Comparison · NCT01385371-sae
SCH 697243 vs Placebo: 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. SCH 697243 vs Placebo: serious adverse events. Trial comparisons, record NCT01385371-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01385371-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 | 0.0186 | 0.0111 | 0.031 | wilson | |
| Risk in group 2 | 0.0121 | 0.00637 | 0.0228 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00651 | -0.00656 | 0.0201 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.54 | 0.67 | 3.53 | log | |
| Odds ratio, group 1 over group 2 | 1.55 | 0.666 | 3.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SCH 697243 than on Placebo | 154 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | SCH 697243 | Participants receiving Grass (Phleum pratense) Pollen Allergen Extract | 14 | 753 | EG000 |
| Group 2 | Placebo | Participants receiving Placebo | 9 | 745 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks).
Source ClinicalTrials.gov
Trial
- Title
- A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067)
- NCT number
- NCT01385371
- Phases
- PHASE3
- Conditions
- Rhinitis Allergic, Conjunctivitis
- Interventions
- Grass (Phleum pratense) pollen allergen extract, Placebo for SCH 697243
- Lead sponsor
- ALK-Abelló A/S
- Results first posted
- 2013-09-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01385371?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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