Comparison · NCT01213043-e4fcf4a5
60 mg/kg Prolastin-C vs 120 mg/kg Prolastin-C: Subjects With Treatment-Emergent Serious Adverse Events (SAEs)
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. 60 mg/kg Prolastin-C vs 120 mg/kg Prolastin-C: Subjects With Treatment-Emergent Serious Adverse Events (SAEs). Trial comparisons, record NCT01213043-e4fcf4a5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01213043-e4fcf4a5
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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 | 0.114 | wilson | |
| Risk in group 2 | 0 | 0 | 0.114 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.114 | 0.114 | 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 | 60 mg/kg Prolastin-C | 0 | 30 | OG000 | |
| Group 2 | 120 mg/kg Prolastin-C | 0 | 30 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Subjects With Treatment-Emergent Serious Adverse Events (SAEs)
- Description
- Number of subjects who experienced at least one treatment-emergent SAE.
- Time frame
- 22 weeks
- Population
- All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).
Source ClinicalTrials.gov
Trial
- Title
- Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency
- NCT number
- NCT01213043
- Phases
- PHASE2
- Conditions
- Emphysema, Alpha 1-antitrypsin Deficiency (AATD)
- Interventions
- Prolastin-C, 60 mg/kg, Prolastin-C, 120 mg/kg
- Lead sponsor
- Grifols Therapeutics LLC
- Results first posted
- 2013-05-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01213043?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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