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.