Parameter | Total (N = 330) | ||
---|---|---|---|
N of events | N of patients | % patients | |
Total TEAEs | 349 | 147 | 44.5 |
Seriousness | |||
  Non-serious | 341 | 145 | 43.9 |
  Seriousa | 8 | 7 | 2.1 |
Severity | |||
  Mild | 314 | 132 | 40.0 |
  Moderate | 29 | 23 | 7.0 |
  Severe | 6 | 5 | 1.5 |
Relationship to study drug | |||
  Related | 263 | 126 | 38.2 |
  Not related | 86 | 55 | 16.7 |
Action taken | |||
  No action taken | 185 | 92 | 27.9 |
  Dose reduced | 60 | 37 | 11.2 |
  Dose increased | 50 | 33 | 10.0 |
  Dose interrupted | 6 | 4 | 1.2 |
  Treatment discontinued | 48 | 32 | 9.7 |
Outcome | |||
  Resolved | 299 | 133 | 40.3 |
  Resolved with sequelae | 0 | 0 | 0.0 |
  Resolving | 19 | 16 | 4.8 |
  Not resolved | 22 | 18 | 5.5 |
  Death | 0 | 0 | 0.0 |
  Unknown | 9 | 9 | 2.7 |