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NCT02546986 · ADVERSE EVENTS

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 116 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 135 days post last dose (Up to approximately 18 months)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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.

33 / 5151 / 5132 / 51
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.

28 / 4948 / 4927 / 49

Group identifiers: EG000: CC-486 and Pembrolizumab (CC-486 + PBZ) · EG001: Placebo and Pembrolizumab (PBO + PBZ)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Pericardial effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Diplopia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Colitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Intestinal perforation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Death
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Fatigue

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      49
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      49
    term
    Hyperthyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      49
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      49
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      49
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      49
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
    term
    Gastrooesophageal reflux disease
Complete source fields
event Groups
  1. deaths Num Affected
    32
    deaths Num At Risk
    51
    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
    EG000
    other Num Affected
    51
    other Num At Risk
    51
    serious Num Affected
    33
    serious Num At Risk
    51
    title
    CC-486 and Pembrolizumab (CC-486 + PBZ)
  2. deaths Num Affected
    27
    deaths Num At Risk
    49
    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
    EG001
    other Num Affected
    48
    other Num At Risk
    49
    serious Num Affected
    28
    serious Num At Risk
    49
    title
    Placebo and Pembrolizumab (PBO + PBZ)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      49
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      49
    term
    Hyperthyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      49
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      49
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      49
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      49
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
    term
    Gastrooesophageal reflux disease
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Pericardial effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Diplopia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Colitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Intestinal perforation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Death
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Fatigue
time Frame
All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 116 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 135 days post last dose (Up to approximately 18 months)

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