TriangleNCT00976989 · OUTCOME
Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events
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 Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)
What was measured
Percentage of participants with LVEF events without signs or symptoms of cardiac events.
Analysis population: Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.
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
Neoadjuvant Period (n=72, 75, 76)
| 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 | 4.0 | Not reported | Not reported | Not reported | Not reported |
| T+P Concomitant Non-Anthracycline Chemotherapy | 2.6 | Not reported | Not reported | Not reported | Not reported |
Adjuvant Period (n= 66, 64, 63)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | 3.0 | Not reported | Not reported | Not reported | Not reported |
| T+P Sequential Anthracycline-based Chemotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| T+P Concomitant Non-Anthracycline Chemotherapy | 4.8 | Not reported | Not reported | Not reported | Not reported |
Follow-up Period (n=21, 18, 23)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| T+P Sequential Anthracycline-based Chemotherapy | 11.1 | Not reported | Not reported | Not reported | Not reported |
| T+P Concomitant Non-Anthracycline Chemotherapy | 4.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5.6
- group Id
- OG001
- value
- 4.0
- group Id
- OG002
- value
- 2.6
- title
- Neoadjuvant Period (n=72, 75, 76)
- categories
- measurements
- group Id
- OG000
- value
- 3.0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4.8
- title
- Adjuvant Period (n= 66, 64, 63)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 11.1
- group Id
- OG002
- value
- 4.3
- title
- Follow-up Period (n=21, 18, 23)
- 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 events without signs or symptoms of cardiac events.
- 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 analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.
- reporting Status
- POSTED
- time Frame
- From baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)
- title
- Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice