NCT01592370 · OUTCOME
Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Percent of change from baseline
- Interval / dispersion
- Standard Deviation
- Time frame
- From baseline (last measurement before start of study treatment) to last available measurement after start of study treatment (88 weeks for Nivo mono, 93 weeks for nivo+ipi, 25 weeks for nivo+liri)
What was measured
mSWAT is a scoring technique involving the direct assessment of the percentage of body-surface-area (BSA) affected by skin lesions. There are 12 body regions (each one assigned a different percentage of BSA). For each body region, the assigned BSA percentage is multiplied by a factor weighing the type and severity of lesion observed (patch= x1, plaque = x2, tumor= x4). The sum of the individual body region sub-scores is then summed to generate the final mSWAT score, which ranges from 0 (best outcome) to 400 (worst outcome).
Analysis population: All Treated Participants with cutaneous T Cell lymphoma and available measurements
Groups in this outcome
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
| Group | Source count |
|---|---|
| Nivolumab Monotherapy (Expansion) | 1 |
| Nivolumab + Ipilimumab | 1 |
| Nivolumab + Lirilumab | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab Monotherapy (Expansion) | 8.70 | NA | Not reported | Not reported | Only 1 participant with available measurements at baseline and 88 weeks |
| Nivolumab + Ipilimumab | 63.03 | NA | Not reported | Not reported | Only 1 participant with available measurements at baseline and 93 weeks |
| Nivolumab + Lirilumab | -39.49 | NA | Not reported | Not reported | Only 1 participant with available measurements at baseline and 25 weeks |
Complete source fields
- classes
- categories
- measurements
- comment
- Only 1 participant with available measurements at baseline and 88 weeks
- group Id
- OG000
- spread
- NA
- value
- 8.70
- comment
- Only 1 participant with available measurements at baseline and 93 weeks
- group Id
- OG001
- spread
- NA
- value
- 63.03
- comment
- Only 1 participant with available measurements at baseline and 25 weeks
- group Id
- OG002
- spread
- NA
- value
- -39.49
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- units
- Participants
- description
- mSWAT is a scoring technique involving the direct assessment of the percentage of body-surface-area (BSA) affected by skin lesions. There are 12 body regions (each one assigned a different percentage of BSA). For each body region, the assigned BSA percentage is multiplied by a factor weighing the type and severity of lesion observed (patch= x1, plaque = x2, tumor= x4). The sum of the individual body region sub-scores is then summed to generate the final mSWAT score, which ranges from 0 (best outcome) to 400 (worst outcome).
- dispersion Type
- Standard Deviation
- groups
- description
- 3mg/kg of nivolumab
- id
- OG000
- title
- Nivolumab Monotherapy (Expansion)
- description
- 3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
- id
- OG001
- title
- Nivolumab + Ipilimumab
- description
- 3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
- id
- OG002
- title
- Nivolumab + Lirilumab
- param Type
- MEAN
- population Description
- All Treated Participants with cutaneous T Cell lymphoma and available measurements
- reporting Status
- POSTED
- time Frame
- From baseline (last measurement before start of study treatment) to last available measurement after start of study treatment (88 weeks for Nivo mono, 93 weeks for nivo+ipi, 25 weeks for nivo+liri)
- title
- Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score
- type
- SECONDARY
- unit Of Measure
- Percent of change from baseline
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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