TriangleNCT01007942 · 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
- 95% Confidence Interval
- Time frame
- Every 6 weeks until disease progression or death which ever occurred first up to about 41 months
What was measured
ORR was defined as the percentage of participants whose best overall response was either complete response (CR) or partial response (PR) according to RECIST version 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Analysis population: The Full Analysis Set (FAS) consisted of all randomized patients.
Groups in this outcome
Everolimus + Vinorelbine + Trastuzumab
Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
Placebo + Vinorelbine + Trastuzumab
Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
| Group | Source count |
|---|---|
| Everolimus + Vinorelbine + Trastuzumab | 284 |
| Placebo + Vinorelbine + Trastuzumab | 285 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus + Vinorelbine + Trastuzumab | 40.8 | Not reported | 35.1 | 46.8 | Not reported |
| Placebo + Vinorelbine + Trastuzumab | 37.2 | Not reported | 31.6 | 43.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.1
- upper Limit
- 46.8
- value
- 40.8
- group Id
- OG001
- lower Limit
- 31.6
- upper Limit
- 43.1
- value
- 37.2
- denoms
- counts
- group Id
- OG000
- value
- 284
- group Id
- OG001
- value
- 285
- units
- Participants
- description
- ORR was defined as the percentage of participants whose best overall response was either complete response (CR) or partial response (PR) according to RECIST version 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
- id
- OG000
- title
- Everolimus + Vinorelbine + Trastuzumab
- description
- Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
- id
- OG001
- title
- Placebo + Vinorelbine + Trastuzumab
- param Type
- NUMBER
- population Description
- The Full Analysis Set (FAS) consisted of all randomized patients.
- reporting Status
- POSTED
- time Frame
- Every 6 weeks until disease progression or death which ever occurred first up to about 41 months
- title
- Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice