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NCT02120157 · ADVERSE EVENTS

Adverse events

Myeloablative Haploidentical BMT With Post-transplant Cyclophosphamide for Pediatric Patients With Hematologic Malignancies · Source last updated 2021-11-26

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
Adverse event data was collected up to 180 days after transplantation. Mortality was observed for up to 2 year post-intervention.
Other-event reporting threshold
5%

Adverse events reported at each visit during time at transplant center and up to 180 days post-transplantation.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Haploidentical BMT With PTCy for Acute Leukemias and MDS

Patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS): Days -6 through -3: Busulfan q 5-6h IV q24h x 4 days Days -2 and -1: Cyclophosphamide 50mg/kg/day IV x 2 days+ Mesna 40 mg/kg/day IV For patients with acute lymphocytic leukemia (ALL) and lymphoblastic lymphoma: Days -5 through -4: Cyclophosphamide 50mg/kg/day IV q24h x 2 days+Mesna 40 mg/kg/day IV Days -3 through -1: total body irradiation (TBI) 200 Centigray (cGy) twice a day for 3 days All patients Day 0: Infuse unmanipulated bone marrow Day +3 and +4: Cyclophosphamide 50 mg/kg/day IV + Mesna 40 mg/kg IBW/day IV Day +5: Begin tacrolimus 0.015mg/kg IBW/dose IV over 4 hours q 12h and mycophenolate mofetil (MMF)15mg/kg po/IV tid with maximum daily dose 3 gm/day Day +30: Assess chimerism and disease status in bone marrow Day +35: Discontinue MMF Day +60: Assess chimerism and disease status in bone marrow Day 180: Discontinue tacrolimus Cyclophosphamide: Chemotherapy administration TBI: Radiation Therapy Busulfan: Chemotherapy Administered Unmanipulated Bone Marrow: Bone Marrow Transplant Tacrolimus: Immunosuppressive Drug Administered Mycophenolate mofetil: Immunosuppressive Drug Administered

14 / 3213 / 328 / 32

Group identifiers: EG000: Haploidentical BMT With PTCy for Acute Leukemias and MDS

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
    General disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      3
    term
    Fever
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      4
    term
    Veno-occlusive Disease/ Hepatic Sinusoidal Obstruction Syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      3
    term
    Graft Failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Acute GVHD
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Broviac Cather Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Intracranial Hemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Cystitis

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 CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      20
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      4
    term
    Anorexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      32
      num Events
      10
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      32
      num Events
      6
    term
    Fever
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      4
    term
    Hypertension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      4
    term
    Hypokalemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      32
      num Events
      5
    term
    Hypomagnesemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      32
      num Events
      13
    term
    Oral Mucositis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      5
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
      num Events
      8
    term
    Neutrophil Count Decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      27
    term
    Platelet Count Decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      32
      num Events
      11
    term
    Vomiting
Complete source fields
description
Adverse events reported at each visit during time at transplant center and up to 180 days post-transplantation.
event Groups
  1. deaths Num Affected
    8
    deaths Num At Risk
    32
    description
    Patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS): Days -6 through -3: Busulfan q 5-6h IV q24h x 4 days Days -2 and -1: Cyclophosphamide 50mg/kg/day IV x 2 days+ Mesna 40 mg/kg/day IV For patients with acute lymphocytic leukemia (ALL) and lymphoblastic lymphoma: Days -5 through -4: Cyclophosphamide 50mg/kg/day IV q24h x 2 days+Mesna 40 mg/kg/day IV Days -3 through -1: total body irradiation (TBI) 200 Centigray (cGy) twice a day for 3 days All patients Day 0: Infuse unmanipulated bone marrow Day +3 and +4: Cyclophosphamide 50 mg/kg/day IV + Mesna 40 mg/kg IBW/day IV Day +5: Begin tacrolimus 0.015mg/kg IBW/dose IV over 4 hours q 12h and mycophenolate mofetil (MMF)15mg/kg po/IV tid with maximum daily dose 3 gm/day Day +30: Assess chimerism and disease status in bone marrow Day +35: Discontinue MMF Day +60: Assess chimerism and disease status in bone marrow Day 180: Discontinue tacrolimus Cyclophosphamide: Chemotherapy administration TBI: Radiation Therapy Busulfan: Chemotherapy Administered Unmanipulated Bone Marrow: Bone Marrow Transplant Tacrolimus: Immunosuppressive Drug Administered Mycophenolate mofetil: Immunosuppressive Drug Administered
    id
    EG000
    other Num Affected
    13
    other Num At Risk
    32
    serious Num Affected
    14
    serious Num At Risk
    32
    title
    Haploidentical BMT With PTCy for Acute Leukemias and MDS
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      20
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      4
    term
    Anorexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      32
      num Events
      10
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      32
      num Events
      6
    term
    Fever
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      4
    term
    Hypertension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      4
    term
    Hypokalemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      32
      num Events
      5
    term
    Hypomagnesemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      32
      num Events
      13
    term
    Oral Mucositis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      5
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
      num Events
      8
    term
    Neutrophil Count Decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      27
    term
    Platelet Count Decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      32
      num Events
      11
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      3
    term
    Fever
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
      num Events
      4
    term
    Veno-occlusive Disease/ Hepatic Sinusoidal Obstruction Syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      3
    term
    Graft Failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Acute GVHD
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Broviac Cather Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Intracranial Hemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    NCI CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Cystitis
time Frame
Adverse event data was collected up to 180 days after transplantation. Mortality was observed for up to 2 year post-intervention.

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