TriangleNCT04325828 · OUTCOME
Overall Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 13 months
What was measured
Overall response rate (ORR) was defined as the percentage of participants who achieve partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version1.1, including with either confirmed best overall response of complete response (CR) or PR during the study. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR is defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, in absence of new lesions or unequivocal progression of non-target lesions.
Analysis population: Response evaluable set included all participants who were androgen receptor (AR) positive by local test and were confirmed evaluable by independent central radiology review (ICRR) and also, who received at least 1 dose of study drug and had at least 1 postbaseline disease assessment or died due to disease progression before first postbaseline disease assessment. Here, 'N' (number of participants analyzed) included 24 response evaluable participants who were analyzed for this outcome measure.
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 | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Apalutamide + Goserelin | 25 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 25
- denoms
- counts
- group Id
- OG000
- value
- 24
- units
- Participants
- description
- Overall response rate (ORR) was defined as the percentage of participants who achieve partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version1.1, including with either confirmed best overall response of complete response (CR) or PR during the study. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR is defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, in absence of new lesions or unequivocal progression of non-target lesions.
- 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
- NUMBER
- population Description
- Response evaluable set included all participants who were androgen receptor (AR) positive by local test and were confirmed evaluable by independent central radiology review (ICRR) and also, who received at least 1 dose of study drug and had at least 1 postbaseline disease assessment or died due to disease progression before first postbaseline disease assessment. Here, 'N' (number of participants analyzed) included 24 response evaluable participants who were analyzed for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Up to 13 months
- title
- Overall Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice