TriangleNCT00976989 · OUTCOME
Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period
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 up to approximately 18 weeks
What was measured
Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of \<50% during the pre-operative (neoadjuvant) period.
Analysis population: Safety population included all participants who were randomized and received study drug.
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 | 72 |
| T+P Sequential Anthracycline-based Chemotherapy | 75 |
| T+P Concomitant Non-Anthracycline Chemotherapy | 76 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | 5.6 | Not reported | Not reported | Not reported | Not reported |
| T+P Sequential Anthracycline-based Chemotherapy | 5.3 | Not reported | Not reported | Not reported | Not reported |
| T+P Concomitant Non-Anthracycline Chemotherapy | 3.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5.6
- group Id
- OG001
- value
- 5.3
- group Id
- OG002
- value
- 3.9
- denoms
- counts
- group Id
- OG000
- value
- 72
- group Id
- OG001
- value
- 75
- group Id
- OG002
- value
- 76
- units
- Participants
- description
- Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of \<50% during the pre-operative (neoadjuvant) period.
- 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
- Safety population included all participants who were randomized and received study drug.
- reporting Status
- POSTED
- time Frame
- From baseline up to approximately 18 weeks
- title
- Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice