Comparison · NCT01283009-sae
Arm 1: Inactive Substance vs Arm 2: Methylprednisolone: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Arm 1: Inactive Substance vs Arm 2: Methylprednisolone: serious adverse events. Trial comparisons, record NCT01283009-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01283009-sae
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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 | 0.564 | 0.507 | 0.621 | wilson | |
| Risk in group 2 | 0.562 | 0.505 | 0.618 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00217 | -0.0778 | 0.0821 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.87 | 1.16 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.727 | 1.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm 1: Inactive Substance than on Arm 2: Methylprednisolone | 461 | from the risk difference interval | the interval includes no difference |
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 | Arm 1: Inactive Substance | Inactive substance~Methylprednisolone: Methylprednisolone will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day). | 162 | 287 | EG000 |
| Group 2 | Arm 2: Methylprednisolone | Methylprednisolone~Methylprednisolone: Methylprednisolone will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day). | 167 | 297 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All SAEs were reported from Randomization to day 180.
Source ClinicalTrials.gov
Trial
- Title
- Extended Steroid in Use in Community Acquired Pneumonia (CAP)(e)
- NCT number
- NCT01283009
- Phases
- PHASE3
- Conditions
- Community Acquired Respiratory Disease Syndrome
- Interventions
- Inactive Substance, Methylprednisolone
- Lead sponsor
- VA Office of Research and Development
- Results first posted
- 2020-10-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01283009?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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