TriangleNCT01801436 · OUTCOME
Number of Participants With Response to Treatment at Day 11 of Cycle 8
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Day 11 of Cycle 8
What was measured
Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.
Analysis population: The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.
Groups in this outcome
Bortezomib
Participants received 1.3 mg per m\^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
| Group | Source count |
|---|---|
| Bortezomib | 14 |
Reported measurements
Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib | 2 | Not reported | Not reported | Not reported | Not reported |
Partial response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib | 3 | Not reported | Not reported | Not reported | Not reported |
Minimal response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib | 2 | Not reported | Not reported | Not reported | Not reported |
Stable disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib | 1 | Not reported | Not reported | Not reported | Not reported |
Progression
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Response
- categories
- measurements
- group Id
- OG000
- value
- 3
- title
- Partial response
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Minimal response
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Stable disease
- categories
- measurements
- group Id
- OG000
- value
- 6
- title
- Progression
- denoms
- counts
- group Id
- OG000
- value
- 14
- units
- Participants
- description
- Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.
- groups
- description
- Participants received 1.3 mg per m\^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
- id
- OG000
- title
- Bortezomib
- param Type
- NUMBER
- population Description
- The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.
- reporting Status
- POSTED
- time Frame
- Day 11 of Cycle 8
- title
- Number of Participants With Response to Treatment at Day 11 of Cycle 8
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice