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NCT00975975 · ADVERSE EVENTS

Adverse events

Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer · Source last updated 2016-02-26

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 transplant until the end of the study, for up to 2 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Overall

Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells

7 / 1717 / 17Not reported / Not reported

Group identifiers: EG000: Overall

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    CARDIAC ARRHYTHMIA - OTHER
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    CONDUCTION ABNORMALITY/ATRIOVENTRICULAR HEART BLOCK - ASYSTOLE
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    DIARRHEA
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    GASTROINTESTINAL - OTHER
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    PAIN - ABDOMEN NOS
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    FATIGUE (ASTHENIA, LETHARGY, MALAISE)
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
    term
    INFECTION - OTHER
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    INFECTION WITH UNKNOWN ANC - BLOOD
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    term
    HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    LYMPHATICS - OTHER
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    PALPITATIONS
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    PETECHIAE/PURPURA (HEMORRHAGE/BLEEDING INTO SKIN OR MUCOSA)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    term
    CARDIAC ARRHYTHMIA - OTHER
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    CARDIAC GENERAL - OTHER
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL FIBRILLATION
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL TACHYCARDIA/PAROXYSMAL ATRIAL TACHYCARDIA
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    term
    SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      17
    term
    SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    VENTRICULAR ARRHYTHMIA - PVCS
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    AUDITORY/EAR - OTHER
Complete source fields
event Groups
  1. description
    Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
    id
    EG000
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    7
    serious Num At Risk
    17
    title
    Overall
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    term
    HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    LYMPHATICS - OTHER
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    PALPITATIONS
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    PETECHIAE/PURPURA (HEMORRHAGE/BLEEDING INTO SKIN OR MUCOSA)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    term
    CARDIAC ARRHYTHMIA - OTHER
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    CARDIAC GENERAL - OTHER
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL FIBRILLATION
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL TACHYCARDIA/PAROXYSMAL ATRIAL TACHYCARDIA
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    term
    SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      17
    term
    SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    VENTRICULAR ARRHYTHMIA - PVCS
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    AUDITORY/EAR - OTHER
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    CARDIAC ARRHYTHMIA - OTHER
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    CONDUCTION ABNORMALITY/ATRIOVENTRICULAR HEART BLOCK - ASYSTOLE
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    DIARRHEA
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    GASTROINTESTINAL - OTHER
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    PAIN - ABDOMEN NOS
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    FATIGUE (ASTHENIA, LETHARGY, MALAISE)
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
    term
    INFECTION - OTHER
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    INFECTION WITH UNKNOWN ANC - BLOOD
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS
time Frame
From transplant until the end of the study, for up to 2 years

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Preserved source evidence · Not medical advice