TABLE 3.

Summary of adverse events, adverse drug reactions, and adverse events of special interest in the SYMPHONY HD‐Long study (safety analysis population)

	SYMPHONY HD‐Long (N = 136)
	n	%
Adverse events (≥5% subjects)
Any adverse events	133	97.8
Viral upper respiratory tract infection	67	49.3
Contusion	23	16.9
Diarrhea	23	16.9
Shunt stenosis	20	14.7
Upper respiratory tract inflammation	17	12.5
Excoriation	12	8.8
Vomiting	12	8.8
Muscle spasms	11	8.1
Back pain	10	7.4
Eczema	10	7.4
Shunt occlusion	10	7.4
Influenza	9	6.6
Pharyngitis	9	6.6
Skin exfoliation	9	6.6
Gastroenteritis	8	5.9
Constipation	7	5.1
Dermatitis contact	7	5.1
Dry eye	7	5.1
Hypertension	7	5.1
Myalgia	7	5.1
Pain in extremity	7	5.1
Serious adverse events (≥2 subjects)
Any serious adverse events	31	22.8
Shunt occlusion	6	4.4
Pneumonia	4	2.9
Cholangitis	3	2.2
Adverse drug reactions (≥2 subjects)
Any adverse drug reactions	12	8.8
Hypertension	4	2.9
Eczema	2	1.5
Serious adverse drug reactions
Any serious adverse drug reactions	2	1.5
Peripheral arterial occlusive disease	1	0.7
Brain stem infarction	1	0.7
Hypertension	7	5.1
Hypertension	7	5.1
Embolic and thrombotic events	17	12.5
Shunt occlusion	10	7.4
Cerebral infarction	3 a	2.2
Peripheral arterial occlusive disease	2	1.5
Brain stem infarction	1 a	0.7
Transient ischaemic attack	1	0.7
Venous occlusion	1	0.7
Malignant or unspecified tumors	3	2.2
Colon cancer	1	0.7
Gastric cancer	1	0.7
Glottis carcinoma	1	0.7
Retinal disorders	11	8.1
Retinal hemorrhage	3 b	2.2
Diabetic retinopathy	3	2.2
Retinal exudates	2 c	1.5
Diabetic retinal oedema	1	0.7
Macular oedema	1 c	0.7
Retinal detachment	1	0.7
Vitreous hemorrhage	1	0.7
Macular hole	1 b	0.7

^a One subject experienced both adverse events (AEs).

^b One subject experienced both AEs.

^c One subject experienced both AEs.