Table 2.

Treatment-emergent adverse events (reported in ≥10% of patients in each study)

MedDRA preferred term Number of patients (%)	Module 1A N = 44		Module 1B-1 N = 23		Module 2A N = 31
	All AEs	Grade ≥3	All AEs	Grade ≥3	All AEs	Grade ≥3
Any treatment-emergent AE	44 (100.0)	21 (47.7)	23 (100.0)	10 (43.5)	31 (100.0)	21 (67.7)
Diarrhea	38 (86.4)	2 (4.5)	21 (91.3)	3 (13.0)	28 (90.3)	6 (19.4)
Vomiting	36 (81.8)	1 (2.3)	14 (60.9)	2 (8.7)	26 (83.9)	1 (3.2)
Nausea	34 (77.3)	0	22 (95.7)	1 (4.3)	26 (83.9)	3 (9.7)
Fatigue	17 (38.6)	0	11 (47.8)	1 (4.3)	15 (48.4)	1 (3.2)
Abdominal pain	12 (27.3)	0	6 (26.1)	0	8 (25.8)	0
Anemia	10 (22.7)	2 (4.5)	0	1 (4.3)	4 (12.9)	3 (9.7)
Decreased appetite	9 (20.5)	1 (2.3)	3 (13.0)	0	13 (41.9)	0
ALT increased	8 (18.2)	1 (2.3)	0	0	7 (22.6)	2 (6.5)
Cough	8 (18.2)	0	3 (13.0)	0	3 (9.7)	1 (3.2)
Upper respiratory tract infection	8 (18.2)	0	3 (13.0)	0	0	0
Constipation	7 (15.9)	0	7 (30.4)	0	8 (25.8)	0
AST increased	7 (15.9)	0	0	0	7 (22.6)	1 (3.2)
Dyspnea	6 (13.6)	2 (4.5)	0	0	5 (16.1)	2 (6.5)
Back pain	6 (13.6)	0	0	0	2 (6.5)	0
Urinary tract infection	5 (11.4)	0	0	0	3 (9.7)	0
Abdominal pain upper	4 (9.1)	0	0	0	8 (25.8)	0
Headache	4 (9.1)	0	0	0	8 (25.8)	0
Weight decreased	4 (9.1)	1 (2.3)	0	0	4 (12.9)	0
Dizziness	2 (4.5)	0	0	0	5 (16.1)	0
Dysphagia	2 (4.5)	0	0	0	4 (12.9)	0
Hypocalcaemia	2 (4.5)	0	0	0	4 (12.9)	0
Rash	1 (2.3)	0	0	0	6 (19.4)	1 (3.2)
Hyperglycemia	1 (2.3)	0	0	0	5 (16.1)	0
Stomatitis	1 (2.3)	0	3 (13.0)	1 (4.3)	4 (12.9)	0
Dysgeusia	1 (2.3)	0	0	0	4 (12.9)	0
Hypokalaemia	0	0	0	0	5 (16.1)	2 (6.5)
Taste disorder	0	0	0	0	4 (12.9)	0

Patients with multiple incidences of the same AE are counted once for each preferred term.

Includes AEs with an onset date on or after the date of first dose and up to and including 28 days following the date of last dose of study medication.

AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, MedDRA Medical Dictionary for Regulatory Activities.