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NCT01198067 · ADVERSE EVENTS

Adverse events

Pomalidomide in Treating Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia · Source last updated 2025-09-04

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
All Adverse Events were collected through Study Completion (Avg. 1 Year)
Other-event reporting threshold
0%

Toxicity graded using NCI Common Terminology Criteria for Adverse Events, v3.0 Nonheme Pomalidomide dose limiting toxicity gr 3 \~\>except gr3\> fatigue, nausea/vomiting, or nonheme abnormal labs resolving to gr1 / baseline 14 days 1st dose. Hematologic toxicity defined as gr4 neutropenia lasting \> 14 days, febrile neutropenia, thrombocytopenia (plt #\< 25k) \> 14 days. All AEs recorded from study entry/first dose-30 days after last dose and/or AE resolution:1/1/2011 to 6/7/2022.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 2

2mg Pomolidomide per day per Cycle (Cycle = 28 days)

3 / 33 / 30 / 3
Cohort 3

1mg Pomolidomide per day per Cycle (Cycle = 28 days)

1 / 66 / 60 / 6

Group identifiers: EG000: Cohort 2 · EG001: Cohort 3

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
    Nervous system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Syncope
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Infection (Knee)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Caudia Equina Syndrome

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Allergic rhinitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Allergy/Immunology (Other) - Allergic Sinusitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Allergy/Immunology (Other) - Lidocaine
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Allergy/Immunology (Other) - Respiratory
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Anxiety
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      2
    term
    Back pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Blood glucose increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Bone pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Bruising
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Bruising - Injury / Laceration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Conjunctival disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Constipation
Complete source fields
description
Toxicity graded using NCI Common Terminology Criteria for Adverse Events, v3.0 Nonheme Pomalidomide dose limiting toxicity gr 3 \~\>except gr3\> fatigue, nausea/vomiting, or nonheme abnormal labs resolving to gr1 / baseline 14 days 1st dose. Hematologic toxicity defined as gr4 neutropenia lasting \> 14 days, febrile neutropenia, thrombocytopenia (plt #\< 25k) \> 14 days. All AEs recorded from study entry/first dose-30 days after last dose and/or AE resolution:1/1/2011 to 6/7/2022.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    2mg Pomolidomide per day per Cycle (Cycle = 28 days)
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Cohort 2
  2. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    1mg Pomolidomide per day per Cycle (Cycle = 28 days)
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Cohort 3
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Allergic rhinitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Allergy/Immunology (Other) - Allergic Sinusitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Allergy/Immunology (Other) - Lidocaine
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Allergy/Immunology (Other) - Respiratory
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Anxiety
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      2
    term
    Back pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Blood glucose increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Bone pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Bruising
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Bruising - Injury / Laceration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Conjunctival disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Syncope
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Infection (Knee)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Caudia Equina Syndrome
time Frame
All Adverse Events were collected through Study Completion (Avg. 1 Year)

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