TriangleNCT01564784 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first.
What was measured
OS was defined as the time from randomization to date of death due to any cause. Participants last known to be alive were censored at date of last contact.
Analysis population: ITT population - included all participants randomized. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population.
Groups in this outcome
Inotuzumab Ozogamicin
Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\^2 (for a total cycle dose of 1.5 mg/m\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
Defined Investigator's Choice of Chemotherapy
Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
| Group | Source count |
|---|---|
| Inotuzumab Ozogamicin | 164 |
| Defined Investigator's Choice of Chemotherapy | 162 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Inotuzumab Ozogamicin | 7.7 | Not reported | 6.0 | 9.2 | Not reported |
| Defined Investigator's Choice of Chemotherapy | 6.2 | Not reported | 4.7 | 8.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.568
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 97.5
- ci Upper Limit
- 0.993
- estimate Comment
- Stratified HR, i.e., based on analysis stratified by randomization stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0105
- param Type
- Hazard Ratio (HR)
- param Value
- 0.751
- statistical Method
- 1-sided stratified log-rank p-value
Complete source fields
- analyses
- ci Lower Limit
- 0.568
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 97.5
- ci Upper Limit
- 0.993
- estimate Comment
- Stratified HR, i.e., based on analysis stratified by randomization stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0105
- param Type
- Hazard Ratio (HR)
- param Value
- 0.751
- statistical Method
- 1-sided stratified log-rank p-value
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.0
- upper Limit
- 9.2
- value
- 7.7
- group Id
- OG001
- lower Limit
- 4.7
- upper Limit
- 8.3
- value
- 6.2
- denoms
- counts
- group Id
- OG000
- value
- 164
- group Id
- OG001
- value
- 162
- units
- Participants
- description
- OS was defined as the time from randomization to date of death due to any cause. Participants last known to be alive were censored at date of last contact.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\^2 (for a total cycle dose of 1.5 mg/m\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
- id
- OG000
- title
- Inotuzumab Ozogamicin
- description
- Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
- id
- OG001
- title
- Defined Investigator's Choice of Chemotherapy
- param Type
- MEDIAN
- population Description
- ITT population - included all participants randomized. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population.
- reporting Status
- POSTED
- time Frame
- Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first.
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice