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NCT00222105 · ADVERSE EVENTS

Adverse events

A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life · Source last updated 2017-07-02

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1

Doxil, Thalidomide, Dexamethasone Doxil: Doxil 40 mg/m2 IV day 1 Thalidomide: 50-100 mg day 1-28 Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18

8 / 250 / 252 / 25

Group identifiers: EG000: Arm 1

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
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      25
      num Events
      5
    term
    Infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Acute Renal Failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Dehydration
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Arrhythmia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Complete source fields
    event Groups
    1. deaths Num Affected
      2
      deaths Num At Risk
      25
      description
      Doxil, Thalidomide, Dexamethasone Doxil: Doxil 40 mg/m2 IV day 1 Thalidomide: 50-100 mg day 1-28 Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      25
      serious Num Affected
      8
      serious Num At Risk
      25
      title
      Arm 1
    frequency Threshold
    0
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        25
        num Events
        5
      term
      Infection
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        25
        num Events
        1
      term
      Acute Renal Failure
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        25
        num Events
        1
      term
      Dehydration
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        25
        num Events
        1
      term
      Arrhythmia

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

    Preserved source evidence · Not medical advice