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NCT01292603 · ADVERSE EVENTS

Adverse events

A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia · Source last updated 2018-12-19

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 from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.
Other-event reporting threshold
5%

New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1: Rituximab SC 1400 mg

Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).

5 / 1613 / 16Not reported / Not reported
Part 1: Rituximab SC 1600 mg

Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).

8 / 1716 / 17Not reported / Not reported
Part 1: Rituximab SC 1870 mg

PParticipant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).

4 / 2221 / 22Not reported / Not reported
Part 1: Rituximab SC 1000 mg

One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error. Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).

1 / 11 / 1Not reported / Not reported
Part 1: No SC Dose Received

These participants were withdrawn prior to SC treatment.

3 / 87 / 8Not reported / Not reported
Part 2 : Rituximab IV 500 mg/m^2

Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).

35 / 8980 / 89Not reported / Not reported
Part 2: Rituximab SC 1600 mg

Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).

32 / 8581 / 85Not reported / Not reported

Group identifiers: EG000: Part 1: Rituximab SC 1400 mg · EG001: Part 1: Rituximab SC 1600 mg · EG002: Part 1: Rituximab SC 1870 mg · EG003: Part 1: Rituximab SC 1000 mg · EG004: Part 1: No SC Dose Received · EG005: Part 2 : Rituximab IV 500 mg/m^2 · EG006: Part 2: Rituximab SC 1600 mg

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      85
    term
    Febrile Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Bone Marrow Failure
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      85
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      85
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      85
    term
    Peumonia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Gastroenteritis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Pelvic Infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Skin Infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      85
    term
    Upper Respiratory Tract Infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Adenocarcinoma Gastric
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Brain Neoplasm

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      51
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      54
      num At Risk
      85
    term
    Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      15
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      16
      num At Risk
      85
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      21
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      11
      num At Risk
      85
    term
    Anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      25
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      20
      num At Risk
      85
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Agranulocytosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Febrile Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Granulocytopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      31
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      32
      num At Risk
      85
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      20
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      18
      num At Risk
      85
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      85
    term
    Diarrhoea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Abdominal pain upper
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      85
    term
    Constipation
Complete source fields
description
New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.
event Groups
  1. description
    Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
    id
    EG000
    other Num Affected
    13
    other Num At Risk
    16
    serious Num Affected
    5
    serious Num At Risk
    16
    title
    Part 1: Rituximab SC 1400 mg
  2. description
    Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    17
    serious Num Affected
    8
    serious Num At Risk
    17
    title
    Part 1: Rituximab SC 1600 mg
  3. description
    PParticipant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
    id
    EG002
    other Num Affected
    21
    other Num At Risk
    22
    serious Num Affected
    4
    serious Num At Risk
    22
    title
    Part 1: Rituximab SC 1870 mg
  4. description
    One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error. Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
    id
    EG003
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Part 1: Rituximab SC 1000 mg
  5. description
    These participants were withdrawn prior to SC treatment.
    id
    EG004
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    3
    serious Num At Risk
    8
    title
    Part 1: No SC Dose Received
  6. description
    Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
    id
    EG005
    other Num Affected
    80
    other Num At Risk
    89
    serious Num Affected
    35
    serious Num At Risk
    89
    title
    Part 2 : Rituximab IV 500 mg/m^2
  7. description
    Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
    id
    EG006
    other Num Affected
    81
    other Num At Risk
    85
    serious Num Affected
    32
    serious Num At Risk
    85
    title
    Part 2: Rituximab SC 1600 mg
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      51
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      54
      num At Risk
      85
    term
    Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      15
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      16
      num At Risk
      85
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      21
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      11
      num At Risk
      85
    term
    Anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      25
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      20
      num At Risk
      85
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Agranulocytosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Febrile Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Granulocytopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      31
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      32
      num At Risk
      85
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      20
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      18
      num At Risk
      85
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      85
    term
    Diarrhoea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Abdominal pain upper
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      85
    term
    Constipation
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      85
    term
    Febrile Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Bone Marrow Failure
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      85
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      85
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      85
    term
    Peumonia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Gastroenteritis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Pelvic Infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Skin Infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      85
    term
    Upper Respiratory Tract Infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Adenocarcinoma Gastric
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      89
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      85
    term
    Brain Neoplasm
time Frame
Adverse Events were recorded from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.

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Preserved source evidence · Not medical advice