TriangleNCT02907359 · OUTCOME
Time to First Response, Complete Response (CR) and Best Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- Full Range
- Time frame
- From study Day 1 to the earliest date that a response was first documented (up to approximately 46.6 months)
What was measured
Time to first response was the time(days) from randomization to first date when any response was achieved. Time to CR was the time(days) from randomization to first date when CR was achieved. Time to best response was the time(days) from randomization to first date when participant's best response (CR,PR,mCR or HI) was achieved. CR:BM:≤5% myeloblasts, Peripheral blood:Hgb≥11g/dL,PLTs≥100x10\^9/L,Neutrophils≥1.0x10\^9/L,Blasts 0%. PR: All CR criteria except BM blasts decreased≥50% over pretreatment but still \>5%,Cellularity,morphology not relevant. mCR: Reduction of BM blasts to≤5%; decrease ≥50% with/without normalization of peripheral counts. HI responses:1)HI-E:Hgb increase≥1.5 g/dL, Relevant reduction of RBC units transfusions by absolute≥4 RBC transfusions/8wk compared with pretreatment transfusion number previous 8wk. 2)HI-P:Absolute increase≥30x10\^9/L starting\>20x10\^9/L PLTs; Increase from≤20 to\>20x10\^9/L and by≥100% 3)HI-N:≥100% granulocyte increase, absolute increase\>0.5x10\^9/L.
Analysis population: The Efficacy Analysis Set included all participants randomly assigned to the study treatment. Overall number of participants analyzed are the number of participants with data available for analysis. 'Number Analyzed' indicates the number of participants with response.
Groups in this outcome
Guadecitabine
Participants received Guadecitabine 60 mg/m\^2, SC, on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles).
Treatment Choice
Participants received one of the three treatment choice options: 1. LDAC 20 mg/m\^2 SC/IV once daily for 14 days of each 28-day cycles for at least 4 cycles in absence of disease progression or unacceptable toxicity.Participants who were responding or had stable disease were to continue treatment as per standard institutional practice. 2. Standard IC of a 7+3 regimen:Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and anthracycline(daunorubicin(45-60 mg)/idarubicin(9-12 mg)/mitoxantrone(8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles. 3. BSC as needed during the treatment included,but was not limited to,blood transfusions(RBCs or platelets),growth factors including erythropoiesis stimulating agents,granulocyte stimulating factors,iron chelating therapy,and broad-spectrum antibiotics and/or antifungals. Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.
| Group | Source count |
|---|---|
| Guadecitabine | 61 |
| Treatment Choice | 21 |
Reported measurements
Time to First Response (CR, PR, mCR, or HI)
| Group | Source count |
|---|---|
| Guadecitabine | 61 |
| Treatment Choice | 21 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Guadecitabine | 63.0 | Not reported | 28 | 323 | Not reported |
| Treatment Choice | 67.0 | Not reported | 21 | 295 | Not reported |
Time to CR
| Group | Source count |
|---|---|
| Guadecitabine | 4 |
| Treatment Choice | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Guadecitabine | 91.0 | Not reported | 56 | 106 | Not reported |
| Treatment Choice | 266.0 | Not reported | 266.0 | 266.0 | Not reported |
Time to Best Response (CR, PR, mCR, or HI)
| Group | Source count |
|---|---|
| Guadecitabine | 61 |
| Treatment Choice | 21 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Guadecitabine | 64.0 | Not reported | 28 | 469 | Not reported |
| Treatment Choice | 77.0 | Not reported | 23 | 295 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28
- upper Limit
- 323
- value
- 63.0
- group Id
- OG001
- lower Limit
- 21
- upper Limit
- 295
- value
- 67.0
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 21
- units
- Participants
- title
- Time to First Response (CR, PR, mCR, or HI)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 56
- upper Limit
- 106
- value
- 91.0
- group Id
- OG001
- lower Limit
- 266.0
- upper Limit
- 266.0
- value
- 266.0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Time to CR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28
- upper Limit
- 469
- value
- 64.0
- group Id
- OG001
- lower Limit
- 23
- upper Limit
- 295
- value
- 77.0
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 21
- units
- Participants
- title
- Time to Best Response (CR, PR, mCR, or HI)
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 21
- units
- Participants
- description
- Time to first response was the time(days) from randomization to first date when any response was achieved. Time to CR was the time(days) from randomization to first date when CR was achieved. Time to best response was the time(days) from randomization to first date when participant's best response (CR,PR,mCR or HI) was achieved. CR:BM:≤5% myeloblasts, Peripheral blood:Hgb≥11g/dL,PLTs≥100x10\^9/L,Neutrophils≥1.0x10\^9/L,Blasts 0%. PR: All CR criteria except BM blasts decreased≥50% over pretreatment but still \>5%,Cellularity,morphology not relevant. mCR: Reduction of BM blasts to≤5%; decrease ≥50% with/without normalization of peripheral counts. HI responses:1)HI-E:Hgb increase≥1.5 g/dL, Relevant reduction of RBC units transfusions by absolute≥4 RBC transfusions/8wk compared with pretreatment transfusion number previous 8wk. 2)HI-P:Absolute increase≥30x10\^9/L starting\>20x10\^9/L PLTs; Increase from≤20 to\>20x10\^9/L and by≥100% 3)HI-N:≥100% granulocyte increase, absolute increase\>0.5x10\^9/L.
- dispersion Type
- Full Range
- groups
- description
- Participants received Guadecitabine 60 mg/m\^2, SC, on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles).
- id
- OG000
- title
- Guadecitabine
- description
- Participants received one of the three treatment choice options: 1. LDAC 20 mg/m\^2 SC/IV once daily for 14 days of each 28-day cycles for at least 4 cycles in absence of disease progression or unacceptable toxicity.Participants who were responding or had stable disease were to continue treatment as per standard institutional practice. 2. Standard IC of a 7+3 regimen:Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and anthracycline(daunorubicin(45-60 mg)/idarubicin(9-12 mg)/mitoxantrone(8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles. 3. BSC as needed during the treatment included,but was not limited to,blood transfusions(RBCs or platelets),growth factors including erythropoiesis stimulating agents,granulocyte stimulating factors,iron chelating therapy,and broad-spectrum antibiotics and/or antifungals. Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.
- id
- OG001
- title
- Treatment Choice
- param Type
- MEDIAN
- population Description
- The Efficacy Analysis Set included all participants randomly assigned to the study treatment. Overall number of participants analyzed are the number of participants with data available for analysis. 'Number Analyzed' indicates the number of participants with response.
- reporting Status
- POSTED
- time Frame
- From study Day 1 to the earliest date that a response was first documented (up to approximately 46.6 months)
- title
- Time to First Response, Complete Response (CR) and Best Response
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice