Comparison · NCT01462344-d02b6b11
FSC DPI vs FP DPI: Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period.
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. FSC DPI vs FP DPI: Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period. Trial comparisons, record NCT01462344-d02b6b11. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01462344-d02b6b11
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.00123 | wilson | |
| Risk in group 2 | 0 | 0 | 0.00124 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.00124 | 0.00123 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | FSC DPI | Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. | 0 | 3,107 | OG000 |
| Group 2 | FP DPI | Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment. | 0 | 3,101 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period.
- Description
- Number of participants experiencing asthma-related death over the 6-month study treatment period are presented.
- Time frame
- From Day 1 up to 6 months
- Population
- ITT Population
Source ClinicalTrials.gov
Trial
- Title
- 6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old
- NCT number
- NCT01462344
- Phases
- PHASE4
- Conditions
- Asthma
- Interventions
- ADVAIR 100/50mcg, ADVAIR 250/50mcg, FLOVENT 100mcg, FLOVENT 250mcg
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2016-10-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01462344?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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