Statistical analysis
migraine, headaches, headache, migraines
ADVERSE EVENT, ADVERSE EVENT, MIGRAINES, MIGRAINE, EVENTS
Infusion and adverse event data were pooled across three Gammaplex studies (GMX01, GMX04, GMX07). Summaries of infusion protocol were generated to identify the proportion of infusions following the 15-minute rate escalation protocol and reaching the maximum infusion rate. Adverse events were documented based on direct observation during each infusion, interviews with the patient, and/or diary entries. Summaries of tolerability were generated to identify the proportion of infusions associated with product-related AEs. Product-related AEs were defined as those considered possibly, probably, or definitely related to administration of the product by the investigator. Infusion-associated AEs were defined as those occurring during or within 72 hours of the end of the infusion, specifically headaches and migraines. When assessing infusion protocol and tolerability, 95% confidence intervals for the proportion of infusions were calculated using the Clopper-Pearson (exact) method. Differences in tolerability across product formulation, dose categories, infusion order, and PI diagnosis were summarized using a 95% confidence interval for difference of proportions. All analyses were produced using SAS 9.4. All Exploratory subgroup analyses were conducted by gender (male vs female), age (adult vs pediatric), product formulation (5% IVIG vs 10% IVIG), infusion schedule (every 21 days vs every 28 days), and dose tertile (≤429 mg/kg, >429-≤526 mg/kg, and >526 mg/kg). Exploratory bivariate analyses were conducted for age and product formulation, age and gender, and gender and product formulation. Data were analyzed both by infusions and by patients to evaluate the extent to which a subset of patients accounted for headache and migraine events.