TriangleNCT01041404 · OUTCOME
Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)
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
- BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
What was measured
For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.
Analysis population: FAS
Groups in this outcome
Fluoropyrimidine/Cisplatin (FP)
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
| Group | Source count |
|---|---|
| Fluoropyrimidine/Cisplatin (FP) | 290 |
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 294 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fluoropyrimidine/Cisplatin (FP) | 34.5 | Not reported | 29.0 | 40.3 | Not reported |
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 47.3 | Not reported | 41.5 | 53.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 4.7
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 20.9
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0017
- param Type
- Difference in Response Rates
- param Value
- 12.80
- statistical Method
- Chi-squared
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 4.7
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 20.9
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0017
- param Type
- Difference in Response Rates
- param Value
- 12.80
- statistical Method
- Chi-squared
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29.0
- upper Limit
- 40.3
- value
- 34.5
- group Id
- OG001
- lower Limit
- 41.5
- upper Limit
- 53.2
- value
- 47.3
- denoms
- counts
- group Id
- OG000
- value
- 290
- group Id
- OG001
- value
- 294
- units
- Participants
- description
- For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
- id
- OG000
- title
- Fluoropyrimidine/Cisplatin (FP)
- description
- Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
- id
- OG001
- title
- Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
- param Type
- NUMBER
- population Description
- FAS
- reporting Status
- POSTED
- time Frame
- BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
- title
- Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice