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NCT00217425 · ADVERSE EVENTS

Adverse events

Bevacizumab and Combination Chemotherapy in Treating Patients With Peripheral T-Cell Lymphoma or Natural Killer Cell Neoplasms · Source last updated 2023-06-18

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
Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (ACHOP Followed by MA)

Adverse events in all treated patients regardless of eligibility.

34 / 4439 / 44Not reported / Not reported

Group identifiers: EG000: Treatment (ACHOP Followed by MA)

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
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      44
    term
    White blood cell decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      44
    term
    Lymphocyte count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      44
    term
    Neutrophil count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      44
    term
    Platelet count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Ventricular arrhythmia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
    term
    Left ventricular systolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Restrictive cardiomyopathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      44
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Weight loss

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
    term
    Allergic rhinitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      44
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      44
    term
    White blood cell decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      44
    term
    Lymphocyte count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      44
    term
    Neutrophil count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      44
    term
    Platelet count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      44
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      44
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      44
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
    term
    Hyperhidrosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      44
    term
    Weight loss
Complete source fields
event Groups
  1. description
    Adverse events in all treated patients regardless of eligibility.
    id
    EG000
    other Num Affected
    39
    other Num At Risk
    44
    serious Num Affected
    34
    serious Num At Risk
    44
    title
    Treatment (ACHOP Followed by MA)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
    term
    Allergic rhinitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      44
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      44
    term
    White blood cell decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      44
    term
    Lymphocyte count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      44
    term
    Neutrophil count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      44
    term
    Platelet count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      44
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      44
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      44
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
    term
    Hyperhidrosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      44
    term
    Weight loss
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      44
    term
    White blood cell decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      44
    term
    Lymphocyte count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      44
    term
    Neutrophil count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      44
    term
    Platelet count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Ventricular arrhythmia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
    term
    Left ventricular systolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Restrictive cardiomyopathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      44
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    term
    Weight loss
time Frame
Assessed every 3 weeks while on treatment and for 30 days after the end of treatment

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