TriangleNCT00441168 · OUTCOME
Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- months
- Interval / dispersion
- Not reported
- Time frame
- every 28 days during treatment period for up to 6 to 8 cycles
What was measured
DOR was defined as the duration from the date of the best confirmed response for subjects who achieved CR or PR to the date of first documented evidence of PD (or relapse for subjects who experienced CR) over the duration of the study. DOR = (\[Date of PD or date of censoring - Date of best response\]+1)/30.44.
Analysis population: Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.There was insufficient data to perform Kaplan Meier analysis (data available for 5 subjects in the VAD group and 6 subjects in the PAD group).
Groups in this outcome
VAD Treatment
vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
PAD Treatment
bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
| Group | Source count |
|---|---|
| VAD Treatment | 5 |
| PAD Treatment | 6 |
Reported measurements
patient 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| VAD Treatment | 1.68 | Not reported | 1.68 | 6.18 | Not reported |
| PAD Treatment | 2.83 | Not reported | 2.83 | 7.69 | Not reported |
patient 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| VAD Treatment | 6.18 | Not reported | Not reported | Not reported | Not reported |
| PAD Treatment | 7.69 | Not reported | Not reported | Not reported | Not reported |
patient 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| VAD Treatment | 3.71 | Not reported | Not reported | Not reported | Not reported |
| PAD Treatment | 5.52 | Not reported | Not reported | Not reported | Not reported |
patient 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| VAD Treatment | 5.42 | Not reported | Not reported | Not reported | Not reported |
| PAD Treatment | 6.57 | Not reported | Not reported | Not reported | Not reported |
patient 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| VAD Treatment | 4.73 | Not reported | Not reported | Not reported | Not reported |
| PAD Treatment | 4.96 | Not reported | Not reported | Not reported | Not reported |
patient 6
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| VAD Treatment | NA | Not reported | Not reported | Not reported | only 5 patients have been analyzed in this arm |
| PAD Treatment | 7.42 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.68
- upper Limit
- 6.18
- value
- 1.68
- group Id
- OG001
- lower Limit
- 2.83
- upper Limit
- 7.69
- value
- 2.83
- title
- patient 1
- categories
- measurements
- group Id
- OG000
- value
- 6.18
- group Id
- OG001
- value
- 7.69
- title
- patient 2
- categories
- measurements
- group Id
- OG000
- value
- 3.71
- group Id
- OG001
- value
- 5.52
- title
- patient 3
- categories
- measurements
- group Id
- OG000
- value
- 5.42
- group Id
- OG001
- value
- 6.57
- title
- patient 4
- categories
- measurements
- group Id
- OG000
- value
- 4.73
- group Id
- OG001
- value
- 4.96
- title
- patient 5
- categories
- measurements
- comment
- only 5 patients have been analyzed in this arm
- group Id
- OG000
- value
- NA
- group Id
- OG001
- value
- 7.42
- title
- patient 6
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- DOR was defined as the duration from the date of the best confirmed response for subjects who achieved CR or PR to the date of first documented evidence of PD (or relapse for subjects who experienced CR) over the duration of the study. DOR = (\[Date of PD or date of censoring - Date of best response\]+1)/30.44.
- groups
- description
- vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
- id
- OG000
- title
- VAD Treatment
- description
- bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
- id
- OG001
- title
- PAD Treatment
- param Type
- NUMBER
- population Description
- Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.There was insufficient data to perform Kaplan Meier analysis (data available for 5 subjects in the VAD group and 6 subjects in the PAD group).
- reporting Status
- POSTED
- time Frame
- every 28 days during treatment period for up to 6 to 8 cycles
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice