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NCT00049673 · ADVERSE EVENTS

Adverse events

Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma · Source last updated 2023-09-13

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
9 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Prednisone

Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity. prednisone: Given orally thalidomide: Given orally

5 / 165165 / 16550 / 165
Observation

Patients undergo observation.

2 / 163158 / 16361 / 163

Group identifiers: EG000: Prednisone · EG001: Observation

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
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    term
    Sinus bradycardia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    term
    Colitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
    term
    Other
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    term
    Syncope
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
    term
    Renal failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    term
    Pneumonitis

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
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      163
    term
    Edema
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      163
    term
    Inner ear/hearing
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    term
    Cushingoid appearance
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      163
    term
    Blurred vision
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      97
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      163
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      163
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      163
    term
    Mouth dryness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      163
    term
    Dyspepsia/heartburn
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      163
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      163
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      163
    term
    Vomiting
Complete source fields
event Groups
  1. deaths Num Affected
    50
    deaths Num At Risk
    165
    description
    Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity. prednisone: Given orally thalidomide: Given orally
    id
    EG000
    other Num Affected
    165
    other Num At Risk
    165
    serious Num Affected
    5
    serious Num At Risk
    165
    title
    Prednisone
  2. deaths Num Affected
    61
    deaths Num At Risk
    163
    description
    Patients undergo observation.
    id
    EG001
    other Num Affected
    158
    other Num At Risk
    163
    serious Num Affected
    2
    serious Num At Risk
    163
    title
    Observation
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      163
    term
    Edema
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      163
    term
    Inner ear/hearing
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    term
    Cushingoid appearance
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      163
    term
    Blurred vision
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      97
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      163
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      163
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      163
    term
    Mouth dryness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      163
    term
    Dyspepsia/heartburn
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      163
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      163
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      163
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    term
    Sinus bradycardia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    term
    Colitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
    term
    Other
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    term
    Syncope
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
    term
    Renal failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
    term
    Pneumonitis
time Frame
9 years

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Preserved source evidence · Not medical advice