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NCT00058240 · ADVERSE EVENTS

Adverse events

Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma · Source last updated 2017-07-02

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
Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.
Other-event reporting threshold
5%

Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Levels 1-3

Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles

11 / 4240 / 40Not reported / Not reported
Dose Level 4

Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles

1 / 1616 / 16Not reported / Not reported

Group identifiers: EG000: Dose Levels 1-3 · EG001: Dose Level 4

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
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE version 2.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      42
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hyperacute Tumor Lysis

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
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      40
      num Events
      30
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      16
      num Events
      16
    term
    Absolute Neutrophil Count
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      16
      num Events
      11
    term
    WBC
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      40
      num Events
      15
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      16
      num Events
      7
    term
    Platelets
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hemorhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hypotension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      40
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Hypoxia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      40
      num Events
      16
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      16
      num Events
      12
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Abdominal pain/cramping
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      40
      num Events
      13
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    AST SGOT(serum glutamic oxaloacetic transaminase) or ALT, SGPT (serum glutamic pyruvic transaminase)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Bilirubin
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Renal Failture
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Pain
Complete source fields
description
Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4
event Groups
  1. description
    Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
    id
    EG000
    other Num Affected
    40
    other Num At Risk
    40
    serious Num Affected
    11
    serious Num At Risk
    42
    title
    Dose Levels 1-3
  2. description
    Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    1
    serious Num At Risk
    16
    title
    Dose Level 4
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      40
      num Events
      30
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      16
      num Events
      16
    term
    Absolute Neutrophil Count
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      16
      num Events
      11
    term
    WBC
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      40
      num Events
      15
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      16
      num Events
      7
    term
    Platelets
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hemorhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hypotension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      40
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Hypoxia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      40
      num Events
      16
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      16
      num Events
      12
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Abdominal pain/cramping
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      40
      num Events
      13
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    AST SGOT(serum glutamic oxaloacetic transaminase) or ALT, SGPT (serum glutamic pyruvic transaminase)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Bilirubin
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Renal Failture
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE version 2.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      42
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hyperacute Tumor Lysis
time Frame
Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years.

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Preserved source evidence · Not medical advice