TriangleNCT02168101 · OUTCOME
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety of MLN9708 When Used as Maintenance After Allogeneic Stem Cell Transplant for Multiple Myeloma Multiple Myeloma
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
- Defined as the time from Day 1 of study drug administration until 30 days after treatment completion for up to 2 years.
What was measured
Defined as the number of participants with treatment-emergent grade 3/4/5 adverse events/serious adverse events utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.0 determined to be related to MLN9708.
Analysis population: All patients who received at least one dose of MLN9708.
Groups in this outcome
MLN9708 - 2.3 mg
Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
MLN9708 - 3 mg
Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
MLN9708 - 4 mg
Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
| Group | Source count |
|---|---|
| MLN9708 - 2.3 mg | 3 |
| MLN9708 - 3 mg | 3 |
| MLN9708 - 4 mg | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MLN9708 - 2.3 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| MLN9708 - 3 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| MLN9708 - 4 mg | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- units
- Participants
- description
- Defined as the number of participants with treatment-emergent grade 3/4/5 adverse events/serious adverse events utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.0 determined to be related to MLN9708.
- groups
- description
- Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
- id
- OG000
- title
- MLN9708 - 2.3 mg
- description
- Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
- id
- OG001
- title
- MLN9708 - 3 mg
- description
- Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
- id
- OG002
- title
- MLN9708 - 4 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All patients who received at least one dose of MLN9708.
- reporting Status
- POSTED
- time Frame
- Defined as the time from Day 1 of study drug administration until 30 days after treatment completion for up to 2 years.
- title
- Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety of MLN9708 When Used as Maintenance After Allogeneic Stem Cell Transplant for Multiple Myeloma Multiple Myeloma
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice