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NCT00075608 · ADVERSE EVENTS

Adverse events

2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis · Source last updated 2017-01-27

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
1 year
Other-event reporting threshold
5%

Adverse events were assessed for up to 1 year.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Second Transplant

Participants who received a second transplant

12 / 1212 / 12Not reported / Not reported

Group identifiers: EG000: Second Transplant

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
    Grade IV
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      3
    term
    Sepsis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade III and IV
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      12
      num Events
      8
    term
    febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade IV
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Acute renal failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade III and IV
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      12
      num Events
      8
    term
    fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade III
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade III
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      5
    term
    diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade III
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      5
    term
    hypotension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    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.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      12
      num Events
      13
    term
    nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      6
    term
    diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    peripheral edema
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    dyspnea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    hypocalcemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    hypoalbuminemia
Complete source fields
description
Adverse events were assessed for up to 1 year.
event Groups
  1. description
    Participants who received a second transplant
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    12
    serious Num At Risk
    12
    title
    Second Transplant
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      12
      num Events
      13
    term
    nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      6
    term
    diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    peripheral edema
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    dyspnea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    hypocalcemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    hypoalbuminemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade IV
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      3
    term
    Sepsis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade III and IV
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      12
      num Events
      8
    term
    febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade IV
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Acute renal failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade III and IV
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      12
      num Events
      8
    term
    fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade III
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade III
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      5
    term
    diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade III
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      5
    term
    hypotension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    arrhythmia
time Frame
1 year

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Preserved source evidence · Not medical advice