Table 4. Adverse Events (Safety Population).^*.

Event	177Lu-Dotatate Group (N = 111)		Control Group (N = 110)		P Value†
	Any Grade	Grade 3 or 4	Any Grade	Grade 3 or 4	Any Grade
	number of patients (percent)
Any adverse event	105 (95)	46 (41)	92 (84)	36 (33)	0.01
Gastrointestinal disorders
Nausea	65 (59)	4 (4)	13 (12)	2 (2)	<0.001
Vomiting	52 (47)	8 (7)	11 (10)	1 (1)	<0.001
Abdominal pain	29 (26)	3 (3)	29 (26)	6 (5)	1.00
Diarrhea	32 (29)	3 (3)	21 (19)	2 (2)	0.11
Distension	14 (13)	0	15 (14)	0	0.84
General disorders
Fatigue or asthenia	44 (40)	2 (2)	28 (25)	2 (2)	0.03
Edema peripheral	16 (14)	0	8 (7)	0	0.13
Blood disorders
Thrombocytopenia	28 (25)	2 (2)	1 (1)	0	<0.001
Anemia	16 (14)	0	6 (5)	0	0.04
Lymphopenia	20 (18)	10 (9)	2 (2)	0	<0.001
Leukopenia	11 (10)	1 (1)	1 (1)	0	0.005
Neutropenia	6 (5)	1 (1)	1 (1)	0	0.12
Musculoskeletal disorders
Musculoskeletal pain	32 (29)	2 (2)	22 (20)	1 (1)	0.16
Nutrition disorders
Decreased appetite	20 (18)	0	9 (8)	3 (3)	0.04
Nervous system disorders
Headache	18 (16)	0	5 (5)	0	0.007
Dizziness	12 (11)	0	6 (5)	0	0.22
Vascular disorders
Flushing	14 (13)	1 (1)	10 (9)	0	0.52
Skin disorders
Alopecia	12 (11)	0	2 (2)	0	0.01
Respiratory disorders
Cough	12 (11)	0	6 (5)	0	0.22

^*Shown are all adverse events that were reported in at least 10% of the patients in the ¹⁷⁷Lu-Dotatate group, with the exception of neutropenia, which was reported in less than 10% of the patients in the ¹⁷⁷Lu-Dotatate group. For the individual events, the system organ classes in the Medical Dictionary for Regulatory Activities (MedDRA) hierarchy are shown in bold and are followed by the MedDRA preferred terms (not bold). The safety population included all patients who underwent randomization and received at least one dose of trial treatment.

^†P values were calculated with the use of Fisher's exact text.