TriangleNCT04035486 · OUTCOME
Duration of Response (DoR) (Safety Run-In Treatment Arms Only)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Months
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to 45 months
What was measured
Duration of response (DoR) is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression or death in the absence of disease progression (i.e. date of progression free survival event or censoring - date of first response + 1). The end of response should coincide with the date of progression or death from any cause used for the progression free survival endpoint. The time of the initial response is defined as the latest of the dates contributing towards the first visit that was Complete response or Partial response that was subsequently confirmed. Per the protocol, the safety run-in treatment arms were combined and analyzed regardless of chemotherapy received for consistency with the randomized component.
Analysis population: Participants from the Safety Analysis Set, which includes all participants in the Safety Run-In Treatment Arms who received at least 1 dose of study treatment (osimertinib, cisplatin, carboplatin, or pemetrexed), that had a confirmed response.
Groups in this outcome
Overall Safety Run-In Participants
Includes all participants in both Safety Run-In treatment arms: AZD9291 + Carboplatin + Pemetrexed and AZD9291 + Cisplatin + Pemetrexed
| Group | Source count |
|---|---|
| Overall Safety Run-In Participants | 26 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Overall Safety Run-In Participants | 27.5 | 13.48 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 13.48
- value
- 27.5
- denoms
- counts
- group Id
- OG000
- value
- 26
- units
- Participants
- description
- Duration of response (DoR) is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression or death in the absence of disease progression (i.e. date of progression free survival event or censoring - date of first response + 1). The end of response should coincide with the date of progression or death from any cause used for the progression free survival endpoint. The time of the initial response is defined as the latest of the dates contributing towards the first visit that was Complete response or Partial response that was subsequently confirmed. Per the protocol, the safety run-in treatment arms were combined and analyzed regardless of chemotherapy received for consistency with the randomized component.
- dispersion Type
- Standard Deviation
- groups
- description
- Includes all participants in both Safety Run-In treatment arms: AZD9291 + Carboplatin + Pemetrexed and AZD9291 + Cisplatin + Pemetrexed
- id
- OG000
- title
- Overall Safety Run-In Participants
- param Type
- MEAN
- population Description
- Participants from the Safety Analysis Set, which includes all participants in the Safety Run-In Treatment Arms who received at least 1 dose of study treatment (osimertinib, cisplatin, carboplatin, or pemetrexed), that had a confirmed response.
- reporting Status
- POSTED
- time Frame
- Up to 45 months
- title
- Duration of Response (DoR) (Safety Run-In Treatment Arms Only)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice