TriangleNCT03521154 · OUTCOME
Objective Response Rate by Blinded Independent Central Review (BICR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- % of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Every 8 weeks for first 48 weeks, then every 12 weeks until radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
What was measured
Percentage of evaluable patients with at least one BICR assessed visit response of complete response (CR) or partial response (PR). CR defined as disappearance of all target lesions (TL) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm. PR defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline sum of diameters). Responses include both confirmed and unconfirmed BICR responses
Analysis population: Full analysis set
Groups in this outcome
Osimertinib
80mg once daily tablet
Placebo
Matching Placebo
| Group | Source count |
|---|---|
| Osimertinib | 143 |
| Placebo | 73 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib | 57.3 | Not reported | 48.8 | 65.6 | Not reported |
| Placebo | 32.9 | Not reported | 22.3 | 44.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.54
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.08
- estimate Comment
- An odds ratio \> 1 favours osimertinib
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 2.77
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 1.54
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.08
- estimate Comment
- An odds ratio \> 1 favours osimertinib
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 2.77
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 48.8
- upper Limit
- 65.6
- value
- 57.3
- group Id
- OG001
- lower Limit
- 22.3
- upper Limit
- 44.9
- value
- 32.9
- denoms
- counts
- group Id
- OG000
- value
- 143
- group Id
- OG001
- value
- 73
- units
- Participants
- description
- Percentage of evaluable patients with at least one BICR assessed visit response of complete response (CR) or partial response (PR). CR defined as disappearance of all target lesions (TL) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm. PR defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline sum of diameters). Responses include both confirmed and unconfirmed BICR responses
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 80mg once daily tablet
- id
- OG000
- title
- Osimertinib
- description
- Matching Placebo
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- Full analysis set
- reporting Status
- POSTED
- time Frame
- Every 8 weeks for first 48 weeks, then every 12 weeks until radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
- title
- Objective Response Rate by Blinded Independent Central Review (BICR)
- type
- SECONDARY
- unit Of Measure
- % of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice