TriangleNCT00293384 · OUTCOME
Proportion of Participants With Controlled Acute Vomiting
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
- at 0-24 hours
What was measured
No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.
Analysis population: Evaluable for response
Groups in this outcome
Aprepitant, Dexamethasone, Cytoxan & Kytril
Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning. Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3 Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration. Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
| Group | Source count |
|---|---|
| Aprepitant, Dexamethasone, Cytoxan & Kytril | 35 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Aprepitant, Dexamethasone, Cytoxan & Kytril | 20 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- group Description
- Optimal Simon design for phase II study. p0=45% p1=65%.
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.10
- p Value Comment
- 85% statistical power
- param Type
- proportion
- param Value
- .57
- statistical Method
- Simon optimal design
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- group Description
- Optimal Simon design for phase II study. p0=45% p1=65%.
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.10
- p Value Comment
- 85% statistical power
- param Type
- proportion
- param Value
- .57
- statistical Method
- Simon optimal design
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 20
- denoms
- counts
- group Id
- OG000
- value
- 35
- units
- Participants
- description
- No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.
- groups
- description
- Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning. Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3 Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration. Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
- id
- OG000
- title
- Aprepitant, Dexamethasone, Cytoxan & Kytril
- param Type
- NUMBER
- population Description
- Evaluable for response
- reporting Status
- POSTED
- time Frame
- at 0-24 hours
- title
- Proportion of Participants With Controlled Acute Vomiting
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice