TriangleNCT03258554 · OUTCOME
Competing Mortality (Percentage of Participants Who Died Due to Causes Other Than Study Cancer)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years.
What was measured
Failure is defined as Death from second primary, protocol treatment, or "other cause". Failure time is defined as time from randomization to first occurrence of failure, death due to study cancer or unknown cause (competing risk), or last follow-up (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided.
Analysis population: Randomized participants
Groups in this outcome
RT+ Cetuximab
IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
RT + Durvalumab
IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| RT+ Cetuximab | 63 |
| RT + Durvalumab | 123 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RT+ Cetuximab | 5.3 | Not reported | 1.4 | 13.4 | Not reported |
| RT + Durvalumab | 10.5 | Not reported | 5.7 | 17.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.57
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.38
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3201
- p Value Comment
- Two-sided significance level = 0.05
- param Type
- Hazard Ratio (HR)
- param Value
- 1.75
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.57
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.38
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3201
- p Value Comment
- Two-sided significance level = 0.05
- param Type
- Hazard Ratio (HR)
- param Value
- 1.75
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- 13.4
- value
- 5.3
- group Id
- OG001
- lower Limit
- 5.7
- upper Limit
- 17.0
- value
- 10.5
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 123
- units
- Participants
- description
- Failure is defined as Death from second primary, protocol treatment, or "other cause". Failure time is defined as time from randomization to first occurrence of failure, death due to study cancer or unknown cause (competing risk), or last follow-up (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- RT+ Cetuximab
- description
- IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- RT + Durvalumab
- param Type
- NUMBER
- population Description
- Randomized participants
- reporting Status
- POSTED
- time Frame
- From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years.
- title
- Competing Mortality (Percentage of Participants Who Died Due to Causes Other Than Study Cancer)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice