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NCT00090051 · ADVERSE EVENTS

Adverse events

FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients · Source last updated 2017-08-01

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 collected from study start to 28 days after treatment completion (Median observation time= 26 months). Serious Adverse Events were collected 1 year after treatment completion (Median observation time= 37 months).
Other-event reporting threshold
5%

The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up, whether withdrawn prematurely or not. 272 patients received FC only and 274 patients received FCR.

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.

132 / 272232 / 272Not reported / Not reported
Fludarabine+Cyclophosphamide+Rituximab (FCR)

Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.

138 / 274251 / 274Not 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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      274
    term
    Abdominal Distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Abdominal Pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Acute Coronary Syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Acute Sinusitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Agranulocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Alpha Haemolytic Streptococcal Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      274
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      274
    term
    Anaemia Haemolytic Autoimmune
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Angina Pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Angina Unstable
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      274
    term
    Aplasia Pure Red Cell
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Arrhythmia

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
      110
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      120
      num At Risk
      274
    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
      47
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      274
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      274
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      274
    term
    Granulocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      274
    term
    Febrile Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      274
    term
    Upper Respiratory Tract Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      274
    term
    Bronchitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      274
    term
    Nasopharyngitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      274
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      274
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      274
    term
    Chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      274
    term
    Asthenia
Complete source fields
description
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up, whether withdrawn prematurely or not. 272 patients received FC only and 274 patients received FCR.
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
    232
    other Num At Risk
    272
    serious Num Affected
    132
    serious Num At Risk
    272
    title
    Fludarabine+Cyclophosphamide (FC)
  2. description
    Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
    id
    EG001
    other Num Affected
    251
    other Num At Risk
    274
    serious Num Affected
    138
    serious Num At Risk
    274
    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
      110
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      120
      num At Risk
      274
    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
      47
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      274
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      274
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      274
    term
    Granulocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      274
    term
    Febrile Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      274
    term
    Upper Respiratory Tract Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      274
    term
    Bronchitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      274
    term
    Nasopharyngitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      274
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      274
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      274
    term
    Chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      274
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      274
    term
    Abdominal Distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Abdominal Pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Acute Coronary Syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Acute Sinusitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Agranulocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Alpha Haemolytic Streptococcal Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      274
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      274
    term
    Anaemia Haemolytic Autoimmune
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Angina Pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Angina Unstable
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      274
    term
    Aplasia Pure Red Cell
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      272
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      274
    term
    Arrhythmia
time Frame
Adverse Events were collected from study start to 28 days after treatment completion (Median observation time= 26 months). Serious Adverse Events were collected 1 year after treatment completion (Median observation time= 37 months).

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