TriangleNCT01120184 · OUTCOME
Hospitalization Days
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- Full Range
- Time frame
- Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
What was measured
Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment. Reported values represent number of days admitted per participants.
Analysis population: Safety population. Number of participants analyzed=participants with hospitalization and data available for calculation of the parameter.
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 | 353 |
| Trastuzumab Emtansine + Placebo | 361 |
| Trastuzumab Emtansine + Pertuzumab | 366 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Taxane | 6 | Not reported | 1 | 50 | Not reported |
| Trastuzumab Emtansine + Placebo | 5 | Not reported | 1 | 117 | Not reported |
| Trastuzumab Emtansine + Pertuzumab | 8 | Not reported | 1 | 381 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 50
- value
- 6
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 117
- value
- 5
- group Id
- OG002
- lower Limit
- 1
- upper Limit
- 381
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 353
- group Id
- OG001
- value
- 361
- group Id
- OG002
- value
- 366
- units
- Participants
- description
- Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment. Reported values represent number of days admitted per participants.
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- Safety population. Number of participants analyzed=participants with hospitalization and data available for calculation of the parameter.
- reporting Status
- POSTED
- time Frame
- Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
- title
- Hospitalization Days
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice