Comparison · NCT03919773-sae
Treatment IVIG Arm vs Treatment Albumin Arm: 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. Treatment IVIG Arm vs Treatment Albumin Arm: serious adverse events. Trial comparisons, record NCT03919773-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03919773-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 | 0.0714 | 0.0198 | 0.226 | wilson | |
| Risk in group 2 | 0.0769 | 0.0214 | 0.241 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00549 | -0.178 | 0.159 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.929 | 0.141 | 6.12 | log | |
| Odds ratio, group 1 over group 2 | 0.923 | 0.12 | 7.08 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Treatment IVIG Arm than on Treatment Albumin Arm | 182 | 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 | Treatment IVIG Arm | IVIG (Gammunex-C) infusion (0.4 gm/kg) every week for 4 weeks, then every 2 weeks for 8 weeks (12 weeks total).~IVIG: If you participate in this study there will be 18 scheduled treatment infusions during the 30 week study period. All the study visits and treatment visits will be outpatient visits.~Once you qualify to participate in the study and begin treatment, there will be two 12 week treatment periods separated by a 6 week washout period. The infusion visits will take approximately 3-4 hours each. | 2 | 28 | EG000 |
| Group 2 | Treatment Albumin Arm | albumin infusion (0.4 gm/kg) every week for 4 weeks then every 2 weeks for 8 weeks (12 weeks total) during~Albumin: This will be the matching placebo used in the study. | 2 | 26 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 30 weeks
Source ClinicalTrials.gov
Trial
- Title
- IVIG (Gamunex-C) Treatment Study for POTS Subjects
- NCT number
- NCT03919773
- Phases
- PHASE1, PHASE2
- Conditions
- Postural Tachycardia Syndrome
- Interventions
- IVIG, Albumin
- Lead sponsor
- University of Texas Southwestern Medical Center
- Results first posted
- 2024-09-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03919773?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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