TriangleNCT02545907 · OUTCOME
Amyloidotic Organ Response Rate Within 3 Months and 6 Months Based on Biochemical, Electrocardiographical, and Radiographical Assessment.
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
- Within 3 months and 6 months
What was measured
Amyloidotic organ response rate is assessed using the following criteria: Heart - Interventricular septal thickness decreased by 2 mm or 10% improvement in ejection fraction or a 30% and 35 pMol/L reduction in NT-ProBNP (only applicable if there is no change or \<25% improvement in renal function) or significant improvement in lateral wall TDI S wave and E/E' ratio Kidney - 50% decrease (at least 0.5 g/day) in 24-hr urinary protein loss (urine protein must be\>0.5 g/day pretreatment) without fall in creatinine clearance of ≥25% from baseline Liver - 50% decrease in abnormal alkaline phosphatase value or a decrease in liver size radiographically by at least 2 cm Nerve - Improvement in electromyogram nerve conduction velocity Soft tissue - Definite clinical and/or radiographic improvement with associated functional improvement in affected tissue. The percentage of patients who achieve organ response within 3 and 6 months of trial registration will be reported.
Groups in this outcome
Dose Level 0- Safety Population
All patients allocated to dose level 0 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.
Dose Level 1- Safety Population
All patients allocated to dose level 1 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.
| Group | Source count |
|---|---|
| Dose Level 0- Safety Population | 3 |
| Dose Level 1- Safety Population | 7 |
Reported measurements
Source class 1
Response within 3 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 0- Safety Population | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 1- Safety Population | 0 | Not reported | Not reported | Not reported | Not reported |
Response within 6 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 0- Safety Population | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 1- Safety Population | 0 | Not reported | Not reported | Not reported | Not reported |
No response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 0- Safety Population | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 1- Safety Population | 7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Response within 3 months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Response within 6 months
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- title
- No response
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Amyloidotic organ response rate is assessed using the following criteria: Heart - Interventricular septal thickness decreased by 2 mm or 10% improvement in ejection fraction or a 30% and 35 pMol/L reduction in NT-ProBNP (only applicable if there is no change or \<25% improvement in renal function) or significant improvement in lateral wall TDI S wave and E/E' ratio Kidney - 50% decrease (at least 0.5 g/day) in 24-hr urinary protein loss (urine protein must be\>0.5 g/day pretreatment) without fall in creatinine clearance of ≥25% from baseline Liver - 50% decrease in abnormal alkaline phosphatase value or a decrease in liver size radiographically by at least 2 cm Nerve - Improvement in electromyogram nerve conduction velocity Soft tissue - Definite clinical and/or radiographic improvement with associated functional improvement in affected tissue. The percentage of patients who achieve organ response within 3 and 6 months of trial registration will be reported.
- groups
- description
- All patients allocated to dose level 0 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.
- id
- OG000
- title
- Dose Level 0- Safety Population
- description
- All patients allocated to dose level 1 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.
- id
- OG001
- title
- Dose Level 1- Safety Population
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Within 3 months and 6 months
- title
- Amyloidotic Organ Response Rate Within 3 Months and 6 Months Based on Biochemical, Electrocardiographical, and Radiographical Assessment.
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice