TriangleNCT04322539 · OUTCOME
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From first occurrence of PR or CR until the first documentation progression or death, whichever comes first (up to 22 months
What was measured
DOR was defined as the time (in months) from the first occurrence of PR or CR by RECIST Version 1.1, until the first date that progressive disease is documented by RECIST Version 1.1, or death, whichever comes first. Only those participants with confirmed responses of CR or PR were included in this analysis. DOR was calculated as (date of death or PD or last assessment - date of first occurrence of confirmed CR or PR + 1)/30.4375.
Analysis population: Analysis was performed on subset of participants who had a response. Here, '0' in 'overall number of participants analyzed represents that DOR could only be analyzed in participants who achieved a response. As no participant in the Placebo Plus BSC Group cohort achieved any response, no DOR is available.
Groups in this outcome
Fruquintinib + BSC Group
Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
Placebo + BSC Group
Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
| Group | Source count |
|---|---|
| Fruquintinib + BSC Group | 7 |
| Placebo + BSC Group | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fruquintinib + BSC Group | 10.7 | Not reported | 3.9 | NA | Upper limit of 95% CI was not estimable due to limited number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI was not estimable due to limited number of participants with events.
- group Id
- OG000
- lower Limit
- 3.9
- upper Limit
- NA
- value
- 10.7
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- DOR was defined as the time (in months) from the first occurrence of PR or CR by RECIST Version 1.1, until the first date that progressive disease is documented by RECIST Version 1.1, or death, whichever comes first. Only those participants with confirmed responses of CR or PR were included in this analysis. DOR was calculated as (date of death or PD or last assessment - date of first occurrence of confirmed CR or PR + 1)/30.4375.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
- id
- OG000
- title
- Fruquintinib + BSC Group
- description
- Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
- id
- OG001
- title
- Placebo + BSC Group
- param Type
- MEDIAN
- population Description
- Analysis was performed on subset of participants who had a response. Here, '0' in 'overall number of participants analyzed represents that DOR could only be analyzed in participants who achieved a response. As no participant in the Placebo Plus BSC Group cohort achieved any response, no DOR is available.
- reporting Status
- POSTED
- time Frame
- From first occurrence of PR or CR until the first documentation progression or death, whichever comes first (up to 22 months
- title
- Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice