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NCT03317899 · ADVERSE EVENTS

Adverse events

Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma · Source last updated 2025-12-17

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
Patients will be followed for adverse events for 60 days post-Auto HSCT
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Group I (auto HSCT tbo-filgrastim)

Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days. Hematopoietic Cell Transplantation: Undergo auto HSCT Tbo-filgrastim: Given subcutaneously Laboratory Biomarker Analysis: Correlative Studies

6 / 3737 / 376 / 37
Group II (auto HSCT)

Patients undergo auto Hematopoietic Cell Transplantation (HSCT). Hematopoietic Cell Transplantation: Undergo auto HSCT Laboratory Biomarker Analysis: Correlative Studies

10 / 3939 / 399 / 39

Group identifiers: EG000: Group I (auto HSCT tbo-filgrastim) · EG001: Group II (auto HSCT)

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
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      37
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Hypoxia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Hypoglycemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Asparte aminotransferase
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Alanine aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    syncope
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Typhlitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    hypotension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Small Bowel Obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    infection/infestation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Engraftment syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Thromboembolic event

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
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Atrial Fibrillation (grade1)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Atrial Fibrillation ( grade 2)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Atrial Fibrillation (Grade 3)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Aortic Stenosis Grade 2
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    asymptomatic LV dysfunction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    B12 deficiency
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    cardiomyopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    coronary artery disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    chest pain grade 1
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    chest pain grade 2
Complete source fields
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    37
    description
    Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days. Hematopoietic Cell Transplantation: Undergo auto HSCT Tbo-filgrastim: Given subcutaneously Laboratory Biomarker Analysis: Correlative Studies
    id
    EG000
    other Num Affected
    37
    other Num At Risk
    37
    serious Num Affected
    6
    serious Num At Risk
    37
    title
    Group I (auto HSCT tbo-filgrastim)
  2. deaths Num Affected
    9
    deaths Num At Risk
    39
    description
    Patients undergo auto Hematopoietic Cell Transplantation (HSCT). Hematopoietic Cell Transplantation: Undergo auto HSCT Laboratory Biomarker Analysis: Correlative Studies
    id
    EG001
    other Num Affected
    39
    other Num At Risk
    39
    serious Num Affected
    10
    serious Num At Risk
    39
    title
    Group II (auto HSCT)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Atrial Fibrillation (grade1)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Atrial Fibrillation ( grade 2)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Atrial Fibrillation (Grade 3)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Aortic Stenosis Grade 2
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    asymptomatic LV dysfunction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    B12 deficiency
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    cardiomyopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    coronary artery disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    chest pain grade 1
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    chest pain grade 2
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      37
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Hypoxia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Hypoglycemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Asparte aminotransferase
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Alanine aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    syncope
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Typhlitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    hypotension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Small Bowel Obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    infection/infestation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Engraftment syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Thromboembolic event
time Frame
Patients will be followed for adverse events for 60 days post-Auto HSCT

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