Comparison · NCT02525861-eed6e44c
Cohort I: GLASSIA (High-end) vs Cohort II: GLASSIA (Low-end): Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 72 Hours Following the End of IP Infusion
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. Cohort I: GLASSIA (High-end) vs Cohort II: GLASSIA (Low-end): Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 72 Hours Following the End of IP Infusion. Trial comparisons, record NCT02525861-eed6e44c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02525861-eed6e44c
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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 | 0.556 | 0.337 | 0.754 | wilson | |
| Risk in group 2 | 0.438 | 0.231 | 0.668 | wilson | |
| Risk difference, group 1 minus group 2 | 0.118 | -0.2 | 0.405 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.27 | 0.635 | 2.54 | log | |
| Odds ratio, group 1 over group 2 | 1.61 | 0.414 | 6.24 | log | |
| Number needed to treat, for one more participant with the outcome on Cohort I: GLASSIA (High-end) than on Cohort II: GLASSIA (Low-end) | 8.47 | 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 | Cohort I: GLASSIA (High-end) | Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions). | 10 | 18 | OG000 |
| Group 2 | Cohort II: GLASSIA (Low-end) | Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions). | 7 | 16 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 72 Hours Following the End of IP Infusion
- Description
An Treatment-emergent AR and suspected AR was any TEAE which met any of the following criteria: a; A TEAE that began during infusion or within 72 hours (or 3 days where time of onset is not available) following the end of IP infusion, or b; A TEAE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or c; A TEAE for which causality assessment was missing or indeterminate. Number of participants with both treatment-emergent ARs plus suspected ARs were collectively reported.
- Time frame
- From start of study treatment up to 72 hours post infusion
- Population
- Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures.
Source ClinicalTrials.gov
Trial
- Title
- GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study
- NCT number
- NCT02525861
- Phases
- PHASE3
- Conditions
- Alpha1-antitrypsin Deficiency
- Interventions
- GLASSIA
- Lead sponsor
- Baxalta now part of Shire
- Results first posted
- 2021-10-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02525861?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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