Table 3.

Treatment-related severe AEs, AEs leading to discontinuation and serious AEs

Event type	25 mg/240 mg* n (%) N=55			50 mg/240 mg* n (%) N=3
	Total N=55	PDAC N=18	MSS mCRC N=33
Related severe AEs
Autoimmune hepatitis	1 (2%) [1]	0 (0%) [0]	1 (3%) [1]	1 (33%) [1]
Cardiomyopathy	0 (0%) [0]	0 (0%) [0]	0 (0%) [0]	1 (33%) [1]
Multiple organ dysfunction syndrome	0 (0%) [0]	0 (0%) [0]	0 (0%) [0]	1 (33%) [1]
Pulmonary edema	0 (0%) [0]	0 (0%) [0]	0 (0%) [0]	1 (33%) [1]
Hypertension	2 (4%) [6]	1 (6%) [1]	1 (3%) [5]	0 (0%) [0]
Diarrhea	2 (4%) [2]	2 (11%) [2]	0 (0%) [0]	0 (0%) [0]
Hyponatremia	1 (2%) [3]	0 (0%) [0]	1 (3%) [1]	0 (0%) [0]
Aspartate aminotransferase increased	1 (2%) [1]	0 (0%) [0]	0 (0%) [0]	0 (0%) [0]
Colitis	1 (2%) [1]	0 (0%) [0]	1 (3%) [1]	0 (0%) [0]
Encephalopathy	1 (2%) [1]	0 (0%) [0]	0 (0%) [0]	0 (0%) [0]
Fatigue	1 (2%) [1]	1 (6%) [1]	0 (0%) [0]	0 (0%) [0]
Pneumonitis	1 (2%) [1]	0 (0%) [0]	0 (0%) [0]	0 (0%) [0]
Related leading to discontinuation
Multiple organ dysfunction syndrome	0 (0%) [0]			1 (33%) [1]
Pulmonary edema	0 (0%) [0]			1 (33%) [1]
Pneumonitis	2 (4%) [2]			0 (0%) [0]
Autoimmune hepatitis	1 (2%) [1]			0 (0%) [0]
Encephalopathy	1 (2%) [1]			0 (0%) [0]
Vomiting	1 (2%) [1]			0 (0%) [0]
Related Serious AEs
Autoimmune hepatitis	1 (2%) [1]			1 (33%) [1]
Cardiomyopathy	0 (0%) [0]			1 (33%) [1]
Multiple organ dysfunction syndrome	0 (0%) [0]			1 (33%) [1]
Pulmonary edema	0 (0%) [0]			1 (33%) [1]
Pneumonitis	2 (4%) [3]			0 (0%) [0]
Pyrexia	1 (2%) [2]			0 (0%) [0]
Diarrhea	1 (2%) [1]			0 (0%) [0]
Encephalopathy	1 (2%) [1]			0 (0%) [0]
Transaminitis	1 (2%) [1]			0 (0%) [0]

*For any given AE, the results are presented as the number of participants with the event: n, the proportion of participants with the event: (%), and the number of events: [e].

AEs, adverse events; MSS mCRC, microsatellite stable metastatic colorectal cancer; PDAC, pancreatic ductal adenocarcinoma.