Table 4.

Safety overview

	Vismodegib 150 mg/day + pirfenidone ≤ 2403 mg/day (N = 21)
Patients with ≥ 1 TEAE, n (%)	21 (100)
Total number of TEAEs	135
TEAE leading to withdrawal from study, n (%)	4 (19.0)
Patients with ≥ 1 SAE, n (%)	3 (14.3)
Total number of SAEs	5
Related SAE, n (%)a	1 (4.8)
Deaths, n (%)b	1 (4.8)
Patients with ≥ 1 AESI
Muscle spasms, n (%)	16 (76.2)
Total number of muscle spasm events	28
Infections, n (%)	7 (33.3)
Total number of infections	7

AESI adverse event of special interest, IPF idiopathic pulmonary fibrosis, SAE serious adverse event, TEAE treatment-emergent adverse event

^aSAE dehydration related to vismodegib

^bCause of death reported as IPF