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MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00094653
First received: October 21, 2004
Last updated: June 29, 2011
Last verified: June 2011
Results First Received: April 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Melanoma
Metastases
Interventions: Drug: MDX-010 (anti-CTLA4) monoclonal antibody
Biological: MDX-1379 (gp100) Melanoma Peptide Vaccine

  Participant Flow
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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
Of the 1783 participants who enrolled and were screened for study participation, a total of 676 subjects were randomized.

Reporting Groups
  Description
Ipilimumab Plus gp100 Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
Ipilimumab Monotherapy Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
gp100 Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

Participant Flow:   Overall Study
    Ipilimumab Plus gp100     Ipilimumab Monotherapy     gp100  
STARTED     403     137     136  
Treated     381     131     131  
COMPLETED     82     31     10  
NOT COMPLETED     321     106     126  
Death                 306                 100                 119  
Subject Withdrew Consent                 10                 2                 3  
Not specified                 2                 2                 2  
Lost to Follow-up                 3                 2                 1  
Protocol Violation                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ipilimumab Plus gp100 Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
Ipilimumab Monotherapy Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
gp100 Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
Total Total of all reporting groups

Baseline Measures
    Ipilimumab Plus gp100     Ipilimumab Monotherapy     gp100     Total  
Number of Participants  
[units: participants]
  403     137     136     676  
Age  
[units: years]
Mean ( Full Range )
  55.6  
  ( 24 to 84 )  
  56.8  
  ( 19 to 88 )  
  57.4  
  ( 23 to 90 )  
  56.2  
  ( 19 to 90 )  
Age, Customized  
[units: participants]
       
< 65 years     291     95     94     480  
>=65 years     112     42     42     196  
Gender  
[units: participants]
       
Female     156     56     63     275  
Male     247     81     73     401  
Race/Ethnicity, Customized  
[units: Participants]
       
White     380     129     129     638  
Black     3     1     1     5  
Hispanic     18     7     5     30  
Other     2     0     1     3  
Duration of Melanoma [1]
[units: years]
Mean ( Full Range )
  5.09  
  ( 0.2 to 38.9 )  
  4.34  
  ( -0.0 to 35.9 )  
  5.65  
  ( 0.3 to 31.2 )  
  5.05  
  ( -0.0 to 38.9 )  
Melanoma Stage [2]
[units: Participants]
       
M0     5     1     4     10  
M1a     37     14     11     62  
M1b     76     22     23     121  
M1c     285     100     98     483  
Prior Interleukin-2 Therapy  
[units: Participants]
       
No     314     105     103     522  
Yes     89     32     33     154  
Lactate Dehydrogenase [3]
[units: Participants]
       
>upper limit of normal (ULN)     149     53     52     254  
<=ULN     252     84     81     417  
unknown     2     0     3     5  
[1] Duration of melanoma is the number of years from date of initial diagnosis to the date of randomization. The randomization of 1 participant in the ipilumumab monotherapy cohort was prior to the initial diagnostic date. Data for 2 participants in the ipilimumab + gp100 cohort were missing.
[2] The "M" in the TNM (tumor, node, metastasis) system refers to distant metastases—whether, and how far, the cancer has spread outside the original site. M0: There is no evidence that the cancer has spread beyond the original site. M1: The cancer has spread beyond the original site. M1a: The cancer has spread to other areas of skin, underneath the epidermis to the dermis (subcutaneous), or to lymph node(s). M1b: The cancer has spread to the lung(s) only. M1c: The cancer has spread to other organs and/or locations in the body with or without elevated LDH.
[3] Upper limit of normal (ULN) was 250 U/L for most assessments (some variation caused by tests performed at local laboratories).



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone   [ Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) ]

2.  Secondary:   Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy   [ Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) ]

3.  Secondary:   12-, 18-, and 24-Month Survival Rates   [ Time Frame: Month 12, Month 18, Month 24 ]

4.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) ]

5.  Secondary:   Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24   [ Time Frame: Week 12, Week 24 ]

6.  Secondary:   Time to Progression (TTP)   [ Time Frame: from time of randomization to date of PD or death due to PD (end of the study was defined as the time at which 481 deaths were observed [264 weeks]) ]

7.  Secondary:   Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD)   [ Time Frame: BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1. ]

8.  Secondary:   Determination of Best Overall Response Rate (BORR)   [ Time Frame: Up to week 24 ]

9.  Secondary:   Time to Response   [ Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) ]

10.  Secondary:   Duration of Response   [ Time Frame: from time of initial drug administration to date of PD or death due to PD (the end of the study was defined as the time at which 481 deaths were observed [264 weeks]) ]

11.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: Up to week 24 ]

12.  Secondary:   Delayed Response (Response Beyond Week 24)   [ Time Frame: from Week 24 to end of study (the end of the study was defined as the time at which 481 deaths were observed [264 weeks]) ]

13.  Secondary:   Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12   [ Time Frame: Baseline (Day 1, Cycle1), Week 12 ]

14.  Secondary:   Percentage of Participants With On-Study Adverse Events (AEs) and AEs With an Outcome of Death   [ Time Frame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). ]

15.  Secondary:   Percentage of Participants With Immune-Related Adverse Events (irAEs)   [ Time Frame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). ]

16.  Secondary:   Percentage of Participants With Worst On-Study Hematological Abnormalities   [ Time Frame: On-study laboratory results are results reported after the first dose date and within 70 days of last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). ]

17.  Secondary:   Percentage of Participants With Worst On-Study Liver Abnormalities   [ Time Frame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). ]

18.  Secondary:   Percentage of Participants With Worst On-Study Renal Abnormalities   [ Time Frame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). ]

19.  Secondary:   Clinically Meaningful Changes in Vital Signs and Physical Examinations   [ Time Frame: vital signs and physical examination were evaluated at screening and at Weeks 1, 4, 7, 10, 12, 16, 20, 24, 28, 36, and every 3 months thereafter ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Ipilimumab Monotherapy Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
Ipilimumab Plus gp100 Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
gp100 Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

Serious Adverse Events
    Ipilimumab Monotherapy     Ipilimumab Plus gp100     gp100  
Total, serious adverse events        
# participants affected / at risk     55/131 (41.98%)     155/380 (40.79%)     52/132 (39.39%)  
Blood and lymphatic system disorders        
ANAEMIA † 1      
# participants affected / at risk     4/131 (3.05%)     5/380 (1.32%)     5/132 (3.79%)  
HAEMOLYTIC ANAEMIA † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
LEUKOCYTOSIS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
NEUTROPENIA † 1      
# participants affected / at risk     1/131 (0.76%)     1/380 (0.26%)     0/132 (0.00%)  
THROMBOCYTOPENIA † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
Cardiac disorders        
ATRIAL FIBRILLATION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     1/132 (0.76%)  
CARDIAC FAILURE † 1      
# participants affected / at risk     1/131 (0.76%)     1/380 (0.26%)     0/132 (0.00%)  
CARDIAC FAILURE CONGESTIVE † 1      
# participants affected / at risk     1/131 (0.76%)     1/380 (0.26%)     0/132 (0.00%)  
CARDIAC TAMPONADE † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
CARDIOPULMONARY FAILURE † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
CORONARY ARTERY DISEASE † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
PERICARDIAL EFFUSION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
SUPRAVENTRICULAR TACHYCARDIA † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
TACHYCARDIA † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
Endocrine disorders        
ADRENAL INSUFFICIENCY † 1      
# participants affected / at risk     1/131 (0.76%)     1/380 (0.26%)     0/132 (0.00%)  
HYPOGONADISM † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
HYPOPHYSITIS † 1      
# participants affected / at risk     2/131 (1.53%)     1/380 (0.26%)     0/132 (0.00%)  
HYPOPITUITARISM † 1      
# participants affected / at risk     2/131 (1.53%)     3/380 (0.79%)     0/132 (0.00%)  
HYPOTHYROIDISM † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
Eye disorders        
IRIDOCYCLITIS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
Gastrointestinal disorders        
ABDOMINAL DISTENSION † 1      
# participants affected / at risk     1/131 (0.76%)     1/380 (0.26%)     0/132 (0.00%)  
ABDOMINAL PAIN † 1      
# participants affected / at risk     2/131 (1.53%)     4/380 (1.05%)     5/132 (3.79%)  
ABDOMINAL PAIN UPPER † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
ABDOMINAL WALL MASS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
ASCITES † 1      
# participants affected / at risk     1/131 (0.76%)     1/380 (0.26%)     0/132 (0.00%)  
COLITIS † 1      
# participants affected / at risk     7/131 (5.34%)     14/380 (3.68%)     0/132 (0.00%)  
CONSTIPATION † 1      
# participants affected / at risk     0/131 (0.00%)     3/380 (0.79%)     1/132 (0.76%)  
DIARRHOEA † 1      
# participants affected / at risk     6/131 (4.58%)     16/380 (4.21%)     0/132 (0.00%)  
DYSPHAGIA † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     1/132 (0.76%)  
GASTRITIS † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
GASTROINTESTINAL HAEMORRHAGE † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
GASTROINTESTINAL PERFORATION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
HAEMATOCHEZIA † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
HAEMORRHOIDS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
ILEUS † 1      
# participants affected / at risk     0/131 (0.00%)     3/380 (0.79%)     0/132 (0.00%)  
INTESTINAL HAEMORRHAGE † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
INTESTINAL OBSTRUCTION † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
INTESTINAL PERFORATION † 1      
# participants affected / at risk     0/131 (0.00%)     3/380 (0.79%)     0/132 (0.00%)  
INTUSSUSCEPTION † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     2/132 (1.52%)  
LARGE INTESTINAL OBSTRUCTION † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
LARGE INTESTINE PERFORATION † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
NAUSEA † 1      
# participants affected / at risk     2/131 (1.53%)     6/380 (1.58%)     4/132 (3.03%)  
PERITONITIS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
PROCTALGIA † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
RECTAL STENOSIS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
SMALL INTESTINAL OBSTRUCTION † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
UPPER GASTROINTESTINAL HAEMORRHAGE † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
VOMITING † 1      
# participants affected / at risk     3/131 (2.29%)     7/380 (1.84%)     3/132 (2.27%)  
General disorders        
ADVERSE EVENT † 1      
# participants affected / at risk     1/131 (0.76%)     3/380 (0.79%)     0/132 (0.00%)  
ASTHENIA † 1      
# participants affected / at risk     3/131 (2.29%)     4/380 (1.05%)     1/132 (0.76%)  
CHEST PAIN † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
CHILLS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
DISEASE PROGRESSION † 1      
# participants affected / at risk     2/131 (1.53%)     6/380 (1.58%)     3/132 (2.27%)  
FATIGUE † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
GAIT DISTURBANCE † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     1/132 (0.76%)  
GENERAL PHYSICAL HEALTH DETERIORATION † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     2/132 (1.52%)  
GENERALISED OEDEMA † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
HERNIA OBSTRUCTIVE † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
INFLUENZA LIKE ILLNESS † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
INFUSION RELATED REACTION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
INJECTION SITE REACTION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
INJECTION SITE ULCER † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
MULTI-ORGAN FAILURE † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     2/132 (1.52%)  
OEDEMA † 1      
# participants affected / at risk     2/131 (1.53%)     1/380 (0.26%)     0/132 (0.00%)  
OEDEMA PERIPHERAL † 1      
# participants affected / at risk     1/131 (0.76%)     1/380 (0.26%)     0/132 (0.00%)  
PAIN † 1      
# participants affected / at risk     1/131 (0.76%)     3/380 (0.79%)     0/132 (0.00%)  
PYREXIA † 1      
# participants affected / at risk     2/131 (1.53%)     7/380 (1.84%)     1/132 (0.76%)  
Hepatobiliary disorders        
ACUTE HEPATIC FAILURE † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
BILE DUCT OBSTRUCTION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
CHOLECYSTITIS † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
HEPATIC FAILURE † 1      
# participants affected / at risk     1/131 (0.76%)     1/380 (0.26%)     0/132 (0.00%)  
HEPATITIS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
HYPERBILIRUBINAEMIA † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
JAUNDICE † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
JAUNDICE CHOLESTATIC † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
Infections and infestations        
APPENDICITIS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
BACTERAEMIA † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
BRONCHOPNEUMONIA † 1      
# participants affected / at risk     1/131 (0.76%)     1/380 (0.26%)     0/132 (0.00%)  
CATHETER RELATED INFECTION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
CELLULITIS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     1/132 (0.76%)  
CYSTITIS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
ENTEROCOCCAL BACTERAEMIA † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
ERYSIPELAS † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
EYELID INFECTION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
GASTROINTESTINAL INFECTION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
HEPATITIS A † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
HEPATITIS B † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
INFECTION † 1      
# participants affected / at risk     1/131 (0.76%)     1/380 (0.26%)     0/132 (0.00%)  
LOCALISED INFECTION † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
LOWER RESPIRATORY TRACT INFECTION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
MENINGITIS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
PERIRECTAL ABSCESS † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
PNEUMONIA † 1      
# participants affected / at risk     2/131 (1.53%)     8/380 (2.11%)     3/132 (2.27%)  
POSTOPERATIVE WOUND INFECTION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
PSEUDOMONAL SEPSIS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
SEPSIS † 1      
# participants affected / at risk     3/131 (2.29%)     4/380 (1.05%)     0/132 (0.00%)  
SEPTIC SHOCK † 1      
# participants affected / at risk     1/131 (0.76%)     1/380 (0.26%)     1/132 (0.76%)  
URINARY TRACT INFECTION † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     3/132 (2.27%)  
Injury, poisoning and procedural complications        
ACCIDENTAL OVERDOSE † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
FEMORAL NECK FRACTURE † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
GASTROINTESTINAL STOMA COMPLICATION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
HIP FRACTURE † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
PROCEDURAL COMPLICATION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
Investigations        
ASPARTATE AMINOTRANSFERASE INCREASED † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
BLOOD CORTICOTROPHIN DECREASED † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
GAMMA-GLUTAMYLTRANSFERASE INCREASED † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
INTERNATIONAL NORMALISED RATIO ABNORMAL † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
URINE OUTPUT DECREASED † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
Metabolism and nutrition disorders        
DECREASED APPETITE † 1      
# participants affected / at risk     2/131 (1.53%)     3/380 (0.79%)     1/132 (0.76%)  
DEHYDRATION † 1      
# participants affected / at risk     1/131 (0.76%)     8/380 (2.11%)     4/132 (3.03%)  
FAILURE TO THRIVE † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
HYPOALBUMINAEMIA † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
HYPOGLYCAEMIA † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
HYPONATRAEMIA † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
HYPOPHAGIA † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
MALNUTRITION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
TUMOUR LYSIS SYNDROME † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
Musculoskeletal and connective tissue disorders        
ARTHRALGIA † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     1/132 (0.76%)  
BACK PAIN † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     2/132 (1.52%)  
BONE PAIN † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     1/132 (0.76%)  
MUSCULAR WEAKNESS † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
MUSCULOSKELETAL PAIN † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
NECK PAIN † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
PAIN IN EXTREMITY † 1      
# participants affected / at risk     0/131 (0.00%)     3/380 (0.79%)     1/132 (0.76%)  
PATHOLOGICAL FRACTURE † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
POLYMYALGIA RHEUMATICA † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
BASAL CELL CARCINOMA † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
CANCER PAIN † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
INTRACRANIAL TUMOUR HAEMORRHAGE † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
MALIGNANT ASCITES † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
MALIGNANT MELANOMA † 1      
# participants affected / at risk     0/131 (0.00%)     3/380 (0.79%)     1/132 (0.76%)  
MALIGNANT NEOPLASM PROGRESSION † 1      
# participants affected / at risk     0/131 (0.00%)     3/380 (0.79%)     0/132 (0.00%)  
METASTASES TO BREAST † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
METASTASES TO CENTRAL NERVOUS SYSTEM † 1      
# participants affected / at risk     2/131 (1.53%)     3/380 (0.79%)     0/132 (0.00%)  
METASTASES TO SPINE † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
METASTATIC MALIGNANT MELANOMA † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
METASTATIC NEOPLASM † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
METASTATIC PAIN † 1      
# participants affected / at risk     1/131 (0.76%)     3/380 (0.79%)     0/132 (0.00%)  
TUMOUR HAEMORRHAGE † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     2/132 (1.52%)  
TUMOUR PAIN † 1      
# participants affected / at risk     2/131 (1.53%)     2/380 (0.53%)     1/132 (0.76%)  
Nervous system disorders        
APHASIA † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
ATAXIA † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
BRAIN OEDEMA † 1      
# participants affected / at risk     1/131 (0.76%)     2/380 (0.53%)     0/132 (0.00%)  
CEREBRAL HAEMORRHAGE † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     2/132 (1.52%)  
CEREBROVASCULAR ACCIDENT † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
COMA † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     1/132 (0.76%)  
CONVULSION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     1/132 (0.76%)  
DEPRESSED LEVEL OF CONSCIOUSNESS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
DIZZINESS † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     2/132 (1.52%)  
DYSARTHRIA † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
EPIDURITIS † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
GUILLAIN-BARRE SYNDROME † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
HAEMORRHAGE INTRACRANIAL † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
HEADACHE † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     1/132 (0.76%)  
HYDROCEPHALUS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
HYPOAESTHESIA † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
INTRACRANIAL PRESSURE INCREASED † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
LETHARGY † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
MENINGEAL DISORDER † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
MYOCLONUS † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
SPINAL CORD COMPRESSION † 1      
# participants affected / at risk     1/131 (0.76%)     3/380 (0.79%)     0/132 (0.00%)  
SYNCOPE † 1      
# participants affected / at risk     1/131 (0.76%)     1/380 (0.26%)     0/132 (0.00%)  
Psychiatric disorders        
ANXIETY † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
CONFUSIONAL STATE † 1      
# participants affected / at risk     2/131 (1.53%)     1/380 (0.26%)     1/132 (0.76%)  
DELIRIUM † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
MENTAL STATUS CHANGES † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
Renal and urinary disorders        
ATONIC URINARY BLADDER † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
BLADDER PAIN † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
GLOMERULONEPHRITIS † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
HYDRONEPHROSIS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
RENAL FAILURE † 1      
# participants affected / at risk     3/131 (2.29%)     3/380 (0.79%)     0/132 (0.00%)  
RENAL FAILURE ACUTE † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
RENAL TUBULAR NECROSIS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
URETERIC OBSTRUCTION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
URINARY INCONTINENCE † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     1/132 (0.76%)  
URINARY RETENTION † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
Reproductive system and breast disorders        
BREAST MASS † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
PELVIC PAIN † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
Respiratory, thoracic and mediastinal disorders        
ACUTE PULMONARY OEDEMA † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
ACUTE RESPIRATORY DISTRESS SYNDROME † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
BRONCHIAL OBSTRUCTION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
COUGH † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
DYSPNOEA † 1      
# participants affected / at risk     3/131 (2.29%)     2/380 (0.53%)     7/132 (5.30%)  
HAEMOPTYSIS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
HAEMOTHORAX † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
PAINFUL RESPIRATION † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
PLEURAL EFFUSION † 1      
# participants affected / at risk     2/131 (1.53%)     5/380 (1.32%)     4/132 (3.03%)  
PLEURITIC PAIN † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
PNEUMONITIS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
PULMONARY EMBOLISM † 1      
# participants affected / at risk     1/131 (0.76%)     3/380 (0.79%)     2/132 (1.52%)  
PULMONARY HAEMORRHAGE † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
RESPIRATORY ARREST † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
RESPIRATORY DEPRESSION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
RESPIRATORY FAILURE † 1      
# participants affected / at risk     1/131 (0.76%)     2/380 (0.53%)     0/132 (0.00%)  
SLEEP APNOEA SYNDROME † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
Skin and subcutaneous tissue disorders        
LEUKOCYTOCLASTIC VASCULITIS † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
RASH † 1      
# participants affected / at risk     0/131 (0.00%)     2/380 (0.53%)     0/132 (0.00%)  
RASH GENERALISED † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
RASH PRURITIC † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
TOXIC EPIDERMAL NECROLYSIS † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
Vascular disorders        
ANGIOPATHY † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
ARTERIAL THROMBOSIS LIMB † 1      
# participants affected / at risk     1/131 (0.76%)     0/380 (0.00%)     0/132 (0.00%)  
DEEP VEIN THROMBOSIS † 1      
# participants affected / at risk     2/131 (1.53%)     5/380 (1.32%)     1/132 (0.76%)  
HAEMATOMA † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     1/132 (0.76%)  
HYPERTENSIVE CRISIS † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
HYPOTENSION † 1      
# participants affected / at risk     3/131 (2.29%)     1/380 (0.26%)     2/132 (1.52%)  
LYMPHOEDEMA † 1      
# participants affected / at risk     0/131 (0.00%)     0/380 (0.00%)     1/132 (0.76%)  
SUPERIOR VENA CAVAL OCCLUSION † 1      
# participants affected / at risk     0/131 (0.00%)     1/380 (0.26%)     0/132 (0.00%)  
THROMBOSIS † 1      
# participants affected / at risk     1/131 (0.76%)     1/380 (0.26%)     0/132 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.1




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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
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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.


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


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:


Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00094653     History of Changes
Other Study ID Numbers: MDX010-20, CA184-002
Study First Received: October 21, 2004
Results First Received: April 22, 2011
Last Updated: June 29, 2011
Health Authority: United States: Food and Drug Administration