TABLE 2.
Summary of adverse events, adverse drug reactions, and adverse events of special interest in the SYMPHONY ND‐Long study (safety analysis population)
| SYMPHONY ND‐Long (N = 132) | ||
|---|---|---|
| n | % | |
| Adverse events (≥5% subjects) | ||
| Any adverse events | 115 | 87.1 |
| Viral upper respiratory tract infection | 34 | 25.8 |
| Chronic kidney disease | 11 | 8.3 |
| Hypertension | 10 | 7.6 |
| Constipation | 8 | 6.1 |
| Contusion | 8 | 6.1 |
| Diarrhea | 8 | 6.1 |
| Serious adverse events a (≥2 subjects) | ||
| Any serious adverse events | 34 | 25.8 |
| Chronic kidney disease | 7 | 5.3 |
| Renal impairment | 3 | 2.3 |
| Atrial fibrillation | 2 | 1.5 |
| Cardiac failure congestive | 2 | 1.5 |
| Adverse drug reactions (≥2 subjects) | ||
| Any adverse drug reactions | 18 | 13.6 |
| Hypertension | 4 | 3.0 |
| Blood pressure increased | 2 | 1.5 |
| Fibrin D dimer increased | 2 | 1.5 |
| Serious adverse drug reactionsa | ||
| Any serious adverse drug reactions | 2 | 1.5 |
| Renal impairment | 1 | 0.8 |
| Anti‐neutrophil cytoplasmic antibody positive vasculitis | 1 | 0.8 |
| Hypertension | 15 | 11.4 |
| Hypertension | 10 | 7.6 |
| Blood pressure increased | 4 | 3.0 |
| Essential hypertension | 1 | 0.8 |
| Embolic and thrombotic events | 1 | 0.8 |
| Deep vein thrombosis | 1 | 0.8 |
| Malignant or unspecified tumors | 1 | 0.8 |
| Plasma cell myeloma | 1 | 0.8 |
| Retinal disorders | 11 | 8.3 |
| Retinal hemorrhage | 4 b | 3.0 |
| Diabetic retinopathy | 2 | 1.5 |
| Retinal tear | 2 c | 1.5 |
| Vitreous hemorrhage | 2 c | 1.5 |
| Macular degeneration | 1 | 0.8 |
| Retinal detachment | 1 c | 0.8 |
| Retinal exudates | 1 b | 0.8 |
| Vitreous floaters | 1 | 0.8 |
a
Deaths were excluded.
b
One subject experienced both adverse events (AEs).
c
One subject experienced both AEs.