TriangleNCT02853331 · OUTCOME
Progression Free Survival Rate (PFS Rate) at Month 18 in All Participants
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
- 95% Confidence Interval
- Time frame
- Month 18
What was measured
The PFS rate was determined in all participants at Month 18. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The date of PD was approximated by the date of the first assessment at which PD was documented per RECIST 1.1 by Blinded Independent Central Review (BICR). Death was always considered as confirmed PD. Participants who did not experience PFS were censored at the last disease assessment. The PFS rate at Month 18 is presented.
Analysis population: The analysis population consisted of all randomized participants.
Groups in this outcome
Pembrolizumab + Axitinib
Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
Sunitinib
Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
| Group | Source count |
|---|---|
| Pembrolizumab + Axitinib | 432 |
| Sunitinib | 429 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Axitinib | 41.1 | Not reported | 33.5 | 48.5 | Not reported |
| Sunitinib | 32.8 | Not reported | 25.4 | 40.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 33.5
- upper Limit
- 48.5
- value
- 41.1
- group Id
- OG001
- lower Limit
- 25.4
- upper Limit
- 40.4
- value
- 32.8
- denoms
- counts
- group Id
- OG000
- value
- 432
- group Id
- OG001
- value
- 429
- units
- Participants
- description
- The PFS rate was determined in all participants at Month 18. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The date of PD was approximated by the date of the first assessment at which PD was documented per RECIST 1.1 by Blinded Independent Central Review (BICR). Death was always considered as confirmed PD. Participants who did not experience PFS were censored at the last disease assessment. The PFS rate at Month 18 is presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
- id
- OG000
- title
- Pembrolizumab + Axitinib
- description
- Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
- id
- OG001
- title
- Sunitinib
- param Type
- NUMBER
- population Description
- The analysis population consisted of all randomized participants.
- reporting Status
- POSTED
- time Frame
- Month 18
- title
- Progression Free Survival Rate (PFS Rate) at Month 18 in All Participants
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice