TriangleNCT00755040 · OUTCOME
Number of Patients That Develop Ocular GVHD While on Study in the Two Arms (Ocular Cyclosporine (Restasis) vs. Placebo)
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
- Up to 2 years after transplantation
What was measured
Data analysis will be performed on an intention-to-treat basis. Logistic regression will be used to estimate the odds ratio and 95% confidence interval of the two treatment groups with the adjustment of baseline covariates. Outcome comparisons for categorical/dichotomous variables will be assessed by 2 test or Fisher's exact test where expected cell frequencies were \<5; continuous variables will be compared by X/2 test or by Mann-Whitney U test where the data are strongly skewed.
Analysis population: Number of patients that develop ocular GVHD while on study
Groups in this outcome
Arm I
Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant. cyclosporine ophthalmic emulsion: Given as eye drops
Arm II
Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant. placebo: Given as eye drops
| Group | Source count |
|---|---|
| Arm I | 83 |
| Arm II | 81 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I | 9 | Not reported | Not reported | Not reported | Not reported |
| Arm II | 8 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- >0.99
- param Type
- Odds Ratio (OR)
- param Value
- 1.11
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- >0.99
- param Type
- Odds Ratio (OR)
- param Value
- 1.11
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 81
- units
- Participants
- description
- Data analysis will be performed on an intention-to-treat basis. Logistic regression will be used to estimate the odds ratio and 95% confidence interval of the two treatment groups with the adjustment of baseline covariates. Outcome comparisons for categorical/dichotomous variables will be assessed by 2 test or Fisher's exact test where expected cell frequencies were \<5; continuous variables will be compared by X/2 test or by Mann-Whitney U test where the data are strongly skewed.
- groups
- description
- Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant. cyclosporine ophthalmic emulsion: Given as eye drops
- id
- OG000
- title
- Arm I
- description
- Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant. placebo: Given as eye drops
- id
- OG001
- title
- Arm II
- param Type
- NUMBER
- population Description
- Number of patients that develop ocular GVHD while on study
- reporting Status
- POSTED
- time Frame
- Up to 2 years after transplantation
- title
- Number of Patients That Develop Ocular GVHD While on Study in the Two Arms (Ocular Cyclosporine (Restasis) vs. Placebo)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice