TriangleNCT04035486 · OUTCOME
Depth of Response (Percent Change From Baseline in Tumor Diameter) (Randomized Component)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Percent change from baseline
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 33 months after the first patient is randomized.
What was measured
Depth of Response (percent change from Baseline in tumor diameter) is defined as the relative percent change in the sum of the longest diameters of RECIST 1.1 target lesions (TL) at the nadir in the absence of new lesions or progression of non-target lesions (NTL) compared to baseline. The best percentage change in TL size is the maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction. Tumor assessments of the chest and abdomen (including the entire liver and both adrenal glands) were performed using RECIST 1.1 by the investigator on images from CT (preferred) or MRI with IV contrast.
Analysis population: Full Analysis Set, includes all randomized participants.
Groups in this outcome
Randomized: AZD9291 + Chemo
Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W
Randomized: AZD9291
Osimertinib (AZD9291) 80mg QD.
| Group | Source count |
|---|---|
| Randomized: AZD9291 + Chemo | 275 |
| Randomized: AZD9291 | 276 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomized: AZD9291 + Chemo | -50.77 | Not reported | -53.75 | -47.78 | Not reported |
| Randomized: AZD9291 | -47.41 | Not reported | -50.39 | -44.43 | Not reported |
Source statistical analyses
- ci Lower Limit
- -7.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.72
- estimate Comment
- A difference in least square means less than 0 favors the Osimertinib (AZD9291) + Chemo treatment arm.
- group Description
- The analysis was performed using analysis of covariance with baseline tumor size and time from baseline scan to randomization as covariates and with factors race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1067
- param Type
- Least Square Mean Difference
- param Value
- -3.36
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Lower Limit
- -7.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.72
- estimate Comment
- A difference in least square means less than 0 favors the Osimertinib (AZD9291) + Chemo treatment arm.
- group Description
- The analysis was performed using analysis of covariance with baseline tumor size and time from baseline scan to randomization as covariates and with factors race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1067
- param Type
- Least Square Mean Difference
- param Value
- -3.36
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -53.75
- upper Limit
- -47.78
- value
- -50.77
- group Id
- OG001
- lower Limit
- -50.39
- upper Limit
- -44.43
- value
- -47.41
- denoms
- counts
- group Id
- OG000
- value
- 275
- group Id
- OG001
- value
- 276
- units
- Participants
- description
- Depth of Response (percent change from Baseline in tumor diameter) is defined as the relative percent change in the sum of the longest diameters of RECIST 1.1 target lesions (TL) at the nadir in the absence of new lesions or progression of non-target lesions (NTL) compared to baseline. The best percentage change in TL size is the maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction. Tumor assessments of the chest and abdomen (including the entire liver and both adrenal glands) were performed using RECIST 1.1 by the investigator on images from CT (preferred) or MRI with IV contrast.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W
- id
- OG000
- title
- Randomized: AZD9291 + Chemo
- description
- Osimertinib (AZD9291) 80mg QD.
- id
- OG001
- title
- Randomized: AZD9291
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Full Analysis Set, includes all randomized participants.
- reporting Status
- POSTED
- time Frame
- Up to approximately 33 months after the first patient is randomized.
- title
- Depth of Response (Percent Change From Baseline in Tumor Diameter) (Randomized Component)
- type
- SECONDARY
- unit Of Measure
- Percent change from baseline
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice