TriangleNCT04975308 · OUTCOME
Time to Sustained Worsening of the "Worst Pain" as Measured by Worst Pain NRS (Between Arm C and Arm A)
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
- Randomization through follow-up (up to 20 months)
What was measured
Time to sustained worsening of worst pain is defined as the time from randomization to the first increase (≥2 points) in the weekly average of the worst pain score, with confirmation in the next consecutive week. It was measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single-item, participant-administered, 11-point horizontal scale ranging from 0 to 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine." Participants not known to have sustained worsening will be censored at the last documented assessment.
Analysis population: All participants who were randomly assigned to either arm A or arm C concurrently and had at least one NRS assessment available (including censored). Number of participants censored in "Arm C=163," "Arm A=162."
Groups in this outcome
Arm C: Imlunestrant + Abemaciclib
Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met.
Arm A: Imlunestrant
Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.
| Group | Source count |
|---|---|
| Arm C: Imlunestrant + Abemaciclib | 204 |
| Arm A: Imlunestrant | 198 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm C: Imlunestrant + Abemaciclib | NA | Not reported | NA | NA | Due to the high number of censored participants, there were not enough events to estimate the median and 95% confidence interval. |
| Arm A: Imlunestrant | NA | Not reported | NA | NA | Due to the high number of censored participants, there were not enough events to estimate the median and 95% confidence interval. |
Complete source fields
- classes
- categories
- measurements
- comment
- Due to the high number of censored participants, there were not enough events to estimate the median and 95% confidence interval.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Due to the high number of censored participants, there were not enough events to estimate the median and 95% confidence interval.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 204
- group Id
- OG001
- value
- 198
- units
- Participants
- description
- Time to sustained worsening of worst pain is defined as the time from randomization to the first increase (≥2 points) in the weekly average of the worst pain score, with confirmation in the next consecutive week. It was measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single-item, participant-administered, 11-point horizontal scale ranging from 0 to 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine." Participants not known to have sustained worsening will be censored at the last documented assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met.
- id
- OG000
- title
- Arm C: Imlunestrant + Abemaciclib
- description
- Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.
- id
- OG001
- title
- Arm A: Imlunestrant
- param Type
- MEDIAN
- population Description
- All participants who were randomly assigned to either arm A or arm C concurrently and had at least one NRS assessment available (including censored). Number of participants censored in "Arm C=163," "Arm A=162."
- reporting Status
- POSTED
- time Frame
- Randomization through follow-up (up to 20 months)
- title
- Time to Sustained Worsening of the "Worst Pain" as Measured by Worst Pain NRS (Between Arm C and Arm A)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice