Table 2

Most common (≥10%) treatment-related adverse events in the safety population (N=106)

Treatment-related adverse eventAll grades, n (%)Grades 3–4, n %
Patients with any event91 (86)32 (30)
Visual impairment46 (43)6 (6)
Fatigue39 (37)2 (2)
Keratopathy*38 (36)9 (9)
Nausea31 (29)0
Peripheral neuropathy29 (27)3 (3)
Dry eye26 (25)2 (2)
Diarrhea23 (22)2 (2)
Photophobia15 (14)0
Decreased appetite14 (13)1 (1)
Neutropenia14 (13)2 (2)
Abdominal pain12 (11)2 (2)
Vomiting12 (11)0
Cataract11 (10)0
Pneumonitis11 (10)2 (2)
  • Data cut-off: December 22, 2022.

  • NOTE: Adverse events were evaluated on the basis of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Adverse events were linked to system organ class and preferred term (group and list terms included) using the Medical Dictionary for Regulatory Activities, version 24.0. When counting events, each record is counted once for each adverse event entered in the electronic case report form. For the remaining frequencies, each patient is counted once, with the worst grade for each preferred term, system organ class, or overall. Related events include those with a drug relationship of possibly related, probably related, or definitely related.

  • *The grouped preferred term ‘keratopathy’ includes all with the following preferred terms: corneal cyst, corneal disorder, corneal epithelial microcysts, keratitis, keratopathy, limbal stem-cell deficiency, corneal opacity, corneal erosion, corneal pigmentation, corneal deposits, keratitis interstitial, punctate keratitis, and corneal epithelial defect.