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NCT00281918 · ADVERSE EVENTS

Adverse events

Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia · Source last updated 2013-09-19

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 Events were recorded until 28 days after completion of study treatment (median time approximately 21 months). Serious Adverse Events reported until 1 year post-treatment or initiation of new CLL treatment (median time approximately 42 months).
Other-event reporting threshold
5%

The safety population included all participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Fludarabine+Cyclophosphamide (FC)

Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.

164 / 398122 / 398Not reported / Not reported
Fludarabine+Cyclophosphamide+Rituximab (FCR)

Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.

186 / 402185 / 402Not reported / Not reported

Group identifiers: EG000: Fludarabine+Cyclophosphamide (FC) · EG001: Fludarabine+Cyclophosphamide+Rituximab (FCR)

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
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      402
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      402
    term
    Herpes Zoster
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      402
    term
    Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      402
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      402
    term
    Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      402
    term
    Gastroenteritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      402
    term
    Sinusitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      402
    term
    Erysipelas
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      402
    term
    Hepatitis B
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      402
    term
    Pneumocystis Jiroveci Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      402
    term
    Pneumocystis Jiroveci Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      402
    term
    Pneumonia Primary Atypical

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
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      116
      num At Risk
      402
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      402
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      402
    term
    Thrombocytopenia
Complete source fields
description
The safety population included all participants who received at least one dose of study drug.
event Groups
  1. description
    Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
    id
    EG000
    other Num Affected
    122
    other Num At Risk
    398
    serious Num Affected
    164
    serious Num At Risk
    398
    title
    Fludarabine+Cyclophosphamide (FC)
  2. description
    Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
    id
    EG001
    other Num Affected
    185
    other Num At Risk
    402
    serious Num Affected
    186
    serious Num At Risk
    402
    title
    Fludarabine+Cyclophosphamide+Rituximab (FCR)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      116
      num At Risk
      402
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      402
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      402
    term
    Thrombocytopenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      402
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      402
    term
    Herpes Zoster
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      402
    term
    Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      402
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      402
    term
    Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      402
    term
    Gastroenteritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      402
    term
    Sinusitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      402
    term
    Erysipelas
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      402
    term
    Hepatitis B
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      402
    term
    Pneumocystis Jiroveci Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      402
    term
    Pneumocystis Jiroveci Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      402
    term
    Pneumonia Primary Atypical
time Frame
Adverse Events were recorded until 28 days after completion of study treatment (median time approximately 21 months). Serious Adverse Events reported until 1 year post-treatment or initiation of new CLL treatment (median time approximately 42 months).

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