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Trial record 1 of 1 for:    CA184-104
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Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin

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ClinicalTrials.gov Identifier: NCT01285609
Recruitment Status : Completed
First Posted : January 28, 2011
Results First Posted : June 23, 2016
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lung Cancer - Non Small Cell Squamous
Interventions Drug: Ipilimumab
Drug: Placebo
Drug: Paclitaxel
Drug: Carboplatin
Enrollment 1289
Recruitment Details  
Pre-assignment Details 1289 participants were enrolled and 956 were randomized (479 Ipilimumab, 477 Placebo). 948 were treated (475 Ipilimumab, 473 Placebo). Reasons for non-treatment is 4 no longer met study criteria, 2 adverse events unrelated to study drug, 1 participant request to discontinue, and 1 other.
Arm/Group Title Ipilimumab With Paclitaxel/Carboplatin Placebo With Paclitaxel/Carboplatin
Hide Arm/Group Description Ipilimumab + Active Chemotherapy Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses Placebo + Active Chemotherapy Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Period Title: Randomized
Started [1] 479 [2] 477 [2]
Treated With Chemotherapy (1st Dose) 475 473
Completed [3] 388 361
Not Completed 91 116
Reason Not Completed
Progressive Disease             41             61
Adverse Event Unrelated to Study Drug             18             18
Study Drug Toxicity             13             14
Death             5             7
Withdrawal by Subject             8             11
Subject No Longer Met Study Criteria             1             1
Undisclosed Reasons             1             0
Randomized but not Treated             4             4
[1]
Started = Randomized
[2]
Represents participants randomized to this arm prior to 1st dose of chemotherapy treatment
[3]
Completed = Continued to Blinded Therapy
Period Title: Treated With Blinded Therapy
Started [1] 388 361
Completed [2] 1 2
Not Completed 387 359
Reason Not Completed
Progressive Disease             223             305
Study Drug Toxicity             87             14
Adverse Event Unrelated to Study Drug             36             14
Withdrawal by Subject             20             7
Death             11             3
Maximum Clinical Benefit             2             4
Not Reported             0             2
Poor/Non-Compliance             1             2
Subject No Longer Met Study Criteria             1             0
Administrative Reason by Sponsor             1             3
Physician and Patient decision             1             3
Participant refused participation             1             0
Participant started radiotherapy             1             0
Participant hospitalized             1             0
Investigator's assessment             1             0
PI decision to discontinue             0             1
Worsening of general condition             0             1
[1]
Started = Received at least one dose of Blinded Therapy
[2]
Completed = Completed the Blinded Therapy treatment phase
Arm/Group Title Ipilimumab With Paclitaxel/Carboplatin Placebo With Paclitaxel/Carboplatin Total
Hide Arm/Group Description Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses Total of all reporting groups
Overall Number of Baseline Participants 388 361 749
Hide Baseline Analysis Population Description
Randomized Participants Who Received at Least One Dose of Blinded Study Therapy
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 388 participants 361 participants 749 participants
63.7  (8.27) 63.7  (8.70) 63.7  (8.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 388 participants 361 participants 749 participants
Female
62
  16.0%
52
  14.4%
114
  15.2%
Male
326
  84.0%
309
  85.6%
635
  84.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 388 participants 361 participants 749 participants
American Indian or Alaska Native
0
   0.0%
1
   0.3%
1
   0.1%
Asian
106
  27.3%
108
  29.9%
214
  28.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   0.8%
3
   0.8%
6
   0.8%
White
276
  71.1%
243
  67.3%
519
  69.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   0.8%
6
   1.7%
9
   1.2%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 388 participants 361 participants 749 participants
0
135
  34.8%
124
  34.3%
259
  34.6%
1
251
  64.7%
234
  64.8%
485
  64.8%
2
1
   0.3%
3
   0.8%
4
   0.5%
3
1
   0.3%
0
   0.0%
1
   0.1%
[1]
Measure Description: ECOG Performance Status is a 6-item scale used to assess disease progression, daily functioning, appropriate treatment, and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all pre-disease performance without restriction and (worst score) 5=death.
Disease Stage at Study Entry   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 388 participants 361 participants 749 participants
Stage IV
367
  94.6%
333
  92.2%
700
  93.5%
Recurrent
21
   5.4%
28
   7.8%
49
   6.5%
[1]
Measure Description: Non-Small Cell Lung Cancer is categorized in 4 Stages (I-IV). I: Cancer located only in lungs and has not spread to any lymph nodes. II: Cancer in the lung and nearby lymph nodes. III: Cancer in the lung and lymph nodes in the middle of the chest. Stage III has two subtypes, IIIA (cancer has spread only to lymph nodes on the same side of the chest where the cancer started) and IIIB (cancer has spread to the lymph nodes on the opposite side of the chest, or above the collar bone). IV: Cancer has spread to both lungs, to fluid in the area around the lungs, or to another part of the body.
