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NCT00057811 · ADVERSE EVENTS

Adverse events

Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma · Source last updated 2014-09-19

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%

For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)

Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.

2 / 4632 / 46Not reported / Not reported
Group C (Chemotherapy, Monoclonal Antibody Therapy)

Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.

6 / 4235 / 42Not reported / Not reported

Group identifiers: EG000: Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) · EG001: Group C (Chemotherapy, Monoclonal Antibody Therapy)

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      46
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Febrile neutropenia
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Cardiac disorders - Other, specify
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Sinus tachycardia
  5. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Photophobia
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    Abdominal pain
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Colitis
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Esophageal pain
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Esophagitis
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      42
      num Events
      6
    term
    Mucositis oral
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Nausea
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Oral pain

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      46
      num Events
      32
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      42
      num Events
      32
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Blood and lymphatic system disorders - Other, specify
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Bone marrow hypocellular
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Disseminated intravascular coagulation
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      46
      num Events
      18
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      42
      num Events
      22
    term
    Febrile neutropenia
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Asystole
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    Cardiac disorders - Other, specify
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Mobitz type I
  9. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Sinus bradycardia
  10. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    Sinus tachycardia
  11. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    External ear inflammation
  12. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Hearing impaired
Complete source fields
description
For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
event Groups
  1. description
    Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
    id
    EG000
    other Num Affected
    32
    other Num At Risk
    46
    serious Num Affected
    2
    serious Num At Risk
    46
    title
    Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)
  2. description
    Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
    id
    EG001
    other Num Affected
    35
    other Num At Risk
    42
    serious Num Affected
    6
    serious Num At Risk
    42
    title
    Group C (Chemotherapy, Monoclonal Antibody Therapy)
frequency Threshold
0
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      46
      num Events
      32
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      42
      num Events
      32
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Blood and lymphatic system disorders - Other, specify
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Bone marrow hypocellular
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Disseminated intravascular coagulation
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      46
      num Events
      18
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      42
      num Events
      22
    term
    Febrile neutropenia
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Asystole
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    Cardiac disorders - Other, specify
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Mobitz type I
  9. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Sinus bradycardia
  10. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    Sinus tachycardia
  11. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    External ear inflammation
  12. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Hearing impaired
serious Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      46
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Febrile neutropenia
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Cardiac disorders - Other, specify
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Sinus tachycardia
  5. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Photophobia
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    Abdominal pain
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Colitis
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Esophageal pain
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Esophagitis
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      42
      num Events
      6
    term
    Mucositis oral
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Nausea
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      46
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Oral pain

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

Preserved source evidence · Not medical advice