TriangleNCT00434161 · OUTCOME
Incidence of Cataract Development or Progression (Change of ≥0.3 in Lens Opacities Classification System III (LOCS III Score)) at Month 6.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- 6 Months
What was measured
Number of participants from the primary cataract subset showing an increase from baseline of \>= 0.3 in the Lens Opacities Classification System III (LOCS III score). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist trained in LOCS III uses a slit lamp for examining the lens of the eye. The classification evaluates four features: posterior subcapsular cataract(P),cortical cataract(C),nuclear opalescence(NO) and nuclear color(NC). NO and NC are 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. In the current study, cataract development or progression was defined as an increase from baseline of ≥ 0.3 on any of the three features P, C or NO (NC is of less importance and has not been analysed further in this study).
Analysis population: Of the 281 subjects who participated in the acute phase of the study a total of 101 subjects study were eligible for participation in the cataract assessment procedures, 22 in the placebo group and 79 in the palifermin group. Number of patients with non-missing values at Months 6; were 17 in the placebo group and 53 in the palifermin group.
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
Yes
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 6 | Not reported | Not reported | Not reported | Not reported |
| Palifermin | 23 | Not reported | Not reported | Not reported | Not reported |
No
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 11 | Not reported | Not reported | Not reported | Not reported |
| Palifermin | 30 | Not reported | Not reported | Not reported | Not reported |
Missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 5 | Not reported | Not reported | Not reported | Not reported |
| Palifermin | 26 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -21.669
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 33.43
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value Comment
- According to statistical analysis plan it was not planned to calculate any P-Value.
- param Type
- Risk Difference (RD)
- param Value
- 5.88
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- -21.669
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 33.43
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value Comment
- According to statistical analysis plan it was not planned to calculate any P-Value.
- param Type
- Risk Difference (RD)
- param Value
- 5.88
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 23
- title
- Yes
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 30
- title
- No
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 26
- title
- Missing
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 79
- units
- Participants
- description
- Number of participants from the primary cataract subset showing an increase from baseline of \>= 0.3 in the Lens Opacities Classification System III (LOCS III score). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist trained in LOCS III uses a slit lamp for examining the lens of the eye. The classification evaluates four features: posterior subcapsular cataract(P),cortical cataract(C),nuclear opalescence(NO) and nuclear color(NC). NO and NC are 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. In the current study, cataract development or progression was defined as an increase from baseline of ≥ 0.3 on any of the three features P, C or NO (NC is of less importance and has not been analysed further in this study).
- 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
- NUMBER
- population Description
- Of the 281 subjects who participated in the acute phase of the study a total of 101 subjects study were eligible for participation in the cataract assessment procedures, 22 in the placebo group and 79 in the palifermin group. Number of patients with non-missing values at Months 6; were 17 in the placebo group and 53 in the palifermin group.
- reporting Status
- POSTED
- time Frame
- 6 Months
- title
- Incidence of Cataract Development or Progression (Change of ≥0.3 in Lens Opacities Classification System III (LOCS III Score)) at Month 6.
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice