Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01570387 · ADVERSE EVENTS

Adverse events

A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis · Source last updated 2020-09-22

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
6 years
Other-event reporting threshold
5%

Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I - Cohort 1 (Pomalidomide 2mg)

Drug: Pomalidomide Cohort 1 = 2 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22

2 / 66 / 61 / 6
Phase I - Cohort 2 (Pomalidomide 3mg)

Drug: Pomalidomide Cohort 2 = 3 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22

0 / 33 / 30 / 3
Phase I - Cohort 3 (Pomalidomide 4mg)

Drug: Pomalidomide Cohort 3 = 4 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22

3 / 66 / 60 / 6
Phase II Expansion- Maximum Tolerated Dose

Drug: Pomalidomide Maximum Tolerated Dose = 4 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22

3 / 1212 / 121 / 12

Group identifiers: EG000: Phase I - Cohort 1 (Pomalidomide 2mg) · EG001: Phase I - Cohort 2 (Pomalidomide 3mg) · EG002: Phase I - Cohort 3 (Pomalidomide 4mg) · EG003: Phase II Expansion- Maximum Tolerated 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
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Upper respiratory infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    myocardial infarction

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
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      12
      num Events
      15
    term
    White blood cell count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    wheezing
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      12
      num Events
      5
    term
    weakness
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    visual blurring
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    urinary urgency
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    urinary incontinence
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    urinary frequency
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      2
    term
    urinary hesitancy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      12
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      12
      num Events
      6
    term
    hyperuricemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      12
      num Events
      4
    term
    upper respiratory infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    hypertriglyceridemia
Complete source fields
description
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    Drug: Pomalidomide Cohort 1 = 2 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Phase I - Cohort 1 (Pomalidomide 2mg)
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Drug: Pomalidomide Cohort 2 = 3 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Phase I - Cohort 2 (Pomalidomide 3mg)
  3. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Drug: Pomalidomide Cohort 3 = 4 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Phase I - Cohort 3 (Pomalidomide 4mg)
  4. deaths Num Affected
    1
    deaths Num At Risk
    12
    description
    Drug: Pomalidomide Maximum Tolerated Dose = 4 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
    id
    EG003
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    3
    serious Num At Risk
    12
    title
    Phase II Expansion- Maximum Tolerated Dose
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      12
      num Events
      15
    term
    White blood cell count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    wheezing
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      12
      num Events
      5
    term
    weakness
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    visual blurring
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    urinary urgency
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    urinary incontinence
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    urinary frequency
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      2
    term
    urinary hesitancy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      12
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      12
      num Events
      6
    term
    hyperuricemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      12
      num Events
      4
    term
    upper respiratory infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    hypertriglyceridemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Upper respiratory infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    myocardial infarction
time Frame
6 years

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice