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NCT04682405 · ADVERSE EVENTS

Adverse events

Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM) · Source last updated 2023-12-15

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 events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Uproleselan + Standard of Care Melphalan

Patients will receive six doses of Uproleselan intravenously. The doses will begin the evening of Day -3 and continue every 12 hours through the morning of Day 0, prior to hematopoietic stem cell transplant (auto-HCT). On the evening of Day -2, patients also receive one dose of standard of care Melphalan intravenously.

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Placebo + Standard of Care Melphalan

Patients will receive six doses of placebo intravenously. The doses will begin the evening of Day -3 and continue every 12 hours through the morning of Day 0, prior to hematopoietic stem cell transplant (auto-HCT). On the evening of Day -2, patients also receive one dose of standard of care Melphalan intravenously.

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Group identifiers: EG000: Uproleselan + Standard of Care Melphalan · EG001: Placebo + Standard of Care Melphalan

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    term
    Fever
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Sinusitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Bacteremia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Lung Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    term
    Skin Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    term
    Sepsis

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 (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      25
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      25
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    term
    Sinus Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    term
    Supraventricular Tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    term
    Ear Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Adrenal Insufficiency
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Diplopia; estropia; right eye conjunctional hemorrhage
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Eye Disorders - other
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Blurred Vision
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Extraocular Muscle Paresis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Periorbital Edema
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    term
    Photophobia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Vision Decreased
Complete source fields
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    26
    description
    Patients will receive six doses of Uproleselan intravenously. The doses will begin the evening of Day -3 and continue every 12 hours through the morning of Day 0, prior to hematopoietic stem cell transplant (auto-HCT). On the evening of Day -2, patients also receive one dose of standard of care Melphalan intravenously.
    id
    EG000
    other Num Affected
    26
    other Num At Risk
    26
    serious Num Affected
    5
    serious Num At Risk
    26
    title
    Uproleselan + Standard of Care Melphalan
  2. deaths Num Affected
    3
    deaths Num At Risk
    25
    description
    Patients will receive six doses of placebo intravenously. The doses will begin the evening of Day -3 and continue every 12 hours through the morning of Day 0, prior to hematopoietic stem cell transplant (auto-HCT). On the evening of Day -2, patients also receive one dose of standard of care Melphalan intravenously.
    id
    EG001
    other Num Affected
    25
    other Num At Risk
    25
    serious Num Affected
    5
    serious Num At Risk
    25
    title
    Placebo + Standard of Care Melphalan
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      25
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      25
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    term
    Sinus Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    term
    Supraventricular Tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    term
    Ear Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Adrenal Insufficiency
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Diplopia; estropia; right eye conjunctional hemorrhage
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Eye Disorders - other
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Blurred Vision
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Extraocular Muscle Paresis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Periorbital Edema
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    term
    Photophobia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Vision Decreased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    term
    Fever
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Sinusitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Bacteremia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Lung Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    term
    Skin Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    term
    Sepsis
time Frame
Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).

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