Comparison · NCT01213043-e72ef2fd
60 mg/kg Prolastin-C vs 120 mg/kg Prolastin-C: Subjects 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. 60 mg/kg Prolastin-C vs 120 mg/kg Prolastin-C: Subjects With Treatment-Emergent Adverse Events (TEAEs). Trial comparisons, record NCT01213043-e72ef2fd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01213043-e72ef2fd
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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 | 0.767 | 0.591 | 0.882 | wilson | |
| Risk in group 2 | 0.6 | 0.423 | 0.754 | wilson | |
| Risk difference, group 1 minus group 2 | 0.167 | -0.0672 | 0.378 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.28 | 0.898 | 1.82 | log | |
| Odds ratio, group 1 over group 2 | 2.19 | 0.716 | 6.7 | log | |
| Number needed to treat, for one more participant with the outcome on 60 mg/kg Prolastin-C than on 120 mg/kg Prolastin-C | 6 | 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 | 60 mg/kg Prolastin-C | 23 | 30 | OG000 | |
| Group 2 | 120 mg/kg Prolastin-C | 18 | 30 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Subjects With Treatment-Emergent Adverse Events (TEAEs)
- Description
Number of subjects experiencing at least one TEAE. TEAEs were defined as any adverse event (AE) during the study that began on or after the date of first dose of investigational product (i.e., Prolastin-C).
- 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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