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NCT01177735 · ADVERSE EVENTS

Adverse events

Pomalidomide in Gene Expression Profiling (GEP)-Defined High-risk Multiple Myeloma · Source last updated 2021-04-22

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pomalidomide

Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.

6 / 7171 / 71Not reported / Not reported

Group identifiers: EG000: Pomalidomide

Serious adverse events

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

  1. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      71
      num Events
      2
    term
    Acute renal failure
  2. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Hospitalization for sinus infection
  3. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      71
      num Events
      3
    term
    Hospialization for progressive disease, sepsis and pneumonia
  4. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Hospitalization for removal of port
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Hospitalization for fever
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      71
      num Events
      2
    term
    RSV Pneumonia
  7. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Fever neutropenia dehydration
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      71
      num Events
      4
    term
    Hospitalization for neutropenic fever
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Hospitalization due to acute liver failure hepatitis B flare
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Hospitalization for pneumonia
  11. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      71
      num Events
      2
    term
    Atrial Fibrilation
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Pancytopenia

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
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      71
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      71
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      71
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      71
    term
    Blood/Bone Marrow
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      71
    term
    Cardiac Arrhythmia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      71
    term
    Cardiac General
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      71
    term
    Constitutional Symptoms
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      71
    term
    Dermatology / Skin
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      71
    term
    Gastrointestinal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      71
    term
    Hemorrhage / Bleeding
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      71
    term
    Hepatobiliary / Pancreas
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      71
    term
    Infection
Complete source fields
event Groups
  1. description
    Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
    id
    EG000
    other Num Affected
    71
    other Num At Risk
    71
    serious Num Affected
    6
    serious Num At Risk
    71
    title
    Pomalidomide
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      71
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      71
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      71
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      71
    term
    Blood/Bone Marrow
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      71
    term
    Cardiac Arrhythmia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      71
    term
    Cardiac General
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      71
    term
    Constitutional Symptoms
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      71
    term
    Dermatology / Skin
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      71
    term
    Gastrointestinal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      71
    term
    Hemorrhage / Bleeding
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      71
    term
    Hepatobiliary / Pancreas
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      71
    term
    Infection
serious Events
  1. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      71
      num Events
      2
    term
    Acute renal failure
  2. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Hospitalization for sinus infection
  3. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      71
      num Events
      3
    term
    Hospialization for progressive disease, sepsis and pneumonia
  4. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Hospitalization for removal of port
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Hospitalization for fever
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      71
      num Events
      2
    term
    RSV Pneumonia
  7. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Fever neutropenia dehydration
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      71
      num Events
      4
    term
    Hospitalization for neutropenic fever
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Hospitalization due to acute liver failure hepatitis B flare
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Hospitalization for pneumonia
  11. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      71
      num Events
      2
    term
    Atrial Fibrilation
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Pancytopenia

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