1.Primary Outcome
Title Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Hide Description Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Time Frame Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least one dose of blinded therapy
Arm/Group Title Ipilimumab With Paclitaxel/Carboplatin Placebo With Paclitaxel/Carboplatin
Hide Arm/Group Description:
Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Overall Number of Participants Analyzed 388 361
Median (95% Confidence Interval)
Unit of Measure: months
13.37
(11.76 to 14.78)
12.42
(11.60 to 13.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab With Paclitaxel/Carboplatin, Placebo With Paclitaxel/Carboplatin
Comments Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2517
Comments [Not Specified]
Method Log Rank
Comments p-value based on an unstratified 2-sided log rank test
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.907
Confidence Interval (2-Sided) 95%
0.767 to 1.072
Estimation Comments Hazard of Ipilimumab over Hazard of Placebo with 2-sided 95% confidence intervals are based on an unstratified Cox proportional hazards model with treatment as the single covariate
2.Secondary Outcome
Title Overall Survival (OS) in All Randomized Participants at Primary Endpoint
Hide Description Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Time Frame Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Ipilimumab With Paclitaxel/Carboplatin Placebo With Paclitaxel/Carboplatin
Hide Arm/Group Description:
Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Overall Number of Participants Analyzed 479 477
Median (95% Confidence Interval)
Unit of Measure: months
10.94
(9.56 to 12.02)
10.74
(9.66 to 11.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab With Paclitaxel/Carboplatin, Placebo With Paclitaxel/Carboplatin
Comments Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2421
Comments p-value based on stratified 2-sided log-rank test
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.917
Confidence Interval (2-Sided) 95%
0.792 to 1.061
Estimation Comments Hazard of Ipilimumab over Placebo with 2-sided 95% confidence intervals based on a stratified Cox proportional hazards model with several stratification factors and treatment as the single covariate
3.Secondary Outcome
Title Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Hide Description Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
Time Frame Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least one dose of blinded therapy
Arm/Group Title Ipilimumab With Paclitaxel/Carboplatin Placebo With Paclitaxel/Carboplatin
Hide Arm/Group Description:
Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Overall Number of Participants Analyzed 388 361
Median (95% Confidence Interval)
Unit of Measure: months
5.55
(5.36 to 5.85)
5.59
(5.52 to 5.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab With Paclitaxel/Carboplatin, Placebo With Paclitaxel/Carboplatin
Comments Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0678
Comments [Not Specified]
Method Log Rank
Comments p-value based on an unstratified 2-sided log rank test
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.869
Confidence Interval (2-Sided) 95%
0.749 to 1.009
Estimation Comments Hazard of Ipilimumab over Hazard of Placebo with 2-sided 95% confidence intervals are based on an unstratified Cox proportional hazards model with treatment as the single covariate
Time Frame Day of first dose to 90 days post final dose, up to August 2017 (approximately 72 months post study start)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 10 MG/KG Ipilimumab + Paclitaxel/ Carbop Placebo + Paclitaxel/ Carboplatin
Hide Arm/Group Description Ipilimumab + Active Chemotherapy Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses Placebo + Active Chemotherapy Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
All-Cause Mortality
10 MG/KG Ipilimumab + Paclitaxel/ Carbop Placebo + Paclitaxel/ Carboplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   359/475 (75.58%)   371/473 (78.44%) 
Show Serious Adverse Events Hide Serious Adverse Events
10 MG/KG Ipilimumab + Paclitaxel/ Carbop Placebo + Paclitaxel/ Carboplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   300/475 (63.16%)   235/473 (49.68%) 
Blood and lymphatic system disorders     
Anaemia  1  21/475 (4.42%)  10/473 (2.11%) 
Bone marrow failure  1  2/475 (0.42%)  1/473 (0.21%) 
Pancytopenia  1  1/475 (0.21%)  0/473 (0.00%) 
Agranulocytosis  1  1/475 (0.21%)  0/473 (0.00%) 
Leukopenia  1  3/475 (0.63%)  5/473 (1.06%) 
Thrombocytopenia  1  7/475 (1.47%)  11/473 (2.33%) 
Leukocytosis  1  1/475 (0.21%)  0/473 (0.00%) 
Anaemia of malignant disease  1  0/475 (0.00%)  1/473 (0.21%) 
Disseminated intravascular coagulation  1  1/475 (0.21%)  1/473 (0.21%) 
Haemorrhagic anaemia  1  0/475 (0.00%)  1/473 (0.21%) 
Febrile neutropenia  1  20/475 (4.21%)  11/473 (2.33%) 
Neutropenia  1  16/475 (3.37%)  9/473 (1.90%) 
Cardiac disorders     
Pericardial effusion  1  0/475 (0.00%)  1/473 (0.21%) 
Angina pectoris  1  0/475 (0.00%)  1/473 (0.21%) 
Atrial flutter  1  1/475 (0.21%)  1/473 (0.21%) 
Cardiac tamponade  1  0/475 (0.00%)  1/473 (0.21%) 
Tachycardia  1  1/475 (0.21%)  1/473 (0.21%) 
Ventricular fibrillation  1  0/475 (0.00%)  1/473 (0.21%) 
Arrhythmia  1  1/475 (0.21%)  0/473 (0.00%) 
Atrial fibrillation  1  5/475 (1.05%)  8/473 (1.69%) 
Cardiac failure  1  1/475 (0.21%)  3/473 (0.63%) 
Cardio-respiratory arrest  1  5/475 (1.05%)  2/473 (0.42%) 
Cardiovascular insufficiency  1  1/475 (0.21%)  0/473 (0.00%) 
Pericarditis  1  0/475 (0.00%)  2/473 (0.42%) 
Acute myocardial infarction  1  2/475 (0.42%)  0/473 (0.00%) 
Cardiopulmonary failure  1  1/475 (0.21%)  0/473 (0.00%) 
Supraventricular tachycardia  1  1/475 (0.21%)  0/473 (0.00%) 
Cardiac arrest  1  2/475 (0.42%)  2/473 (0.42%) 
Cardiac failure congestive  1  1/475 (0.21%)  0/473 (0.00%) 
Cardiogenic shock  1  1/475 (0.21%)  0/473 (0.00%) 
Palpitations  1  0/475 (0.00%)  1/473 (0.21%) 
Sinus tachycardia  1  1/475 (0.21%)  1/473 (0.21%) 
Ear and labyrinth disorders     
Vertigo  1  0/475 (0.00%)  2/473 (0.42%) 
Endocrine disorders     
Hypophysitis  1  2/475 (0.42%)  0/473 (0.00%) 
Adrenocortical insufficiency acute  1  1/475 (0.21%)  0/473 (0.00%) 
Hyperthyroidism  1  1/475 (0.21%)  0/473 (0.00%) 
Hypopituitarism  1  2/475 (0.42%)  0/473 (0.00%) 
Thyroiditis  1  1/475 (0.21%)  0/473 (0.00%) 
Adrenal insufficiency  1  2/475 (0.42%)  0/473 (0.00%) 
Hypothalamo-pituitary disorder  1  1/475 (0.21%)  0/473 (0.00%) 
Endocrine disorder  1  1/475 (0.21%)  0/473 (0.00%) 
Eye disorders     
Pupils unequal  1  1/475 (0.21%)  0/473 (0.00%) 
Ulcerative keratitis  1  1/475 (0.21%)  0/473 (0.00%) 
Gastrointestinal disorders     
Autoimmune colitis  1  2/475 (0.42%)  1/473 (0.21%) 
Colitis  1  14/475 (2.95%)  2/473 (0.42%) 
Diverticular perforation  1  1/475 (0.21%)  0/473 (0.00%) 
Haematemesis  1  0/475 (0.00%)  1/473 (0.21%) 
Crohn's disease  1  1/475 (0.21%)  0/473 (0.00%) 
Ileal perforation  1  1/475 (0.21%)  0/473 (0.00%) 
Intestinal perforation  1  3/475 (0.63%)  0/473 (0.00%) 
Large intestine perforation  1  1/475 (0.21%)  0/473 (0.00%) 
Vomiting  1  6/475 (1.26%)  5/473 (1.06%) 
Abdominal pain upper  1  1/475 (0.21%)  1/473 (0.21%) 
Impaired gastric emptying  1  1/475 (0.21%)  0/473 (0.00%) 
Pancreatitis  1  1/475 (0.21%)  0/473 (0.00%) 
Rectal haemorrhage  1  1/475 (0.21%)  0/473 (0.00%) 
Constipation  1  1/475 (0.21%)  2/473 (0.42%) 
Diarrhoea  1  37/475 (7.79%)  10/473 (2.11%) 
Intestinal obstruction  1  1/475 (0.21%)  0/473 (0.00%) 
Subileus  1  1/475 (0.21%)  0/473 (0.00%) 
Abdominal pain  1  3/475 (0.63%)  1/473 (0.21%) 
Colitis ischaemic  1  1/475 (0.21%)  0/473 (0.00%) 
Dysphagia  1  1/475 (0.21%)  1/473 (0.21%) 
Gastrointestinal haemorrhage  1  0/475 (0.00%)  2/473 (0.42%) 
Ileus  1  0/475 (0.00%)  3/473 (0.63%) 
Nausea  1  2/475 (0.42%)  1/473 (0.21%) 
Stomatitis  1  1/475 (0.21%)  0/473 (0.00%) 
General disorders     
Performance status decreased  1  1/475 (0.21%)  0/473 (0.00%) 
Asthenia  1  5/475 (1.05%)  7/473 (1.48%) 
Chest pain  1  1/475 (0.21%)  4/473 (0.85%) 
Device dislocation  1  1/475 (0.21%)  0/473 (0.00%) 
General physical health deterioration  1  7/475 (1.47%)  10/473 (2.11%) 
Swelling  1  1/475 (0.21%)  0/473 (0.00%) 
Disease progression  1  4/475 (0.84%)  5/473 (1.06%) 
Death  1  10/475 (2.11%)  7/473 (1.48%) 
Extravasation  1  1/475 (0.21%)  0/473 (0.00%) 
Pyrexia  1  21/475 (4.42%)  14/473 (2.96%) 
Chills  1  1/475 (0.21%)  0/473 (0.00%) 
Malaise  1  0/475 (0.00%)  1/473 (0.21%) 
Pain  1  3/475 (0.63%)  0/473 (0.00%) 
Device occlusion  1  0/475 (0.00%)  1/473 (0.21%) 
Fatigue  1  8/475 (1.68%)  7/473 (1.48%) 
Sudden death  1  3/475 (0.63%)  1/473 (0.21%) 
Multi-organ failure  1  3/475 (0.63%)  1/473 (0.21%) 
Systemic inflammatory response syndrome  1  1/475 (0.21%)  0/473 (0.00%) 
Hepatobiliary disorders     
Cholangitis acute  1  1/475 (0.21%)  0/473 (0.00%) 
Cholecystitis acute  1  0/475 (0.00%)  1/473 (0.21%) 
Hepatotoxicity  1  1/475 (0.21%)  0/473 (0.00%) 
Bile duct stenosis  1  1/475 (0.21%)  0/473 (0.00%) 
Cholestasis  1  0/475 (0.00%)  1/473 (0.21%) 
Hepatic function abnormal  1  1/475 (0.21%)  0/473 (0.00%) 
Hepatocellular injury  1  1/475 (0.21%)  0/473 (0.00%) 
Liver disorder  1  0/475 (0.00%)  1/473 (0.21%) 
Portal vein thrombosis  1  1/475 (0.21%)  0/473 (0.00%) 
Hydrocholecystis  1  0/475 (0.00%)  1/473 (0.21%) 
Cholangitis  1  0/475 (0.00%)  1/473 (0.21%) 
Drug-induced liver injury  1  1/475 (0.21%)  0/473 (0.00%) 
Hepatitis  1  1/475 (0.21%)  0/473 (0.00%) 
Cholecystitis  1  1/475 (0.21%)  1/473 (0.21%) 
Acute hepatic failure  1  1/475 (0.21%)  0/473 (0.00%) 
Jaundice cholestatic  1  1/475 (0.21%)  0/473 (0.00%) 
Immune system disorders     
Hypersensitivity  1  3/475 (0.63%)  1/473 (0.21%) 
Drug hypersensitivity  1  3/475 (0.63%)  1/473 (0.21%) 
Infections and infestations     
Bronchitis  1  1/475 (0.21%)  2/473 (0.42%) 
Device related infection  1  1/475 (0.21%)  1/473 (0.21%) 
Pneumonia bacterial  1  1/475 (0.21%)  0/473 (0.00%) 
Diverticulitis  1  1/475 (0.21%)  0/473 (0.00%) 
Lobar pneumonia  1  1/475 (0.21%)  1/473 (0.21%) 
Staphylococcal infection  1  0/475 (0.00%)  1/473 (0.21%) 
Upper respiratory tract infection  1  1/475 (0.21%)  2/473 (0.42%) 
Nasopharyngitis  1  1/475 (0.21%)  0/473 (0.00%) 
Pulmonary sepsis  1  1/475 (0.21%)  0/473 (0.00%) 
Pulmonary tuberculosis  1  1/475 (0.21%)  0/473 (0.00%) 
Viraemia  1  1/475 (0.21%)  0/473 (0.00%) 
Bronchopneumonia  1  1/475 (0.21%)  2/473 (0.42%) 
Empyema  1  1/475 (0.21%)  0/473 (0.00%) 
Gastroenteritis rotavirus  1  0/475 (0.00%)  1/473 (0.21%) 
Infection  1  3/475 (0.63%)  4/473 (0.85%) 
Necrotising fasciitis  1  1/475 (0.21%)  0/473 (0.00%) 
Septic shock  1  0/475 (0.00%)  1/473 (0.21%) 
Sinusitis  1  0/475 (0.00%)  1/473 (0.21%) 
Abdominal abscess  1  1/475 (0.21%)  0/473 (0.00%) 
Endocarditis  1  0/475 (0.00%)  1/473 (0.21%) 
Febrile infection  1  1/475 (0.21%)  0/473 (0.00%) 
Localised infection  1  0/475 (0.00%)  1/473 (0.21%) 
Lower respiratory tract infection  1  3/475 (0.63%)  2/473 (0.42%) 
Lung abscess  1  3/475 (0.63%)  1/473 (0.21%) 
Lung infection  1  9/475 (1.89%)  5/473 (1.06%) 
Orchitis  1  0/475 (0.00%)  1/473 (0.21%) 
Pneumocystis jirovecii pneumonia  1  1/475 (0.21%)  0/473 (0.00%) 
Cellulitis  1  2/475 (0.42%)  1/473 (0.21%) 
Gastroenteritis  1  1/475 (0.21%)  2/473 (0.42%) 
Laryngitis  1  0/475 (0.00%)  1/473 (0.21%) 
Pneumococcal infection  1  0/475 (0.00%)  1/473 (0.21%) 
Pneumonia  1  37/475 (7.79%)  34/473 (7.19%) 
Herpes zoster  1  0/475 (0.00%)  1/473 (0.21%) 
Respiratory tract infection  1  1/475 (0.21%)  2/473 (0.42%) 
Sepsis  1  7/475 (1.47%)  7/473 (1.48%) 
Tracheobronchitis  1  1/475 (0.21%)  0/473 (0.00%) 
Urinary tract infection  1  3/475 (0.63%)  2/473 (0.42%) 
Infectious colitis  1  1/475 (0.21%)  0/473 (0.00%) 
Neutropenic sepsis  1  1/475 (0.21%)  1/473 (0.21%) 
Pharyngitis  1  2/475 (0.42%)  0/473 (0.00%) 
Tuberculosis  1  1/475 (0.21%)  0/473 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  0/475 (0.00%)  1/473 (0.21%) 
Overdose  1  1/475 (0.21%)  5/473 (1.06%) 
Post procedural complication  1  1/475 (0.21%)  0/473 (0.00%) 
Asbestosis  1  0/475 (0.00%)  1/473 (0.21%) 
Femur fracture  1  0/475 (0.00%)  1/473 (0.21%) 
Toxicity to various agents  1  1/475 (0.21%)  0/473 (0.00%) 
Hip fracture  1  0/475 (0.00%)  1/473 (0.21%) 
Radiation pneumonitis  1  0/475 (0.00%)  1/473 (0.21%) 
Traumatic haemorrhage  1  0/475 (0.00%)  1/473 (0.21%) 
Contusion  1  1/475 (0.21%)  0/473 (0.00%) 
Heart injury  1  1/475 (0.21%)  0/473 (0.00%) 
Joint dislocation  1  0/475 (0.00%)  1/473 (0.21%) 
Infusion related reaction  1  1/475 (0.21%)  0/473 (0.00%) 
Lumbar vertebral fracture  1  0/475 (0.00%)  1/473 (0.21%) 
Fall  1  0/475 (0.00%)  2/473 (0.42%) 
Spinal compression fracture  1  0/475 (0.00%)  1/473 (0.21%) 
Brain contusion  1  1/475 (0.21%)  0/473 (0.00%) 
Brain herniation  1  1/475 (0.21%)  0/473 (0.00%) 
Spinal column injury  1  1/475 (0.21%)  0/473 (0.00%) 
Investigations     
Blood pressure decreased  1  1/475 (0.21%)  0/473 (0.00%) 
Haemoglobin decreased  1  1/475 (0.21%)  2/473 (0.42%) 
White blood cell count decreased  1  0/475 (0.00%)  1/473 (0.21%) 
Aspartate aminotransferase increased  1  1/475 (0.21%)  0/473 (0.00%) 
Blood creatinine increased  1  5/475 (1.05%)  0/473 (0.00%) 
Blood thyroid stimulating hormone decreased  1  1/475 (0.21%)  0/473 (0.00%) 
Weight decreased  1  1/475 (0.21%)  0/473 (0.00%) 
Platelet count decreased  1  1/475 (0.21%)  3/473 (0.63%) 
Red blood cell count decreased  1  0/475 (0.00%)  1/473 (0.21%) 
Alanine aminotransferase increased  1  2/475 (0.42%)  0/473 (0.00%) 
Body temperature increased  1  1/475 (0.21%)  0/473 (0.00%) 
Liver function test abnormal  1  3/475 (0.63%)  0/473 (0.00%) 
C-reactive protein increased  1  1/475 (0.21%)  1/473 (0.21%) 
Renal function test abnormal  1  1/475 (0.21%)  0/473 (0.00%) 
Blood glucose increased  1  0/475 (0.00%)  1/473 (0.21%) 
General physical condition abnormal  1  2/475 (0.42%)  1/473 (0.21%) 
Neutrophil count decreased  1  0/475 (0.00%)  1/473 (0.21%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/475 (0.21%)  3/473 (0.63%) 
Fulminant type 1 diabetes mellitus  1  1/475 (0.21%)  0/473 (0.00%) 
Hypoglycaemia  1  0/475 (0.00%)  1/473 (0.21%) 
Hypomagnesaemia  1  1/475 (0.21%)  2/473 (0.42%) 
Tumour lysis syndrome  1  0/475 (0.00%)  1/473 (0.21%) 
Dehydration  1  8/475 (1.68%)  7/473 (1.48%) 
Hyponatraemia  1  3/475 (0.63%)  0/473 (0.00%) 
Cachexia  1  2/475 (0.42%)  0/473 (0.00%) 
Hypokalaemia  1  2/475 (0.42%)  1/473 (0.21%) 
Hyperglycaemia  1  3/475 (0.63%)  2/473 (0.42%) 
Hyperkalaemia  1  0/475 (0.00%)  1/473 (0.21%) 
Hypercalcaemia  1  1/475 (0.21%)  2/473 (0.42%) 
Type 2 diabetes mellitus  1  0/475 (0.00%)  1/473 (0.21%) 
Musculoskeletal and connective tissue disorders     
Bone pain  1  0/475 (0.00%)  1/473 (0.21%) 
Pathological fracture  1  1/475 (0.21%)  3/473 (0.63%) 
Musculoskeletal pain  1  1/475 (0.21%)  1/473 (0.21%) 
Spinal pain  1  1/475 (0.21%)  0/473 (0.00%) 
Neck pain  1  0/475 (0.00%)  1/473 (0.21%) 
Back pain  1  3/475 (0.63%)  3/473 (0.63%) 
Muscular weakness  1  0/475 (0.00%)  2/473 (0.42%) 
Myositis  1  1/475 (0.21%)  0/473 (0.00%) 
Pain in extremity  1  1/475 (0.21%)  0/473 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  0/475 (0.00%)  1/473 (0.21%) 
Metastases to central nervous system  1  3/475 (0.63%)  3/473 (0.63%) 
Neoplasm progression  1  1/475 (0.21%)  0/473 (0.00%) 
Non-small cell lung cancer  1  2/475 (0.42%)  4/473 (0.85%) 
Colorectal cancer  1  1/475 (0.21%)  0/473 (0.00%) 
Malignant neoplasm progression  1  35/475 (7.37%)  37/473 (7.82%) 
Neuroendocrine carcinoma  1  1/475 (0.21%)  0/473 (0.00%) 
Lung squamous cell carcinoma metastatic  1  0/475 (0.00%)  1/473 (0.21%) 
Small intestine carcinoma  1  0/475 (0.00%)  1/473 (0.21%) 
Lung neoplasm malignant  1  3/475 (0.63%)  8/473 (1.69%) 
Metastases to meninges  1  0/475 (0.00%)  1/473 (0.21%) 
Lung cancer metastatic  1  0/475 (0.00%)  1/473 (0.21%) 
Metastatic neoplasm  1  1/475 (0.21%)  0/473 (0.00%) 
Neoplasm malignant  1  1/475 (0.21%)  1/473 (0.21%) 
Tumour compression  1  0/475 (0.00%)  2/473 (0.42%) 
Cancer pain  1  1/475 (0.21%)  0/473 (0.00%) 
Tumour perforation  1  0/475 (0.00%)  1/473 (0.21%) 
Metastases to liver  1  0/475 (0.00%)  1/473 (0.21%) 
Nervous system disorders     
Depressed level of consciousness  1  0/475 (0.00%)  1/473 (0.21%) 
Peripheral sensory neuropathy  1  1/475 (0.21%)  0/473 (0.00%) 
Spinal cord paralysis  1  1/475 (0.21%)  0/473 (0.00%) 
Cerebral infarction  1  0/475 (0.00%)  1/473 (0.21%) 
Encephalopathy  1  0/475 (0.00%)  1/473 (0.21%) 
Hemiparesis  1  1/475 (0.21%)  1/473 (0.21%) 
Paraesthesia  1  0/475 (0.00%)  1/473 (0.21%) 
Headache  1  0/475 (0.00%)  1/473 (0.21%) 
Brain oedema  1  0/475 (0.00%)  1/473 (0.21%) 
Cervical radiculopathy  1  0/475 (0.00%)  1/473 (0.21%) 
Migraine  1  1/475 (0.21%)  0/473 (0.00%) 
Neuropathy peripheral  1  1/475 (0.21%)  0/473 (0.00%) 
Partial seizures  1  0/475 (0.00%)  1/473 (0.21%) 
Cerebral haemorrhage  1  1/475 (0.21%)  0/473 (0.00%) 
Cerebral ischaemia  1  1/475 (0.21%)  2/473 (0.42%) 
Dizziness  1  0/475 (0.00%)  1/473 (0.21%) 
Hydrocephalus  1  1/475 (0.21%)  0/473 (0.00%) 
Ischaemic stroke  1  0/475 (0.00%)  1/473 (0.21%) 
Brain injury  1  1/475 (0.21%)  0/473 (0.00%) 
Hypersomnia  1  1/475 (0.21%)  0/473 (0.00%) 
Peripheral motor neuropathy  1  0/475 (0.00%)  1/473 (0.21%) 
Syncope  1  3/475 (0.63%)  1/473 (0.21%) 
Cerebrovascular accident  1  3/475 (0.63%)  4/473 (0.85%) 
Facial paresis  1  2/475 (0.42%)  0/473 (0.00%) 
Polyneuropathy  1  1/475 (0.21%)  1/473 (0.21%) 
Seizure  1  1/475 (0.21%)  0/473 (0.00%) 
Guillain-barre syndrome  1  1/475 (0.21%)  0/473 (0.00%) 
Psychiatric disorders     
Completed suicide  1  1/475 (0.21%)  0/473 (0.00%) 
Suicide attempt  1  0/475 (0.00%)  1/473 (0.21%) 
Confusional state  1  3/475 (0.63%)  0/473 (0.00%) 
Depression  1  0/475 (0.00%)  1/473 (0.21%) 
Delirium  1  0/475 (0.00%)  1/473 (0.21%) 
Depressed mood  1  0/475 (0.00%)  1/473 (0.21%) 
Renal and urinary disorders     
Dysuria  1  1/475 (0.21%)  0/473 (0.00%) 
Renal failure  1  4/475 (0.84%)  2/473 (0.42%) 
Tubulointerstitial nephritis  1  1/475 (0.21%)  0/473 (0.00%) 
Nephropathy  1  1/475 (0.21%)  0/473 (0.00%) 
Obstructive uropathy  1  0/475 (0.00%)  1/473 (0.21%) 
Azotaemia  1  0/475 (0.00%)  1/473 (0.21%) 
Acute kidney injury  1  3/475 (0.63%)  2/473 (0.42%) 
Renal colic  1  1/475 (0.21%)  0/473 (0.00%) 
Renal impairment  1  1/475 (0.21%)  2/473 (0.42%) 
Respiratory, thoracic and mediastinal disorders     
Apnoea  1  0/475 (0.00%)  1/473 (0.21%) 
Chronic obstructive pulmonary disease  1  4/475 (0.84%)  8/473 (1.69%) 
Idiopathic pulmonary fibrosis  1  1/475 (0.21%)  0/473 (0.00%) 
Lung infiltration  1  1/475 (0.21%)  0/473 (0.00%) 
Pneumonia aspiration  1  1/475 (0.21%)  0/473 (0.00%) 
Respiratory distress  1  1/475 (0.21%)  1/473 (0.21%) 
Hiccups  1  1/475 (0.21%)  0/473 (0.00%) 
Pulmonary infarction  1  0/475 (0.00%)  1/473 (0.21%) 
Acute pulmonary oedema  1  0/475 (0.00%)  1/473 (0.21%) 
Bronchial disorder  1  0/475 (0.00%)  1/473 (0.21%) 
Bronchostenosis  1  1/475 (0.21%)  0/473 (0.00%) 
Pulmonary embolism  1  11/475 (2.32%)  10/473 (2.11%) 
Pulmonary haemorrhage  1  4/475 (0.84%)  3/473 (0.63%) 
Tachypnoea  1  1/475 (0.21%)  0/473 (0.00%) 
Acute respiratory failure  1  0/475 (0.00%)  3/473 (0.63%) 
Bronchospasm  1  1/475 (0.21%)  0/473 (0.00%) 
Haemoptysis  1  9/475 (1.89%)  10/473 (2.11%) 
Pneumothorax  1  4/475 (0.84%)  1/473 (0.21%) 
Pneumothorax spontaneous  1  1/475 (0.21%)  0/473 (0.00%) 
Atelectasis  1  1/475 (0.21%)  2/473 (0.42%) 
Bronchitis chronic  1  0/475 (0.00%)  1/473 (0.21%) 
Dyspnoea  1  17/475 (3.58%)  16/473 (3.38%) 
Interstitial lung disease  1  3/475 (0.63%)  0/473 (0.00%) 
Cough  1  0/475 (0.00%)  3/473 (0.63%) 
Hypoxia  1  2/475 (0.42%)  0/473 (0.00%) 
Lung disorder  1  1/475 (0.21%)  0/473 (0.00%) 
Pneumonitis  1  4/475 (0.84%)  4/473 (0.85%) 
Respiratory failure  1  6/475 (1.26%)  4/473 (0.85%) 
Acute respiratory distress syndrome  1  1/475 (0.21%)  0/473 (0.00%) 
Pleural effusion  1  2/475 (0.42%)  6/473 (1.27%) 
Pulmonary artery stenosis  1  1/475 (0.21%)  0/473 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis  1  1/475 (0.21%)  0/473 (0.00%) 
Swelling face  1  1/475 (0.21%)  0/473 (0.00%) 
Exfoliative rash  1  1/475 (0.21%)  0/473 (0.00%) 
Dermatitis acneiform  1  1/475 (0.21%)  0/473 (0.00%) 
Skin ulcer  1  0/475 (0.00%)  1/473 (0.21%) 
Erythema multiforme  1  1/475 (0.21%)  0/473 (0.00%) 
Perivascular dermatitis  1  1/475 (0.21%)  0/473 (0.00%) 
Pruritus  1  1/475 (0.21%)  0/473 (0.00%) 
Rash  1  6/475 (1.26%)  0/473 (0.00%) 
Eczema  1  2/475 (0.42%)  0/473 (0.00%) 
Erythema  1  1/475 (0.21%)  0/473 (0.00%) 
Vascular disorders     
Embolism venous  1  0/475 (0.00%)  1/473 (0.21%) 
Peripheral ischaemia  1  1/475 (0.21%)  0/473 (0.00%) 
Superior vena cava syndrome  1  1/475 (0.21%)  1/473 (0.21%) 
Hypertension  1  2/475 (0.42%)  0/473 (0.00%) 
Peripheral embolism  1  0/475 (0.00%)  1/473 (0.21%) 
Shock haemorrhagic  1  1/475 (0.21%)  0/473 (0.00%) 
Circulatory collapse  1  1/475 (0.21%)  0/473 (0.00%) 
Embolism  1  0/475 (0.00%)  1/473 (0.21%) 
Hypotension  1  2/475 (0.42%)  3/473 (0.63%) 
Vena cava thrombosis  1  1/475 (0.21%)  0/473 (0.00%) 
Orthostatic hypotension  1  0/475 (0.00%)  1/473 (0.21%) 
Superior vena cava occlusion  1  1/475 (0.21%)  0/473 (0.00%) 
Phlebitis superficial  1  0/475 (0.00%)  1/473 (0.21%) 
Thrombosis  1  1/475 (0.21%)  0/473 (0.00%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
10 MG/KG Ipilimumab + Paclitaxel/ Carbop Placebo + Paclitaxel/ Carboplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   437/475 (92.00%)   428/473 (90.49%) 
Blood and lymphatic system disorders     
Anaemia  1  171/475 (36.00%)  157/473 (33.19%) 
Leukopenia  1  44/475 (9.26%)  54/473 (11.42%) 
Thrombocytopenia  1  77/475 (16.21%)  70/473 (14.80%) 
Neutropenia  1  107/475 (22.53%)  102/473 (21.56%) 
Gastrointestinal disorders     
Vomiting  1  89/475 (18.74%)  68/473 (14.38%) 
Abdominal pain upper  1  24/475 (5.05%)  23/473 (4.86%) 
Constipation  1  117/475 (24.63%)  103/473 (21.78%) 
Diarrhoea  1  145/475 (30.53%)  89/473 (18.82%) 
Abdominal pain  1  25/475 (5.26%)  26/473 (5.50%) 
Nausea  1  152/475 (32.00%)  151/473 (31.92%) 
Stomatitis  1  27/475 (5.68%)  24/473 (5.07%) 
General disorders     
Oedema peripheral  1  25/475 (5.26%)  31/473 (6.55%) 
Asthenia  1  80/475 (16.84%)  55/473 (11.63%) 
Chest pain  1  26/475 (5.47%)  45/473 (9.51%) 
Mucosal inflammation  1  10/475 (2.11%)  27/473 (5.71%) 
Pyrexia  1  91/475 (19.16%)  70/473 (14.80%) 
Fatigue  1  142/475 (29.89%)  140/473 (29.60%) 
Investigations     
Haemoglobin decreased  1  38/475 (8.00%)  30/473 (6.34%) 
White blood cell count decreased  1  25/475 (5.26%)  31/473 (6.55%) 
Aspartate aminotransferase increased  1  34/475 (7.16%)  20/473 (4.23%) 
Weight decreased  1  44/475 (9.26%)  27/473 (5.71%) 
Platelet count decreased  1  47/475 (9.89%)  32/473 (6.77%) 
Alanine aminotransferase increased  1  37/475 (7.79%)  26/473 (5.50%) 
Neutrophil count decreased  1  31/475 (6.53%)  31/473 (6.55%) 
Metabolism and nutrition disorders     
Decreased appetite  1  145/475 (30.53%)  116/473 (24.52%) 
Hypomagnesaemia  1  27/475 (5.68%)  15/473 (3.17%) 
Dehydration  1  24/475 (5.05%)  7/473 (1.48%) 
Hyponatraemia  1  37/475 (7.79%)  11/473 (2.33%) 
Hypokalaemia  1  51/475 (10.74%)  31/473 (6.55%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  66/475 (13.89%)  61/473 (12.90%) 
Bone pain  1  32/475 (6.74%)  26/473 (5.50%) 
Musculoskeletal pain  1  20/475 (4.21%)  24/473 (5.07%) 
Arthralgia  1  77/475 (16.21%)  58/473 (12.26%) 
Back pain  1  34/475 (7.16%)  38/473 (8.03%) 
Pain in extremity  1  43/475 (9.05%)  43/473 (9.09%) 
Nervous system disorders     
Peripheral sensory neuropathy  1  71/475 (14.95%)  98/473 (20.72%) 
Paraesthesia  1  20/475 (4.21%)  28/473 (5.92%) 
Headache  1  30/475 (6.32%)  22/473 (4.65%) 
Neuropathy peripheral  1  61/475 (12.84%)  57/473 (12.05%) 
Dizziness  1  35/475 (7.37%)  58/473 (12.26%) 
Psychiatric disorders     
Insomnia  1  61/475 (12.84%)  49/473 (10.36%) 
Respiratory, thoracic and mediastinal disorders     
Haemoptysis  1  34/475 (7.16%)  41/473 (8.67%) 
Dyspnoea  1  94/475 (19.79%)  97/473 (20.51%) 
Cough  1  82/475 (17.26%)  85/473 (17.97%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  181/475 (38.11%)  175/473 (37.00%) 
Pruritus  1  78/475 (16.42%)  27/473 (5.71%) 
Rash  1  87/475 (18.32%)  45/473 (9.51%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01285609     History of Changes
Other Study ID Numbers: CA184-104
2009-017396-19 ( EudraCT Number )
First Submitted: January 24, 2011
First Posted: January 28, 2011
Results First Submitted: May 16, 2016
Results First Posted: June 23, 2016
Last Update Posted: September 19, 2018