Trial Outcomes & Findings for Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer (NCT NCT02546986)
NCT ID: NCT02546986
Last Updated: 2025-08-08
Results Overview
PFS was defined according to the FDA Methodology as the time in months from the date of randomization to the date of disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (documented by computed tomography scan, not including symptomatic deterioration) or death for (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Those who did not have disease progression or had not died as of the data cutoff date were censored at the time of the last radiologic assessment where the participant was documented to be progression-free prior to the data cutoff date. Progressive disease includes at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
From Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 12 April 2017; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the PBZ + Placebo arm
Results posted on
2025-08-08
Participant Flow
This study was a multicenter study with 25 sites from the United States, France. Germany, Italy, and Spain.
Qualified participants were randomized in a 1:1 ratio to one of the two treatment groups. Randomization was stratified by cancer histology (non-squamous versus squamous).
Participant milestones
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Treatment Period
STARTED
|
51
|
49
|
|
Treatment Period
COMPLETED
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
51
|
49
|
|
Survival Follow-Up Phase
STARTED
|
36
|
35
|
|
Survival Follow-Up Phase
COMPLETED
|
0
|
0
|
|
Survival Follow-Up Phase
NOT COMPLETED
|
36
|
35
|
Reasons for withdrawal
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Treatment Period
Progressive Disease
|
20
|
22
|
|
Treatment Period
Adverse Event
|
14
|
6
|
|
Treatment Period
Symptomatic Deterioration
|
4
|
3
|
|
Treatment Period
Death
|
3
|
4
|
|
Treatment Period
Physician Decision
|
1
|
2
|
|
Treatment Period
Protocol Violation
|
1
|
0
|
|
Treatment Period
Withdrawal by Subject
|
1
|
1
|
|
Treatment Period
Non-compliance with Study Drug
|
0
|
1
|
|
Treatment Period
Study Terminated by Sponsor
|
0
|
1
|
|
Treatment Period
Miscellaneous
|
7
|
9
|
|
Survival Follow-Up Phase
Missing Status
|
3
|
5
|
|
Survival Follow-Up Phase
Death
|
18
|
12
|
|
Survival Follow-Up Phase
Alive
|
13
|
16
|
|
Survival Follow-Up Phase
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
The Intent-to-Treat population includes all participants who were randomized.
Baseline characteristics by cohort
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
n=51 Participants
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
n=49 Participants
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 Years
STANDARD_DEVIATION 10.03 • n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
64.9 Years
STANDARD_DEVIATION 9.89 • n=7 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
63.9 Years
STANDARD_DEVIATION 9.96 • n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
18 Participants
n=7 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
43 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
31 Participants
n=7 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
57 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
0 Participants
n=7 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
0 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
1 Participants
n=7 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
1 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
0 Participants
n=7 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
0 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
2 Participants
n=7 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
5 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
45 Participants
n=7 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
87 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
0 Participants
n=7 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
0 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
1 Participants
n=7 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
7 Participants
n=5 Participants • The Intent-to-Treat population includes all participants who were randomized.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 = Fully Active
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 = Restrictive but ambulatory
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 = ambulatory but unable to work
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3 = limited self-care
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Stage at Primary Diagnosis
Stage I
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Stage at Primary Diagnosis
Stage II
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Stage at Primary Diagnosis
Stage IIIA
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Stage at Primary Diagnosis
Stage IIIB
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Stage at Primary Diagnosis
Stage IV
|
38 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Histology
Squamous cell carcinoma
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Histology
Other
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Number of Metastatic Sites
|
3.1 Metastatic sites
STANDARD_DEVIATION 1.33 • n=5 Participants
|
2.8 Metastatic sites
STANDARD_DEVIATION 1.25 • n=7 Participants
|
3.0 Metastatic sites
STANDARD_DEVIATION 1.29 • n=5 Participants
|
|
Number of Participants Randomized by Strata
Squamous Cell Carcinoma
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Number of Participants Randomized by Strata
Non-Squamous Cell Carcinoma
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 12 April 2017; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the PBZ + Placebo armPopulation: The Intent-to-Treat population includes all participants who were randomized, regardless of whether they received assigned treatment or not.
PFS was defined according to the FDA Methodology as the time in months from the date of randomization to the date of disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (documented by computed tomography scan, not including symptomatic deterioration) or death for (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Those who did not have disease progression or had not died as of the data cutoff date were censored at the time of the last radiologic assessment where the participant was documented to be progression-free prior to the data cutoff date. Progressive disease includes at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.
Outcome measures
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
n=51 Participants
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
n=49 Participants
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on Food and Drug Administration (FDA) Methodology
|
2.9 months
Interval 1.8 to 4.0
|
4.0 months
Interval 1.5 to 8.0
|
PRIMARY outcome
Timeframe: From Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 12 April 2017; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the PBZ + Placebo armPopulation: The Intent-to-Treat population includes all participants who were randomized, regardless of whether they received assigned treatment or not.
Progression-free survival was defined according to EMA methodology as the time from the date of randomization to the date of disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (documented by computed tomography scan result, not including symptomatic deterioration) or death for (any cause) on or prior to the data cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the last known time that the participant was progression free. However, occasional missing observations or initiation of subsequent new anticancer therapy would not result in censoring for this analysis. Progressive disease is at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.
Outcome measures
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
n=51 Participants
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
n=49 Participants
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on European Medicines Agency Methodology
|
2.9 months
Interval 1.8 to 4.0
|
4.0 months
Interval 1.5 to 7.0
|
SECONDARY outcome
Timeframe: Response was assessed every 6 weeks for the first 24 weeks, then every 9 weeks until DP, new anticancer initiation, or withdrawal of consent; maximum treatment exposure for CC-486 + PBZ was 61 weeks and 60 weeks for PBO +PBZPopulation: The Intent-to-Treat population includes all participants who were randomized, regardless of whether they received assigned treatment or not.
Disease control rate was defined as the percentage of participants who had confirmed stable disease, complete or partial response during the course of study, according to RECIST v1.1, as evaluated by the investigator. RECIST v 1.1 is defined as: * Complete response: disappearance of all target lesions * Partial response: at least a 30% decrease in the sum of diameters of target lesions from baseline * Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease * Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion. When stable disease was believed to be the best response, it must have met the minimum duration of 10 weeks from randomization.
Outcome measures
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
n=51 Participants
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
n=49 Participants
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for a Minimum Duration of 18 Weeks Compared to Baseline
|
25.5 Percentage of Participants
Interval 15.8 to 37.4
|
38.8 Percentage of Participants
Interval 27.1 to 51.5
|
SECONDARY outcome
Timeframe: From Day 1 of treatment up to the clinical cut-off date of 12 April 2017, whichever occurred earlier; median follow-up time for OS was 11.3 months in the CC-486 + PBZ arm and 12.2 months in the PBZ + Placebo armPopulation: The Intent-to-Treat population includes all participants who were randomized.
Overall survival (OS) was defined as the time in months between day 1 of treatment and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.
Outcome measures
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
n=51 Participants
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
n=49 Participants
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Kaplan Meier Estimate of Overall Survival
|
11.9 months
Interval 7.2 to
The upper limit was not estimable as participants were still alive at the time of the clinical cut-off date
|
NA months
Interval 11.0 to
Not estimable as participants were still alive at the time of the clinical cut-off date.
|
SECONDARY outcome
Timeframe: Response was assessed every 6 weeks for the first 24 weeks, then every 9 weeks until DP, new anticancer initiation, or withdrawal of consent; maximum treatment exposure for CC-486 + PBZ was 61 weeks and 60 weeks for PBZ + PBOPopulation: The Intent-to-Treat population includes all participants who were randomized.
The best overall response is defined as the percentage of participants who achieved an objective confirmed complete response or partial response according to RECIST v1.1, compared with baseline where baseline was the last computed tomography (CT) scan obtained prior to or on day 1 of study treatment. RECIST v1.1 is defined as: * Complete response: disappearance of all target lesions * Partial response: at least a 30% decrease in the sum of diameters of target lesions from baseline * Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease * Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.
Outcome measures
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
n=51 Participants
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
n=49 Participants
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response
|
19.6 Percentage of Participants
Interval 11.0 to 31.0
|
14.3 Percentage of Participants
Interval 6.9 to 25.2
|
SECONDARY outcome
Timeframe: From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the PBZ + Placebo armPopulation: The safety population includes all participants who were randomized and received at least one dose of study drug.
Treatment-emergent adverse events (TEAEs) were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product (IP) through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and based on the following scale: Grade 1 = Mild; Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.
Outcome measures
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
n=51 Participants
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
n=49 Participants
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
Any TEAE
|
51 Participants
|
49 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Any TEAE Related to Study Drug
|
47 Participants
|
37 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Any Serious TEAE
|
31 Participants
|
27 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Any Serious TEAE Related to Study Drug
|
12 Participants
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Any CTC Grade 3/4 TEAE
|
40 Participants
|
27 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Any CTC Grade 3/4 TEAE Related to Study Drug
|
25 Participants
|
10 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Any TEAE Leading to Death
|
6 Participants
|
9 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Any TEAE Leading to Dose Reduction
|
10 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Any TEAE Leading to Dose Interruption
|
32 Participants
|
20 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Any TEAE Leading to Drug Discontinuation
|
20 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Pharmacokinetic (PK) blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1Population: The PK population includes participants with evaluable CC-486 plasma PK profile.
Area under the plasma concentration-time curve from Time 0 extrapolated to infinity, calculated as \[AUCt + Ct/ λz\]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If AUC % extrap is ≥25%, AUCi inf was not reported.
Outcome measures
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
n=15 Participants
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of CC-486
Cycle 1 Day 1
|
156.0 ng*h/mL
Geometric Coefficient of Variation 82.64
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of CC-486
Cycle 2 Day 1
|
212.7 ng*h/mL
Geometric Coefficient of Variation 78.06
|
—
|
SECONDARY outcome
Timeframe: PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1Population: The PK population includes participants with evaluable CC-486 plasma PK profile.
Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.
Outcome measures
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
n=15 Participants
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of CC-486
Cycle 1 Day 1
|
152.3 ng·h/mL
Geometric Coefficient of Variation 85.67
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of CC-486
Cycle 2 Day 1
|
196.6 ng·h/mL
Geometric Coefficient of Variation 88.63
|
—
|
SECONDARY outcome
Timeframe: PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1Population: The PK population includes participants with evaluable CC-486 plasma PK profile.
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.
Outcome measures
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
n=15 Participants
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of CC-486
Cycle 1 Day 1
|
94.7 ng/mL
Geometric Coefficient of Variation 69.49
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of CC-486
Cycle 2 Day 1
|
110.0 ng/mL
Geometric Coefficient of Variation 73.46
|
—
|
SECONDARY outcome
Timeframe: PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1Population: The PK population includes participants with evaluable CC-486 plasma PK profile.
Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data.
Outcome measures
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
n=15 Participants
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of CC-486
Cycle 1 Day 1
|
1.5 hours
Interval 0.5 to 3.0
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of CC-486
Cycle 2 Day 1
|
1.5 hours
Interval 0.5 to 3.5
|
—
|
SECONDARY outcome
Timeframe: PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1Population: The PK population includes participants with evaluable CC-486 plasma PK profile.
Terminal phase half-life in plasma, calculated as \[(ln 2)/λz\]. t1/2 was only be calculated when a reliable estimate for λz could be obtained.
Outcome measures
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
n=15 Participants
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Terminal Phase of Half-life (T1/2) of CC-486
Cycle 1 Day 1
|
0.7 hours
Geometric Coefficient of Variation 30.22
|
—
|
|
Terminal Phase of Half-life (T1/2) of CC-486
Cycle 2 Day 1
|
0.9 hours
Geometric Coefficient of Variation 91.72
|
—
|
SECONDARY outcome
Timeframe: PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1Population: The PK population includes participants with evaluable CC-486 plasma PK profile.
Apparent total plasma clearance (CL/F) of CC-486 was calculated as Dose/AUC∞
Outcome measures
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
n=15 Participants
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Apparent Total Plasma Clearance (CL/F) of CC-486
Cycle 1 Day 1
|
1922.7 Liters/hour
Geometric Coefficient of Variation 82.64
|
—
|
|
Apparent Total Plasma Clearance (CL/F) of CC-486
Cycle 2 Day 1
|
1410.4 Liters/hour
Geometric Coefficient of Variation 78.06
|
—
|
SECONDARY outcome
Timeframe: PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1Population: The PK population includes participants with evaluable CC-486 plasma PK profile.
Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz
Outcome measures
| Measure |
CC-486 and Pembrolizumab (CC-486 + PBZ)
n=15 Participants
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Placebo and Pembrolizumab (PBO + PBZ)
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Apparent Volume of Distribution (Vd/F) of CC-486
Cycle 1 Day 1
|
1836.2 Liters
Geometric Coefficient of Variation 100.80
|
—
|
|
Apparent Volume of Distribution (Vd/F) of CC-486
Cycle 2 Day 1
|
1777.1 Liters
Geometric Coefficient of Variation 163.62
|
—
|
Adverse Events
CC-486+Pembrolizumab
Serious events: 31 serious events
Other events: 51 other events
Deaths: 23 deaths
Pembrolizumab+Placebo
Serious events: 27 serious events
Other events: 48 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
CC-486+Pembrolizumab
n=51 participants at risk
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Pembrolizumab+Placebo
n=49 participants at risk
Participants received placebo tablets orally on days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on day 1 of a 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.9%
2/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Cardiac disorders
Pericardial effusion
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Eye disorders
Diplopia
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Gastrointestinal disorders
Colitis
|
3.9%
2/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Gastrointestinal disorders
Nausea
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
General disorders
Asthenia
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
General disorders
Death
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
General disorders
Fatigue
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
General disorders
General physical health deterioration
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
General disorders
Pyrexia
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
6.1%
3/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Hepatobiliary disorders
Hepatic failure
|
3.9%
2/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Hepatobiliary disorders
Hepatitis toxic
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Infections and infestations
Bronchitis
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Infections and infestations
Device related infection
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Infections and infestations
Intervertebral discitis
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Infections and infestations
Osteomyelitis
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Infections and infestations
Pneumonia
|
3.9%
2/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
8.2%
4/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Infections and infestations
Respiratory tract infection
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Infections and infestations
Subcutaneous abscess
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Injury, poisoning and procedural complications
Drug administration error
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Nervous system disorders
Ataxia
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Nervous system disorders
Epilepsy
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Nervous system disorders
Ischaemic stroke
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Nervous system disorders
Somnolence
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Psychiatric disorders
Irritability
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Psychiatric disorders
Mental status changes
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
6.1%
3/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
6.1%
3/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
6.1%
3/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
Other adverse events
| Measure |
CC-486+Pembrolizumab
n=51 participants at risk
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
Pembrolizumab+Placebo
n=49 participants at risk
Participants received placebo tablets orally on days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on day 1 of a 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.5%
12/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
16.3%
8/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.7%
8/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Cardiac disorders
Tachycardia
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Endocrine disorders
Hyperthyroidism
|
3.9%
2/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
6.1%
3/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Endocrine disorders
Hypothyroidism
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
6.1%
3/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Gastrointestinal disorders
Abdominal pain
|
15.7%
8/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
8.2%
4/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.8%
5/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
4.1%
2/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Gastrointestinal disorders
Constipation
|
35.3%
18/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
18.4%
9/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Gastrointestinal disorders
Diarrhoea
|
39.2%
20/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
24.5%
12/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Gastrointestinal disorders
Dyspepsia
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
4.1%
2/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Gastrointestinal disorders
Nausea
|
72.5%
37/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
26.5%
13/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Gastrointestinal disorders
Stomatitis
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Gastrointestinal disorders
Vomiting
|
62.7%
32/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
18.4%
9/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
General disorders
Asthenia
|
43.1%
22/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
34.7%
17/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
General disorders
Fatigue
|
19.6%
10/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
6.1%
3/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
General disorders
General physical health deterioration
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
General disorders
Non-cardiac chest pain
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
General disorders
Oedema peripheral
|
9.8%
5/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
16.3%
8/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
General disorders
Pyrexia
|
35.3%
18/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
26.5%
13/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Infections and infestations
Bronchitis
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
10.2%
5/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Infections and infestations
Oral candidiasis
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Infections and infestations
Upper respiratory tract infection
|
9.8%
5/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
4.1%
2/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Investigations
Alanine aminotransferase increased
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
4.1%
2/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Investigations
Aspartate aminotransferase increased
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
6.1%
3/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Investigations
Blood alkaline phosphatase increased
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Investigations
Weight decreased
|
21.6%
11/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
6.1%
3/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.3%
19/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
40.8%
20/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
6.1%
3/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
4.1%
2/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.8%
6/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.8%
6/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
0.00%
0/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
6.1%
3/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.6%
9/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
6.1%
3/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
8.2%
4/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
8.2%
4/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
10.2%
5/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
10.2%
5/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
6.1%
3/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
10.2%
5/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
16.3%
8/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Nervous system disorders
Dizziness
|
9.8%
5/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
8.2%
4/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Nervous system disorders
Headache
|
9.8%
5/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
8.2%
4/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Nervous system disorders
Paraesthesia
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
8.2%
4/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Nervous system disorders
Somnolence
|
3.9%
2/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
6.1%
3/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Psychiatric disorders
Anxiety
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
4.1%
2/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Psychiatric disorders
Insomnia
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
4.1%
2/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.5%
12/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
34.7%
17/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.6%
10/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
22.4%
11/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
4.1%
2/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.9%
2/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
6.1%
3/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
3/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
8.2%
4/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
4.1%
2/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Vascular disorders
Hypertension
|
11.8%
6/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
|
Vascular disorders
Hypotension
|
7.8%
4/51 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
2.0%
1/49 • From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the for the PBZ + PBO arm.
All-cause mortality timeframe includes deaths from day 1 of study treatment to final data cut-off date of 12 April 2017
|
Additional Information
Anne McClain, Senior Manager, Clinical Trial Disclosure
Celgene Corporation
Phone: 888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year from study completion. Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
- Publication restrictions are in place
Restriction type: OTHER