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NCT00049036 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy and Rituximab in Treating Patients With HIV-Associated Stage I, Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma · Source last updated 2014-05-14

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
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
EPOCH + Concurrent Rituximab

Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.

28 / 5150 / 51Not reported / Not reported
EPOCH Followed by Rituximab

Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.

27 / 5551 / 55Not reported / Not reported

Group identifiers: EG000: EPOCH + Concurrent Rituximab · EG001: EPOCH Followed by Rituximab

Serious adverse events

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

  1. organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Abdominal pain
  2. organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Alopecia
  3. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Anorexia
  4. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Aspartate aminotransferase increased
  5. organ System
    Immune system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Autoimmune disorder
  6. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      2
    term
    Back pain
  7. organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Bone infection
  8. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Bone pain
  9. organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
      num Events
      3
    term
    Catheter related infection
  10. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Chest pain
  11. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Coagulopathy
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Colitis

Other reported adverse events

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

  1. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      51
      num Events
      25
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      55
      num Events
      40
    term
    Abdominal pain
  2. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      51
      num Events
      30
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      55
      num Events
      62
    term
    Alanine aminotransferase increases
  3. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      51
      num Events
      29
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      55
      num Events
      43
    term
    Alkaline phosphatase increases
  4. organ System
    Immune system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      51
      num Events
      19
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      55
      num Events
      7
    term
    Allergic rhinitis
  5. organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      51
      num Events
      46
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      55
      num Events
      39
    term
    Alopecia
  6. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      51
      num Events
      24
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      55
      num Events
      14
    term
    Anorexia
  7. organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      51
      num Events
      25
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      55
      num Events
      19
    term
    Anxiety
  8. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      51
      num Events
      41
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      55
      num Events
      55
    term
    Aspartate aminotransferase increased
  9. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      51
      num Events
      9
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      55
      num Events
      22
    term
    Back pain
  10. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
      num Events
      45
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      55
      num Events
      12
    term
    Blood disorder
  11. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      51
      num Events
      20
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      55
      num Events
      13
    term
    Bone pain
  12. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      51
      num Events
      9
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      55
      num Events
      10
    term
    Chest pain
Complete source fields
event Groups
  1. description
    Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
    id
    EG000
    other Num Affected
    50
    other Num At Risk
    51
    serious Num Affected
    28
    serious Num At Risk
    51
    title
    EPOCH + Concurrent Rituximab
  2. description
    Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
    id
    EG001
    other Num Affected
    51
    other Num At Risk
    55
    serious Num Affected
    27
    serious Num At Risk
    55
    title
    EPOCH Followed by Rituximab
frequency Threshold
5
other Events
  1. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      51
      num Events
      25
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      55
      num Events
      40
    term
    Abdominal pain
  2. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      51
      num Events
      30
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      55
      num Events
      62
    term
    Alanine aminotransferase increases
  3. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      51
      num Events
      29
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      55
      num Events
      43
    term
    Alkaline phosphatase increases
  4. organ System
    Immune system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      51
      num Events
      19
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      55
      num Events
      7
    term
    Allergic rhinitis
  5. organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      51
      num Events
      46
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      55
      num Events
      39
    term
    Alopecia
  6. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      51
      num Events
      24
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      55
      num Events
      14
    term
    Anorexia
  7. organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      51
      num Events
      25
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      55
      num Events
      19
    term
    Anxiety
  8. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      51
      num Events
      41
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      55
      num Events
      55
    term
    Aspartate aminotransferase increased
  9. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      51
      num Events
      9
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      55
      num Events
      22
    term
    Back pain
  10. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
      num Events
      45
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      55
      num Events
      12
    term
    Blood disorder
  11. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      51
      num Events
      20
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      55
      num Events
      13
    term
    Bone pain
  12. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      51
      num Events
      9
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      55
      num Events
      10
    term
    Chest pain
serious Events
  1. organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Abdominal pain
  2. organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Alopecia
  3. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Anorexia
  4. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Aspartate aminotransferase increased
  5. organ System
    Immune system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Autoimmune disorder
  6. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      2
    term
    Back pain
  7. organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Bone infection
  8. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Bone pain
  9. organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
      num Events
      3
    term
    Catheter related infection
  10. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Chest pain
  11. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Coagulopathy
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Colitis

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