Table 2 AEs during treatment

Event	Rentosertib 30 mg QD n = 18	Rentosertib 30 mg BID n = 18	Rentosertib 60 mg QD n = 18	Placebo n = 17
Any AE – no. (%)	13 (72.2)	15 (83.3)	15 (83.3)	12 (70.6)
SAEs^a, grade ≥3 – no. (%)	2 (11.1)	4 (22.2)	7 (38.9)	3 (17.6)
Liver function
Liver injury – no. (%)^b	0 (0)	2 (11.1)	1 (5.6)	0 (0)
ALT increase – no. (%)	0 (0)	0 (0)	1 (5.6)	0 (0)
AST increase – no. (%)	0 (0)	0 (0)	1 (5.6)	0 (0)
SAEs resulting in death – no. (%)	0 (0)	1 (5.6)	0 (0)	0 (0)
AEs considered to be treatment related^c – no. (%)	9 (50.0)	11 (61.1)	14 (77.8)	5 (29.4)
SAEs considered to be treatment related – no. (%)	1 (5.6)	2 (11.1)	2 (11.1)	0 (0)
AEs leading to treatment discontinuation^d – no. (%)	1 (5.6)	5 (27.8)	4 (22.2)	2 (11.8)

^aSAEs were defined as any AE resulting in death or that was life-threatening, required or prolonged hospitalization, resulted in persistent or substantial disability or incapacity, or was judged to jeopardize the subject and may have required medical or surgical intervention to prevent one of the other outcomes listed previously.
^bLiver injury defined as elevated ALT and/or AST ≥3-fold upper level of normal (ULN) combined with blood bilirubin ≥2-fold ULN or ALT and/or AST ≥10-fold ULN. Patients with liver injury are not counted among the totals for elevated ALT, AST or bilirubin individually.
^cAEs were defined as treatment related if the site investigator considered them definitely, probably or possibly related to treatment or with unknown or missing relationship to treatment. The most recent relationship was used when there were multiple records for the same AE.
^dEnrolled participants were considered for discontinuation of treatment if experiencing unacceptable AEs as determined by the site investigator, a need for concomitant medication(s) that interfere with the investigational drug or other study treatment and would constitute a safety hazard, an inability to receive study treatment for medical reason such as surgery, AEs or other diseases, unexplained weight loss if visit 2 BMI <18.5 kg m⁻², changes in ECG requiring intervention, or ECG QTcF >500 ms. See the study protocol, provided after request to the authors, for full criteria.

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