Table 3.
Overview of treatment‐emergent adverse events*
|
Placebo (n = 220) |
DF‐HA (n = 220) |
|
|---|---|---|
| All events | 126 (57.3) | 134 (60.9) |
| Severity of events | ||
| Mild | 107 (48.6) | 114 (51.8) |
| Moderate | 19 (8.6) | 20 (9.1) |
| Severe | 0 (0) | 0 (0) |
| Death | 0 (0) | 0 (0) |
| Serious events | 1 (0.5) | 5 (2.3) |
| Events leading to study drug withdrawal | 2 (0.9) | 3 (1.4) |
| Common events (in ≥2% of patients) | ||
| Nasopharyngitis | 30 (13.6) | 37 (16.8) |
| Eczema | 2 (0.9) | 5 (2.3) |
| Arthralgia | 7 (3.2) | 10 (4.5) |
| Back pain | 7 (3.2) | 7 (3.2) |
| Myalgia | 1 (0.5) | 5 (2.3) |
| Osteoarthritis | 8 (3.6) | 7 (3.2) |
| Injection site joint pain | 6 (2.7) | 6 (2.7) |
| Contusion | 5 (2.3) | 4 (1.8) |
| Ligament sprain | 1 (0.5) | 7 (3.2) |
| Events of special interest | ||
| Events at injection site | 20 (9.1) | 19 (8.6) |
| Gastrointestinal disorders† | 0 (0) | 1 (0.5) |
| Cardiovascular disorders† | 3 (1.4) | 7 (3.2) |
| Renal dysfunction† | 1 (0.5) | 1 (0.5) |
| Anaphylactic reaction† | 6 (2.7) | 4 (1.8) |
| Hypersensitivity† | 12 (5.5) | 12 (5.5) |
*
Adverse events were classified based on the Medical Dictionary for Regulatory Activities (MedDRA) version. 21.1. Values are the number (%).
†
Standardized MedDRA query (broad scope) term. The term “gastrointestinal disorders” indicates gastrointestinal perforation, ulceration, hemorrhage, or obstruction. “Cardiovascular disorders” indicates acute cardiac failure, ischemic heart disease, or cardiac arrhythmias. “Renal dysfunction” indicates acute renal failure or chronic kidney disease.