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NCT00784927 · ADVERSE EVENTS

Adverse events

Lenalidomide, Rituximab, Cyclophosphamide, and Dexamethasone in Treating Patients With Previously Untreated Low-Grade Non-Hodgkin Lymphoma · Source last updated 2016-10-07

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment

40 mg Dexamethasone orally on days 1, 8, 15, 22.

15 / 3333 / 33Not reported / Not reported

Group identifiers: EG000: Treatment

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
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
      num Events
      6
    term
    Hemoglobin decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Colitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Gastrointestinal disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
      num Events
      2
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Leukocyte count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
      num Events
      5
    term
    Neutrophil count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Muscle weakness lower limb
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Tremor
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Dyspnea

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      33
      num Events
      174
    term
    Hemoglobin decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Sinus tachycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Vision blurred
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      33
      num Events
      22
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Esophagitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      33
      num Events
      31
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Oesophagoscopy abnormal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
      num Events
      6
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      33
      num Events
      59
    term
    Edema limbs
Complete source fields
event Groups
  1. description
    40 mg Dexamethasone orally on days 1, 8, 15, 22.
    id
    EG000
    other Num Affected
    33
    other Num At Risk
    33
    serious Num Affected
    15
    serious Num At Risk
    33
    title
    Treatment
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      33
      num Events
      174
    term
    Hemoglobin decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Sinus tachycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Vision blurred
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      33
      num Events
      22
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Esophagitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      33
      num Events
      31
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Oesophagoscopy abnormal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
      num Events
      6
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      33
      num Events
      59
    term
    Edema limbs
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
      num Events
      6
    term
    Hemoglobin decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Colitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Gastrointestinal disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
      num Events
      2
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Leukocyte count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
      num Events
      5
    term
    Neutrophil count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Muscle weakness lower limb
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Tremor
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Dyspnea

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