TriangleNCT00434161 · OUTCOME
Change From Baseline in Posterior Subcapsular (P), Cortical (C) Cataract and Nuclear Opalescence (NO) on the Lens Opacities Classification System III (LOCS III) Scale at Months 6.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Months 6
What was measured
To study the change in cataract from baseline visit to months 6, three cataract main types: nuclear, cortical and posterior subcapsular measured on the Lens Opacities Classification System III (LOCS III) Scale. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in theLOCS III score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist uses a slit lamp for examining the lens of the eye. The classification evaluates: P,C and NO. NO is graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each.
Analysis population: All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.
Groups in this outcome
Placebo
Subjects to receive matched placebo before- and after-high dose chemotherapy.
Palifermin
Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
| Group | Source count |
|---|---|
| Placebo | 22 |
| Palifermin | 79 |
Reported measurements
Summary of difference from baseline in P
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 0.01 | 0.08 | Not reported | Not reported | Not reported |
| Palifermin | 0.12 | 0.40 | Not reported | Not reported | Not reported |
Summary of difference from baseline in C
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 0.14 | 0.29 | Not reported | Not reported | Not reported |
| Palifermin | 0.15 | 0.28 | Not reported | Not reported | Not reported |
Summary of difference from baseline in NO
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 0.12 | 0.26 | Not reported | Not reported | Not reported |
| Palifermin | 0.35 | 0.59 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.134
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.181
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Mean Difference (Net)
- param Value
- 0.023
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- -0.134
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.181
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Mean Difference (Net)
- param Value
- 0.023
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.08
- value
- 0.01
- group Id
- OG001
- spread
- 0.40
- value
- 0.12
- title
- Summary of difference from baseline in P
- categories
- measurements
- group Id
- OG000
- spread
- 0.29
- value
- 0.14
- group Id
- OG001
- spread
- 0.28
- value
- 0.15
- title
- Summary of difference from baseline in C
- categories
- measurements
- group Id
- OG000
- spread
- 0.26
- value
- 0.12
- group Id
- OG001
- spread
- 0.59
- value
- 0.35
- title
- Summary of difference from baseline in NO
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 79
- units
- Participants
- description
- To study the change in cataract from baseline visit to months 6, three cataract main types: nuclear, cortical and posterior subcapsular measured on the Lens Opacities Classification System III (LOCS III) Scale. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in theLOCS III score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist uses a slit lamp for examining the lens of the eye. The classification evaluates: P,C and NO. NO is graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each.
- dispersion Type
- Standard Deviation
- groups
- description
- Subjects to receive matched placebo before- and after-high dose chemotherapy.
- id
- OG000
- title
- Placebo
- description
- Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
- id
- OG001
- title
- Palifermin
- param Type
- MEAN
- population Description
- All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.
- reporting Status
- POSTED
- time Frame
- Months 6
- title
- Change From Baseline in Posterior Subcapsular (P), Cortical (C) Cataract and Nuclear Opalescence (NO) on the Lens Opacities Classification System III (LOCS III) Scale at Months 6.
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice