5. Summary of adverse events experienced.
Study and drug | Privitera 2003 | SANAD A 2007 | |||||
TPM 100 | TPM 200 | CBZ | Total | TPM | CBZ | Total | |
Number experiencing adverse events | 120 | 114 | 111 | 345 | 283 | 260 | 543 |
Number of adverse events | 1063 | 1035 | 970 | 3068 | 2503 | 1339 | 3842 |
Number of adverse events per person (range) | 1 to 40 | 1 to 30 | 1 to 37 | NA | 1 to 35 | 1 to 37 | NA |
Number of drug related adverse eventsa | 578 | 613 | 537 | 1728 | NA | NA | NA |
Number of adverse events requiring action/treatment changeb | 76 | 90 | 72 | 238 | 705 | 529 | 1234 |
Number of participants needing a treatment change/dose changeb | 27 | 31 | 32 | 90 | 185 | 173 | 358 |
CBZ = carbamazepine, NA = not available, TPM = topiramate, TPM 100 = topiramate 100 mg/day, TPM 200 = topiramate 200 mg/day (Privitera 2003)
aDefined as events which are 'very likely,' 'probably' or 'possibly' related in Privitera 2003. Not stated if events were drug‐related in SANAD A 2007. bInformation given only for drug discontinuation in Privitera 2003. Information on drug discontinuation and dose change in SANAD A 2007.