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NCT00709592 · ADVERSE EVENTS

Adverse events

Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT · Source last updated 2018-11-09

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 events collected from first patient accrual up to day 180 or relapse for each subject on each arm.
Other-event reporting threshold
5%

Still collecting SAEs, subjects on trial until death.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
A:Thymoglobulin: 1.7 mg/kg/Day

1.7 mg/kg/d thymoglobulin IV d-9 to -7

7 / 1919 / 19Not reported / Not reported
B:Thymoglobulin: 2.5 mg/kg/Day

2.5 mg/kg/d thymoglobulin IV d-9 to d-7

12 / 2222 / 22Not reported / Not reported

Group identifiers: EG000: A:Thymoglobulin: 1.7 mg/kg/Day · EG001: B:Thymoglobulin: 2.5 mg/kg/Day

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
    notes
    brain
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Syncope
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    liver
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Hepatic
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    brain
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    CNS toxicity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Cardiac dysrhythmia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Hemorrhagic cystitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Fever with out bacteremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
      num Events
      3
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      22
      num Events
      6
    term
    Fever with Bacteremia +/- abscess
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Intra-abdominal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Brain abscess
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    vomiting
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Renal

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      19
      num Events
      19
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      22
      num Events
      22
    term
    Grade 3 neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      19
      num Events
      19
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      22
      num Events
      22
    term
    Lymphopenia post conditioning
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      19
      num Events
      19
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      22
      num Events
      22
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Ocular
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Post transplant neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Bacteremia/Fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Rash
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    UTI
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Urinary tract infection
Complete source fields
description
Still collecting SAEs, subjects on trial until death.
event Groups
  1. description
    1.7 mg/kg/d thymoglobulin IV d-9 to -7
    id
    EG000
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    7
    serious Num At Risk
    19
    title
    A:Thymoglobulin: 1.7 mg/kg/Day
  2. description
    2.5 mg/kg/d thymoglobulin IV d-9 to d-7
    id
    EG001
    other Num Affected
    22
    other Num At Risk
    22
    serious Num Affected
    12
    serious Num At Risk
    22
    title
    B:Thymoglobulin: 2.5 mg/kg/Day
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      19
      num Events
      19
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      22
      num Events
      22
    term
    Grade 3 neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      19
      num Events
      19
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      22
      num Events
      22
    term
    Lymphopenia post conditioning
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      19
      num Events
      19
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      22
      num Events
      22
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Ocular
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Post transplant neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Bacteremia/Fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Rash
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    UTI
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Urinary tract infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    brain
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Syncope
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    liver
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Hepatic
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    brain
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    CNS toxicity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Cardiac dysrhythmia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Hemorrhagic cystitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Fever with out bacteremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
      num Events
      3
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      22
      num Events
      6
    term
    Fever with Bacteremia +/- abscess
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Intra-abdominal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Brain abscess
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    vomiting
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Renal
time Frame
All events collected from first patient accrual up to day 180 or relapse for each subject on each arm.

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