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NCT00625729 · ADVERSE EVENTS

Adverse events

Donor Natural Killer Cell Infusion, Rituximab, Aldesleukin, and Chemotherapy in Treating Patients With Relapsed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia · Source last updated 2017-12-28

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
Serious adverse events were collected after start of chemotherapy treatment (Day -1) through date of death (all within 6 months).
Other-event reporting threshold
5%

Stopping Rules for excess toxicity: * Any non-hematologic grade 4 toxicity except for fevers alone * Grade III/IV GvHD or GvHD requiring more than 7 days of therapy * Hematologic toxicity: prolonged neutropenia defined as an absolute neutrophil count of less than 500 on day +35. Prolonged anemia or thrombocytopenia will not constitute toxicity.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Patients Treated With Natural Killer Cells

Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.

5 / 60 / 6Not reported / Not reported

Group identifiers: EG000: Patients Treated With Natural Killer Cells

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
    notes
    Ventricular arrhythmia - Bigeminy
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Cardiac Arrhythmia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      3
    term
    Death - Disease Progression NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    ANC \<500 at day +35
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Neutrophils/granulocytes (ANC/AGC)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Pulmonary - obstruction/stenosis of airway

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
    description
    Stopping Rules for excess toxicity: * Any non-hematologic grade 4 toxicity except for fevers alone * Grade III/IV GvHD or GvHD requiring more than 7 days of therapy * Hematologic toxicity: prolonged neutropenia defined as an absolute neutrophil count of less than 500 on day +35. Prolonged anemia or thrombocytopenia will not constitute toxicity.
    event Groups
    1. description
      Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      6
      serious Num Affected
      5
      serious Num At Risk
      6
      title
      Patients Treated With Natural Killer Cells
    frequency Threshold
    5
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Ventricular arrhythmia - Bigeminy
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Cardiac Arrhythmia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        6
        num Events
        3
      term
      Death - Disease Progression NOS
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        2
      term
      Infection
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      ANC \<500 at day +35
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Neutrophils/granulocytes (ANC/AGC)
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Pulmonary - obstruction/stenosis of airway
    time Frame
    Serious adverse events were collected after start of chemotherapy treatment (Day -1) through date of death (all within 6 months).

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice