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NCT00215943 · ADVERSE EVENTS

Adverse events

Phase III Randomized Trial of Thalidomide/Dexamethasone Versus Vincristine+Adriamycin+Dexamethasone (VAD) · Source last updated 2014-04-17

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
5 years
Other-event reporting threshold
5%

All participants who received treatment

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Active Comparator: VAD Treatment

VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one "cycle" of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle.

0 / 3636 / 36Not reported / Not reported
Active Comparator: Thalidomide and Dexamethasone Treatment

Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.

1 / 3737 / 37Not reported / Not reported

Group identifiers: EG000: Active Comparator: VAD Treatment · EG001: Active Comparator: Thalidomide and Dexamethasone Treatment

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Pneumonitis/pulmonary infiltrates - Grade 4
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Pulmonary/Upper Respiratory - Other - Grade 3

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
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      37
      num Events
      2
    term
    Abdominal pain or cramping
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      37
      num Events
      2
    term
    Alkaline phosphatase
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      36
      num Events
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Alopecia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
      num Events
      4
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      37
      num Events
      11
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Bilirubin
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      36
      num Events
      27
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      37
      num Events
      28
    term
    Bone pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      37
      num Events
      2
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      37
      num Events
      3
    term
    Confusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      36
      num Events
      15
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      37
      num Events
      31
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      37
      num Events
      5
    term
    Cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      36
      num Events
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      37
      num Events
      14
    term
    Creatinine
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      36
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      37
      num Events
      9
    term
    Dehydration
Complete source fields
description
All participants who received treatment
event Groups
  1. description
    VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one "cycle" of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle.
    id
    EG000
    other Num Affected
    36
    other Num At Risk
    36
    serious Num Affected
    0
    serious Num At Risk
    36
    title
    Active Comparator: VAD Treatment
  2. description
    Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
    id
    EG001
    other Num Affected
    37
    other Num At Risk
    37
    serious Num Affected
    1
    serious Num At Risk
    37
    title
    Active Comparator: Thalidomide and Dexamethasone Treatment
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      37
      num Events
      2
    term
    Abdominal pain or cramping
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      37
      num Events
      2
    term
    Alkaline phosphatase
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      36
      num Events
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Alopecia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
      num Events
      4
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      37
      num Events
      11
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Bilirubin
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      36
      num Events
      27
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      37
      num Events
      28
    term
    Bone pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      37
      num Events
      2
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      37
      num Events
      3
    term
    Confusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      36
      num Events
      15
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      37
      num Events
      31
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      37
      num Events
      5
    term
    Cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      36
      num Events
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      37
      num Events
      14
    term
    Creatinine
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      36
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      37
      num Events
      9
    term
    Dehydration
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Pneumonitis/pulmonary infiltrates - Grade 4
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Pulmonary/Upper Respiratory - Other - Grade 3
time Frame
5 years

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Preserved source evidence · Not medical advice