NCT00976989 · OUTCOME
Efficacy: Percentage of Participants Without an Overall Survival (OS) Event
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
- From baseline to end of study up to 5 years
What was measured
Overall survival (OS) was defined as the time from randomization to the date of death from any cause. Participants who were alive or lost to follow-up were censored at the last known alive date. Participants with no post-baseline information were censored at the date of randomization plus one day.
Analysis population: ITT population included all participants who were randomized to treatment.
Groups in this outcome
T+P Concomitant Anthracycline-based Chemotherapy
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
T+P Sequential Anthracycline-based Chemotherapy
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
T+P Concomitant Non-Anthracycline Chemotherapy
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
| Group | Source count |
|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | 73 |
| T+P Sequential Anthracycline-based Chemotherapy | 75 |
| T+P Concomitant Non-Anthracycline Chemotherapy | 77 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | 93.2 | Not reported | Not reported | Not reported | Not reported |
| T+P Sequential Anthracycline-based Chemotherapy | 90.7 | Not reported | Not reported | Not reported | Not reported |
| T+P Concomitant Non-Anthracycline Chemotherapy | 87.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 93.2
- group Id
- OG001
- value
- 90.7
- group Id
- OG002
- value
- 87.0
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 75
- group Id
- OG002
- value
- 77
- units
- Participants
- description
- Overall survival (OS) was defined as the time from randomization to the date of death from any cause. Participants who were alive or lost to follow-up were censored at the last known alive date. Participants with no post-baseline information were censored at the date of randomization plus one day.
- groups
- description
- 5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
- id
- OG000
- title
- T+P Concomitant Anthracycline-based Chemotherapy
- description
- FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
- id
- OG001
- title
- T+P Sequential Anthracycline-based Chemotherapy
- description
- Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
- id
- OG002
- title
- T+P Concomitant Non-Anthracycline Chemotherapy
- param Type
- NUMBER
- population Description
- ITT population included all participants who were randomized to treatment.
- reporting Status
- POSTED
- time Frame
- From baseline to end of study up to 5 years
- title
- Efficacy: Percentage of Participants Without an Overall Survival (OS) Event
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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