Comparison · NCT01175213-sae
IGSC, 10% - rHuPH20 vs Safety Follow-up - IGSC, 10% or IGIV, 10% Only: serious adverse events
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. IGSC, 10% - rHuPH20 vs Safety Follow-up - IGSC, 10% or IGIV, 10% Only: serious adverse events. Trial comparisons, record NCT01175213-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01175213-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 | 0.143 | 0.077 | 0.25 | wilson | |
| Risk in group 2 | 0.0588 | 0.0202 | 0.159 | wilson | |
| Risk difference, group 1 minus group 2 | 0.084 | -0.036 | 0.198 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.43 | 0.693 | 8.51 | log | |
| Odds ratio, group 1 over group 2 | 2.67 | 0.682 | 10.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on IGSC, 10% - rHuPH20 than on Safety Follow-up - IGSC, 10% or IGIV, 10% Only | 11.9 | 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 | IGSC, 10% - rHuPH20 | Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20). | 9 | 63 | EG000 |
| Group 2 | Safety Follow-up - IGSC, 10% or IGIV, 10% Only | All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%. | 3 | 51 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID
- NCT number
- NCT01175213
- Phases
- PHASE3
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Interventions
- SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety), SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety), IV treatment with IGSC, 10%
- Lead sponsor
- Baxalta now part of Shire
- Results first posted
- 2016-05-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01175213?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT01175213-sae