TriangleNCT01459653 · OUTCOME
Modeling Grade 4 CIN Episode: Patient Level
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
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
What was measured
Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006 Only results with a p-value of \<0.05 are shown in the statistical appendices. H/o=History of; CI=confidence interval; CIN=chemotherapy-induced neutropenia
Analysis population: Evaluable sample with data
Groups in this outcome
EP2006
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
| Group | Source count |
|---|---|
| EP2006 | 1323 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EP2006 | 191 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.592
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.374
- group Description
- History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.001
- param Type
- Odds Ratio (OR)
- param Value
- 2.925
- statistical Method
- Regression, Logistic
- tested Non Inferiority
- false
- ci Lower Limit
- 1.331
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.969
- group Description
- Concomitant antibiotic prophylaxis as patient-level predictor for CIN grade 4 episode
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.005
- param Type
- Odds Ratio (OR)
- param Value
- 2.572
- statistical Method
- Regression, Logistic
- tested Non Inferiority
- false
- ci Lower Limit
- 0.193
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.557
- group Description
- Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 0.328
- statistical Method
- Regression, Logistic
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 1.592
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.374
- group Description
- History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.001
- param Type
- Odds Ratio (OR)
- param Value
- 2.925
- statistical Method
- Regression, Logistic
- tested Non Inferiority
- false
- ci Lower Limit
- 1.331
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.969
- group Description
- Concomitant antibiotic prophylaxis as patient-level predictor for CIN grade 4 episode
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.005
- param Type
- Odds Ratio (OR)
- param Value
- 2.572
- statistical Method
- Regression, Logistic
- tested Non Inferiority
- false
- ci Lower Limit
- 0.193
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.557
- group Description
- Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 0.328
- statistical Method
- Regression, Logistic
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 191
- denoms
- counts
- group Id
- OG000
- value
- 1323
- units
- Participants
- description
- Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006 Only results with a p-value of \<0.05 are shown in the statistical appendices. H/o=History of; CI=confidence interval; CIN=chemotherapy-induced neutropenia
- groups
- description
- Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
- id
- OG000
- title
- EP2006
- param Type
- NUMBER
- population Description
- Evaluable sample with data
- reporting Status
- POSTED
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- title
- Modeling Grade 4 CIN Episode: Patient Level
- type
- SECONDARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice