Comparison · NCT02579239-47eebb0b
Group A - FSHD vs Group B - LGMD2B and FSHD: Number of Participants With a Clinical Laboratory Abnormality Leading to an AE
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. Group A - FSHD vs Group B - LGMD2B and FSHD: Number of Participants With a Clinical Laboratory Abnormality Leading to an AE. Trial comparisons, record NCT02579239-47eebb0b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02579239-47eebb0b
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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 | 0.49 | wilson | |
| Risk in group 2 | 0.286 | 0.117 | 0.546 | wilson | |
| Risk difference, group 1 minus group 2 | -0.286 | -0.546 | 0.232 | 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, for one fewer participant with the outcome on Group A - FSHD than on Group B - LGMD2B and FSHD | 3.5 | 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 | Group A - FSHD | Participants with FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks. | 0 | 4 | OG000 |
| Group 2 | Group B - LGMD2B and FSHD | Participants with LGMD2B and FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 and 3.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks. | 4 | 14 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With a Clinical Laboratory Abnormality Leading to an AE
- Description
Laboratory parameters included hematology (hematocrit, hemoglobin, red blood cell count, white blood cell count with differential \[neutrophils, lymphocytes, monocytes, eosinophils, basophils\], and platelet count); serum chemistries (blood urea nitrogen, creatinine, total bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, total protein, sodium, potassium, bicarbonate, calcium, chloride, magnesium, inorganic phosphate, creatine kinase, lactate dehydrogenase, erythrocyte sedimentation rate, C-reactive protein, troponin, myoglobin, insulin-like growth factor 1, and cholesterol \[(nonfasting\]); urinalysis (color, pH, specific gravity, protein, glucose, ketones, and blood). Clinically significant laboratory abnormalities were based upon Investigator's discretion. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
- Time frame
- Up to End of Study (up to Week 25)
- Population
- Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation.
Source ClinicalTrials.gov
Trial
- Title
- Evaluate Safety and Biological Activity of ATYR1940 in Participants With Limb Girdle Muscular Dystrophy 2B (LGMD2B) and Facioscapulohumeral Muscular Dystrophy (FSHD)
- NCT number
- NCT02579239
- Phases
- PHASE1, PHASE2
- Conditions
- Limb-Girdle Muscular Dystrophies, Facioscapulohumeral Muscular Dystrophy
- Interventions
- ATYR1940, Placebo
- Lead sponsor
- aTyr Pharma, Inc.
- Results first posted
- 2023-10-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02579239?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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