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NCT00083551 · ADVERSE EVENTS

Adverse events

UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy · Source last updated 2015-11-23

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
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Thalidomide

Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.

323 / 323323 / 323Not reported / Not reported
No Thalidomide

Patient received no thalidomide during induction, consolidation, and maintenance therapy.

345 / 345345 / 345Not reported / Not reported

Group identifiers: EG000: Thalidomide · EG001: No Thalidomide

Serious adverse events

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

  1. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      345
    term
    Grade 3 Arrhythmia, NOS
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      345
    term
    Grade 4 Arrhythmia, NOS
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      345
    term
    Grade 3 Cardiac ischemia/infarction
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Grade 4 Cardiac ischemia/infarction
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Grade 3 Cardiovascular-other
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Grade 4 Cardiovascular-other
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      345
    term
    Grade 3 Cerebrovascular ischemia
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Grade 4 Cerebrovascular ischemia
  9. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Grade 3 Conduction abnormality/block
  10. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Grade 4 Conduction abnormality/block
  11. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      345
    term
    Grade 3 Edema
  12. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      345
    term
    Grade 3 Hypertension

Other reported adverse events

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

  1. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      345
    term
    Grade 1 Arrythmia, NOS
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      345
    term
    Grade 2 Arrythmia, NOS
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      345
    term
    Grade 1 Edema
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      345
    term
    Grade 2 Edema
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      345
    term
    Grade 1 Sinus tachycardia
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      345
    term
    Grade 2 Thrombosis/embolism
  7. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      345
    term
    Grade 1 Hypothyroidism
  8. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Grade 2 Hypothyroidism
  9. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      345
    term
    Grade 2 Blurred vision
  10. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Grade 1 Eye - other
  11. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Grade 1 Vision, NOS
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      76
      num At Risk
      345
    term
    Grade 2 Fatigue/malaise/lethargy
Complete source fields
event Groups
  1. description
    Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
    id
    EG000
    other Num Affected
    323
    other Num At Risk
    323
    serious Num Affected
    323
    serious Num At Risk
    323
    title
    Thalidomide
  2. description
    Patient received no thalidomide during induction, consolidation, and maintenance therapy.
    id
    EG001
    other Num Affected
    345
    other Num At Risk
    345
    serious Num Affected
    345
    serious Num At Risk
    345
    title
    No Thalidomide
frequency Threshold
5
other Events
  1. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      345
    term
    Grade 1 Arrythmia, NOS
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      345
    term
    Grade 2 Arrythmia, NOS
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      345
    term
    Grade 1 Edema
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      345
    term
    Grade 2 Edema
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      345
    term
    Grade 1 Sinus tachycardia
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      345
    term
    Grade 2 Thrombosis/embolism
  7. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      345
    term
    Grade 1 Hypothyroidism
  8. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Grade 2 Hypothyroidism
  9. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      345
    term
    Grade 2 Blurred vision
  10. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Grade 1 Eye - other
  11. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Grade 1 Vision, NOS
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      76
      num At Risk
      345
    term
    Grade 2 Fatigue/malaise/lethargy
serious Events
  1. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      345
    term
    Grade 3 Arrhythmia, NOS
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      345
    term
    Grade 4 Arrhythmia, NOS
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      345
    term
    Grade 3 Cardiac ischemia/infarction
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Grade 4 Cardiac ischemia/infarction
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Grade 3 Cardiovascular-other
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Grade 4 Cardiovascular-other
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      345
    term
    Grade 3 Cerebrovascular ischemia
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Grade 4 Cerebrovascular ischemia
  9. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Grade 3 Conduction abnormality/block
  10. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Grade 4 Conduction abnormality/block
  11. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      345
    term
    Grade 3 Edema
  12. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      323
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      345
    term
    Grade 3 Hypertension

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