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NCT00040937 · ADVERSE EVENTS

Adverse events

S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma · Source last updated 2016-12-08

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
Report through 4/10/2007 to match data reported in MS.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Induction/PBSC Mobilization

Not reported

7 / 140140 / 140Not reported / Not reported
Autologous PBSCT

Not reported

0 / 105105 / 105Not reported / Not reported
Prednisone + Thalidomide

Not reported

1 / 7674 / 76Not reported / Not reported

Group identifiers: EG000: Induction/PBSC Mobilization · EG001: Autologous PBSCT · EG002: Prednisone + Thalidomide

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
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Supraventricular arrhythmia
  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
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    GI-other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Respiratory infect w/ neutrop
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Hyperglycemia
  5. 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
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Apnea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Thrombosis/embolism

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 (2.0)
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      94
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      76
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Transplant-pRBC transfusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Transplant-plt transfusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Arrhythmia, NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Vertigo
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Cushingoid appearance
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Blurred vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      76
    term
    Cataract
Complete source fields
event Groups
  1. id
    EG000
    other Num Affected
    140
    other Num At Risk
    140
    serious Num Affected
    7
    serious Num At Risk
    140
    title
    Induction/PBSC Mobilization
  2. id
    EG001
    other Num Affected
    105
    other Num At Risk
    105
    serious Num Affected
    0
    serious Num At Risk
    105
    title
    Autologous PBSCT
  3. id
    EG002
    other Num Affected
    74
    other Num At Risk
    76
    serious Num Affected
    1
    serious Num At Risk
    76
    title
    Prednisone + Thalidomide
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      94
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      76
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Transplant-pRBC transfusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Transplant-plt transfusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Arrhythmia, NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Vertigo
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Cushingoid appearance
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Blurred vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      76
    term
    Cataract
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Supraventricular arrhythmia
  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
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    GI-other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Respiratory infect w/ neutrop
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Hyperglycemia
  5. 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
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Apnea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      105
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Thrombosis/embolism
time Frame
Report through 4/10/2007 to match data reported in MS.

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