Study ID | Treatment | Any AE | Serious AE | AE withdrawal | Other withdrawal |
Bahra 2000 | (1) Zolmitriptan 5 mg oral, n = 114 (2) Zolmitriptan 10 mg oral, n = 111 (3) Placebo, n = 115 | Within 24 h:
(1) 32/114
(2) 43/111
(3) 17/115 AE details reported for ITT population, not safety population |
1 in (2), but 58 days after treatment, and not considered related | None in ITT population within 24 h of treatment One in safety population ‐ no details |
20 pts did not have three episodes |
Cittadini 2006 | (1) Zolmitriptan 5 mg IN, n = 65 (2) Zolmitriptan 10 mg IN, n = 63 (3) Placebo, n = 61 | No data | None | (1) 1/65 (shortness of breath, vomiting, rheumatic pain) | 6 pts lost to follow‐up, 2 pts without clear reason after treating one episode |
Ekbom 1991 | (1) Sumatriptan 6 mg SC, n = 39 (2) Placebo, n = 39 | No time specified: (1) 15/49 (2) 12/47 | None reported | None | 8 pts excluded due to protocol violations, 2 pts had only one episode |
Ekbom 1993 | (1) Sumatriptan 6 mg SC, n = 92 (2) Sumatriptan 12 mg SC, n = 88 (3) Placebo, n = 88 | No time specified: (1) 34/101 (2) 42/94 (3) 15/96 (over 90% mild/mod) | None reported | (3) 1/101 (pressure on neck) | 21 pts had only one episode |
Rapoport 2007 | (1) Zolmitriptan 5 mg IN, n = 52 (2) Zolmitriptan 10 mg IN, n = 49 (3) Placebo, n = 50 | No time specified: (1) 13/52 (2) 16/49 (3) 8/50 (mild, non‐specific, typical of triptans) | None | None | 12 pts lost to follow‐up, 5 withdrew consent, 9 did not have an episode |
Van Vliet 2003 | (1) Sumatriptan 20 mg IN, n = 77 (2) Placebo, n = 77 | No data | None | No data | 7 pts lost to follow‐up, 10 treated attacks of mild intensity |
AE ‐ adverse event; IN ‐ intranasal; ITT ‐ intention‐to‐treat; n ‐ number of participants; pts ‐ participants; SC ‐ subcutaneous |