Table 5. Grading of local adverse events (adapted from 104).

Adverse event	Grade	Measurement
Pain/tenderness at injection or biopsy site	0 1 2 3	No pain Tender to touch only Painful on movement Persistent severe pain at rest
Redness at injection or biopsy site	0 1 2 3	0 mm 1–50 mm 51–100 mm > 100 mm
Swelling at injection or biopsy site	0 1 2 3	0 mm 1–20 mm 21–50 mm > 50 mm
Scaling/pustule/nodule at challenge site	0 1 2 3	0 mm 1–15 mm 16–29 mm ≥ 30 mm
Ulceration at challenge site	0 1 2 3	0 mm 1–9 mm 10–19 mm ≥ 20 mm, or ≥ 3 ulcers at the challenge site
Scarring at challenge site	0 1 2 3	0 mm 1–9 mm 10–19 mm ≥ 20 mm

The following information will be documented for all adverse events: description, date of onset and end date, severity and any treatment or intervention undertaken. The severity of AEs will be assessed using the following scale: 1 = mild, 2 = moderate, 3 = severe.