Comparison · NCT03237325-sae
SGX942 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. SGX942 vs Placebo: serious adverse events. Trial comparisons, record NCT03237325-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03237325-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 | 0.583 | 0.496 | 0.665 | wilson | |
| Risk in group 2 | 0.46 | 0.38 | 0.543 | wilson | |
| Risk difference, group 1 minus group 2 | 0.122 | 0.00217 | 0.237 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.27 | 1 | 1.6 | log | |
| Odds ratio, group 1 over group 2 | 1.64 | 1.01 | 2.66 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SGX942 than on Placebo | 8.18 | 4.21 | 461 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | SGX942 | Patients are randomized 1:1 active/placebo.~SGX942: 1.5 mg/mL SGX942 administered as a 4 minute IV infusion, twice per week starting within 3 days after initiating radiation therapy and continuing through 2 weeks after radiation therapy ends. | 74 | 127 | EG000 |
| Group 2 | Placebo | Patients are randomized 1:1 active/placebo.~Placebo: Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug. | 64 | 139 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse event (AE) data was collected between randomization through 6 weeks after radiation therapy treatment ended. Participants received up to 7 weeks of radiation, for a maximum AE collection time of 13 weeks.
Source ClinicalTrials.gov
Trial
- Title
- DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
- NCT number
- NCT03237325
- Phases
- PHASE3
- Conditions
- Squamous Cell Carcinoma of the Oral Cavity and Oropharynx, Oral Mucositis
- Interventions
- SGX942, Placebo
- Lead sponsor
- Soligenix
- Results first posted
- 2022-08-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03237325?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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