TriangleNCT03734016 · OUTCOME
Overall Response Rate (ORR) Assessed by the Investigator
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 the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
What was measured
ORR is defined as the percentage of participants with a complete response (CR) / complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) per investigator assessment. Disease response was assessed in accordance with the 2008 criteria of the International Workshop on CLL (IWCLL), with modification for treatment-related lymphocytosis in participants with CLL and in accordance with the Lugano classification in participants with SLL.
Analysis population: Intent To Treat (ITT) Analysis Set
Groups in this outcome
Zanubrutinib
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
Ibrutinib
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
| Group | Source count |
|---|---|
| Zanubrutinib | 327 |
| Ibrutinib | 325 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zanubrutinib | 83.5 | Not reported | 79.0 | 87.3 | Not reported |
| Ibrutinib | 74.2 | Not reported | 69.0 | 78.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.04
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.22
- estimate Comment
- Response ratio is the estimated ratio of the overall response rate of the zanubrutinib arm divided by that of the ibrutinib arm.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Non-inferiority testing for ORR was performed using a stratified Wald test based on the stratified Mantel-Haenszel response ratio estimate against the non-inferiority margin of 0.8558 on the log scale.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- <0.0001
- param Type
- Response ratio
- param Value
- 1.12
- statistical Comment
- Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)
- statistical Method
- Stratified Wald test
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0035
- p Value Comment
- Superiority testing was performed using a 2-sided stratified Cochran-Mantel-Haenszel test.
- statistical Comment
- Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.04
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.22
- estimate Comment
- Response ratio is the estimated ratio of the overall response rate of the zanubrutinib arm divided by that of the ibrutinib arm.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Non-inferiority testing for ORR was performed using a stratified Wald test based on the stratified Mantel-Haenszel response ratio estimate against the non-inferiority margin of 0.8558 on the log scale.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- <0.0001
- param Type
- Response ratio
- param Value
- 1.12
- statistical Comment
- Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)
- statistical Method
- Stratified Wald test
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0035
- p Value Comment
- Superiority testing was performed using a 2-sided stratified Cochran-Mantel-Haenszel test.
- statistical Comment
- Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 79.0
- upper Limit
- 87.3
- value
- 83.5
- group Id
- OG001
- lower Limit
- 69.0
- upper Limit
- 78.8
- value
- 74.2
- denoms
- counts
- group Id
- OG000
- value
- 327
- group Id
- OG001
- value
- 325
- units
- Participants
- description
- ORR is defined as the percentage of participants with a complete response (CR) / complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) per investigator assessment. Disease response was assessed in accordance with the 2008 criteria of the International Workshop on CLL (IWCLL), with modification for treatment-related lymphocytosis in participants with CLL and in accordance with the Lugano classification in participants with SLL.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
- id
- OG000
- title
- Zanubrutinib
- description
- Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
- id
- OG001
- title
- Ibrutinib
- param Type
- NUMBER
- population Description
- Intent To Treat (ITT) Analysis Set
- reporting Status
- POSTED
- time Frame
- From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
- title
- Overall Response Rate (ORR) Assessed by the Investigator
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice