Skip to content
← Full study record

NCT01592370 · OUTCOME

Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score

An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma · Source last updated 2025-10-22

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Nivolumab Monotherapy (Expansion)1
Nivolumab + Ipilimumab1
Nivolumab + Lirilumab1

Reported measurements

Source class 1
Values in Percent of change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab Monotherapy (Expansion)8.70NANot reportedNot reportedOnly 1 participant with available measurements at baseline and 88 weeks
Nivolumab + Ipilimumab63.03NANot reportedNot reportedOnly 1 participant with available measurements at baseline and 93 weeks
Nivolumab + Lirilumab-39.49NANot reportedNot reportedOnly 1 participant with available measurements at baseline and 25 weeks
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Only 1 participant with available measurements at baseline and 88 weeks
        group Id
        OG000
        spread
        NA
        value
        8.70
      2. comment
        Only 1 participant with available measurements at baseline and 93 weeks
        group Id
        OG001
        spread
        NA
        value
        63.03
      3. comment
        Only 1 participant with available measurements at baseline and 25 weeks
        group Id
        OG002
        spread
        NA
        value
        -39.49
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. 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
  1. description
    3mg/kg of nivolumab
    id
    OG000
    title
    Nivolumab Monotherapy (Expansion)
  2. 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
  3. 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