Table 3.
Summary of adverse events.
| Description | Polmacoxib 2mg N=147 n (%) E |
Celecoxib 200mg N=147 n (%) E |
|---|---|---|
| Any AE | 18 (12.24) 18 | 21 (14.29) 22 |
| Any TEAEs | 18 (12.24) 18 | 21 (14.29) 22 |
| Any Serious TEAEs | 0 (0) 0 | 0 (0) 0 |
| Any TEAEs due to Study Drug | 13 (8.84) 13 | 17 (11.56) 17 |
| Any Serious TEAES due to Study Drug | 0 (0) 0 | 0 (0) 0 |
| Any Fatal/Life-Threatening due to Study Drug | 0 (0) 0 | 0 (0) 0 |
| Any Grade 1 TEAEs | 13 (8.84) 13 | 17 (11.56) 18 |
| Any Grade 2 TEAEs | 5 (3.40) 5 | 4 (2.72) 4 |
| Any TEAEs leading Withdrawal/Discontinuation from the Study | 0 (0) 0 | 0 (0) 0 |
| Any TEAEs leading treatment with Concomitant Medication | 7 (4.76) 7 | 14 (9.52) 15 |
| TEAEs Outcome | ||
| Improved/Recovery | 1 (0.68) 2 | 0 (0) 0 |
| Resolved with Sequelae | 3 (2.04) 3 | 0 (0) 0 |
| Resolved without Sequelae | 14 (9.52) 14 | 21 (14.29) 22 |