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NCT01242267 · ADVERSE EVENTS

Adverse events

Escalating Doses of Thalidomide in Conjunction With Bortezomib and HIgh Dose Melphalan for BSCT · Source last updated 2026-04-02

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%

The limited number of patients limited our ability to analyze groups separately. As a result, all subjects in the Phase I portion were combined to produce a meaningful analysis.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I - Thalidomide Dose Level 600 mg

Phase I - Thalidomide Dose Level 600 mg

1 / 33 / 30 / 3
Phase I - Thalidomide Dose Level 800 mg

Phase I - Thalidomide Dose Level 800 mg

0 / 33 / 30 / 3
Phase I - Thalidomide Dose Level 1000 mg

Phase I - Thalidomide Dose Level 1000 mg

0 / 33 / 30 / 3
Phase 2

Phase 2 Thalidomide Dose Level 1000 mg

3 / 2020 / 200 / 20

Group identifiers: EG000: Phase I - Thalidomide Dose Level 600 mg · EG001: Phase I - Thalidomide Dose Level 800 mg · EG002: Phase I - Thalidomide Dose Level 1000 mg · EG003: Phase 2

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
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num At Risk
      3
    3. group Id
      EG002
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Engraftment Syndrome with GI Invovlement
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num At Risk
      3
    3. group Id
      EG002
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Rheumatoid Arthritis Flare
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num At Risk
      3
    3. group Id
      EG002
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num At Risk
      3
    3. group Id
      EG002
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Tumor Lysis 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
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Hypotension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Hypertension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Pulmonary Hypertension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Mild Left Atrial Dilatation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Bradycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Deep Venous Thrombosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      20
      num Events
      13
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      20
      num Events
      10
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      20
      num Events
      4
    term
    Anorexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      20
      num Events
      13
    term
    Mucositis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Acid Reflux
Complete source fields
description
The limited number of patients limited our ability to analyze groups separately. As a result, all subjects in the Phase I portion were combined to produce a meaningful analysis.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Phase I - Thalidomide Dose Level 600 mg
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Phase I - Thalidomide Dose Level 600 mg
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Phase I - Thalidomide Dose Level 800 mg
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Phase I - Thalidomide Dose Level 800 mg
  3. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Phase I - Thalidomide Dose Level 1000 mg
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Phase I - Thalidomide Dose Level 1000 mg
  4. deaths Num Affected
    0
    deaths Num At Risk
    20
    description
    Phase 2 Thalidomide Dose Level 1000 mg
    id
    EG003
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    3
    serious Num At Risk
    20
    title
    Phase 2
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Hypotension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Hypertension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Pulmonary Hypertension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Mild Left Atrial Dilatation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Bradycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Deep Venous Thrombosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      20
      num Events
      13
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      20
      num Events
      10
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      20
      num Events
      4
    term
    Anorexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      20
      num Events
      13
    term
    Mucositis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      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
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Acid Reflux
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num At Risk
      3
    3. group Id
      EG002
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Engraftment Syndrome with GI Invovlement
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num At Risk
      3
    3. group Id
      EG002
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Rheumatoid Arthritis Flare
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num At Risk
      3
    3. group Id
      EG002
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num At Risk
      3
    3. group Id
      EG002
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Tumor Lysis Syndrome

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