TriangleNCT05010629 · OUTCOME
Number of Participants With Treatment Related Adverse Events (AE)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- AEs were assessed at Day 1 and Day 4 of each 21-day treatment cycle; assessed for up to 16.6 months.
What was measured
Number of participants with treatment-related AE is defined as the number of participants who experienced at least one AE assessed as possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Analysis population: 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.
Groups in this outcome
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.
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.
| Group | Source count |
|---|---|
| 9-ING-41 + Carboplatin (Part I) | 16 |
| Pembrolizumab + 9-ING-41 + Carboplatin (Part II) | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 9-ING-41 + Carboplatin (Part I) | 16 | Not reported | Not reported | Not reported | Not reported |
| Pembrolizumab + 9-ING-41 + Carboplatin (Part II) | 15 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 15
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 16
- units
- Participants
- description
- Number of participants with treatment-related AE is defined as the number of participants who experienced at least one AE assessed as possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
- groups
- 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.
- id
- OG000
- title
- 9-ING-41 + Carboplatin (Part I)
- 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.
- id
- OG001
- title
- Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
- param Type
- NUMBER
- population Description
- 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.
- reporting Status
- POSTED
- time Frame
- AEs were assessed at Day 1 and Day 4 of each 21-day treatment cycle; assessed for up to 16.6 months.
- title
- Number of Participants With Treatment Related Adverse Events (AE)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice