Comparison · NCT01485796-sae
Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37) vs Safety Follow-up (n=26): serious adverse events
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. Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37) vs Safety Follow-up (n=26): serious adverse events. Trial comparisons, record NCT01485796-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01485796-sae
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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 | 0.0941 | wilson | |
| Risk in group 2 | 0.0385 | 0.00682 | 0.189 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0385 | -0.189 | 0.0608 | 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 a serious adverse event on Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37) than on Safety Follow-up (n=26) | 26 | 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 | Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37) | This analysis set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up (IGI, 10% by IV or SC route). | 0 | 37 | EG000 |
| Group 2 | Safety Follow-up (n=26) | Treatment with rHuPH20 was stopped as of August 2012 following discussion with the FDA. This decision was based on theoretical risks of exposure to anti-rHuPH20 antibodies, not because of any clinical adverse events. 26 subjects still active in Epoch 2 of the study went into a safety follow-up period and were treated with IGI, 10% (GAMMAGARD LIQUID) either intravenously or subcutaneously. | 1 | 26 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Overall: Approximately 1 year Per subject: 7 months
Source ClinicalTrials.gov
Trial
- Title
- Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD
- NCT number
- NCT01485796
- Phases
- PHASE2, PHASE3
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Interventions
- Immune Globulin Infusion (Human), 10%, Recombinant human hyaluronidase
- Lead sponsor
- Baxalta now part of Shire
- Results first posted
- 2017-04-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01485796?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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