TriangleNCT04434469 · OUTCOME
Maximum Concentration Observed (Cmax) of RO7297089
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ug/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Day 1, Cycle 2 Day 8
Analysis population: Only those participants who received full dose were included in the results summary
Groups in this outcome
Dose Escalation Cohort 1: RO7297089
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Dose Escalation Cohort 2: RO7297089
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Dose Escalation Cohort 3: RO7297089
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Dose Escalation Cohort 4: RO7297089
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Dose Escalation Backfill Cohort 4: RO7297089
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
Dose Escalation Cohort 5: RO7297089
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
| Group | Source count |
|---|---|
| Dose Escalation Cohort 1: RO7297089 | 3 |
| Dose Escalation Cohort 2: RO7297089 | 4 |
| Dose Escalation Cohort 3: RO7297089 | 3 |
| Dose Escalation Cohort 4: RO7297089 | 1 |
| Dose Escalation Backfill Cohort 4: RO7297089 | 4 |
| Dose Escalation Cohort 5: RO7297089 | 3 |
Reported measurements
C1D1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort 1: RO7297089 | 7.79 | 21.6 | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 2: RO7297089 | 40.9 | 46.3 | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 3: RO7297089 | 95.9 | 35.8 | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 4: RO7297089 | 314 | NA | Not reported | Not reported | Only 1 participant analyzed |
| Dose Escalation Backfill Cohort 4: RO7297089 | 305 | 15.5 | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 5: RO7297089 | 404 | 12.4 | Not reported | Not reported | Not reported |
C2D8
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort 1: RO7297089 | 9.50 | 24.1 | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 2: RO7297089 | 48.6 | 23.6 | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 3: RO7297089 | 153 | 47.5 | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 4: RO7297089 | 394 | NA | Not reported | Not reported | Only 1 participant analyzed |
| Dose Escalation Backfill Cohort 4: RO7297089 | 541 | 38.9 | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 5: RO7297089 | 966 | 24.7 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 21.6
- value
- 7.79
- group Id
- OG001
- spread
- 46.3
- value
- 40.9
- group Id
- OG002
- spread
- 35.8
- value
- 95.9
- comment
- Only 1 participant analyzed
- group Id
- OG003
- spread
- NA
- value
- 314
- group Id
- OG004
- spread
- 15.5
- value
- 305
- group Id
- OG005
- spread
- 12.4
- value
- 404
- title
- C1D1
- categories
- measurements
- group Id
- OG000
- spread
- 24.1
- value
- 9.50
- group Id
- OG001
- spread
- 23.6
- value
- 48.6
- group Id
- OG002
- spread
- 47.5
- value
- 153
- comment
- Only 1 participant analyzed
- group Id
- OG003
- spread
- NA
- value
- 394
- group Id
- OG004
- spread
- 38.9
- value
- 541
- group Id
- OG005
- spread
- 24.7
- value
- 966
- title
- C2D8
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 3
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
- id
- OG000
- title
- Dose Escalation Cohort 1: RO7297089
- description
- Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
- id
- OG001
- title
- Dose Escalation Cohort 2: RO7297089
- description
- Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
- id
- OG002
- title
- Dose Escalation Cohort 3: RO7297089
- description
- Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
- id
- OG003
- title
- Dose Escalation Cohort 4: RO7297089
- description
- Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
- id
- OG004
- title
- Dose Escalation Backfill Cohort 4: RO7297089
- description
- Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
- id
- OG005
- title
- Dose Escalation Cohort 5: RO7297089
- param Type
- GEOMETRIC_MEAN
- population Description
- Only those participants who received full dose were included in the results summary
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1, Cycle 2 Day 8
- title
- Maximum Concentration Observed (Cmax) of RO7297089
- type
- SECONDARY
- unit Of Measure
- ug/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice