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NCT02112045 · ADVERSE EVENTS

Adverse events

A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation · Source last updated 2019-11-26

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
Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.
Other-event reporting threshold
0%

Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Experimental: Granix and High Dose Melphalan (HDM)

Granix on Day -7 through Day -2. HDM intravenously (IV) on Day -2. Autologous stem cell transplantation on Day 0

10 / 4545 / 4540 / 45
Control: High Dose Melphalan (HDM)

HDM intravenously (IV) on Day -2.

4 / 4545 / 4543 / 45

Group identifiers: EG000: Experimental: Granix and High Dose Melphalan (HDM) · EG001: Control: High Dose Melphalan (HDM)

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
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Atrial filbrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Colonic perforation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Dehydration
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Clostridium difficile
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Lung infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Rhinitis Infective
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Hyperglycemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Acute kidney injury
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      45
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Atrial flutter
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Left ventricular systolic dysfunction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      45
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Supraventricular tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Excessive cerumen
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Impacted cerumen
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Adrenal insufficiency
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    SIADH
Complete source fields
description
Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.
event Groups
  1. deaths Num Affected
    40
    deaths Num At Risk
    45
    description
    Granix on Day -7 through Day -2. HDM intravenously (IV) on Day -2. Autologous stem cell transplantation on Day 0
    id
    EG000
    other Num Affected
    45
    other Num At Risk
    45
    serious Num Affected
    10
    serious Num At Risk
    45
    title
    Experimental: Granix and High Dose Melphalan (HDM)
  2. deaths Num Affected
    43
    deaths Num At Risk
    45
    description
    HDM intravenously (IV) on Day -2.
    id
    EG001
    other Num Affected
    45
    other Num At Risk
    45
    serious Num Affected
    4
    serious Num At Risk
    45
    title
    Control: High Dose Melphalan (HDM)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      45
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Atrial flutter
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Left ventricular systolic dysfunction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      45
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Supraventricular tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Excessive cerumen
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Impacted cerumen
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Adrenal insufficiency
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    SIADH
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Atrial filbrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Colonic perforation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Dehydration
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Clostridium difficile
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Lung infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Rhinitis Infective
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Hyperglycemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Acute kidney injury
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Thromboembolic event
time Frame
Reportable adverse events will be collected from the first dose of study treatment (Day -7) through the Day +30 visit.

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