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NCT05010629 · ADVERSE EVENTS

Adverse events

9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma · Source last updated 2026-08-07

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 followed up to 16.6 months. Survival status was followed up to 38.1 months.
Other-event reporting threshold
0%

Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
9-ING-41 + Carboplatin (Part I)

Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year. Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.

10 / 1616 / 1612 / 16
Pembrolizumab + 9-ING-41 + Carboplatin (Part II)

Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year. Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.

8 / 1616 / 167 / 16

Group identifiers: EG000: 9-ING-41 + Carboplatin (Part I) · EG001: Pembrolizumab + 9-ING-41 + Carboplatin (Part II)

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Atrial flutter
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Dysphagia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Gastrointestinal disorders - Other, specify
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Oral hemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Pancreatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Upper gastrointestinal hemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Death NOS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Disease progression
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Edema face

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 (5.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      16
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      16
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Atrioventricular block first degree
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Cardiac disorders - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Chest pain - cardiac
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Heart failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    term
    Sinus bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Ear and labyrinth disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Ear pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      16
    term
    Hearing impaired
Complete source fields
description
Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
event Groups
  1. deaths Num Affected
    12
    deaths Num At Risk
    16
    description
    Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year. Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.
    id
    EG000
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    10
    serious Num At Risk
    16
    title
    9-ING-41 + Carboplatin (Part I)
  2. deaths Num Affected
    7
    deaths Num At Risk
    16
    description
    Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year. Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    8
    serious Num At Risk
    16
    title
    Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      16
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      16
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Atrioventricular block first degree
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Cardiac disorders - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Chest pain - cardiac
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Heart failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    term
    Sinus bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Ear and labyrinth disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Ear pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      16
    term
    Hearing impaired
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Atrial flutter
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Dysphagia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Gastrointestinal disorders - Other, specify
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Oral hemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Pancreatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Upper gastrointestinal hemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Death NOS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    term
    Disease progression
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    term
    Edema face
time Frame
Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months.

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Preserved source evidence · Independent clinical review pending · Not medical advice