TriangleNCT01041404 · OUTCOME
Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight
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
- BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
What was measured
Change in body weight was categorized as an increase of greater than (\>)5 percent (%), no change (plus or minus \[±\]5%), decrease of \>5-10%, or a decrease of \>10% from BL to the end of study. Time windows were applied in order to assign visits to weight measurements, and the lowest post-screening value recorded was used for the analysis. The percentage change in weight from screening was summarized over time.
Analysis population: FAS. 273 and 283 participants were analyzed in the Fluoropyrimidine, Cisplatin and Trastuzumab, Fluoropyrimidine, Cisplatin groups, respectively.
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) | 273 |
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 283 |
Reported measurements
Increase >5%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fluoropyrimidine/Cisplatin (FP) | 1.5 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 1.1 | Not reported | Not reported | Not reported | Not reported |
No change (±5%)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fluoropyrimidine/Cisplatin (FP) | 51.6 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 50.5 | Not reported | Not reported | Not reported | Not reported |
Decrease >5-10%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fluoropyrimidine/Cisplatin (FP) | 28.2 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 27.2 | Not reported | Not reported | Not reported | Not reported |
Decrease >10%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fluoropyrimidine/Cisplatin (FP) | 18.7 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 21.2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1.5
- group Id
- OG001
- value
- 1.1
- title
- Increase >5%
- categories
- measurements
- group Id
- OG000
- value
- 51.6
- group Id
- OG001
- value
- 50.5
- title
- No change (±5%)
- categories
- measurements
- group Id
- OG000
- value
- 28.2
- group Id
- OG001
- value
- 27.2
- title
- Decrease >5-10%
- categories
- measurements
- group Id
- OG000
- value
- 18.7
- group Id
- OG001
- value
- 21.2
- title
- Decrease >10%
- denoms
- counts
- group Id
- OG000
- value
- 273
- group Id
- OG001
- value
- 283
- units
- Participants
- description
- Change in body weight was categorized as an increase of greater than (\>)5 percent (%), no change (plus or minus \[±\]5%), decrease of \>5-10%, or a decrease of \>10% from BL to the end of study. Time windows were applied in order to assign visits to weight measurements, and the lowest post-screening value recorded was used for the analysis. The percentage change in weight from screening was summarized over time.
- 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. 273 and 283 participants were analyzed in the Fluoropyrimidine, Cisplatin and Trastuzumab, Fluoropyrimidine, Cisplatin groups, respectively.
- reporting Status
- POSTED
- time Frame
- BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
- title
- Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice