TriangleNCT04421027 · OUTCOME
Percentage of Participants With a Change in Oxygen Saturation From < 94% to ≥ 94% From Baseline
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
- 95% Confidence Interval
- Time frame
- Day 10
What was measured
Percentage of participants with a change in oxygen saturation from \< 94% to ≥ 94% from baseline based on National Early Warning Score (NEWS). Measure of the oxygen level of the blood is measure by pulse oximetry. The score is determined from six physiological parameters readily measured over time in hospitalized participants: Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness, as measured by Alert Voice Pain Unresponsive (AVPU). A score is assigned to each parameter, the magnitude of the score representing the extremity of variation from the norm. A weighting score is added for participants needing supplemental oxygen (oxygen delivery by mask or by cannula) The aggregate score is reflective of the participants status.
Analysis population: All participants randomly assigned to study intervention whose oxygen saturation (based on National Early Warning Score) is \< 94% at baseline and have non-missing baseline and at least 1 postbaseline observation are in this population.
Groups in this outcome
Placebo + SOC
Placebo administered orally QD with standard of care.
Baricitinib + SOC
4 mg baricitinib administered orally QD with standard of care.
| Group | Source count |
|---|---|
| Placebo + SOC | 282 |
| Baricitinib + SOC | 282 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + SOC | 52.5 | Not reported | 46.7 | 58.2 | Not reported |
| Baricitinib + SOC | 56.7 | Not reported | 50.9 | 62.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.81
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.63
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.4290
- param Type
- Odds Ratio (OR)
- param Value
- 1.15
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 0.81
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.63
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.4290
- param Type
- Odds Ratio (OR)
- param Value
- 1.15
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 46.7
- upper Limit
- 58.2
- value
- 52.5
- group Id
- OG001
- lower Limit
- 50.9
- upper Limit
- 62.4
- value
- 56.7
- denoms
- counts
- group Id
- OG000
- value
- 282
- group Id
- OG001
- value
- 282
- units
- Participants
- description
- Percentage of participants with a change in oxygen saturation from \< 94% to ≥ 94% from baseline based on National Early Warning Score (NEWS). Measure of the oxygen level of the blood is measure by pulse oximetry. The score is determined from six physiological parameters readily measured over time in hospitalized participants: Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness, as measured by Alert Voice Pain Unresponsive (AVPU). A score is assigned to each parameter, the magnitude of the score representing the extremity of variation from the norm. A weighting score is added for participants needing supplemental oxygen (oxygen delivery by mask or by cannula) The aggregate score is reflective of the participants status.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Placebo administered orally QD with standard of care.
- id
- OG000
- title
- Placebo + SOC
- description
- 4 mg baricitinib administered orally QD with standard of care.
- id
- OG001
- title
- Baricitinib + SOC
- param Type
- NUMBER
- population Description
- All participants randomly assigned to study intervention whose oxygen saturation (based on National Early Warning Score) is \< 94% at baseline and have non-missing baseline and at least 1 postbaseline observation are in this population.
- reporting Status
- POSTED
- time Frame
- Day 10
- title
- Percentage of Participants With a Change in Oxygen Saturation From < 94% to ≥ 94% From Baseline
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice