TriangleNCT02632786 · OUTCOME
NIS-LL Total Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline to 12 months of treatment
What was measured
Change in Neuropathy Impairment Score-Lower Limb (NIS-LL) Total Score in subjects with peripheral nerve involvement. NIS-LL is a scoring system graduated from 0 points to a maximum of 88 points (the absence of all motor, sensory, and reflex activity in the lower extremities). The scale is an additive of all deficits (64 potential points for muscle strength, 8 points for reflexes, and 16 points for sensory function) in the lower extremities. A score of 0 is normal and score of 88 is total impairment.
Analysis population: Peripheral Neuropathy Evaluable Population
Groups in this outcome
NEOD001 24 mg/kg
NEOD001, 24 mg/kg IV every 4 weeks for 12 months
Placebo
Placebo, 0.9% Saline IV every 4 weeks for 12 months
| Group | Source count |
|---|---|
| NEOD001 24 mg/kg | 12 |
| Placebo | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NEOD001 24 mg/kg | -1.2 | Not reported | -3.9 | 1.6 | Not reported |
| Placebo | -0.6 | Not reported | -3.0 | 1.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- -4.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.0
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7570
- param Type
- Mean Difference (Net)
- param Value
- -0.6
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Lower Limit
- -4.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.0
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7570
- param Type
- Mean Difference (Net)
- param Value
- -0.6
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.9
- upper Limit
- 1.6
- value
- -1.2
- group Id
- OG001
- lower Limit
- -3.0
- upper Limit
- 1.8
- value
- -0.6
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 14
- units
- Participants
- description
- Change in Neuropathy Impairment Score-Lower Limb (NIS-LL) Total Score in subjects with peripheral nerve involvement. NIS-LL is a scoring system graduated from 0 points to a maximum of 88 points (the absence of all motor, sensory, and reflex activity in the lower extremities). The scale is an additive of all deficits (64 potential points for muscle strength, 8 points for reflexes, and 16 points for sensory function) in the lower extremities. A score of 0 is normal and score of 88 is total impairment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- NEOD001, 24 mg/kg IV every 4 weeks for 12 months
- id
- OG000
- title
- NEOD001 24 mg/kg
- description
- Placebo, 0.9% Saline IV every 4 weeks for 12 months
- id
- OG001
- title
- Placebo
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Peripheral Neuropathy Evaluable Population
- reporting Status
- POSTED
- time Frame
- Baseline to 12 months of treatment
- title
- NIS-LL Total Score
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice