TriangleNCT01041404 · OUTCOME
Percentage of Participants With a Change in Analgesic Medication During the Study
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
Analgesic medications were recorded throughout the study until disease progression.
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
Taking any analgesic medication
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fluoropyrimidine/Cisplatin (FP) | 29.0 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 29.3 | Not reported | Not reported | Not reported | Not reported |
Discontinued at least 1 medication
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fluoropyrimidine/Cisplatin (FP) | 5.9 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 1.7 | Not reported | Not reported | Not reported | Not reported |
Decreased dose of at least 1 medication
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fluoropyrimidine/Cisplatin (FP) | 0.3 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 0.3 | Not reported | Not reported | Not reported | Not reported |
No change in any medication
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fluoropyrimidine/Cisplatin (FP) | 5.5 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 7.1 | Not reported | Not reported | Not reported | Not reported |
Increased dose or added at least 1 medication
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fluoropyrimidine/Cisplatin (FP) | 17.2 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 20.1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 29.0
- group Id
- OG001
- value
- 29.3
- title
- Taking any analgesic medication
- categories
- measurements
- group Id
- OG000
- value
- 5.9
- group Id
- OG001
- value
- 1.7
- title
- Discontinued at least 1 medication
- categories
- measurements
- group Id
- OG000
- value
- 0.3
- group Id
- OG001
- value
- 0.3
- title
- Decreased dose of at least 1 medication
- categories
- measurements
- group Id
- OG000
- value
- 5.5
- group Id
- OG001
- value
- 7.1
- title
- No change in any medication
- categories
- measurements
- group Id
- OG000
- value
- 17.2
- group Id
- OG001
- value
- 20.1
- title
- Increased dose or added at least 1 medication
- denoms
- counts
- group Id
- OG000
- value
- 290
- group Id
- OG001
- value
- 294
- units
- Participants
- description
- Analgesic medications were recorded throughout the study until disease progression.
- 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 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 a Change in Analgesic Medication During the Study
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice