TriangleNCT03440411 · OUTCOME
Clinical Progression
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
- 57 months
What was measured
defined as the time from random assignment to the early or late strategy to the date of onset of CRAB symptoms or death. Clinical relapse requires one or more direct indicators of progressive disease and end organ dysfunction (CRAB features). Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder: * hypercalcaemia * renal insufficiency * anaemia * bone lesions Any one or more of the following biomarkers of malignancy: * clonal bone marrow plasma cell percentage ≥60% * involved:uninvolved serum free light chain ratio ≥100 * \>1 focal lesions on MRI studies (each focal lesion must be 5 mm or more in size) Progresson was defined accoring to IMWG criteria as reported before
Analysis population: All population
Groups in this outcome
Arm I
Early Treatment
Arm II
Late treatment
| Group | Source count |
|---|---|
| Arm I | 5 |
| Arm II | 4 |
Reported measurements
Source class 1
Not evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I | 5 | Not reported | Not reported | Not reported | Not reported |
| Arm II | 3 | Not reported | Not reported | Not reported | Not reported |
Without CRAB
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm II | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- title
- Not evaluable
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Without CRAB
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- defined as the time from random assignment to the early or late strategy to the date of onset of CRAB symptoms or death. Clinical relapse requires one or more direct indicators of progressive disease and end organ dysfunction (CRAB features). Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder: * hypercalcaemia * renal insufficiency * anaemia * bone lesions Any one or more of the following biomarkers of malignancy: * clonal bone marrow plasma cell percentage ≥60% * involved:uninvolved serum free light chain ratio ≥100 * \>1 focal lesions on MRI studies (each focal lesion must be 5 mm or more in size) Progresson was defined accoring to IMWG criteria as reported before
- groups
- description
- Early Treatment
- id
- OG000
- title
- Arm I
- description
- Late treatment
- id
- OG001
- title
- Arm II
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All population
- reporting Status
- POSTED
- time Frame
- 57 months
- title
- Clinical Progression
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice