TriangleNCT00872521 · OUTCOME
Event Free Survival (EFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- 2 years after Day 1 Cycle 1 of PAD
What was measured
Percentage of participants who did not have any of the following events: Death, Disease progression, Relapse, Cardiovascular accidents, Deep vein thrombosis, Pulmonary embolism, Fracture, Acute renal failure, Nervous system disorders 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).
Analysis population: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
Groups in this outcome
1q21 Not Amplified
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
1q21 Amplified
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
| Group | Source count |
|---|---|
| 1q21 Not Amplified | 58 |
| 1q21 Amplified | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1q21 Not Amplified | 75.0 | Not reported | Not reported | Not reported | Not reported |
| 1q21 Amplified | 69.6 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Description
- Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.01
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- group Description
- Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.01
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 75.0
- group Id
- OG001
- value
- 69.6
- denoms
- counts
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 20
- units
- Participants
- description
- Percentage of participants who did not have any of the following events: Death, Disease progression, Relapse, Cardiovascular accidents, Deep vein thrombosis, Pulmonary embolism, Fracture, Acute renal failure, Nervous system disorders 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).
- groups
- description
- Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
- id
- OG000
- title
- 1q21 Not Amplified
- description
- Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
- id
- OG001
- title
- 1q21 Amplified
- param Type
- NUMBER
- population Description
- Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
- reporting Status
- POSTED
- time Frame
- 2 years after Day 1 Cycle 1 of PAD
- title
- Event Free Survival (EFS)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice