NCT04439110 · OUTCOME
Objective Response Rate (ORR)
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
- Tumor assessments occurred 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
ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among eligible and treated patients. Objective response rate is defined consistent with 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. For each treatment arm, 90% two-sided binomial exact confidence interval will be calculated for ORR.
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) | 2 | Not reported | 1 | 16.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 16.5
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 36
- units
- Participants
- description
- ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among eligible and treated patients. Objective response rate is defined consistent with 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. For each treatment arm, 90% two-sided binomial exact confidence interval will be calculated for ORR.
- 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
- Tumor assessments occurred 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
- Objective Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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