TriangleNCT03717415 · OUTCOME
Number of Participants With Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to 2.32 years
What was measured
Number of participants who experienced serious adverse events (SAE) and adverse events (AE).
Analysis population: All participants who received any study drug.
Groups in this outcome
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
| Group | Source count |
|---|---|
| Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5 | 3 |
| Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5 | 14 |
| Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6 | 5 |
| Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5 | 9 |
| Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5 | 2 |
| Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5 | 18 |
| Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5 | 2 |
| Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5 | 6 |
| Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5 | 11 |
Reported measurements
Any SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5 | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5 | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5 | 6 | Not reported | Not reported | Not reported | Not reported |
Any AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5 | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5 | 13 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6 | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5 | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5 | 18 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5 | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5 | 11 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 6
- title
- Any SAE
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 18
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 11
- title
- Any AE
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 18
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 11
- units
- Participants
- description
- Number of participants who experienced serious adverse events (SAE) and adverse events (AE).
- groups
- description
- Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
- id
- OG000
- title
- Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
- description
- Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
- id
- OG001
- title
- Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
- description
- Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
- id
- OG002
- title
- Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
- description
- Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
- id
- OG003
- title
- Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
- description
- Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
- id
- OG004
- title
- Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
- description
- Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
- id
- OG005
- title
- Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
- description
- Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
- id
- OG006
- title
- Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
- description
- Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
- id
- OG007
- title
- Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
- description
- Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
- id
- OG008
- title
- Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received any study drug.
- reporting Status
- POSTED
- time Frame
- Baseline up to 2.32 years
- title
- Number of Participants With Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice