Table 3.

Adverse Events (Safety Population).

Adverse Event	AK002 (N = 43)	Placebo (N = 22)
	no. of patients (%)
Any serious event	4 (9)*	3 (14)†
Any event during treatment that occurred in ≥5% of patients in either group	39 (91)	18 (82)
Infusion-related reaction‡	26 (60)	5 (23)
Headache	4 (9)	2 (9)
Upper respiratory tract infection	4 (9)	2 (9)
Urinary tract infection	4 (9)	1 (5)
Nausea	3 (7)	3 (14)
Fatigue	3 (7)	2 (9)
Diarrhea	2 (5)	2 (9)
Nasopharyngitis	2 (5)	2 (9)
Abdominal pain	1 (2)	2 (9)
Dehydration	1 (2)	2 (9)
Viral gastroenteritis	1 (2)	2 (9)
Pyrexia	1 (2)	2 (9)
Sinusitis	1 (2)	2 (9)
Cough	0	2 (9)
Influenza	0	2 (9)
Increase in white-cell count	0	2 (9)

^*The serious adverse events that occurred in the combined AK002 group were moderate hypoxia and moderate chest pain (classified as a serious adverse event because the patient was hospitalized) in 1 patient, abdominal pain in 1 patient, dehydration in 1 patient, and anemia and a grade 4 infusion-related reaction in 1 patient. The only serious adverse event that was deemed to be related to AK002 was the infusion-related reaction.

^†The serious adverse events that occurred in the placebo group were mild dehydration in 1 patient (classified as a serious adverse event because the patient was hospitalized), severe anemia in 1 patient, and a change in mental status in 1 patient.

^‡Infusion-related reactions included flushing, a feeling of warmth, headache, nausea, or dizziness. Infusion-related reactions predominantly occurred on the first or second infusions, in which patients in both AK002 groups received identical doses, and the number of infusion-related reactions was numerically higher in the low-dose group (Table S10).