Table 1.

Treatment-related AEs in ê5% of patients and AEs of grade 3 or higher

3 mg (n = 6)5 mg (n = 3)8 mg (n = 4)12 mg (n = 10)16 mg (n = 11)All (N = 34)
Adverse events in ≥5% of patients
 Total number of patients with ≥1 AE6 (100%)2 (66.7%)3 (75%)10 (100%)10 (90.9%)31 (91.2%)
 Total number of AEs177780115226
 Diarrhea1 (16.7%)1 (33.3%)1 (25.0%)5 (50.0%)7 (63.6%)15 (44.1%)
 Fatigue2 (33.3%)1 (33.3%)1 (25.0%)5 (50.0%)5 (45.5%)14 (41.2%)
 Decreased appetite1 (16.7%)1 (33.3%)1 (25.0%)5 (50.0%)5 (45.5%)13 (38.2%)
 Hyperglycemia002 (50.0%)3 (30.0%)8 (72.7%)13 (38.2%)
 Nausea2 (33.3%)1 (33.3%)1 (25.0%)3 (30.0%)6 (54.5%)13 (38.2%)
 Stomatitisa0006 (60.0%)4 (36.4%)10 (29.4%)
 Rashb0003 (30.0%)3 (27.3%)6 (17.6%)
 Vomiting01 (33.3%)004 (36.4%)5 (14.7%)
 Dry mouth0002 (20.0%)1 (9.1%)3 (8.8%)
 Pruritis0003 (30.0%)03 (8.8%)
 Colitis0001 (10.0%)1 (9.1%)2 (5.9%)
 Leukopenia00002 (18.2%)2 (5.9%)
 Mood altered2 (33.3%)00002 (5.9%)
 Neuropathy peripheral1 (16.7%)001 (10.0%)02 (5.9%)
 Pyrexia00002 (18.2%)2 (5.9%)
Adverse events of ≥grade 3
Total number of patients with ≥1 AE0006 (60.0%)8 (72.7%)14 (41.2%)
 Total number of AEs000131629
 Hyperglycemia0002 (20.0%)3 (27.3%)5 (14.7%)
 Rashb0003 (30.0%)1 (9.1%)4 (11.8%)
 Diarrhea00002 (18.2%)2 (5.9%)
 Fatigue00002 (18.2%)2 (5.9%)
 Pruritus0002 (20.0%)02 (5.9%)
 Pneumonitis00001 (9.1%)1 (2.9%)
 Colitis0001 (10.0%)01 (2.9%)
 Exfoliative rash00001 (9.1%)1 (2.9%)
 Lung infection00001 (9.1%)1 (2.9%)
 Renal failure acute0001 (10.0%)01 (2.9%)
 Skin exfoliation00001 (9.1%)1 (2.9%)
 Stomatitis0001 (10.0%)01 (2.9%)
  • aStomatitis includes the following terms: stomatitis, mucosal inflammation, lip ulceration.

  • bRash includes the following terms: rash, rash erythematous, rash maculopapular.