Comparison · NCT03277313-b68f6060
Epoch 1 vs Epoch 2: Number of Participants With All Related (Causally) and/or Temporally Associated TEAEs Excluding Infections
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. Epoch 1 vs Epoch 2: Number of Participants With All Related (Causally) and/or Temporally Associated TEAEs Excluding Infections. Trial comparisons, record NCT03277313-b68f6060. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03277313-b68f6060
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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 | 0.614 | 0.466 | 0.743 | wilson | |
| Risk in group 2 | 0.814 | 0.674 | 0.903 | wilson | |
| Risk difference, group 1 minus group 2 | -0.2 | -0.372 | -0.00975 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.754 | 0.573 | 0.992 | log | |
| Odds ratio, group 1 over group 2 | 0.363 | 0.136 | 0.966 | log | |
| Number needed to treat, for one fewer participant with the outcome on Epoch 1 than on Epoch 2 | 4.99 | 2.69 | 103 | from the risk difference interval |
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 | Epoch 1 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. | 27 | 44 | OG000 |
| Group 2 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. | 35 | 43 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With All Related (Causally) and/or Temporally Associated TEAEs Excluding Infections
- Description
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Number of participants with any related (causally) and/or temporally associated TEAEs (excluding infections) was reported. Temporally-associated TEAEs were defined as TEAEs which begin during infusion of IP or within 72 hours following the end of IP infusion.
- Time frame
- From beginning of infusion up to 72 hours post infusion
- Population
- SAS included all participants who received at least one dose of HyQvia.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects
- NCT number
- NCT03277313
- Phases
- PHASE3
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Interventions
- HYQVIA
- Lead sponsor
- Baxalta now part of Shire
- Results first posted
- 2023-10-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03277313?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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