Table 5 Most Frequently Reported On-Treatment AEs (≥5% Incidence in Any Treatment Group)
Number of participants, n (%) | ||||||
|---|---|---|---|---|---|---|
Adverse Event (Preferred term) | Placebo N = 102 | DNX 5 mg N = 102 | DNX 10 mg N = 103 | DNX 25 mg N = 103 | DNX 35 mg N = 102 | DNX 50 mg N = 102 |
Any event | 63 (62) | 63 (62) | 69 (67) | 68 (66) | 63 (62) | 71 (70) |
Nasopharyngitis | 12 (12) | 8 (8) | 9 (9) | 12 (12) | 14 (14) | 10 (10) |
Upper respiratory tract infection | 5 (5) | 7 (7) | 7 (7) | 9 (9) | 5 (5) | 6 (6) |
Back pain | 4 (4) | 7 (7) | 4 (4) | 6 (6) | 5 (5) | 5 (5) |
Headache | 2 (2) | 4 (4) | 6 (6) | 5 (5) | 8 (8) | 8 (8) |
Arthralgia | 2 (2) | 0 | 5 (5) | 1 (< 1) | 2 (2) | 4 (4) |
Cough | 1 (< 1) | 4 (4) | 1 (< 1) | 2 (2) | 1 (< 1) | 5 (5) |
Pneumonia | 1 (< 1) | 1 (< 1) | 2 (2) | 2 (2) | 1 (< 1) | 5 (5) |