TriangleNCT03465540 · OUTCOME
Progression-free Survival (PFS)
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 end of study (a maximum of 48 weeks)
What was measured
PFS was calculated as time from first dose of investigational product date to disease progression date or death due to any cause, whichever was earlier. PFS time in months: (date of disease progression or death - first dose date +1)/30.4.
Analysis population: Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. Per the statistical analysis plan (SAP), PFS was only to be calculated if the number of participants who experienced events (disease progression or death) was 10 or more in either part 1 or part 2. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.
Groups in this outcome
Part 1a: 80 mg AMG 397
Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Part 1a: 160 mg AMG 397
Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Part 1a: 320 mg AMG 397
Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Part 1b: 80 mg AMG 397
Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Part 1b: 160 mg AMG 397
Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Part 1b: 320 mg AMG 397
Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
| Group | Source count |
|---|---|
| Part 1a: 80 mg AMG 397 | 2 |
| Part 1a: 160 mg AMG 397 | 6 |
| Part 1a: 320 mg AMG 397 | 4 |
| Part 1b: 80 mg AMG 397 | 4 |
| Part 1b: 160 mg AMG 397 | 5 |
| Part 1b: 320 mg AMG 397 | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1a: 80 mg AMG 397 | NA | Not reported | NA | NA | No data are available due to low event rate in the population. |
| Part 1a: 160 mg AMG 397 | NA | Not reported | NA | NA | No data are available due to low event rate in the population. |
| Part 1a: 320 mg AMG 397 | NA | Not reported | NA | NA | No data are available due to low event rate in the population. |
| Part 1b: 80 mg AMG 397 | NA | Not reported | NA | NA | No data are available due to low event rate in the population. |
| Part 1b: 160 mg AMG 397 | NA | Not reported | NA | NA | No data are available due to low event rate in the population. |
| Part 1b: 320 mg AMG 397 | NA | Not reported | NA | NA | No data are available due to low event rate in the population. |
Complete source fields
- classes
- categories
- measurements
- comment
- No data are available due to low event rate in the population.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- No data are available due to low event rate in the population.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- No data are available due to low event rate in the population.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- No data are available due to low event rate in the population.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- No data are available due to low event rate in the population.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- No data are available due to low event rate in the population.
- group Id
- OG005
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 3
- units
- Participants
- description
- PFS was calculated as time from first dose of investigational product date to disease progression date or death due to any cause, whichever was earlier. PFS time in months: (date of disease progression or death - first dose date +1)/30.4.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG000
- title
- Part 1a: 80 mg AMG 397
- description
- Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG001
- title
- Part 1a: 160 mg AMG 397
- description
- Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG002
- title
- Part 1a: 320 mg AMG 397
- description
- Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG003
- title
- Part 1b: 80 mg AMG 397
- description
- Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG004
- title
- Part 1b: 160 mg AMG 397
- description
- Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG005
- title
- Part 1b: 320 mg AMG 397
- param Type
- MEDIAN
- population Description
- Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. Per the statistical analysis plan (SAP), PFS was only to be calculated if the number of participants who experienced events (disease progression or death) was 10 or more in either part 1 or part 2. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.
- reporting Status
- POSTED
- time Frame
- Up to end of study (a maximum of 48 weeks)
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice