Table 6 Safety summary
PT, n (%)a | SAR200 + 26W taper (n = 27) | SAR150 + 26W taper (n = 14) | PBO + 52W taper (n = 28) | PBO + 26W taper (n = 14) |
|---|---|---|---|---|
Treatment-emergent SAE | 7 (26) | 2 (14) | 2 (7) | 3 (21) |
 COVID-19 | 1 (4) | 0 | 0 | 0 |
 Cellulitis | 1 (4) | 0 | 0 | 0 |
 Urosepsis | 1 (4) | 0 | 0 | 0 |
 Lower respiratory tract infection | 0 | 0 | 1 (4) | 0 |
 Pyelonephritis | 0 | 0 | 0 | 1 (7) |
 Septic shock | 0 | 0 | 0 | 1 (7) |
 Neutropenia | 2 (7) | 0 | 0 | 0 |
 Cerebral amyloid angiopathy | 1 (4) | 0 | 0 | 0 |
 Blindness unilateral | 0 | 1 (7) | 0 | 0 |
 Retinal artery occlusion | 0 | 1 (7) | 0 | 0 |
 Aortic dissection | 1 (4) | 0 | 0 | 0 |
 Deep vein thrombosis | 0 | 0 | 1 (4) | 0 |
 Peripheral vascular disorder | 0 | 0 | 0 | 1 (7) |
 Acute respiratory failure | 0 | 0 | 0 | 1 (7) |
 Colitis ulcerative | 0 | 0 | 1 (4) | 0 |
 Hiatus hernia | 0 | 1 (7) | 0 | 0 |
 Femur fracture | 1 (4) | 0 | 0 | 0 |
TEAE leading to permanent treatment discontinuation | 7 (26) | 1 (7) | 2 (7) | 1 (7) |
 COVID-19 | 1 (4) | 0 | 0 | 0 |
 Cellulitis | 1 (4) | 0 | 0 | 0 |
 Ovarian adenoma | 0 | 1 (7) | 0 | 0 |
 Neutropenia | 2 (7) | 0 | 0 | 0 |
 Thyroid cyst | 0 | 0 | 1 (4) | 0 |
 Cerebral amyloid angiopathy | 1 (4) | 0 | 0 | 0 |
 Headache | 1 (4) | 0 | 0 | 0 |
 Atrial fibrillation | 1 (4) | 0 | 0 | 0 |
 Acute respiratory failure | 0 | 0 | 0 | 1 (7) |
 Gastrointestinal disorder | 1 (4) | 0 | 0 | 0 |
 Colitis ulcerative | 0 | 0 | 1 (4) | 0 |
 Alanine aminotransferase increased | 1 (4) | 0 | 0 | 0 |
AESI | 6 (22) | 1 (7) | 2 (7) | 1 (7) |
 Herpes ophthalmic | 1 (4) | 0 | 0 | 0 |
 Herpes zosterb | 0 | 1 (7) | 1 (4) | 0 |
 Cellulitis | 1 (4) | 0 | 0 | 0 |
 COVID-19 | 1 (4) | 0 | 0 | 0 |
 Cellulitis | 1 (4) | 0 | 0 | 0 |
 Herpes zosterc | 0 | 0 | 1 (4) | 0 |
 Lower respiratory tract infection | 0 | 0 | 1 (4) | 0 |
 Pyelonephritis | 0 | 0 | 0 | 1 (7) |
 Septic shock | 0 | 0 | 0 | 1 (7) |
 ALT increasedd | 1 (4) | 0 | 0 | 0 |
 Neutropenia | 2 (7) | 0 | 0 | 0 |
 ALT increasede | 1 (4) | 0 | 0 | 0 |