NCT04439110 · OUTCOME
6 Months Progression-free Survival (PFS) Rate
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
- 90% Confidence Interval
- Time frame
- Assessed at baseline, then every 3 cycles for the first 33 cycles and every 4 cycles thereafter until disease progression, up to 3 years post registration
What was measured
Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.
Analysis population: Patients who were eligible and received protocol treatment
Groups in this outcome
Treatment (Trastuzumab Emtansine)
Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Trastuzumab Emtansine: Given IV
| Group | Source count |
|---|---|
| Treatment (Trastuzumab Emtansine) | 36 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Trastuzumab Emtansine) | 23.6 | Not reported | 14.2 | 39.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.2
- upper Limit
- 39.2
- value
- 23.6
- denoms
- counts
- group Id
- OG000
- value
- 36
- units
- Participants
- description
- Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Trastuzumab Emtansine: Given IV
- id
- OG000
- title
- Treatment (Trastuzumab Emtansine)
- param Type
- NUMBER
- population Description
- Patients who were eligible and received protocol treatment
- reporting Status
- POSTED
- time Frame
- Assessed at baseline, then every 3 cycles for the first 33 cycles and every 4 cycles thereafter until disease progression, up to 3 years post registration
- title
- 6 Months Progression-free Survival (PFS) Rate
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle