Table 4.

Summary of adverse events

System organ class preferred term	KB003 (n=78)	Placebo (n=82)	Total (n=160)
Participants reporting at least 1 infusion-related reaction	4	2	6
All infusion-related reactions reported	6	10*	16
General disorders and administration site conditions	0	5	5
Fatigue	0	2	2
Influenza-like illness	0	2	2
Infusion site pain	0	1	1
Gastrointestinal disorders	1	2	3
Diarrhoea	0	0	0
Nausea	1	0	1
Tongue pruritus	0	2	2
Investigations	1	0	1
Body temperature increased	1	0	1
Nervous system disorder	3	0	3
Dizziness	1	0	1
Headache	2	0	2
Psychiatric disorders	0	1	1
Anxiety	0	1	1
Skin and subcutaneous tissue disorder	1	2	3
Rash	1	2	3

Events are tabulated by each incidence; a reaction may have occurred multiple times in a single participant.

Source: Listing 16.2.7.3 (appendix 16.2).

*Nine of the 10 events reported for the placebo group occurred in a single participant.