Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00299156 · ADVERSE EVENTS

Adverse events

Oral Clofarabine Study in Patients With Myelodysplastic Syndrome · Source last updated 2015-11-03

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
Adverse event collection with each 4-8 weeks course, up to a total of 12 courses of therapy. Overall study period, three years and four months.
Other-event reporting threshold
5%

The first participant of the phase II portion of this study started treatment in August 2009.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Oral Clofarabine

Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.

16 / 3232 / 32Not reported / Not reported
Randomized, Oral Clofarabine 10mg

Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.

8 / 1616 / 16Not reported / Not reported
Randomized, Oral Clofarabine 20mg

Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.

12 / 1616 / 16Not reported / Not reported

Group identifiers: EG000: Oral Clofarabine · EG001: Randomized, Oral Clofarabine 10mg · EG002: Randomized, Oral Clofarabine 20mg

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
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Death
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Death
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Respiratory Failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Renal Failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Death
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Tumor Lysis Syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Cerebrovascular Ischemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      32
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      16
      num Events
      4
    term
    Infection
  7. 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
      32
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Gastrointestinal Hemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Vaginal Hemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Cardiac Arrythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Supraventricular Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Diarrhea

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
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      32
      num Events
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      32
      num Events
      27
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      16
      num Events
      6
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      32
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      32
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Headache
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      32
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Myalgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Acute Renal Failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      32
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Abdominal Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      32
      num Events
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Elevated ALT
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      32
      num Events
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Elevated AST
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      32
      num Events
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      16
      num Events
      4
    term
    Hyperbilirrubinemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      32
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Constipation
Complete source fields
description
The first participant of the phase II portion of this study started treatment in August 2009.
event Groups
  1. description
    Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
    id
    EG000
    other Num Affected
    32
    other Num At Risk
    32
    serious Num Affected
    16
    serious Num At Risk
    32
    title
    Oral Clofarabine
  2. description
    Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    8
    serious Num At Risk
    16
    title
    Randomized, Oral Clofarabine 10mg
  3. description
    Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
    id
    EG002
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    12
    serious Num At Risk
    16
    title
    Randomized, Oral Clofarabine 20mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      32
      num Events
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      32
      num Events
      27
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      16
      num Events
      6
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      32
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      32
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Headache
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      32
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Myalgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Acute Renal Failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      32
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Abdominal Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      32
      num Events
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Elevated ALT
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      32
      num Events
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Elevated AST
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      32
      num Events
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      16
      num Events
      4
    term
    Hyperbilirrubinemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      32
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Death
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Death
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Respiratory Failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Renal Failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Death
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Tumor Lysis Syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Cerebrovascular Ischemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      32
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      16
      num Events
      4
    term
    Infection
  7. 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
      32
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Gastrointestinal Hemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Vaginal Hemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Cardiac Arrythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Supraventricular Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Diarrhea
time Frame
Adverse event collection with each 4-8 weeks course, up to a total of 12 courses of therapy. Overall study period, three years and four months.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice