Comparison · NCT03401671-e5316d54
Japanese vs Non-Hispanic Caucasians: Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as an Adverse Event
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Japanese vs Non-Hispanic Caucasians: Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as an Adverse Event. Trial comparisons, record NCT03401671-e5316d54. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03401671-e5316d54
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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 | 0 | 0.194 | wilson | |
| Risk in group 2 | 0 | 0 | 0.194 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.194 | 0.194 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 | Japanese | Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen. | 0 | 16 | OG000 |
| Group 2 | Non-Hispanic Caucasians | Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen. | 0 | 16 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as an Adverse Event
- Description
Clinical laboratory assessments include hematology, clinical chemistry, coagulation and urinalysis. The investigator will assess out-of-range clinical laboratory values for clinical significance, to indicate whether or not the values are clinically significant. Any changes from baseline in clinical laboratory results which are deemed clinically significant by the investigator are to be recorded as an AE.
- Time frame
- From start of study drug administration up to follow-up (up to 115 days)
- Population
- Safety analysis set included all participants who received at least 1 dose of Lanadelumab.
Source ClinicalTrials.gov
Trial
- Title
- Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects
- NCT number
- NCT03401671
- Phases
- PHASE1
- Conditions
- Healthy Volunteers
- Interventions
- Lanadelumab
- Lead sponsor
- Shire
- Results first posted
- 2019-07-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03401671?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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