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NCT00783367 · ADVERSE EVENTS

Adverse events

Combination Therapy Using Lenalidomide (Revlimid)- Low Dose Dexamethasone and Rituximab for Treatment of Rituximab-Resistant, Non-Aggressive B-Cell Lymphomas · Source last updated 2023-03-30

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 for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1

Revlimid + rituximab with dexamethasone

12 / 2727 / 273 / 27
Cohort 2

Revlimid + rituximab (without dexamethasone)

9 / 2322 / 230 / 23

Group identifiers: EG000: Cohort 1 · EG001: Cohort 2

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
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      23
      num Events
      4
    term
    Neutrophil count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Thromboembolic event
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    urinary retention
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    pneumonia
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    lung infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Respiratory Failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Tumor Flare
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    General disorders and administration site conditions, other: tumor flare
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    unrelated second malignancies
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Neoplasms benign, malignant, and unspecified, Other: unrelated second malignancies
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Pelvic Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Hyperuricemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    hypokalemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Infection of aerodigestive tract
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Infections and infestations - Other: infection of aerodigestive tract

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
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
    term
    Arthralgia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      23
    term
    Neutrophil count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      23
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
    term
    Cough
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      23
    term
    Myalgias
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      23
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      23
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
    term
    dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
    term
    hoarseness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
    term
    Hypokalemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      23
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      23
    term
    Peripheral sensory neuropathy
Complete source fields
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    27
    description
    Revlimid + rituximab with dexamethasone
    id
    EG000
    other Num Affected
    27
    other Num At Risk
    27
    serious Num Affected
    12
    serious Num At Risk
    27
    title
    Cohort 1
  2. deaths Num Affected
    0
    deaths Num At Risk
    23
    description
    Revlimid + rituximab (without dexamethasone)
    id
    EG001
    other Num Affected
    22
    other Num At Risk
    23
    serious Num Affected
    9
    serious Num At Risk
    23
    title
    Cohort 2
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
    term
    Arthralgia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      23
    term
    Neutrophil count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      23
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
    term
    Cough
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      23
    term
    Myalgias
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      23
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      23
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
    term
    dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
    term
    hoarseness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
    term
    Hypokalemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      23
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      23
    term
    Peripheral sensory neuropathy
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      23
      num Events
      4
    term
    Neutrophil count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Thromboembolic event
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    urinary retention
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    pneumonia
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    lung infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Respiratory Failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Tumor Flare
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    General disorders and administration site conditions, other: tumor flare
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    unrelated second malignancies
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Neoplasms benign, malignant, and unspecified, Other: unrelated second malignancies
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Pelvic Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Hyperuricemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    hypokalemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Infection of aerodigestive tract
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Infections and infestations - Other: infection of aerodigestive tract
time Frame
Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy

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