Table 2:

Secondary Outcome: Adverse Events During Tolebrutinib Treatment

		Tolebrutinib
Participants, n (%)^a	All participants (N=130)	5 mg (n=33)	15 mg (n=32)	30 mg (n=33)	60 mg (n=32)
Any AE	70 (54)	19 (58)	17 (53)	18 (55)	16 (50)
Severe AE^b	1 (1)	0	0	0	1 (3)
Serious AE^b	1 (1)	0	0	0	1 (3)
AE leading to death	0	0	0	0	0
AE leading to study discontinuation	0	0	0	0	0
Any AE leading to study treatment discontinuation	0	0	0	0	0
Any treatment-related AE	17 (13)	5 (15)	1 (3)	4 (12)	7 (22)

AEs occurring in >2 participants during 12 weeks of tolebrutinib treatment
Headache	9 (7)	1 (3)	3 (9)	1 (3)	4 (13)
Upper respiratory tract infection	6 (5)	2 (6)	2 (6)	1 (3)	1 (3)
Nasopharyngitis	5 (4)	1 (3)	0	1 (3)	3 (9)
Back pain	4 (3)	1 (3)	1 (3)	2 (6)	0
Peripheral oedema	4 (3)	2 (6)	0	0	2 (6)
Accidental overdose	3 (2)	0	0	0	3 (9)
Gastroenteritis	3 (2)	1 (3)	0	0	2 (6)
Alanine aminotransferase increased^c	3 (2)	1 (3)	0	1 (3)	1 (3)
Respiratory tract infection	3 (2)	0	1 (3)	1 (3)	1 (3)
Muscle spasticity	3 (2)	0	0	1 (3)	2 (6)
Oropharyngeal pain	3 (2)	1 (3)	0	1 (3)	1 (3)
Alopecia	3 (2)	1 (3)	1 (3)	0	1 (3)

Percentage of participants with ≥1 event.

One participant from the tolebrutinib 60-mg arm experienced a serious AE, which was also determined to be severe; the AE was an MS relapse that was reported by an investigator due to hospitalisation for differential diagnosis.

Three participants had elevated alanine aminotransferase levels, 2 of whom (in the 30- and 60-mg arms) had levels >3 times the upper limit of normal.

AE=adverse event. MS=multiple sclerosis. See table S2 (Supplementary Appendix, page 27) for details about safety outcomes of tolebrutinib compared to placebo over weeks 1-4.