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NCT00558896 · ADVERSE EVENTS

Adverse events

CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis · Source last updated 2018-04-18

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
0%

One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Relapsed Myeloma (<4 Prior Regimens): Low Dose

Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

22 / 6060 / 60Not reported / Not reported
Lenalidomide Refractory Myeloma: Low Dose

Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

11 / 3434 / 34Not reported / Not reported
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose

Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

15 / 3534 / 35Not reported / Not reported
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose

Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

11 / 3535 / 35Not reported / Not reported
Relapsed Myeloma (< 4 Prior Regimens): High Dose

Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

21 / 6060 / 60Not reported / Not reported
Relapsed/Refractory Myeloma: High Dose

Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

32 / 119119 / 119Not reported / Not reported
Relapsed Amyloidosis: Low Dose

Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

18 / 3332 / 33Not reported / Not reported

Group identifiers: EG000: Relapsed Myeloma (<4 Prior Regimens): Low Dose · EG001: Lenalidomide Refractory Myeloma: Low Dose · EG002: Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose · EG003: Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose · EG004: Relapsed Myeloma (< 4 Prior Regimens): High Dose · EG005: Relapsed/Refractory Myeloma: High Dose · EG006: Relapsed Amyloidosis: Low Dose

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 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      60
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      35
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      60
      num Events
      2
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      119
      num Events
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Hemoglobin decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      35
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      119
      num Events
      2
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      33
      num Events
      2
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      60
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Cardiac disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      60
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Cardiac valve disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Left ventricular dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Left ventricular failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      60
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Restrictive cardiomyopathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Cataract

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 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      33
      num Events
      2
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      60
      num Events
      707
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      34
      num Events
      241
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      35
      num Events
      239
    4. group Id
      EG003
      num Affected
      34
      num At Risk
      35
      num Events
      134
    5. group Id
      EG004
      num Affected
      55
      num At Risk
      60
      num Events
      348
    6. group Id
      EG005
      num Affected
      115
      num At Risk
      119
      num Events
      418
    7. group Id
      EG006
      num Affected
      31
      num At Risk
      33
      num Events
      277
    term
    Hemoglobin decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      35
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      60
      num Events
      11
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      119
      num Events
      2
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      33
      num Events
      5
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      60
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      33
      num Events
      3
    term
    Atrial tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      119
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Cardiac disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      60
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Cardiac pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Myocardial ischemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      60
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      119
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Premature ventricular contractions
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Restrictive cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      60
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Sinus bradycardia
Complete source fields
description
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
event Groups
  1. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    EG000
    other Num Affected
    60
    other Num At Risk
    60
    serious Num Affected
    22
    serious Num At Risk
    60
    title
    Relapsed Myeloma (<4 Prior Regimens): Low Dose
  2. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    EG001
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    11
    serious Num At Risk
    34
    title
    Lenalidomide Refractory Myeloma: Low Dose
  3. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    EG002
    other Num Affected
    34
    other Num At Risk
    35
    serious Num Affected
    15
    serious Num At Risk
    35
    title
    Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose
  4. description
    Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    EG003
    other Num Affected
    35
    other Num At Risk
    35
    serious Num Affected
    11
    serious Num At Risk
    35
    title
    Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose
  5. description
    Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    EG004
    other Num Affected
    60
    other Num At Risk
    60
    serious Num Affected
    21
    serious Num At Risk
    60
    title
    Relapsed Myeloma (< 4 Prior Regimens): High Dose
  6. description
    Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    EG005
    other Num Affected
    119
    other Num At Risk
    119
    serious Num Affected
    32
    serious Num At Risk
    119
    title
    Relapsed/Refractory Myeloma: High Dose
  7. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    EG006
    other Num Affected
    32
    other Num At Risk
    33
    serious Num Affected
    18
    serious Num At Risk
    33
    title
    Relapsed Amyloidosis: Low Dose
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      33
      num Events
      2
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      60
      num Events
      707
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      34
      num Events
      241
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      35
      num Events
      239
    4. group Id
      EG003
      num Affected
      34
      num At Risk
      35
      num Events
      134
    5. group Id
      EG004
      num Affected
      55
      num At Risk
      60
      num Events
      348
    6. group Id
      EG005
      num Affected
      115
      num At Risk
      119
      num Events
      418
    7. group Id
      EG006
      num Affected
      31
      num At Risk
      33
      num Events
      277
    term
    Hemoglobin decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      35
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      60
      num Events
      11
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      119
      num Events
      2
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      33
      num Events
      5
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      60
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      33
      num Events
      3
    term
    Atrial tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      119
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Cardiac disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      60
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Cardiac pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Myocardial ischemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      60
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      119
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Premature ventricular contractions
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Restrictive cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      60
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Sinus bradycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      60
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      35
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      60
      num Events
      2
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      119
      num Events
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Hemoglobin decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      35
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      119
      num Events
      2
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      33
      num Events
      2
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      60
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Cardiac disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      60
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Cardiac valve disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Left ventricular dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Left ventricular failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      60
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Restrictive cardiomyopathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      60
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      119
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Cataract

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Preserved source evidence · Not medical advice