Table 28. Study 355 Incidence of Common Treatment Emergent Adverse Events by Body System and Preferred Term by Treatment Group (≥ 10% Overall) : Safety Population Table 29. Study 108 Overall Summary of Adverse Events 30. Study 108 Number of Subjects with Adverse Events by Preferred Term 1 Investigator verbatim term: lip papule Treatment-related adverse events (adverse drug reactions) Pivotal studies Study 310 had no summary of Treatment AEs, only a table (Table 14.3.1.3 Adverse Events by System Organ Class and Preferred Term and Relationship to Study Treatment (Safety Population)) which was a 129 page listing of all AEs. studies Table 31. Study 304 Treatment-Related, Treatment-Emergent Adverse Events Reported in at Least 5% of Subjects in Any Treatment Group (Safety Population) Table 32. 108 Number of Subjects with Treatment-Related Adverse Events by Preferred Term Treatment-related SAEs Table 33. Study 310 Serious Adverse Events Related to Study Treatment: Safety Population CBZ = carbamazepine; ZNS = zonisamide were no treatment related SAEs in studies 304 and 355 and only 1 in study 314. Deaths and serious adverse events Pivotal studies One death in Study 3 - unexplained cause. Other studies One in Study 304 - due to RTA. 8 subjects reported 12 SAEs in 314, only 1 SAE (Hyponatraemia) was Treatment-related.
Table 28. Study 355 Incidence of Common Treatment Emergent Adverse Events by Body System and Preferred Term by Treatment Group (≥ 10% Overall) : Safety Population Table 29. Study 108 Overall Summary of Adverse Events 30. Study 108 Number of Subjects with Adverse Events by Preferred Term 1 Investigator verbatim term: lip papule Treatment-related adverse events (adverse drug reactions) Pivotal studies Study 310 had no summary of Treatment AEs, only a table (Table 14.3.1.3 Adverse Events by System Organ Class and Preferred Term and Relationship to Study Treatment (Safety Population)) which was a 129 page listing of all AEs. studies Table 31. Study 304 Treatment-Related, Treatment-Emergent Adverse Events Reported in at Least 5% of Subjects in Any Treatment Group (Safety Population) Table 32. 108 Number of Subjects with Treatment-Related Adverse Events by Preferred Term Treatment-related SAEs Table 33. Study 310 Serious Adverse Events Related to Study Treatment: Safety Population CBZ = carbamazepine; ZNS = zonisamide were no treatment related SAEs in studies 304 and 355 and only 1 in study 314. Deaths and serious adverse events Pivotal studies One death in Study 3 - unexplained cause. Other studies One in Study 304 - due to RTA. 8 subjects reported 12 SAEs in 314, only 1 SAE (Hyponatraemia) was Treatment-related.
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