Table E5.

Serious AEs reported during the study

No.	Description of event	Causal relationship	Expected (Y/N)
1	Subject with severe asthma developed viral symptoms and wheeze 1 wk post-LAIV. Assessed in hospital: oxygen saturations 94% in room air. Admitted for 3 d observation, no change in medical management instituted	Probable	Y
2	Subject with severe asthma noted to have possible early signs of chest infection noted at assessment pre-LAIV, and oral antibiotics commenced. LAIV administered after review by local Investigator. Three days later, subject presented to local hospital with increased wheeze and breathlessness, and admitted for 3 d. Treated with nebulized salbutamol and intravenous antibiotics	Possible	Y
3	Subject with severe asthma; 19 d after LAIV, asthma exacerbation and was admitted to hospital overnight for hourly nebulizers, magnesium sulfate, and intravenous antibiotics. Discharged the next day	Unlikely∗	Y
4	Subject has severe asthma, previous HDU admissions, tolerated LAIV in previous years. Three weeks after LAIV, developed increasing wheeze/cough, prompting presentation to hospital on day 3 of illness. Diagnosed with asthma exacerbation and admitted to HDU, given magnesium sulphate, aminophylline, steroids, and nebulized salbutamol. No antibiotics started. No virology sent, blood studies demonstrated neutrophilia with elevated CRP (48 mg/L). No focal abnormality on chest x-ray. Discharged home after 48 h	Unlikely∗	Y

CRP, C-reactive protein; HDU, high dependency unit; IDMC, Independent Data Monitoring Committee; N, no; PI, principal investigator; Y, yes.

^∗IDMC ascribed unlikely due to very low probability of ongoing viral shedding 3 weeks after LAIV.^E1