TriangleNCT02610777 · OUTCOME
Percentage of Participants With Overall Response
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
- From date of randomization until CR, PR, or hematologic improvement (HI) (up to approximately 5 years)
What was measured
Disease responses (HR MDS/CMML): modified IWG criteria for MDS; low-blast (LB) AML: revised IWG criteria for AML. Overall response(HR MDS/CMML)=CR,PR/HI,LB AML=CR+ CR with incomplete blood count recovery(Cri)+PR.HR MDS/CMML-CR:\<=5%myeloblasts with normal maturation of bone marrow (BM) cell lines,\>=11g/dL Hb,\>=100\*10\^9/L plt,\>=1.0\*10\^9/L ANC,0% blasts in peripheral blood; PR:CR criteria met except BM blasts\>=50%less over pretreatment but still\>5%; HI:hb increase (inc)\>=1.5g/dL if baseline\<11g/dL;plt inc\>=30\*10\^9/L if baseline\>20\*10\^9/L/Inc. from \<20\*10\^9/L-\>20\*10\^9/L, ANC inc. by 100%;absolute inc. of\>0.5\*10\^9/L if baseline\<100\*10\^9/L. LB AML-CR:morphologic leukemia-freestate\>1.0\*10\^9ANC,\>=100\*10\^9/L plt, transfusion independence, no residual evidence of extramedullary leukemia;CRi:fulfill CR criteria except residual neutropenia\<1.0\*10\^9/L/TTP\<100\*10\^9/L;PR:all CR hematological values but\>=50%less in BM aspirate. The percentages are rounded off to report the nearest whole numbers.
Analysis population: REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment.
Groups in this outcome
Azacitidine 75 mg/m^2
Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
| Group | Source count |
|---|---|
| Azacitidine 75 mg/m^2 | 53 |
| Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | 62 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | 71 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -9.09
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 26.38
- estimate Comment
- Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.343
- p Value Comment
- P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.
- param Type
- Absolute Rate Difference
- param Value
- 8.64
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -9.09
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 26.38
- estimate Comment
- Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.343
- p Value Comment
- P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.
- param Type
- Absolute Rate Difference
- param Value
- 8.64
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 71
- denoms
- counts
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 55
- units
- Participants
- description
- Disease responses (HR MDS/CMML): modified IWG criteria for MDS; low-blast (LB) AML: revised IWG criteria for AML. Overall response(HR MDS/CMML)=CR,PR/HI,LB AML=CR+ CR with incomplete blood count recovery(Cri)+PR.HR MDS/CMML-CR:\<=5%myeloblasts with normal maturation of bone marrow (BM) cell lines,\>=11g/dL Hb,\>=100\*10\^9/L plt,\>=1.0\*10\^9/L ANC,0% blasts in peripheral blood; PR:CR criteria met except BM blasts\>=50%less over pretreatment but still\>5%; HI:hb increase (inc)\>=1.5g/dL if baseline\<11g/dL;plt inc\>=30\*10\^9/L if baseline\>20\*10\^9/L/Inc. from \<20\*10\^9/L-\>20\*10\^9/L, ANC inc. by 100%;absolute inc. of\>0.5\*10\^9/L if baseline\<100\*10\^9/L. LB AML-CR:morphologic leukemia-freestate\>1.0\*10\^9ANC,\>=100\*10\^9/L plt, transfusion independence, no residual evidence of extramedullary leukemia;CRi:fulfill CR criteria except residual neutropenia\<1.0\*10\^9/L/TTP\<100\*10\^9/L;PR:all CR hematological values but\>=50%less in BM aspirate. The percentages are rounded off to report the nearest whole numbers.
- groups
- description
- Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
- id
- OG000
- title
- Azacitidine 75 mg/m^2
- description
- Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
- id
- OG001
- title
- Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
- param Type
- NUMBER
- population Description
- REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment.
- reporting Status
- POSTED
- time Frame
- From date of randomization until CR, PR, or hematologic improvement (HI) (up to approximately 5 years)
- title
- Percentage of Participants With Overall Response
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice