Comparison · NCT02741596-sae
Rollover vs Non-Rollover: 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. Rollover vs Non-Rollover: serious adverse events. Trial comparisons, record NCT02741596-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02741596-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 | 0.11 | 0.0641 | 0.183 | wilson | |
| Risk in group 2 | 0.0874 | 0.0467 | 0.158 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0227 | -0.0614 | 0.106 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.26 | 0.554 | 2.86 | log | |
| Odds ratio, group 1 over group 2 | 1.29 | 0.52 | 3.21 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Rollover than on Non-Rollover | 44 | 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 | Rollover | Participants who rolled from the DX-2930-03 (NCT02586805) study received 300 milligrams (mg) of DX-2930 subcutaneous (SC) injection on Day 0 followed by a second dose after participants reported their first HAE attack and continued to receive repeated SC administrations of 300 mg DX-2930 every 2 weeks (q2wks) throughout the treatment period (up to 924 days). A wash-out period of a minimum of 10 days and a maximum of 18 days were required between subsequent administrations. | 12 | 109 | EG000 |
| Group 2 | Non-Rollover | Participants who directly entered in to this DX-2930-04 study received 300 mg of DX-2930 SC injection on Day 0 and continued to receive SC administrations of 300 mg DX-2930 every 2 weeks throughout the treatment period (up to 924 days). | 9 | 103 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of the study up to follow-up (Day 952)
Source ClinicalTrials.gov
Trial
- Title
- Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
- NCT number
- NCT02741596
- Phases
- PHASE3
- Conditions
- Hereditary Angioedema (HAE)
- Interventions
- DX-2930, DX-2930
- Lead sponsor
- Shire
- Results first posted
- 2020-05-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02741596?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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