TriangleNCT00627393 · OUTCOME
Percentage of Participants Who Are Alive at 42 Days After Treatment and Have Had Microbial Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Measured at Day 42
What was measured
Microbial response was defined as follows: * A negative blood culture test at 42 days after randomization for subjects with fungemia (candidemia or fusariosis) or bacteremia. * Improvement of signs and symptoms of infectious disease (complete or partial response) at 42 days after randomization.
Analysis population: All adjudicated or deceased subjects in intention-to-treat analyses.
Groups in this outcome
Control Arm
Received antimicrobial therapy alone.
Granulocyte Arm
Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
| Group | Source count |
|---|---|
| Control Arm | 49 |
| Granulocyte Arm | 48 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Control Arm | 42.9 | Not reported | Not reported | Not reported | Not reported |
| Granulocyte Arm | 41.7 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.20
- estimate Comment
- Control group is the reference group. Model adjusted for infection strata, underlying disease, zubrod score, respiratory symptoms, and age.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.73
- param Type
- Odds Ratio (OR)
- param Value
- 1.19
- statistical Comment
- Ordinary multiple logistic regression including treatment arm, infection strata, underlying disease, zubrod score, respiratory symptoms, and age.
- statistical Method
- Regression, Logistic
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.20
- estimate Comment
- Control group is the reference group. Model adjusted for infection strata, underlying disease, zubrod score, respiratory symptoms, and age.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.73
- param Type
- Odds Ratio (OR)
- param Value
- 1.19
- statistical Comment
- Ordinary multiple logistic regression including treatment arm, infection strata, underlying disease, zubrod score, respiratory symptoms, and age.
- statistical Method
- Regression, Logistic
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 42.9
- group Id
- OG001
- value
- 41.7
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 48
- units
- Participants
- description
- Microbial response was defined as follows: * A negative blood culture test at 42 days after randomization for subjects with fungemia (candidemia or fusariosis) or bacteremia. * Improvement of signs and symptoms of infectious disease (complete or partial response) at 42 days after randomization.
- groups
- description
- Received antimicrobial therapy alone.
- id
- OG000
- title
- Control Arm
- description
- Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
- id
- OG001
- title
- Granulocyte Arm
- param Type
- NUMBER
- population Description
- All adjudicated or deceased subjects in intention-to-treat analyses.
- reporting Status
- POSTED
- time Frame
- Measured at Day 42
- title
- Percentage of Participants Who Are Alive at 42 Days After Treatment and Have Had Microbial Response
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice