TriangleNCT04162873 · OUTCOME
The Number of Days From Surgery to the Initiation of Radiation and Adjuvant Therapy
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- days
- Interval / dispersion
- Standard Deviation
- Time frame
- up to 3 months
What was measured
The day of surgery will be considered day 0 and the number of days will be counted until the first dose of adjuvant radiation. This outcome measure will report the mean number of days from surgery to the initiation of radiation and adjuvant therapy for the Celecoxib and Placebo Arms.
Analysis population: Two participants in the Celecoxib Arm did not receive adjuvant radiation therapy and were not evaluable for this endpoint. One other participant from the Celecoxib Arm only received two doses of study treatment and was not evaluable for this endpoint. One participant in the Placebo Arm did not receive adjuvant radiation therapy and was not evaluable for this endpoint.
Groups in this outcome
Celecoxib Arm
Patients received celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Placebo Arm
Patients received placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Placebo: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
| Group | Source count |
|---|---|
| Celecoxib Arm | 2 |
| Placebo Arm | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Celecoxib Arm | 53.5 | 9.19 | Not reported | Not reported | Not reported |
| Placebo Arm | 60.17 | 20.04 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 9.19
- value
- 53.5
- group Id
- OG001
- spread
- 20.04
- value
- 60.17
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- The day of surgery will be considered day 0 and the number of days will be counted until the first dose of adjuvant radiation. This outcome measure will report the mean number of days from surgery to the initiation of radiation and adjuvant therapy for the Celecoxib and Placebo Arms.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients received celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- id
- OG000
- title
- Celecoxib Arm
- description
- Patients received placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Placebo: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- id
- OG001
- title
- Placebo Arm
- param Type
- MEAN
- population Description
- Two participants in the Celecoxib Arm did not receive adjuvant radiation therapy and were not evaluable for this endpoint. One other participant from the Celecoxib Arm only received two doses of study treatment and was not evaluable for this endpoint. One participant in the Placebo Arm did not receive adjuvant radiation therapy and was not evaluable for this endpoint.
- reporting Status
- POSTED
- time Frame
- up to 3 months
- title
- The Number of Days From Surgery to the Initiation of Radiation and Adjuvant Therapy
- type
- PRIMARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice