TriangleNCT00111813 · OUTCOME
Mean Duration of Treatment With Vorinostat
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Days
- Interval / dispersion
- Full Range
- Time frame
- Day 1 to an event causing discontinuation from the study, assessed up to 29 months
What was measured
Event causing discontinuation from the study was defined as (1) progressive disease OR (2) intolerable toxicity. Progressive disease was defined as: * \>25% increase in the level of serum monoclonal paraprotein. * 25% increase in 24-hour urinary light chain excretion. * \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy. * Development of new bone lesions or soft tissue plasmacytomas. * Development of hypercalcemia. Intolerable toxicity was based on the clinical judgment of the investigator.
Groups in this outcome
All Participants
Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m\^2, 0.9 mg/m\^2, 1.1 mg/m\^2, or 1.3 mg/m\^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level.
| Group | Source count |
|---|---|
| All Participants | 34 |
Reported measurements
200 mg
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 4.6 | Not reported | 1 | 15 | Not reported |
300 mg
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 72.6 | Not reported | 28 | 210 | Not reported |
400 mg
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 107.1 | Not reported | 11 | 496 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 15
- value
- 4.6
- title
- 200 mg
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28
- upper Limit
- 210
- value
- 72.6
- title
- 300 mg
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11
- upper Limit
- 496
- value
- 107.1
- title
- 400 mg
- denoms
- counts
- group Id
- OG000
- value
- 34
- units
- Participants
- description
- Event causing discontinuation from the study was defined as (1) progressive disease OR (2) intolerable toxicity. Progressive disease was defined as: * \>25% increase in the level of serum monoclonal paraprotein. * 25% increase in 24-hour urinary light chain excretion. * \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy. * Development of new bone lesions or soft tissue plasmacytomas. * Development of hypercalcemia. Intolerable toxicity was based on the clinical judgment of the investigator.
- dispersion Type
- Full Range
- groups
- description
- Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m\^2, 0.9 mg/m\^2, 1.1 mg/m\^2, or 1.3 mg/m\^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level.
- id
- OG000
- title
- All Participants
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Day 1 to an event causing discontinuation from the study, assessed up to 29 months
- title
- Mean Duration of Treatment With Vorinostat
- type
- PRIMARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice