3.3 | Adverse Events (AEs) and Serious Adverse Events (SAEs)
All causally related AE that occurred during treatment (treatment-emergent adverse events) and their frequency are presented in Table 3 [28]. Some patients experienced multiple AEs. The most common treatment emergent AE was drowsiness (mild, moderate and severe in 68%, 44% and 16%, respectively). Fatigue was also common experienced as mild in 4%, moderate in 20% and severe in 12% of patients. Vomiting was also reported as mild in 20%, moderate in 4% and severe in 12% of patients respectively.
In 6 (24%) patients, vomiting was associated with nausea. In one patient nausea and vomiting were reported as persistent that subsided on interrupting the administration of the cannabis-based medicine. The last administered dose in this patient occurred on day 9 (first dose of the day) of the dose escalation phase of Stage II. In this patient the cannabis-based medicine was not tolerated at a dose frequency of 8 doses per day unless asleep. The patient discontinued administering the cannabis-based medicine for the rest of the dose escalation period and the treatment phase.