Table 2.
Dosing and adverse events
| Dose of TIL‐TC150 |
| Mean dose = 13.3 mg/kg/day (Range 7–16) CBD/0.27 mg/kg/day (range 0.14–0.32) THC |
| Achieved target dose = 9/19(42.1%) |
| Mean CBD maintenance dose = 464.21 mg/day (Range 120–840) |
| Mean THC maintenance dose = 9.28 mg/day (range 2.4–16.8) |
| Adverse events | Number of participants, N = 19 (%) | Correlation, r | P‐Value |
|---|---|---|---|
| Nervous system | |||
| Somnolence/tiredness | 17 (89.5) | −0.975 | 0.034a |
| Increased seizure | 4 (21) | 0.369 | 0.533 |
| Gastrointestinal | |||
| Diarrhea | 6 (31.6) | 0.447 | 0.500 |
| Constipation | 5 (26.3) | −0.667 | 0.267 |
| Gagging | 3 (15.8) | 0.633 | 0.333 |
| General | |||
| Poor balance | 8 (42.1) | −0.738 | 0.200 |
| Sleep disturbance | 4 (21) | 0.224 | 0.995 |
| Mood change/Hyperactivity | 4 (21) | −0.359 | 0.633 |
| Infections | |||
| Upper respiratory tract infection | 4 (21%) | −0.894 | 0.100 |
| Urinary tract infection | 2 (10.5%) | −0.866 | 0.200 |
| Metabolism | |||
| Anorexia | 10 (52.6%) | 0.4 | 0.517 |
| Increased appetite | 3 (15.8%) | −0.707 | 0.400 |
| Side effects Reported in 1 participant (5.3%) | |||
| Gastrointestinal Disturbances (unspecified); Screaming; Bruxism; Hiccups; Facial Acne; Alopecia; Pneumonia; Hyperhidrosis; Hand tremor; Oily Urine; Conjunctivitis; Slowed processing. | |||
Data for adverse events are n (%). Adverse events reported only in one participant were grouped together. Thirteen (68%) of 19 participants that experienced somnolence were on concomitant Clobazam.
a
Signifies statistical significance (P < 0.05), r value for correlation.