TriangleNCT01380145 · OUTCOME
Assessment of Survival and Time to Subsequent Therapy
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
- Continuously on study and for up to 5 years post-study
What was measured
Progression-free survival (PFS) was calculated as the date from first immunization to first observation of disease progression or death due to any cause, censored on the start date of subsequent therapy or at the last date of disease assessment for subjects without a PFS event. Overall survival (OS) was calculated as the date from first immunization to death due to any cause, censored at the date of last follow-up for subjects who were alive at the time of the analysis. Time to subsequent therapy was calculated as the date from first immunization to start of subsequent therapy for myeloma, censored at the date of death or last follow-up for subjects who did not receive subsequent therapy.
Analysis population: The Evaluable Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.
Groups in this outcome
Evaluable Analysis Set
Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.
| Group | Source count |
|---|---|
| Evaluable Analysis Set | 13 |
Reported measurements
Median PFS using the Kaplan-Meier Method
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Evaluable Analysis Set | 751 | Not reported | 379 | NA | Upper limit of the confidence interval was not reached. |
Median OS using the Kaplan-Meier Method
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Evaluable Analysis Set | 829 | Not reported | 829 | NA | Upper limit of the confidence interval was not reached. |
Median Time to Subsequent Therapy using Kaplan-Meier Method
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Evaluable Analysis Set | 805 | Not reported | 414 | NA | Upper limit of the confidence interval was not reached. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of the confidence interval was not reached.
- group Id
- OG000
- lower Limit
- 379
- upper Limit
- NA
- value
- 751
- title
- Median PFS using the Kaplan-Meier Method
- categories
- measurements
- comment
- Upper limit of the confidence interval was not reached.
- group Id
- OG000
- lower Limit
- 829
- upper Limit
- NA
- value
- 829
- title
- Median OS using the Kaplan-Meier Method
- categories
- measurements
- comment
- Upper limit of the confidence interval was not reached.
- group Id
- OG000
- lower Limit
- 414
- upper Limit
- NA
- value
- 805
- title
- Median Time to Subsequent Therapy using Kaplan-Meier Method
- denoms
- counts
- group Id
- OG000
- value
- 13
- units
- Participants
- description
- Progression-free survival (PFS) was calculated as the date from first immunization to first observation of disease progression or death due to any cause, censored on the start date of subsequent therapy or at the last date of disease assessment for subjects without a PFS event. Overall survival (OS) was calculated as the date from first immunization to death due to any cause, censored at the date of last follow-up for subjects who were alive at the time of the analysis. Time to subsequent therapy was calculated as the date from first immunization to start of subsequent therapy for myeloma, censored at the date of death or last follow-up for subjects who did not receive subsequent therapy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.
- id
- OG000
- title
- Evaluable Analysis Set
- param Type
- MEDIAN
- population Description
- The Evaluable Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.
- reporting Status
- POSTED
- time Frame
- Continuously on study and for up to 5 years post-study
- title
- Assessment of Survival and Time to Subsequent Therapy
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice