TriangleNCT02610140 · OUTCOME
Percentage of Participants With Confirmed Improvement of Symptoms Characteristic of Mesothelioma
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
- 95% Confidence Interval
- Time frame
- up to approx. 30 months (data cut-off: 31-May-2017)
What was measured
Improvement rate of symptoms characteristic of mesothelioma was defined as the number of patients with confirmed improvement of symptoms characteristic of mesothelioma (based on the MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma, MDASI-MPM), divided by the number of patients evaluable for improvement of symptoms characteristic of mesothelioma.
Analysis population: The secondary efficacy analysis was performed in the ITT (Intent-to-treat) analysis set.
Groups in this outcome
Anetumab Ravtansine
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
Vinorelbine
Active comparator: 30 mg/m\^2 once weekly
| Group | Source count |
|---|---|
| Anetumab Ravtansine | 166 |
| Vinorelbine | 82 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anetumab Ravtansine | 22.5 | Not reported | 15.1 | 31.4 | Not reported |
| Vinorelbine | 17.9 | Not reported | 8.9 | 30.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- -8.20
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.51
- group Description
- Anetumab ravtansine versus vinorelbine
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.244
- param Type
- Difference (%) improvement rate symptoms
- param Value
- 4.65
- statistical Comment
- 1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -8.20
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.51
- group Description
- Anetumab ravtansine versus vinorelbine
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.244
- param Type
- Difference (%) improvement rate symptoms
- param Value
- 4.65
- statistical Comment
- 1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.1
- upper Limit
- 31.4
- value
- 22.5
- group Id
- OG001
- lower Limit
- 8.9
- upper Limit
- 30.4
- value
- 17.9
- denoms
- counts
- group Id
- OG000
- value
- 166
- group Id
- OG001
- value
- 82
- units
- Participants
- description
- Improvement rate of symptoms characteristic of mesothelioma was defined as the number of patients with confirmed improvement of symptoms characteristic of mesothelioma (based on the MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma, MDASI-MPM), divided by the number of patients evaluable for improvement of symptoms characteristic of mesothelioma.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
- id
- OG000
- title
- Anetumab Ravtansine
- description
- Active comparator: 30 mg/m\^2 once weekly
- id
- OG001
- title
- Vinorelbine
- param Type
- NUMBER
- population Description
- The secondary efficacy analysis was performed in the ITT (Intent-to-treat) analysis set.
- reporting Status
- POSTED
- time Frame
- up to approx. 30 months (data cut-off: 31-May-2017)
- title
- Percentage of Participants With Confirmed Improvement of Symptoms Characteristic of Mesothelioma
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice