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NCT00274924 · ADVERSE EVENTS

Adverse events

Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma · Source last updated 2023-06-29

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
Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Step 1 - All Treated Patients

All treated patients regardless of eligibility.

58 / 9997 / 99Not reported / Not reported
Step 2 - Mid-treatment PET Positive

Patients who were mid-treatment PET positive and who received R-ICE in step 2 regardless of eligibility.

17 / 1717 / 17Not reported / Not reported
Step 2 - Mid-treatment PET Negative

Patients who were mid-treatment PET negative and who received additional R-CHOP in step 2 regardless of eligibility.

25 / 7675 / 76Not reported / Not reported

Group identifiers: EG000: Step 1 - All Treated Patients · EG001: Step 2 - Mid-treatment PET Positive · EG002: Step 2 - Mid-treatment PET Negative

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      76
    term
    Leukocytes decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      76
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      76
    term
    Neutrophils decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Platelets decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Hypotension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Fever w/o neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Weight gain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Coagulation-other

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Allergic rhinitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      57
      num At Risk
      76
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      76
    term
    Leukocytes decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      76
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      76
    term
    Neutrophils decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      76
    term
    Platelets decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      76
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    term
    Fever w/o neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      76
    term
    Insomnia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Rigors/chills
Complete source fields
event Groups
  1. description
    All treated patients regardless of eligibility.
    id
    EG000
    other Num Affected
    97
    other Num At Risk
    99
    serious Num Affected
    58
    serious Num At Risk
    99
    title
    Step 1 - All Treated Patients
  2. description
    Patients who were mid-treatment PET positive and who received R-ICE in step 2 regardless of eligibility.
    id
    EG001
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    17
    serious Num At Risk
    17
    title
    Step 2 - Mid-treatment PET Positive
  3. description
    Patients who were mid-treatment PET negative and who received additional R-CHOP in step 2 regardless of eligibility.
    id
    EG002
    other Num Affected
    75
    other Num At Risk
    76
    serious Num Affected
    25
    serious Num At Risk
    76
    title
    Step 2 - Mid-treatment PET Negative
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Allergic rhinitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      57
      num At Risk
      76
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      76
    term
    Leukocytes decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      76
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      76
    term
    Neutrophils decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      76
    term
    Platelets decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      76
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    term
    Fever w/o neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      76
    term
    Insomnia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Rigors/chills
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      76
    term
    Leukocytes decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      76
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      76
    term
    Neutrophils decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Platelets decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Hypotension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Fever w/o neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Weight gain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Coagulation-other
time Frame
Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.

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Preserved source evidence · Not medical advice