TriangleNCT01213472 · OUTCOME
Number of Patients With Serious Adverse Events (SAEs) That Are Causally Related to Treatment Administration by Maximum Grade
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 study treatment period (maximum duration = 49 months).
What was measured
A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient, is a grade 4 AE according to the Common Terminology Criteria for Adverse Events (CTCAE, v 4.0), in addition, in this study, Grade 3 or higher pIMDs will be considered as medically significant and will therefore be notified as SAE. No serious adverse events were reported during the study period that are causally related to treatment administration by maximum grade.
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NY-ESO 1 Group | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 33
- units
- Participants
- description
- A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient, is a grade 4 AE according to the Common Terminology Criteria for Adverse Events (CTCAE, v 4.0), in addition, in this study, Grade 3 or higher pIMDs will be considered as medically significant and will therefore be notified as SAE. No serious adverse events were reported during the study period that are causally related to treatment administration by maximum grade.
- 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 study treatment period (maximum duration = 49 months).
- title
- Number of Patients With Serious Adverse Events (SAEs) That Are Causally Related to Treatment Administration by Maximum Grade
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice