Clinical trial data
ADVERSE EVENTS, INJECTION SITE REACTION, EVENTS, RESPIRATORY TRACT INFECTION (RTI)
The clinical trial data was captured in four master databases namely Screening/enrolment, Events, Lab results, and Follow-up, which consisted of 59 datasets in total. The Screening/enrolment database contained the participant demographics, medical and social history, and trial specific information such as inclusion/exclusion criteria, informed consent, and randomization. This database was therefore essential for covariate information to be tested in subsequent analyses. In the Events database, all information on adverse events was collected. Events were categorized as injection site reaction (ISR), respiratory tract infection (RTI), or other. Events were given a health status score by the clinical team with 0 representing healthy participant, 1 representing mild symptoms, 2 representing moderate symptoms, 3 representing severe symptoms, 4 representing hospitalization, 5 representing hospitalization with supplemental oxygen, 6 representing hospitalization with mechanical ventilation, and 7 representing deathThe four master databases were transferred from the data management to the pharmacometric team through secure file transfer protocol (sFTP, WinSCP v. 5.19.3