Table 2.

Incidence of TEAEs.

TEAE category, n (%)	Total, n = 71
Any TEAE	67 (94.4)
Any grade ≥ III TEAE	22 (31.0)
Any treatment-relateda TEAE	38 (53.5)
Any grade ≥ III treatment-related TEAE	1 (1.4)
Any TEAE with outcome of death	0
Any SAE	17 (23.9)
Any treatment-related SAE	1 (1.4)
Any TEAE leading to treatment discontinuation	4 (5.6)

	Overall	Grade III	Grade IV/V	Treatment-related
Individual TEAEs
Injection-site erythema	14 (19.7)	0	0	14 (19.7)
Constipation	13 (18.3)	0	0	0
Nausea	12 (16.9)	0	0	3 (4.2)
Decreased appetite	10 (14.1)	0	0	2 (2.8)
Vomiting	9 (12.7)	0	0	1 (1.4)
Cough	9 (12.7)	0	0	1 (1.4)
Injection-site pain	8 (11.3)	0	0	8 (11.3)
Hyponatremia	8 (11.3)	3 (4.2)	0	0
Headache	8 (11.3)	0	0	1 (1.4)
Dyspnea	8 (11.3)	1 (1.4)	0	0
Injection-site reaction	7 (9.9)	0	0	7 (9.9)
Fall	7 (9.9)	0	0	0
Dizziness	7 (9.9)	0	0	0
Anemia	6 (8.5)	3 (4.2)	0	0
Hypokalemia	6 (8.5)	1 (1.4)	0	0
Leukocytosis	5 (7.0)	3 (4.2)	0	0
Diarrhea	5 (7.0)	1 (1.4)	0	0
Pyrexia	5 (7.0)	1 (1.4)	0	0
Asthenia	4 (5.6)	0	0	0
Contusion	4 (5.6)	0	0	1 (1.4)
Hyperglycemia	4 (5.6)	1 (1.4)	0	0
Hypoalbuminemia	4 (5.6)	0	0	0
Dysgeusia	4 (5.6)	0	0	0
Rash	4 (5.6)	1 (1.4)	0	3 (4.2)
Hyperphosphatemia	3 (4.2)	0	0	0
Muscular weakness	3 (4.2)	0	0	0
Pneumonia	2 (2.8)	2 (2.8)	0	0
Vasogenic cerebral edema	2 (2.8)	0	0	0
Confusional state	2 (2.8)	0	0	0
Upper-airway cough syndrome	2 (2.8)	0	0	1 (1.4)

Injection-related reactions are in bold font.

SAE serious adverse event, TEAE treatment-emergent adverse event.

^aAssessed as possibly, probably, or definitely related to study drug.