Table 2

 Frequency of serious adverse events

Adverse eventΔ9-THC (n = 24)Cannabis extract (n = 27)Placebo (n = 23)
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 relapse8†28122
Urinary tract infection30303‡1
Pneumonia/chest infection105§(1 died)1 (died)11 (died)
Seizure001 (died)012
Insertion of baclofen pump001100
Limb fracture001010
No. of events (no. of patients)20 (18)4 (4)22 (21)5 (5)16 (15)7 (7)