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NCT00732641 · ADVERSE EVENTS

Adverse events

Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7) · Source last updated 2017-04-04

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
Not reported
Other-event reporting threshold
5%

Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Peginterferon α-2b

Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.

27 / 12394 / 123Not reported / Not reported
No Treatment

Participants were observed and received no treatment

21 / 12163 / 121Not reported / Not reported

Group identifiers: EG000: Peginterferon α-2b · EG001: No Treatment

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
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
      num Events
      1
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    THROMBOCYTOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    ACUTE MYOCARDIAL INFARCTION
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
      num Events
      1
    term
    ATRIAL FIBRILLATION
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    MYOCARDIAL INFARCTION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    PRIMARY HYPOTHYROIDISM
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    CATARACT
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    EYE PAIN
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      123
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
      num Events
      1
    term
    RETINAL DETACHMENT
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    RETINAL VEIN THROMBOSIS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      123
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
      num Events
      1
    term
    VISUAL ACUITY REDUCED

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
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      123
      num Events
      13
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      121
      num Events
      17
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      123
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      121
      num Events
      3
    term
    LEUKOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      123
      num Events
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
      num Events
      1
    term
    NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      123
      num Events
      20
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      121
      num Events
      3
    term
    THROMBOCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      123
      num Events
      20
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      121
      num Events
      3
    term
    DIARRHOEA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      123
      num Events
      26
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      121
      num Events
      3
    term
    ASTHENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      123
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
      num Events
      1
    term
    FATIGUE
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      123
      num Events
      36
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      121
      num Events
      11
    term
    INFLUENZA LIKE ILLNESS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      123
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      121
      num Events
      8
    term
    PAIN
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      123
      num Events
      51
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      121
      num Events
      28
    term
    PYREXIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      123
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    HEPATOTOXICITY
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      123
      num Events
      13
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      121
      num Events
      12
    term
    BRONCHITIS
Complete source fields
description
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
event Groups
  1. description
    Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
    id
    EG000
    other Num Affected
    94
    other Num At Risk
    123
    serious Num Affected
    27
    serious Num At Risk
    123
    title
    Peginterferon α-2b
  2. description
    Participants were observed and received no treatment
    id
    EG001
    other Num Affected
    63
    other Num At Risk
    121
    serious Num Affected
    21
    serious Num At Risk
    121
    title
    No Treatment
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      123
      num Events
      13
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      121
      num Events
      17
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      123
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      121
      num Events
      3
    term
    LEUKOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      123
      num Events
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
      num Events
      1
    term
    NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      123
      num Events
      20
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      121
      num Events
      3
    term
    THROMBOCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      123
      num Events
      20
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      121
      num Events
      3
    term
    DIARRHOEA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      123
      num Events
      26
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      121
      num Events
      3
    term
    ASTHENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      123
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
      num Events
      1
    term
    FATIGUE
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      123
      num Events
      36
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      121
      num Events
      11
    term
    INFLUENZA LIKE ILLNESS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      123
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      121
      num Events
      8
    term
    PAIN
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      123
      num Events
      51
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      121
      num Events
      28
    term
    PYREXIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      123
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    HEPATOTOXICITY
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      123
      num Events
      13
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      121
      num Events
      12
    term
    BRONCHITIS
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
      num Events
      1
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    THROMBOCYTOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    ACUTE MYOCARDIAL INFARCTION
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
      num Events
      1
    term
    ATRIAL FIBRILLATION
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    MYOCARDIAL INFARCTION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    PRIMARY HYPOTHYROIDISM
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    CATARACT
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    EYE PAIN
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      123
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
      num Events
      1
    term
    RETINAL DETACHMENT
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      121
      num Events
      0
    term
    RETINAL VEIN THROMBOSIS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      123
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      121
      num Events
      1
    term
    VISUAL ACUITY REDUCED

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