Table 3

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

Event type25 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 hepatitis1 (2%) [1]0 (0%) [0]1 (3%) [1]1 (33%) [1]
 Cardiomyopathy0 (0%) [0]0 (0%) [0]0 (0%) [0]1 (33%) [1]
 Multiple organ dysfunction syndrome0 (0%) [0]0 (0%) [0]0 (0%) [0]1 (33%) [1]
 Pulmonary edema0 (0%) [0]0 (0%) [0]0 (0%) [0]1 (33%) [1]
 Hypertension2 (4%) [6]1 (6%) [1]1 (3%) [5]0 (0%) [0]
 Diarrhea2 (4%) [2]2 (11%) [2]0 (0%) [0]0 (0%) [0]
 Hyponatremia1 (2%) [3]0 (0%) [0]1 (3%) [1]0 (0%) [0]
 Aspartate aminotransferase increased1 (2%) [1]0 (0%) [0]0 (0%) [0]0 (0%) [0]
 Colitis1 (2%) [1]0 (0%) [0]1 (3%) [1]0 (0%) [0]
 Encephalopathy1 (2%) [1]0 (0%) [0]0 (0%) [0]0 (0%) [0]
 Fatigue1 (2%) [1]1 (6%) [1]0 (0%) [0]0 (0%) [0]
 Pneumonitis1 (2%) [1]0 (0%) [0]0 (0%) [0]0 (0%) [0]
Related leading to discontinuation
 Multiple organ dysfunction syndrome0 (0%) [0]1 (33%) [1]
 Pulmonary edema0 (0%) [0]1 (33%) [1]
 Pneumonitis2 (4%) [2]0 (0%) [0]
 Autoimmune hepatitis1 (2%) [1]0 (0%) [0]
 Encephalopathy1 (2%) [1]0 (0%) [0]
 Vomiting1 (2%) [1]0 (0%) [0]
Related Serious AEs
 Autoimmune hepatitis1 (2%) [1]1 (33%) [1]
 Cardiomyopathy0 (0%) [0]1 (33%) [1]
 Multiple organ dysfunction syndrome0 (0%) [0]1 (33%) [1]
 Pulmonary edema0 (0%) [0]1 (33%) [1]
 Pneumonitis2 (4%) [3]0 (0%) [0]
 Pyrexia1 (2%) [2]0 (0%) [0]
 Diarrhea1 (2%) [1]0 (0%) [0]
 Encephalopathy1 (2%) [1]0 (0%) [0]
 Transaminitis1 (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.