TriangleNCT04325828 · OUTCOME
Progression-free Survival (PFS) as Assessed by ICRR
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
- Up to 13 months
What was measured
PFS was defined as the time from the date of the initial dose of study intervention to the date of first documented disease progression as defined in the RECIST version 1.1, or death due to any cause, whichever occurred first. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Analysis population: Treated analysis set included all participants who received at least 1 dose of study intervention.
Groups in this outcome
Apalutamide + Goserelin
Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
| Group | Source count |
|---|---|
| Apalutamide + Goserelin | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Apalutamide + Goserelin | 7.43 | Not reported | 3.65 | NA | The upper limit of 95% confidence interval was not estimable due to less number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit of 95% confidence interval was not estimable due to less number of participants with events.
- group Id
- OG000
- lower Limit
- 3.65
- upper Limit
- NA
- value
- 7.43
- denoms
- counts
- group Id
- OG000
- value
- 31
- units
- Participants
- description
- PFS was defined as the time from the date of the initial dose of study intervention to the date of first documented disease progression as defined in the RECIST version 1.1, or death due to any cause, whichever occurred first. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
- id
- OG000
- title
- Apalutamide + Goserelin
- param Type
- MEDIAN
- population Description
- Treated analysis set included all participants who received at least 1 dose of study intervention.
- reporting Status
- POSTED
- time Frame
- Up to 13 months
- title
- Progression-free Survival (PFS) as Assessed by ICRR
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice