Comparison · NCT03918239-4e93f013
SHP643 Prefilled Syringe (PFS) vs SHP643 Autoinjector (AI): Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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): Number of Participants With Treatment-Emergent Adverse Events (TEAEs). Trial comparisons, record NCT03918239-4e93f013. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03918239-4e93f013
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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 | 0.202 | 0.133 | 0.294 | wilson | |
| Risk in group 2 | 0.313 | 0.229 | 0.411 | wilson | |
| Risk difference, group 1 minus group 2 | -0.11 | -0.23 | 0.0143 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.647 | 0.393 | 1.07 | log | |
| Odds ratio, group 1 over group 2 | 0.557 | 0.287 | 1.08 | log | |
| Number needed to treat, for one fewer participant with the outcome on SHP643 Prefilled Syringe (PFS) than on SHP643 Autoinjector (AI) | 9.06 | 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). | 19 | 94 | OG000 |
| 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). | 30 | 96 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- Description
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the investigational product (IP) or medicinal product. A treatment-emergent AE (TEAE) was defined as any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the IP or medicinal product.
- Time frame
- From start of study drug administration up to Day 112 (End of Study/Early Termination [EOS/ET])
- Population
- Safety analysis set consisted of all randomized participants who received the dose of SHP643.
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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