Comparison · NCT03116347-7bc39985
HyQvia New Starters vs HyQvia Pre-treated: Safety: Number of Participants With Any Serious TEAEs (Excluding Infections)
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. HyQvia New Starters vs HyQvia Pre-treated: Safety: Number of Participants With Any Serious TEAEs (Excluding Infections). Trial comparisons, record NCT03116347-7bc39985. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03116347-7bc39985
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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 | 0.143 | wilson | |
| Risk in group 2 | 0.158 | 0.0552 | 0.376 | wilson | |
| Risk difference, group 1 minus group 2 | -0.158 | -0.376 | 0.0183 | 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 HyQvia New Starters than on HyQvia Pre-treated | 6.33 | 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 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | 0 | 23 | OG000 |
| Group 2 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. | 3 | 19 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Safety: Number of Participants With Any Serious TEAEs (Excluding Infections)
- Description
Serious TEAE were the AEs that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in-patient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Number of participants with any serious TEAEs (excluding infections) was reported.
- Time frame
- From start of study drug administration up to 20 months
- Population
- Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia.
Source ClinicalTrials.gov
Trial
- Title
- Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects
- NCT number
- NCT03116347
- Phases
- PHASE4
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Interventions
- HYQVIA, KIOVIG, Cuvitru
- Lead sponsor
- Baxalta now part of Shire
- Results first posted
- 2023-01-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03116347?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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