Table 4 Unsolicited adverse events - summary table

Subjects with at least one or more AE	Ad26/MVA	Ad26/Ad26 + gp140	Placebo
Analysis set: full analysis set	10	9	6
Post-any dose	10	9	6
Unsolicited AE	5 (50.0%)	6(66.7%)	2 (33.3%)
Unsolicited AE with severity grade 1 as worst grade	2 (20.0%)	2 (22.2%)	2 (33.3%)
Unsolicited AE with severity grade 2 as worst grade	1 (10.0%)	3 (33.3%)	0
Unsolicited AE with severity grade 3 as worst grade	2 (20.0%)	1 (11.1%)	0
Unsolicited AE with severity grade 4 as worst grade	0	0	0
Unsolicited AE that is thought to be related^a to vaccine	2 (20.0%)	2 (22.2%)	1 (16.7%)
Unsolicited AE with worst grade 3 or 4 thought to be related^a to vaccine	1 (10.0%)	0	0
AE leading to study discontinuation	0	0	0
AE leading to permanent stop of the vaccine	0	0	0
SAE	0	0	0
SAE that is thought to be related^a to vaccine	0	0	0
SAE that is leading to study discontinuation	0	0	0
AEs with fatal^b outcome	0	0	0

Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. Only unsolicited AEs collected during the 28-day post-vaccination phase are included.
AE adverse event, SAE serious adverse event.
^aAn AE is categorized as related if assessed by the investigator as possibly, probably, or very likely related to study vaccination.
^bAEs leading to death are based on AE outcome of Fatal.

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