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NCT00211185 · ADVERSE EVENTS

Adverse events

A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma · Source last updated 2020-03-18

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
From date of administration of first dose up to 30 days after the last dose, or for any event that was present prior to study drug and continued after the first dose of study treatment but worsened in intensity, up to approximately 5 years 9 months
Other-event reporting threshold
0%

Treatment-emergent adverse events and serious adverse events were reported. Safety population included all treated participants. Participants who did not receive at least 1 dose of study treatment were excluded from this population. All toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Denileukin Diftitox in Combination With CHOP

Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.

25 / 4949 / 4918 / 49

Group identifiers: EG000: Denileukin Diftitox in Combination With CHOP

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
    Immune system disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Allergic reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Allergy-other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    term
    Leukocytes
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    term
    Neutrophils
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    term
    Platelets
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Supra Arrhyth: Sinus Tachy
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    term
    Cardiac ischemia/infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Cardiopulmonary arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Hypotension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Left vent. diastolic dysfunct.
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      49
    term
    Fever

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
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      49
    term
    Edema-limb
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      49
    term
    ALT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      49
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      49
    term
    Weight gain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      49
    term
    Hypocalcemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    term
    Dry skin
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      49
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      49
    term
    Hypoalbuminemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    term
    Ulceration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      49
    term
    AST
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      49
    term
    Rigors/chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      49
    term
    Dyspnea
Complete source fields
description
Treatment-emergent adverse events and serious adverse events were reported. Safety population included all treated participants. Participants who did not receive at least 1 dose of study treatment were excluded from this population. All toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0.
event Groups
  1. deaths Num Affected
    18
    deaths Num At Risk
    49
    description
    Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.
    id
    EG000
    other Num Affected
    49
    other Num At Risk
    49
    serious Num Affected
    25
    serious Num At Risk
    49
    title
    Denileukin Diftitox in Combination With CHOP
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      49
    term
    Edema-limb
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      49
    term
    ALT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      49
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      49
    term
    Weight gain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      49
    term
    Hypocalcemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    term
    Dry skin
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      49
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      49
    term
    Hypoalbuminemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    term
    Ulceration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      49
    term
    AST
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      49
    term
    Rigors/chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      49
    term
    Dyspnea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Allergic reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Allergy-other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    term
    Leukocytes
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    term
    Neutrophils
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    term
    Platelets
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Supra Arrhyth: Sinus Tachy
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    term
    Cardiac ischemia/infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Cardiopulmonary arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Hypotension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Left vent. diastolic dysfunct.
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      49
    term
    Fever
time Frame
From date of administration of first dose up to 30 days after the last dose, or for any event that was present prior to study drug and continued after the first dose of study treatment but worsened in intensity, up to approximately 5 years 9 months

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Preserved source evidence · Not medical advice