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NCT01251952 · ADVERSE EVENTS

Adverse events

Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation · Source last updated 2017-06-20

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
Denileukin Diftitox (Ontak)

Denileukin Diftitox (Ontak) administered Post Autologous Transplantation. Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21. Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360.

2 / 20 / 2Not reported / Not reported

Group identifiers: EG000: Denileukin Diftitox (Ontak)

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
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Low BUN
  2. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      2
    term
    Hypophosphatemia
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Hyponatremia
  4. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Hypokalemia
  5. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Hypoxia
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Febrile neutropenia
  7. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Streptococcus in urine

Other reported adverse events

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

    Complete source fields
    event Groups
    1. description
      Denileukin Diftitox (Ontak) administered Post Autologous Transplantation. Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21. Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      2
      serious Num Affected
      2
      serious Num At Risk
      2
      title
      Denileukin Diftitox (Ontak)
    frequency Threshold
    5
    serious Events
    1. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Low BUN
    2. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        2
        num Events
        2
      term
      Hypophosphatemia
    3. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Hyponatremia
    4. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Hypokalemia
    5. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Hypoxia
    6. organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Febrile neutropenia
    7. organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Streptococcus in urine

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    Preserved source evidence · Not medical advice