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NCT02281084 · ADVERSE EVENTS

Adverse events

Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes · Source last updated 2024-10-04

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
SAE and Non-SAEs were collected from first dose until 28 days after the last dose of CC-486 (90 days after the last dose of durvalumab) or the last follow up visit, whichever date is later (Up to 91 months). Participants were assessed for all-cause mortality from first dose till death due to any cause (Up to 91 months).
Other-event reporting threshold
5%

The number at Risk for All-Cause Mortality represents all enrolled participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents safety population that include all enrolled subjects who have received at least 1 dose of IP and had at least 1 post-dose safety assessment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Stable Disease (SD) Cohort: Oral Azacitidine

Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

25 / 3232 / 3222 / 32
Progressive Disease (PD) Cohort: Oral Azacitidine

Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

15 / 2222 / 2218 / 22
Stable Disease Cohort: Oral Azacitidine and Durvalumab

Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

4 / 66 / 63 / 6
Progressive Disease Cohort: Oral Azacitidine and Durvalumab

Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

5 / 55 / 55 / 5

Group identifiers: EG000: Stable Disease (SD) Cohort: Oral Azacitidine · EG001: Progressive Disease (PD) Cohort: Oral Azacitidine · EG002: Stable Disease Cohort: Oral Azacitidine and Durvalumab · EG003: Progressive Disease Cohort: Oral Azacitidine and Durvalumab

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
    26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Hyperleukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Haematemesis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Intestinal ischaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Rectal haemorrhage

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
    26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      5
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Splenomegaly
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      5
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    term
    Pericardial effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    term
    Sinus bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    term
    Tricuspid valve disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Ear pain
Complete source fields
description
The number at Risk for All-Cause Mortality represents all enrolled participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents safety population that include all enrolled subjects who have received at least 1 dose of IP and had at least 1 post-dose safety assessment.
event Groups
  1. deaths Num Affected
    22
    deaths Num At Risk
    32
    description
    Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    EG000
    other Num Affected
    32
    other Num At Risk
    32
    serious Num Affected
    25
    serious Num At Risk
    32
    title
    Stable Disease (SD) Cohort: Oral Azacitidine
  2. deaths Num Affected
    18
    deaths Num At Risk
    22
    description
    Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    EG001
    other Num Affected
    22
    other Num At Risk
    22
    serious Num Affected
    15
    serious Num At Risk
    22
    title
    Progressive Disease (PD) Cohort: Oral Azacitidine
  3. deaths Num Affected
    3
    deaths Num At Risk
    6
    description
    Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Stable Disease Cohort: Oral Azacitidine and Durvalumab
  4. deaths Num Affected
    5
    deaths Num At Risk
    5
    description
    Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    EG003
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    5
    serious Num At Risk
    5
    title
    Progressive Disease Cohort: Oral Azacitidine and Durvalumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      5
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Splenomegaly
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      5
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    term
    Pericardial effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    term
    Sinus bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    term
    Tricuspid valve disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Ear pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Hyperleukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Haematemesis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Intestinal ischaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    term
    Rectal haemorrhage
time Frame
SAE and Non-SAEs were collected from first dose until 28 days after the last dose of CC-486 (90 days after the last dose of durvalumab) or the last follow up visit, whichever date is later (Up to 91 months). Participants were assessed for all-cause mortality from first dose till death due to any cause (Up to 91 months).

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Preserved source evidence · Not medical advice