FIGURE LEGENDS:
Figure 1: Multiple Ascending Dose (MAD) schema for Stage II. After baseline assessments, patients started with one spray of cannabis-based medicine (1.25 mg each of Δ9-THC and CBD in 0.15 mL) every 4 h while awake for 3 days, then dose escalated to two sprays every 4 hours while awake for 3 days, and finally dose escalated to three sprays every 4 hours while awake for 3 days.
Figure 2: PK of Stage I SAD. Mean (SEM) plasma concentration over time for Δ9-THC and CBD on Day 1 (single dose of 2.5 mg Δ9-THC/2.5 mg CBD) and Day 2 (three doses of 7.5 mg Δ9-THC/7.5 mg CBD).
Figure 3: Morphine Milligram equivalent doses administered between the two groups.
Figure 4: Mean daily Δ9-THC + CBD doses administered every 4 hours unless asleep from day 1 to day 15. [Day 1-3, Day 4-6, Day 7-9 = dose escalation phase; Day 10-15 = treatment phase].
Figure 5: NPRS scores for all patients.
** denotes significant difference from baseline with p<0.01, one-way ANOVA.
Figure 6: EORTC-QLQ-30 scores relevant to improvement or deterioration of global functioning and symptoms.