TriangleNCT02516241 · OUTCOME
Disease Control Rate (DCR) at 12 Months, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
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
- Not reported
- Time frame
- Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020)
What was measured
Disease control rate (DCR) at 12 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 48 weeks (-7 days, i.e., 329 days), following the start of study treatment.
Analysis population: Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.
Groups in this outcome
Combination Therapy
MEDI4736 (Durvalumab) + Tremelimumab
Monotherapy
MEDI4736 (Durvalumab)
Standard of Care
Standard of Care Chemotherapy Treatment
| Group | Source count |
|---|---|
| Combination Therapy | 342 |
| Monotherapy | 346 |
| Standard of Care | 344 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Therapy | 38.0 | Not reported | Not reported | Not reported | Not reported |
| Monotherapy | 28.0 | Not reported | Not reported | Not reported | Not reported |
| Standard of Care | 50.6 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.432
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.802
- estimate Comment
- The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0008
- p Value Comment
- P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
- param Type
- Odds Ratio (OR)
- param Value
- 0.59
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.270
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.512
- estimate Comment
- The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
- param Type
- Odds Ratio (OR)
- param Value
- 0.37
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 0.432
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.802
- estimate Comment
- The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0008
- p Value Comment
- P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
- param Type
- Odds Ratio (OR)
- param Value
- 0.59
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 0.270
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.512
- estimate Comment
- The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
- param Type
- Odds Ratio (OR)
- param Value
- 0.37
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- value
- 38.0
- group Id
- OG001
- value
- 28.0
- group Id
- OG002
- value
- 50.6
- denoms
- counts
- group Id
- OG000
- value
- 342
- group Id
- OG001
- value
- 346
- group Id
- OG002
- value
- 344
- units
- Participants
- description
- Disease control rate (DCR) at 12 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 48 weeks (-7 days, i.e., 329 days), following the start of study treatment.
- groups
- description
- MEDI4736 (Durvalumab) + Tremelimumab
- id
- OG000
- title
- Combination Therapy
- description
- MEDI4736 (Durvalumab)
- id
- OG001
- title
- Monotherapy
- description
- Standard of Care Chemotherapy Treatment
- id
- OG002
- title
- Standard of Care
- param Type
- NUMBER
- population Description
- Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.
- reporting Status
- POSTED
- time Frame
- Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020)
- title
- Disease Control Rate (DCR) at 12 Months, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice