TriangleNCT03206970 · OUTCOME
Overall Response Rate (ORR) As Assessed By Independent Review Committee
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 1 year and 11 months
What was measured
The ORR was assessed in accordance with the 2014 modification of the International Working Group on non-Hodgkin Lymphoma Criteria. The ORR was defined as the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR). The BOR was defined as the best response recorded from the start of zanubrutinib until data cut or start of new antineoplastic treatment. Participants with no post-baseline response assessment (due to any reason) were considered non-responders for BOR.
Analysis population: Safety Analysis Set: All participants who received any dose of study drug.
Groups in this outcome
Zanubrutinib
Zanubrutinib (160 mg) administered BID until disease progression, unacceptable toxicity or death, withdrawal of consent, lost to follow up, or study termination by sponsor, which comes first.
| Group | Source count |
|---|---|
| Zanubrutinib | 86 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zanubrutinib | 72 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 74.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 90.8
- group Description
- A binomial exact test was performed to test against the null hypothesis H0: ORR=0.40 using the significant level of 0.025 (1-sided)
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- <.0001
- param Type
- Clopper-Pearson
- param Value
- 83.7
- statistical Method
- Binomial Exact Test
Complete source fields
- analyses
- ci Lower Limit
- 74.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 90.8
- group Description
- A binomial exact test was performed to test against the null hypothesis H0: ORR=0.40 using the significant level of 0.025 (1-sided)
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- <.0001
- param Type
- Clopper-Pearson
- param Value
- 83.7
- statistical Method
- Binomial Exact Test
- classes
- categories
- measurements
- group Id
- OG000
- value
- 72
- denoms
- counts
- group Id
- OG000
- value
- 86
- units
- Participants
- description
- The ORR was assessed in accordance with the 2014 modification of the International Working Group on non-Hodgkin Lymphoma Criteria. The ORR was defined as the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR). The BOR was defined as the best response recorded from the start of zanubrutinib until data cut or start of new antineoplastic treatment. Participants with no post-baseline response assessment (due to any reason) were considered non-responders for BOR.
- groups
- description
- Zanubrutinib (160 mg) administered BID until disease progression, unacceptable toxicity or death, withdrawal of consent, lost to follow up, or study termination by sponsor, which comes first.
- id
- OG000
- title
- Zanubrutinib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Analysis Set: All participants who received any dose of study drug.
- reporting Status
- POSTED
- time Frame
- Up to 1 year and 11 months
- title
- Overall Response Rate (ORR) As Assessed By Independent Review Committee
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice