TriangleNCT01772472 · OUTCOME
Percentage of Participants With Cardiac Events as Adjudicated by the Cardiac Review Committee
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
- Up to approximately 126 months
What was measured
Cardiac events were defined as death from cardiac cause or severe congestive heart failure (New York Heart Association \[NYHA\] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of 10 percentage points or more from baseline to an LVEF of \< 50%. Other cardiac-related events (e.g., any symptomatic congestive heart failure \[CHF\] associated with a 10% drop in LVEF to \< 50%; asymptomatic declines in LVEF requiring dose delay) were summarized as adjudicated by the Cardiac Review Committee. Percentages have been rounded off.
Analysis population: SE population included all randomized participants who received any amount of study treatment.
Groups in this outcome
Trastuzumab
Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
Trastuzumab Emtansine
Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
| Group | Source count |
|---|---|
| Trastuzumab | 720 |
| Trastuzumab Emtansine | 740 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab | 4.2 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab Emtansine | 3.1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4.2
- group Id
- OG001
- value
- 3.1
- denoms
- counts
- group Id
- OG000
- value
- 720
- group Id
- OG001
- value
- 740
- units
- Participants
- description
- Cardiac events were defined as death from cardiac cause or severe congestive heart failure (New York Heart Association \[NYHA\] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of 10 percentage points or more from baseline to an LVEF of \< 50%. Other cardiac-related events (e.g., any symptomatic congestive heart failure \[CHF\] associated with a 10% drop in LVEF to \< 50%; asymptomatic declines in LVEF requiring dose delay) were summarized as adjudicated by the Cardiac Review Committee. Percentages have been rounded off.
- groups
- description
- Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
- id
- OG000
- title
- Trastuzumab
- description
- Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
- id
- OG001
- title
- Trastuzumab Emtansine
- param Type
- NUMBER
- population Description
- SE population included all randomized participants who received any amount of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to approximately 126 months
- title
- Percentage of Participants With Cardiac Events as Adjudicated by the Cardiac Review Committee
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice