.17%) |
1/595 (0.17%) |
| AUTONOMIC NEUROPATHY † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| TRANSIENT ISCHAEMIC ATTACK † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| PERIPHERAL MOTOR NEUROPATHY † A # participants affected / at risk |
1/603 (0.17%) |
3/595 (0.50%) |
| DEMYELINATING POLYNEUROPATHY † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| PERIPHERAL SENSORY NEUROPATHY † A # participants affected / at risk |
0/603 (0.00%) |
6/595 (1.01%) |
| DEPRESSED LEVEL OF CONSCIOUSNESS † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| Psychiatric disorders | ||
| DEPRESSED MOOD † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| CONFUSIONAL STATE † A # participants affected / at risk |
4/603 (0.66%) |
2/595 (0.34%) |
| Renal and urinary disorders | ||
| DYSURIA † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| OLIGURIA † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| RENAL ATROPHY † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| RENAL FAILURE † A # participants affected / at risk |
3/603 (0.50%) |
0/595 (0.00%) |
| HYDRONEPHROSIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| RENAL FAILURE ACUTE † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| CYSTITIS HAEMORRHAGIC † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| Reproductive system and breast disorders | ||
| VAGINAL HAEMORRHAGE † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| Respiratory, thoracic and mediastinal disorders | ||
| COUGH † A # participants affected / at risk |
2/603 (0.33%) |
0/595 (0.00%) |
| HYPOXIA † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| DYSPNOEA † A # participants affected / at risk |
25/603 (4.15%) |
10/595 (1.68%) |
| EPISTAXIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| ALVEOLITIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| PNEUMONITIS † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| PNEUMOTHORAX † A # participants affected / at risk |
1/603 (0.17%) |
3/595 (0.50%) |
| LUNG DISORDER † A # participants affected / at risk |
2/603 (0.33%) |
0/595 (0.00%) |
| PLEURITIC PAIN † A # participants affected / at risk |
1/603 (0.17%) |
2/595 (0.34%) |
| PLEURAL EFFUSION † A # participants affected / at risk |
13/603 (2.16%) |
7/595 (1.18%) |
| PULMONARY OEDEMA † A # participants affected / at risk |
2/603 (0.33%) |
0/595 (0.00%) |
| PULMONARY EMBOLISM † A # participants affected / at risk |
3/603 (0.50%) |
5/595 (0.84%) |
| RESPIRATORY FAILURE † A # participants affected / at risk |
3/603 (0.50%) |
1/595 (0.17%) |
| ACUTE RESPIRATORY FAILURE † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| ACUTE RESPIRATORY DISTRESS SYNDROME † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| Skin and subcutaneous tissue disorders | ||
| RASH † A # participants affected / at risk |
1/603 (0.17%) |
3/595 (0.50%) |
| BLISTER † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| PURPURA † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| ERYTHEMA † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| DERMATITIS † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| SKIN ULCER † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| SKIN LESION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| NAIL DISORDER † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| SKIN REACTION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| SWELLING FACE † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| EXFOLIATIVE RASH † A # participants affected / at risk |
0/603 (0.00%) |
2/595 (0.34%) |
| SKIN EXFOLIATION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| SKIN DISCOLOURATION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| DERMATITIS EXFOLIATIVE † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| STEVENS-JOHNSON SYNDROME † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME † A # participants affected / at risk |
3/603 (0.50%) |
5/595 (0.84%) |
| Surgical and medical procedures | ||
| CATHETER PLACEMENT † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| CENTRAL VENOUS CATHETERISATION † A # participants affected / at risk |
0/603 (0.00%) |
3/595 (0.50%) |
| Vascular disorders | ||
| SHOCK † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| PHLEBITIS † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| THROMBOSIS † A # participants affected / at risk |
2/603 (0.33%) |
2/595 (0.34%) |
| HYPOTENSION † A # participants affected / at risk |
1/603 (0.17%) |
4/595 (0.67%) |
| LYMPHOEDEMA † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| HYPERTENSION † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| THROMBOPHLEBITIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| VENOUS THROMBOSIS † A # participants affected / at risk |
0/603 (0.00%) |
1/595 (0.17%) |
| DEEP VEIN THROMBOSIS † A # participants affected / at risk |
6/603 (1.00%) |
3/595 (0.50%) |
| VENOUS THROMBOSIS LIMB † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| JUGULAR VEIN THROMBOSIS † A # participants affected / at risk |
1/603 (0.17%) |
0/595 (0.00%) |
| † | Indicates events were collected by systematic assessment. |
|---|---|
| A | Term from vocabulary, MedDRA 10.1 |
Other Adverse Events
More Information
| 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:
|
| 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. |
| Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
| Study ID Numbers: | CA163-048 |
| Study First Received: | May 7, 2004 |
| Results First Received: | May 1, 2009 |
| Last Updated: | November 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00082433 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
