TriangleNCT00597116 · OUTCOME
Number of Participants With Disease Control.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Assessed at 2 months.
What was measured
Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD.
Analysis population: Only patients in the evaluable for efficacy population were included.It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles(unless progressive disease occurred at cycle 1)and who had at least one post-treatment tumour assessment.
Groups in this outcome
Vandetanib
Vandetanib 300 mg/day oral
Vinorelbine
Vinorelbine 30 mg/m2 iv, administrated weekly
| Group | Source count |
|---|---|
| Vandetanib | 12 |
| Vinorelbine | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vandetanib | 0 | Not reported | 0 | 0 | Not reported |
| Vinorelbine | 5 | Not reported | 0 | 0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 10
- units
- Participants
- description
- Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD.
- groups
- description
- Vandetanib 300 mg/day oral
- id
- OG000
- title
- Vandetanib
- description
- Vinorelbine 30 mg/m2 iv, administrated weekly
- id
- OG001
- title
- Vinorelbine
- param Type
- NUMBER
- population Description
- Only patients in the evaluable for efficacy population were included.It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles(unless progressive disease occurred at cycle 1)and who had at least one post-treatment tumour assessment.
- reporting Status
- POSTED
- time Frame
- Assessed at 2 months.
- title
- Number of Participants With Disease Control.
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice