Trial Outcomes & Findings for Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Non-Squamous Non-Small Cell Lung Cancer (NCT NCT01471197)
NCT ID: NCT01471197
Last Updated: 2014-05-12
Results Overview
Overall survival (OS) was defined as the time from the date of randomization until the date of death. For those participants who did not die by the time the study was terminated and last patient, last visit occurred, OS was censored (+) on the last date the participant was known to be alive. OS is presented below in increasing monthly categories of survival. OS analysis was to be performed when a total of approximately 132 deaths were observed but due to the early termination of the study, statistical analyses were not performed.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started
Results posted on
2014-05-12
Participant Flow
Study started July 2012 and completed February 2013. After 9 participants enrolled, the study was terminated for administrative reasons unrelated to adverse events (AEs) or expectation of efficacy associated with either ipilimumab or pemetrexed.
9 participants enrolled; 8 participants randomized; 1 participant not randomized due to disease progression and death.
Participant milestones
| Measure |
Ipilimumab 10 mg/kg
Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
|
Pemetrexed 500 mg/m^2
Pemetrexed: IV solution, IV, 500 milligram per meter squared (mg/m\^2), Once every 3 weeks during Treatment Phase, 10 minute infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Ipilimumab 10 mg/kg
Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
|
Pemetrexed 500 mg/m^2
Pemetrexed: IV solution, IV, 500 milligram per meter squared (mg/m\^2), Once every 3 weeks during Treatment Phase, 10 minute infusion.
|
|---|---|---|
|
Overall Study
Disease Progression
|
4
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Study Drug Toxicity
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Non-Squamous Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Ipilimumab 10 mg/kg
n=6 Participants
Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
|
Pemetrexed 500 mg/m^2
n=2 Participants
Pemetrexed: IV solution, IV, 500 mg/m\^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 8.85 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 1.41 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 7.54 • n=5 Participants
|
|
Age, Customized
Less than (<) 65 years
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Age, Customized
Greater than, equal to (>=) 65 years
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
ECOG PS 0
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
ECOG PS 1
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study startedPopulation: All participants who received at least one dose of either study drug.
Overall survival (OS) was defined as the time from the date of randomization until the date of death. For those participants who did not die by the time the study was terminated and last patient, last visit occurred, OS was censored (+) on the last date the participant was known to be alive. OS is presented below in increasing monthly categories of survival. OS analysis was to be performed when a total of approximately 132 deaths were observed but due to the early termination of the study, statistical analyses were not performed.
Outcome measures
| Measure |
Ipilimumab 10 mg/kg
n=6 Participants
Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
|
Pemetrexed 500 mg/m^2
n=2 Participants
Pemetrexed: IV solution, IV, 500 mg/m\^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
|
|---|---|---|
|
Overall Survival of Participants During the Study - All Treated Participants
Overall Survival 4.6 months+(censored)
|
1 participants
|
0 participants
|
|
Overall Survival of Participants During the Study - All Treated Participants
Overall Survival 0.9 months
|
1 participants
|
0 participants
|
|
Overall Survival of Participants During the Study - All Treated Participants
Overall Survival 1.8 months
|
1 participants
|
0 participants
|
|
Overall Survival of Participants During the Study - All Treated Participants
Overall Survival 3.9 months+(censored)
|
1 participants
|
0 participants
|
|
Overall Survival of Participants During the Study - All Treated Participants
Overall Survival 4.4 months+(censored)
|
2 participants
|
0 participants
|
|
Overall Survival of Participants During the Study - All Treated Participants
Overall Survival 5.4 months+(censored)
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started.Population: All participants who were randomized and treated with at least one dose of either study drug.
Due to study termination, the categories presented below are deaths occurring within 30 days of last dose and deaths occurring within 32 days of last dose. If the study had not been terminated early, the categories presented would have been 30 days and 90 days after last dose.
Outcome measures
| Measure |
Ipilimumab 10 mg/kg
n=6 Participants
Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
|
Pemetrexed 500 mg/m^2
n=2 Participants
Pemetrexed: IV solution, IV, 500 mg/m\^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
|
|---|---|---|
|
Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants
Death within 30 Days of Last Dose
|
1 participants
|
0 participants
|
|
Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants
Death within 32 Days of Last Dose
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to Date of last patient, last visit, approximately 7 months after study started.Population: All participants who received at least one dose of study drug.
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Participants were evaluated from Day 1 (first day of treatment with study drug) to the date of the last participant, last visit of the study.
Outcome measures
| Measure |
Ipilimumab 10 mg/kg
n=6 Participants
Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
|
Pemetrexed 500 mg/m^2
n=2 Participants
Pemetrexed: IV solution, IV, 500 mg/m\^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
|
|---|---|---|
|
Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants
Deaths
|
2 participants
|
0 participants
|
|
Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants
SAEs
|
5 participants
|
1 participants
|
|
Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants
AEs
|
6 participants
|
2 participants
|
|
Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants
AEs leading to discontinuation
|
1 participants
|
0 participants
|
Adverse Events
Ipilimumab 10 mg/kg
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Pemetrexed 500 mg/m^2
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ipilimumab 10 mg/kg
n=6 participants at risk
Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
|
Pemetrexed 500 mg/m^2
n=2 participants at risk
Pemetrexed: IV solution, IV, 500 mg/m\^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Arterial injury
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Infections and infestations
Bronchitis
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Cardiac disorders
Acute myocardial infarction
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Endocrine disorders
Hypopituitarism
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
50.0%
1/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
Other adverse events
| Measure |
Ipilimumab 10 mg/kg
n=6 participants at risk
Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
|
Pemetrexed 500 mg/m^2
n=2 participants at risk
Pemetrexed: IV solution, IV, 500 mg/m\^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Investigations
Lipase increased
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
50.0%
1/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Investigations
Blood glucose increased
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
50.0%
1/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Eye disorders
Conjunctivitis
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Gastrointestinal disorders
Eructation
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Injury, poisoning and procedural complications
Excoriation
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Investigations
Hepatic enzyme increased
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
General disorders
Asthenia
|
33.3%
2/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Renal and urinary disorders
Pollakiuria
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
50.0%
1/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
General disorders
Fatigue
|
33.3%
2/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Endocrine disorders
Hypopituitarism
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Investigations
Amylase increased
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
4/6 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
0.00%
0/2 • Day 1 to Last patient, last visit, approximately 7 months after start of study.
Study initiated 11 July 2012, was terminated and last patient, last visit was 25 Feb 2013
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER