Comparison · NCT00814320-sae
IV Administration of IGIV, 10% vs SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up): 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. IV Administration of IGIV, 10% vs SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up): serious adverse events. Trial comparisons, record NCT00814320-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00814320-sae
On this page
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 | 0.0345 | 0.0118 | 0.0965 | wilson | |
| Risk in group 2 | 0.145 | 0.0847 | 0.236 | wilson | |
| Risk difference, group 1 minus group 2 | -0.11 | -0.204 | -0.0238 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.239 | 0.0698 | 0.815 | log | |
| Odds ratio, group 1 over group 2 | 0.211 | 0.0574 | 0.778 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on IV Administration of IGIV, 10% than on SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up) | 9.08 | 4.9 | 41.9 | 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 | IV Administration of IGIV, 10% | Consists of Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of IV infusions of immune globulin intravenous (IGIV), 10%. | 3 | 87 | EG000 |
| Group 2 | SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up) | Consists of participants treated SC with IGIV, 10% at 108% of IV dose during administration of IGIV, 10%. This arm INCLUDES participants during ramp-up. Ramp-up: Participants were treated with SC infusions of IGIV, 10% with recombinant human hyaluronidase (rHuPH20). Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC. During SC administration of IGIV, 10% with rHuPh20, aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV. | 12 | 83 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Gammagard Liquid and rHuPH20 in PID
- NCT number
- NCT00814320
- Phases
- PHASE3
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Interventions
- Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV), Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)
- Lead sponsor
- Baxalta now part of Shire
- Results first posted
- 2015-12-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00814320?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00814320-sae