TriangleNCT01213472 · OUTCOME
The Duration of Response for Patients With CR, PR or Stable Disease (SD) Status
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)
What was measured
The duration of response was measured from the time when the measurement criteria for CR/PR (whichever was recorded first) or SD evaluation were met until the first date that first PD or death was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started). Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the sum of LD of target lesions recorded previously but not necessarily at baseline (The minimal time interval required between two measurements for determination of SD was at least 16 weeks.). The analysis was not performed as initially planned.
Analysis population: As study development was stopped earlier and decision was taken not to perform further testing on biological samples already collected, except if a scientific rationale remained relevant, analyses on Duration of Response for Patients With CR, PR or SD Status, as required in this outcome, were not performed.
Groups in this outcome
NY-ESO 1 Group
Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
| Group | Source count |
|---|---|
| NY-ESO 1 Group | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- The duration of response was measured from the time when the measurement criteria for CR/PR (whichever was recorded first) or SD evaluation were met until the first date that first PD or death was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started). Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the sum of LD of target lesions recorded previously but not necessarily at baseline (The minimal time interval required between two measurements for determination of SD was at least 16 weeks.). The analysis was not performed as initially planned.
- groups
- description
- Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
- id
- OG000
- title
- NY-ESO 1 Group
- population Description
- As study development was stopped earlier and decision was taken not to perform further testing on biological samples already collected, except if a scientific rationale remained relevant, analyses on Duration of Response for Patients With CR, PR or SD Status, as required in this outcome, were not performed.
- reporting Status
- POSTED
- time Frame
- From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)
- title
- The Duration of Response for Patients With CR, PR or Stable Disease (SD) Status
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice