TriangleNCT01213472 · OUTCOME
Summary of Deaths Related to Progressive Disease of Cancer Under Study Reported After the Study Treatment, in the Period of Long-term Follow-up for Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- During the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.]
What was measured
Summary of deaths included death, autopsy performed and cause of death. Progression of the tumor was recorded in the clinical assessments. Death due to progressive disease was to be recorded on a specific form in the case report form but not as a serious adverse event (SAE). However, if the investigator considered that there was a causal relationship between the administration of the treatment or protocol design/procedures and the disease progression, then this must be reported as an SAE.
Analysis population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.
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 | 33 |
Reported measurements
Death, Yes
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NY-ESO 1 Group | 8 | Not reported | Not reported | Not reported | Not reported |
Death, No
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NY-ESO 1 Group | 25 | Not reported | Not reported | Not reported | Not reported |
Autopsy performed, Yes
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NY-ESO 1 Group | 0 | Not reported | Not reported | Not reported | Not reported |
Autopsy performed, No
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NY-ESO 1 Group | 6 | Not reported | Not reported | Not reported | Not reported |
Autopsy performed, Unknown
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NY-ESO 1 Group | 2 | Not reported | Not reported | Not reported | Not reported |
Cause of death, Disease under study (melanoma)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NY-ESO 1 Group | 8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- title
- Death, Yes
- categories
- measurements
- group Id
- OG000
- value
- 25
- title
- Death, No
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Autopsy performed, Yes
- categories
- measurements
- group Id
- OG000
- value
- 6
- title
- Autopsy performed, No
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Autopsy performed, Unknown
- categories
- measurements
- group Id
- OG000
- value
- 8
- title
- Cause of death, Disease under study (melanoma)
- denoms
- counts
- group Id
- OG000
- value
- 33
- units
- Participants
- description
- Summary of deaths included death, autopsy performed and cause of death. Progression of the tumor was recorded in the clinical assessments. Death due to progressive disease was to be recorded on a specific form in the case report form but not as a serious adverse event (SAE). However, if the investigator considered that there was a causal relationship between the administration of the treatment or protocol design/procedures and the disease progression, then this must be reported as an SAE.
- 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
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.
- reporting Status
- POSTED
- time Frame
- During the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.]
- title
- Summary of Deaths Related to Progressive Disease of Cancer Under Study Reported After the Study Treatment, in the Period of Long-term Follow-up for Survival
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice