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NCT01237951 · ADVERSE EVENTS

Adverse events

High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma · Source last updated 2020-05-05

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
Up to 2 years
Other-event reporting threshold
1%

All-Cause Mortality was monitored in for all enrolled 75 participants ( 1 participant died before receiving treatment and 4 while on study) and 74 participants with Serious and Other Adverse Events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Gemcitabine/Busulfan/Melphalan

Participants with refractory or relapsed myeloma received high-dose GemBuMel with ASCT.

31 / 7471 / 745 / 75

Group identifiers: EG000: Gemcitabine/Busulfan/Melphalan

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
    Gastrointestinal disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      74
    term
    Mucositis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      74
    term
    Dermatitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      74
    term
    Infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
    term
    Cardiac
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      74
    term
    Hyperbilirubinemia

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
    Gastrointestinal disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      74
    term
    Mucositis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      74
    term
    Dermatitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      74
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      74
    term
    Infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      74
    term
    Cardiac
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      74
    term
    Hyperbilirubinemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    term
    Hand-foot syndrome
Complete source fields
description
All-Cause Mortality was monitored in for all enrolled 75 participants ( 1 participant died before receiving treatment and 4 while on study) and 74 participants with Serious and Other Adverse Events.
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    75
    description
    Participants with refractory or relapsed myeloma received high-dose GemBuMel with ASCT.
    id
    EG000
    other Num Affected
    71
    other Num At Risk
    74
    serious Num Affected
    31
    serious Num At Risk
    74
    title
    Gemcitabine/Busulfan/Melphalan
frequency Threshold
1
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      74
    term
    Mucositis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      74
    term
    Dermatitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      74
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      74
    term
    Infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      74
    term
    Cardiac
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      74
    term
    Hyperbilirubinemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    term
    Hand-foot syndrome
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      74
    term
    Mucositis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      74
    term
    Dermatitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      74
    term
    Infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
    term
    Cardiac
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTC AE v3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      74
    term
    Hyperbilirubinemia
time Frame
Up to 2 years

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

Preserved source evidence · Not medical advice