NCT02546986 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events
Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer · Source last updated 2026-07-22
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 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 arm
What was measured
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.
Analysis population: The safety population includes all participants who were randomized and received at least one dose of study drug.
Groups in this outcome
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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 51 |
|---|
| Placebo and Pembrolizumab (PBO + PBZ) | 49 |
|---|
Reported measurements
Any TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 51 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo and Pembrolizumab (PBO + PBZ) | 49 | Not reported | Not reported | Not reported | Not reported |
|---|
Any TEAE Related to Study Drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo and Pembrolizumab (PBO + PBZ) | 37 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Serious TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo and Pembrolizumab (PBO + PBZ) | 27 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Serious TEAE Related to Study Drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo and Pembrolizumab (PBO + PBZ) | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Any CTC Grade 3/4 TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 40 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo and Pembrolizumab (PBO + PBZ) | 27 | Not reported | Not reported | Not reported | Not reported |
|---|
Any CTC Grade 3/4 TEAE Related to Study Drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo and Pembrolizumab (PBO + PBZ) | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Any TEAE Leading to Death
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo and Pembrolizumab (PBO + PBZ) | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Any TEAE Leading to Dose Reduction
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo and Pembrolizumab (PBO + PBZ) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Any TEAE Leading to Dose Interruption
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 32 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo and Pembrolizumab (PBO + PBZ) | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
Any TEAE Leading to Drug Discontinuation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo and Pembrolizumab (PBO + PBZ) | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 49
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 47
- group Id
- OG001
- value
- 37
- title
- Any TEAE Related to Study Drug
- categories
- measurements
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 27
- title
- Any Serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 6
- title
- Any Serious TEAE Related to Study Drug
- categories
- measurements
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 27
- title
- Any CTC Grade 3/4 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 10
- title
- Any CTC Grade 3/4 TEAE Related to Study Drug
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 9
- title
- Any TEAE Leading to Death
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 1
- title
- Any TEAE Leading to Dose Reduction
- categories
- measurements
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 20
- title
- Any TEAE Leading to Dose Interruption
- categories
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 8
- title
- Any TEAE Leading to Drug Discontinuation
- denoms
- counts
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 49
- units
- Participants
- description
- 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.
- groups
- description
- 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.
- id
- OG000
- title
- CC-486 and Pembrolizumab (CC-486 + PBZ)
- description
- 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.
- id
- OG001
- title
- Placebo and Pembrolizumab (PBO + PBZ)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety population includes all participants who were randomized and received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- 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 arm
- title
- Number of Participants With Treatment Emergent Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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