TriangleNCT01120184 · OUTCOME
Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module
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
- At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2
What was measured
The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with diarrhea was calculated using following formula: \[number of participants with any level of either symptom divided by the number analyzed\] multiplied by 100.
Analysis population: ITT Population (Protocol Amendment C Subpopulation). Only participants with a FACT-C score at the designated visit (n) were included in the analysis.
Groups in this outcome
Trastuzumab + Taxane
Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
Trastuzumab Emtansine + Placebo
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
Trastuzumab Emtansine + Pertuzumab
Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
| Group | Source count |
|---|---|
| Trastuzumab + Taxane | 173 |
| Trastuzumab Emtansine + Placebo | 171 |
| Trastuzumab Emtansine + Pertuzumab | 154 |
Reported measurements
Diarrhea, Baseline (n=173,170,153)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Taxane | 15.0 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab Emtansine + Placebo | 7.6 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab Emtansine + Pertuzumab | 11.8 | Not reported | Not reported | Not reported | Not reported |
Diarrhea, Cycle 1 Day 8 (n=124,117,98)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Taxane | 34.7 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab Emtansine + Placebo | 17.9 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab Emtansine + Pertuzumab | 34.7 | Not reported | Not reported | Not reported | Not reported |
Diarrhea, Cycle 2 Day 1 (n=161,160,144)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Taxane | 24.2 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab Emtansine + Placebo | 11.3 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab Emtansine + Pertuzumab | 39.6 | Not reported | Not reported | Not reported | Not reported |
Diarrhea, Cycle 2 Day 8 (n=125,123,107)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Taxane | 34.4 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab Emtansine + Placebo | 8.1 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab Emtansine + Pertuzumab | 41.1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 15.0
- group Id
- OG001
- value
- 7.6
- group Id
- OG002
- value
- 11.8
- title
- Diarrhea, Baseline (n=173,170,153)
- categories
- measurements
- group Id
- OG000
- value
- 34.7
- group Id
- OG001
- value
- 17.9
- group Id
- OG002
- value
- 34.7
- title
- Diarrhea, Cycle 1 Day 8 (n=124,117,98)
- categories
- measurements
- group Id
- OG000
- value
- 24.2
- group Id
- OG001
- value
- 11.3
- group Id
- OG002
- value
- 39.6
- title
- Diarrhea, Cycle 2 Day 1 (n=161,160,144)
- categories
- measurements
- group Id
- OG000
- value
- 34.4
- group Id
- OG001
- value
- 8.1
- group Id
- OG002
- value
- 41.1
- title
- Diarrhea, Cycle 2 Day 8 (n=125,123,107)
- denoms
- counts
- group Id
- OG000
- value
- 173
- group Id
- OG001
- value
- 171
- group Id
- OG002
- value
- 154
- units
- Participants
- description
- The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with diarrhea was calculated using following formula: \[number of participants with any level of either symptom divided by the number analyzed\] multiplied by 100.
- groups
- description
- Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
- id
- OG000
- title
- Trastuzumab + Taxane
- description
- Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
- id
- OG001
- title
- Trastuzumab Emtansine + Placebo
- description
- Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
- id
- OG002
- title
- Trastuzumab Emtansine + Pertuzumab
- param Type
- NUMBER
- population Description
- ITT Population (Protocol Amendment C Subpopulation). Only participants with a FACT-C score at the designated visit (n) were included in the analysis.
- reporting Status
- POSTED
- time Frame
- At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2
- title
- Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice