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NCT00006436 · ADVERSE EVENTS

Adverse events

EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection · Source last updated 2026-08-03

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
Date treatment consent signed to date off study, approximately 209 months and 17 days.
Other-event reporting threshold
0%

One participant declined to participate before treatment started.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1-Combination Chemo and Biological Therapy

Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles

23 / 6766 / 6712 / 67

Group identifiers: EG000: Arm 1-Combination Chemo and Biological Therapy

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
    General disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Abdominal pain or cramping
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Acidosis (metabolic or respiratory)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Bone pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Cardiovascular/Arrhythmia-Other (Asystole)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      67
      num Events
      3
    term
    CNS hemorrhage/bleeding
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      67
      num Events
      2
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Constitutional Symptoms-Other (Death- Accident/Overdose)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      2
    term
    Creatinine
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Dehydration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Edema
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (fever of unknown origin without clinically or microbiologically documented infection) (ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
    organ System
    Infections and infestations
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      67
      num Events
      9
    term
    Febrile neutropenia

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
    Gastrointestinal disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      67
      num Events
      10
    term
    Abdominal pain or cramping
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      67
      num Events
      34
    term
    Alkaline phosphatase
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Allergic reaction/hypersensitivity (including drug fever)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      67
      num Events
      9
    term
    Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      67
      num Events
      28
    term
    Alopecia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      67
      num Events
      5
    term
    Amylase
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      67
      num Events
      23
    term
    Anorexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      67
      num Events
      5
    term
    Arthralgia (joint pain)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      67
      num Events
      9
    term
    Bicarbonate
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      67
      num Events
      20
    term
    Bilirubin
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      67
      num Events
      44
    term
    Bone pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Bruising (in absence of grade 3 or 4 thrombocytopenia)
Complete source fields
description
One participant declined to participate before treatment started.
event Groups
  1. deaths Num Affected
    12
    deaths Num At Risk
    67
    description
    Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
    id
    EG000
    other Num Affected
    66
    other Num At Risk
    67
    serious Num Affected
    23
    serious Num At Risk
    67
    title
    Arm 1-Combination Chemo and Biological Therapy
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      67
      num Events
      10
    term
    Abdominal pain or cramping
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      67
      num Events
      34
    term
    Alkaline phosphatase
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Allergic reaction/hypersensitivity (including drug fever)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      67
      num Events
      9
    term
    Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      67
      num Events
      28
    term
    Alopecia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      67
      num Events
      5
    term
    Amylase
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      67
      num Events
      23
    term
    Anorexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      67
      num Events
      5
    term
    Arthralgia (joint pain)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      67
      num Events
      9
    term
    Bicarbonate
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      67
      num Events
      20
    term
    Bilirubin
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      67
      num Events
      44
    term
    Bone pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Bruising (in absence of grade 3 or 4 thrombocytopenia)
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Abdominal pain or cramping
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Acidosis (metabolic or respiratory)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Bone pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Cardiovascular/Arrhythmia-Other (Asystole)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      67
      num Events
      3
    term
    CNS hemorrhage/bleeding
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      67
      num Events
      2
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Constitutional Symptoms-Other (Death- Accident/Overdose)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      2
    term
    Creatinine
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Dehydration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Edema
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (fever of unknown origin without clinically or microbiologically documented infection) (ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
    organ System
    Infections and infestations
    source Vocabulary
    CTC 2.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      67
      num Events
      9
    term
    Febrile neutropenia
time Frame
Date treatment consent signed to date off study, approximately 209 months and 17 days.

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