Comparison · NCT03918239-sae
SHP643 Prefilled Syringe (PFS) vs SHP643 Autoinjector (AI): 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. SHP643 Prefilled Syringe (PFS) vs SHP643 Autoinjector (AI): serious adverse events. Trial comparisons, record NCT03918239-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03918239-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 | 0.0213 | 0.00585 | 0.0743 | wilson | |
| Risk in group 2 | 0.0208 | 0.00573 | 0.0728 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000443 | -0.0538 | 0.0556 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.147 | 7.1 | log | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.141 | 7.41 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SHP643 Prefilled Syringe (PFS) than on SHP643 Autoinjector (AI) | 2,260 | 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 | SHP643 Prefilled Syringe (PFS) | Participants received 300 milligram (mg) of SHP643 PFS Subcutaneous (SC) injection into the abdomen on Day 1 during the in-house treatment period (Day 1 to Day 5). | 2 | 94 | EG000 |
| Group 2 | SHP643 Autoinjector (AI) | Participants received 300 mg of SHP643 AI SC injection into the abdomen on Day 1 during the in-house treatment period (Day 1 to Day 5). | 2 | 96 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of study drug administration up to Day 112 (End of Study/Early Termination [EOS/ET])
Source ClinicalTrials.gov
Trial
- Title
- A Study to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants.
- NCT number
- NCT03918239
- Phases
- PHASE1
- Conditions
- Healthy Volunteers
- Interventions
- SHP643
- Lead sponsor
- Shire
- Results first posted
- 2020-12-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03918239?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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