Table 2.
Summary of AEs among all treated patientsa
| FX006 16 mg (n = 102) | FX006 32 mg (n = 104) | Saline placebo (n = 100) | |
|---|---|---|---|
| Patients with ≥1 AE | 43 (42.2) | 46 (44.2) | 43 (43.0) |
| AEs occurring in >2.0% of patients in any treatment groupb | |||
| Arthralgia (any joint) | 10 (9.8) | 8 (7.7) | 16 (16.0) |
| Back pain | 3 (2.9) | 2 (1.9) | 2 (2.0) |
| Bronchitis | 3 (2.9) | 2 (1.9) | 2 (2.0) |
| Headache | 3 (2.9) | 4 (3.8) | 2 (2.0) |
| Joint swelling | 4 (3.9) | 5 (4.8) | 5 (5.0) |
| Ligament sprain | 4 (3.9) | 4 (3.8) | 2 (2.0) |
| Nasopharyngitis | 2 (2.0) | 2 (1.9) | 4 (4.0) |
| Neck pain | 0 (0.0) | 3 (2.9) | 0 (0.0) |
| Sinusitis | 3 (2.9) | 2 (1.9) | 1 (1.0) |
| Toothache | 0 (0.0) | 3 (2.9) | 1 (1.0) |
| Patients with ≥1 serious AE | 1 (1.0) | 3 (2.9) | 0 (0.0) |
| Patients with ≥1 AE leading to study discontinuation | 4 (3.9)c | 4 (3.8)d | 1 (1.0)e |
| Drug‐related | 1 (1.0)f | 0 (0.0) | 1 (1.0)f |
| Due to serious AE | 0 (0.0) | 1 (1.0)g | 0 (0.0) |
| Patients with ≥1 index knee–related AE | 15 (14.7) | 14 (13.5) | 17 (17.0) |
| Index knee–related AEs occurring in >2.0% of patients in any treatment groupb | |||
| Arthralgia | 8 (7.8) | 7 (6.7) | 14 (14.0) |
| Joint swelling | 4 (3.9) | 4 (3.8) | 3 (3.0) |
| Ligament sprain | 3 (2.9) | 1 (1.0) | 0 (0.0) |
| Patients with ≥1 index knee–related serious AE | 1 (1.0) | 1 (1.0) | 0 (0.0) |
| Patients with ≥1 index knee–related AE leading to study discontinuation | 4 (3.9)c | 3 (2.9)d | 1 (1.0)e |
| Drug‐related | 1 (1.0)f | 0 (0.0) | 1 (1.0)f |
| Due to serious AE | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Values are the number (%).
Listed in alphabetical order.
Joint effusion (day 131, grade 1, not related to study drug), arthralgia (day 57, grade 2, definitely related to study drug), and joint swelling (day 57, grade 3, not related to study drug) in 1 patient each, and arthralgia, arthritis, joint swelling, and synovial cyst all in 1 patient (day 88, all grade 2 and either not related or unlikely related to study drug). All adverse events (AEs) were index knee related.
Joint swelling (day 84, grade 1, not related to study drug), worsening ankle osteoarthritis (OA) (day 37, grade 2, not related to study drug, serious), positive Klebsiella test (day 21, subsequently considered to be a false‐positive finding by the investigator, grade 3, not related to study drug), and synovitis (day 112, grade 3, unlikely related to study drug). All AEs were index knee related except ankle OA.
Arthralgia (day 41, grade 3, probably related to study drug); index knee related.
Arthralgia.
Ankle OA.