Frequency of serious adverse events
| Adverse event | Δ9-THC (n = 24) | Cannabis extract (n = 27) | Placebo (n = 23) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| CM | DM | CM | DM | CM | DM | ||||||
| Data are number of patients unless otherwise indicated. CM, chose to continue medication; DM, chose to discontinue medication. †6 patients; ‡2 patients; §4 patients. ¶Other events were as follows (* indicates where patient chose not to continue trial medication at the end of the main study). Cannabis extract group: blocked/insertion of suprapubic catheter*; haematuria*; relapse/urinary tract infection; symptoms of nervous breakdown (inappropriate serious adverse event report); viral gastroenteritis. Δ9-THC group: carcinoma of cervix (died)*; cellulitis; dizziness + chest pain (non-cardiac); drug induced cholestasis*; groin abscess; lymph node biopsy (carcinoma of bronchus; died 9 months post-trial); pleural effusion; possible transient ischaemic attack; urinary tract infection and bowel problem; urinary tract infection and relapse. Placebo group: cerebrovascular episode; chest pain; disease progression (not relapse); hospitalisation for physiotherapy; ischaemic heart disease (died); overdose of analgesics; pulmonary embolism*; relapse/cellulitis; review/respite. | |||||||||||
| Relapse/possible relapse | 8† | 2 | 8 | 1 | 2 | 2 | |||||
| Urinary tract infection | 3 | 0 | 3 | 0 | 3‡ | 1 | |||||
| Pneumonia/chest infection | 1 | 0 | 5§(1 died) | 1 (died) | 1 | 1 (died) | |||||
| Seizure | 0 | 0 | 1 (died) | 0 | 1 | 2 | |||||
| Insertion of baclofen pump | 0 | 0 | 1 | 1 | 0 | 0 | |||||
| Limb fracture | 0 | 0 | 1 | 0 | 1 | 0 | |||||
| Other¶ | 8 | 2 | 3 | 2 | 8 | 1 | |||||
| No. of events (no. of patients) | 20 (18) | 4 (4) | 22 (21) | 5 (5) | 16 (15) | 7 (7) | |||||