TriangleNCT02610140 · OUTCOME
Time to Worsening of Pain
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- up to approx. 30 months (data cut-off: 31-May-2017)
What was measured
Time to worsening of pain (TTWP) was defined in patients evaluable for assessing worsening of pain, as time from randomization until the first worsening of pain. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of pain were censored at the date of their last MDASI-MPM assessment with a non-missing pain score.
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 | 210 | Not reported | 127 | NA | value cannot be estimated due to censored data |
| Vinorelbine | NA | Not reported | 85 | NA | value cannot be estimated due to censored data |
Source statistical analyses
- ci Lower Limit
- 0.557
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.533
- group Description
- Anetumab ravtansine versus vinorelbine
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.378916
- param Type
- Hazard Ratio (HR)
- param Value
- 0.924
- statistical Comment
- one-sided log-rank test stratified by time to progression (TTP) on first line treatment
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.557
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.533
- group Description
- Anetumab ravtansine versus vinorelbine
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.378916
- param Type
- Hazard Ratio (HR)
- param Value
- 0.924
- statistical Comment
- one-sided log-rank test stratified by time to progression (TTP) on first line treatment
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- value cannot be estimated due to censored data
- group Id
- OG000
- lower Limit
- 127
- upper Limit
- NA
- value
- 210
- comment
- value cannot be estimated due to censored data
- group Id
- OG001
- lower Limit
- 85
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 166
- group Id
- OG001
- value
- 82
- units
- Participants
- description
- Time to worsening of pain (TTWP) was defined in patients evaluable for assessing worsening of pain, as time from randomization until the first worsening of pain. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of pain were censored at the date of their last MDASI-MPM assessment with a non-missing pain score.
- 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
- MEDIAN
- 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
- Time to Worsening of Pain
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice