Table 2 Safety outcomes
Parameters, n (%) | VDZ alone (N = 73) | VDZ + BUD (N = 50) | Overall population (N = 123) | p-value | |
|---|---|---|---|---|---|
AE | 17 (23.3) | 13 (26.0) | 30 (24.4) | 0.7308 | |
Severity of AE | Mild | 7 (41.2) | 10 (76.9) | 17 (56.7) | |
Moderate | 8 (47.1) | 7 (53.8) | 15 (50.0) | ||
Severe | 3 (17.6) | 1 (7.7) | 4 (13.3) | ||
SAE | 6 (8.2) | 3 (6.0) | 9 (7.3) | 0.6424 | |
Severity of SAE | Mild | 0 (0.0) | 0 (0.0) | 0 (0.0) | - |
Moderate | 5 (83.3) | 2 (66.7) | 7 (77.8) | ||
Severe | 1 (16.7) | 1 (33.3) | 2 (22.2) | ||
Description of AE > 5% | GI disorders | 6 (35.3) | 6 (46.2) | 12 (40.0) | - |
Abdominal distension | 1 (16.7) | 1 (16.7) | 2 (16.7) | ||
Anal fissure | 1 (16.7) | 1 (16.7) | 2 (16.7) | ||
Bile acid malabsorption | 0 (0.0) | 1 (16.7) | 1 (8.3) | ||
Constipation | 0 (0.0) | 1 (16.7) | 1 (8.3) | ||
Worsening Crohn’s disease | 3 (50.0) | 0 (0.0) | 3 (25.0) | ||
Flatulence | 1 (16.7) | 1 (16.7) | 2 (16.7) | ||
Nausea | 1 (16.7) | 1 (16.7) | 2 (16.7) | ||
Toothache | 1 (16.7) | 0 (0.0) | 1 (8.3) | ||
Vomiting | 0 (0.0) | 1 (16.7) | 1 (8.3) | ||
Infections and infestations | 6 (35.3) | 4 (30.8) | 10 (33.3) | ||
Anal abscess | 1 (16.7) | 1 (25.0) | 2 (20.0) | ||
Cytomegalovirus infection | 1 (16.7) | 0 (0.0) | 1 (10.0) | ||
Gastroenteritis | 1 (16.7) | 1 (25.0) | 2 (20.0) | ||
Overgrowth bacterial | 0 (0.0) | 1 (25.0) | 1 (10.0) | ||
Pneumonia | 1 (16.7) | 0 (0.0) | 1 (10.0) | ||
Upper respiratory tract infection | 2 (33.3) | 0 (0.0) | 2 (20.0) | ||
Urinary tract infection | 0 (0.0) | 1 (25.0) | 1 (10.0) | ||
Musculoskeletal and connective tissue disorders | 7 (41.2) | 1 (7.7) | 8 (26.7) | ||
Arthralgia | 4 (57.1) | 0 (0.0) | 4 (50.0) | ||
Muscular weakness | 0 (0.0) | 1 (100.0) | 1 (12.5) | ||
Osteoarthritis | 1 (14.3) | 0 (0.0) | 1 (12.5) | ||
Pain in the extremity | 2 (28.6) | 0 (0.0) | 2 (25.0) | ||
General disorders and administration site conditions | 3 (17.6) | 5 (38.5) | 8 (26.7) | ||
Fatigue | 2 (66.7) | 4 (80.0) | 6 (75.0) | ||
Edema peripheral | 0 (0.0) | 1 (20.0) | 1 (12.5) | ||
Pyrexia | 1 (33.3) | 0 (0.0) | 1 (12.5) | ||
Rash | 1 (33.3) | 2 (40.0) | 3 (37.5) | ||
Nervous system disorders | 2 (11.8) | 5 (38.5) | 7 (23.3) | ||
Dizziness | 0 (0.0) | 1 (20.0) | 1 (14.3) | ||
Epilepsy | 0 (0.0) | 1 (20.0) | 1 (14.3) | ||
Headache | 2 (100.0) | 4 (80.0) | 6 (85.7) | ||
Skin and subcutaneous tissue disorders | 2 (11.8) | 1 (7.7) | 3 (10.0) | ||
Eczema | 1 (50.0) | 0 (0.0) | 1 (33.3) | ||
Erythema | 1 (50.0) | 0 (0.0) | 1 (33.3) | ||
Pruritus | 0 (0.0) | 1 (100.0) | 1 (33.3) | ||
Surgical and medical procedures | 1 (5.9) | 1 (7.7) | 2 (6.7) | ||
Investigations | 0 (0.0) | 2 (15.4) | 2 (6.7) | ||
Outcome related to AE | Fatal | 0 (0.0) | 0 (0.0) | 0 (0.0) | - |
Recovered/resolved | 15 (88.2) | 10 (76.9) | 25 (83.3) | ||
Recovering/resolving | 1 (5.9) | 5 (38.5) | 6 (20.0) | ||
Not recovered/not resolved | 4 (23.5) | 2 (15.4) | 6 (20.0) | ||
Recovered with sequelae/resolved with sequelae | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
Unknown | 2 (11.8) | 0 (0.0) | 2 (6.7) | ||