Comparison · NCT03607838-sae
SI-6603 vs Sham: 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. SI-6603 vs Sham: serious adverse events. Trial comparisons, record NCT03607838-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03607838-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 | 0.0419 | 0.0205 | 0.084 | wilson | |
| Risk in group 2 | 0.0345 | 0.0159 | 0.0732 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00743 | -0.0368 | 0.0534 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.22 | 0.417 | 3.54 | log | |
| Odds ratio, group 1 over group 2 | 1.23 | 0.403 | 3.72 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SI-6603 than on Sham | 135 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: sham.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | SI-6603 | Condoliase: 1.25U, intradiscal injection, one time~For patients in the active treatment group, a volume of 1.0 mL was administered into the intervertebral disc in a single dose. | 7 | 167 | EG000 |
| Group 2 | Sham | Sham injection~For patients in the control group, a solution was not prepared, and the needle was not placed in the intervertebral disc. | 6 | 174 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 52 weeks
Source ClinicalTrials.gov
Trial
- Title
- SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)
- NCT number
- NCT03607838
- Phases
- PHASE3
- Conditions
- Lumbar Disc Herniation
- Interventions
- SI-6603, Sham injection
- Lead sponsor
- Seikagaku Corporation
- Results first posted
- 2025-07-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03607838?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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