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NCT00075946 · ADVERSE EVENTS

Adverse events

Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma · Source last updated 2024-02-01

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
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I: Induction Rituximab

Patients received rituximab IV once a week for 4 weeks. Patients were re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab were randomized to one of the two treatment arms.

23 / 50036 / 500Not reported / Not reported
Arm A: Rituximab Retreatment

Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.

5 / 1695 / 169Not reported / Not reported
Arm B: Rituximab Scheduled

Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.

10 / 17714 / 177Not reported / Not reported

Group identifiers: EG000: Arm I: Induction Rituximab · EG001: Arm A: Rituximab Retreatment · EG002: Arm B: Rituximab Scheduled

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
    Immune system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
    term
    Anaphylaxis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
    term
    Hearing impaired
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
    term
    Lymphocyte count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
    term
    Neutrophil count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
    term
    Platelet count 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
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
    term
    Ventricular arrhythmia
  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
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      177
    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
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
    term
    Fever
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
    term
    Insomnia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
    term
    Rash maculo-papular

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
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      177
    term
    Fatigue
Complete source fields
event Groups
  1. description
    Patients received rituximab IV once a week for 4 weeks. Patients were re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab were randomized to one of the two treatment arms.
    id
    EG000
    other Num Affected
    36
    other Num At Risk
    500
    serious Num Affected
    23
    serious Num At Risk
    500
    title
    Arm I: Induction Rituximab
  2. description
    Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    169
    serious Num Affected
    5
    serious Num At Risk
    169
    title
    Arm A: Rituximab Retreatment
  3. description
    Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
    id
    EG002
    other Num Affected
    14
    other Num At Risk
    177
    serious Num Affected
    10
    serious Num At Risk
    177
    title
    Arm B: Rituximab Scheduled
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      177
    term
    Fatigue
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
    term
    Anaphylaxis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
    term
    Hearing impaired
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
    term
    Lymphocyte count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
    term
    Neutrophil count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
    term
    Platelet count 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
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
    term
    Ventricular arrhythmia
  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
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      177
    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
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
    term
    Fever
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
    term
    Insomnia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
    term
    Rash maculo-papular
time Frame
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice