TriangleNCT04434469 · OUTCOME
Time to Maximum Concentration Observed (Tmax) of RO7297089
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- EOI, day
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1 Day 1
Analysis population: Cohorts reported with participants excluded from descriptive statistics due to not receiving the full dose: Cohort 2: 1 participant Cohort 3: 1 participant Cohort 4A: 2 participants Cohort 4B reported with 1 participant excluded from descriptive statistics due to apparent outlier and 1 participant due to or missing sample.
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 | 4 |
| Dose Escalation Backfill Cohort 4: RO7297089 | 4 |
| Dose Escalation Cohort 5: RO7297089 | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort 1: RO7297089 | 0.25 | Not reported | 0.08 | 0.25 | Not reported |
| Dose Escalation Cohort 2: RO7297089 | 0.17 | Not reported | 0.08 | 0.25 | Not reported |
| Dose Escalation Cohort 3: RO7297089 | 0.08 | Not reported | 0.08 | 0.08 | Not reported |
| Dose Escalation Cohort 4: RO7297089 | 0.25 | Not reported | 0.25 | 0.25 | Not reported |
| Dose Escalation Backfill Cohort 4: RO7297089 | 1.08 | Not reported | 1.08 | 1.17 | Not reported |
| Dose Escalation Cohort 5: RO7297089 | 1.08 | Not reported | 1.08 | 2.11 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.08
- upper Limit
- 0.25
- value
- 0.25
- group Id
- OG001
- lower Limit
- 0.08
- upper Limit
- 0.25
- value
- 0.17
- group Id
- OG002
- lower Limit
- 0.08
- upper Limit
- 0.08
- value
- 0.08
- group Id
- OG003
- lower Limit
- 0.25
- upper Limit
- 0.25
- value
- 0.25
- group Id
- OG004
- lower Limit
- 1.08
- upper Limit
- 1.17
- value
- 1.08
- group Id
- OG005
- lower Limit
- 1.08
- upper Limit
- 2.11
- value
- 1.08
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 3
- units
- Participants
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- Cohorts reported with participants excluded from descriptive statistics due to not receiving the full dose: Cohort 2: 1 participant Cohort 3: 1 participant Cohort 4A: 2 participants Cohort 4B reported with 1 participant excluded from descriptive statistics due to apparent outlier and 1 participant due to or missing sample.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1
- title
- Time to Maximum Concentration Observed (Tmax) of RO7297089
- type
- SECONDARY
- unit Of Measure
- EOI, day
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice