Comparison · NCT03463031-deaths
GSP 301 NS vs Placebo NS: deaths from any cause
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. GSP 301 NS vs Placebo NS: deaths from any cause. Trial comparisons, record NCT03463031-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03463031-deaths
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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 | 0.00000000000000000173 | 0.0168 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0171 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0171 | 0.0168 | 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 harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | GSP 301 NS | Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days | 0 | 225 | EG000 |
| Group 2 | Placebo NS | Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days | 0 | 221 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
AEs and SAEs were collected from the time of signing the informed consent form (ICF) until the follow up contact which was approximately 22 days and up to 27 days with 7 to 10 days of a placebo run-in period and 14 days of treatment period, with allowable window periods for the study visits.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
- NCT number
- NCT03463031
- Phases
- PHASE3
- Conditions
- Seasonal Allergic Rhinitis (SAR)
- Interventions
- GSP 301 NS, GSP 301 Placebo NS
- Lead sponsor
- Glenmark Specialty S.A.
- Results first posted
- 2019-10-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03463031?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT03463031-deaths