Study ID | Treatment | Any AE | SAE | AE withdrawal | Other withdrawal |
Brandes 2007 Study 1 | (1) suma/naprox 85/500 mg, n = 370 (2) suma 85 mg, n = 365 (3) naprox 500 mg, n = 361 (4) placebo, n = 365 |
≤ 24 h: (1) 100/370 (2) 89/365 (3) 48/361 (4) 45/365 |
No SAE with combination, naproxen alone, or placebo in either study. 1 person admitted to hospital with palpitations following sumatriptan 85 mg | 1 person in (2) with palpitations | Exclusions ‐ took medication but no evaluable data: (1) 6 (2) 4 (3) 5 (4) 5 |
Brandes 2007 Study 2 | (1) suma/naprox 85/500 mg, n = 367 (2) suma 85 mg, n = 370 (3) naprox 500 mg, n = 371 (4) placebo, n = 387 |
≤ 24 h: (1) 97/367 (2) 105/370 (3) 52/371 (4) 39/387 |
No SAE | None | Exclusions ‐ took medication but no evaluable data: (1) 5 (2) 8 (3) 7 (4) 5 |
Calhoun 2014 | (1) suma/naprox 85/500 mg, n = 43 (2) placebo n = 43 | No data | No data | No data | No data |
Lipton 2009 Study 1 | (1) suma/naprox 85/500 mg, n = 447 (1693 attacks) (2) placebo, n = 123 (424 attacks) |
≤ 72 h: Study 1, 1st attack: (1) 57/447 (2) 15/123 All attacks: (1) 153/1693 (2) 28/424 |
7 SAE across both studies, but judged not related to study medication, and occurred > 72 h after taking study medication. No details of groups | (1) 8 (3 chest discomfort) (2) 0 All judged related to study medication; mild/mod severity |
People lost to follow‐up or withdrawn for any attack: (1) < 6% (2) < 8% |
Lipton 2009 Study 2 | (1) suma/naprox 85/500 mg, n = 458 (1678 attacks) (2) placebo, n = 107 (422 attacks) |
≤ 72 h: 1st attack: (1) 85/458 (2) 15/107 All attacks: (1) 219/1678 (2) 36/422 |
(1) 6 (3 chest discomfort, 3 nausea) (2) 1 (nausea) All judged related to study medication; mild/mod severity |
People lost to follow‐up or withdrawn for any attack: (1) < 6% (2) < 7% |
|
Mannix 2009 Study 1 | (1) suma/naprox 85/500 mg, n = 152 (2) placebo, n = 160 |
≤ 48 h (possibly 24 h) AEs consistent with known profile of 2 drugs Drug‐related AE frequency < 1% |
None | None | Excluded from efficacy analysis: (1) 1 (2) 0 |
Mannix 2009 Study 2 | (1) suma/naprox 85/500 mg, n = 151 (2) placebo, n = 160 |
≤ 48 h (possibly 24 h) AEs consistent with known profile of 2 drugs Drug‐related AE frequency < 5% |
None | None | Excluded from efficacy analysis: (1) 0 (2) 1 |
Mathew 2009 Study 1 | (1) suma/naprox 85/500 mg, n = 144 (2) placebo, n = 144 |
Assume AE reported for safety population within 24 h (1) 16/144 (2) 6/144 | None reported | 1 AE withdrawal following placebo | 5 people in (1) and (2) took medication, but not included in ITT. Unclear, but probably had no post‐baseline efficacy data |
Mathew 2009 Study 2 | (1) suma/naprox 85/500 mg, n = 139 (2) placebo, n = 139 |
Assume AE reported for safety population within 24 h (1) 13/139 (2) 7/139 |
None reported | None | 2 people in (1) and (2) took medication, but not included in ITT. Unclear, but probably had no post‐baseline efficacy data |
Silberstein 2008 Study 1 | (1) suma/naprox 85/500 mg, n = 283 (2) placebo, n = 297 |
AE reported for safety population during study period (up to 1 week) (1) 31/283 (2) 21/297 | None | None | 3 people in (1) and 1 in (2) took medication but had no post‐baseline efficacy data |
Silberstein 2008 Study 2 | (1) suma/naprox 85/500 mg, n = 278 (2) placebo, n = 264 |
AE reported for safety population during study period (up to 1 week) (1) 39/278 (2) 24/264 |
None | None | 2 people in (1) and 5 in (2) took medication but had no post‐baseline efficacy data |
Smith 2005 | (1) suma/naprox 50/500 mg, n = 251 (2) suma 50 mg, n = 229 (3) naprox 500 mg, n = 250 (4) placebo, n = 241 |
AE reported for safety population up to 72 h (1) 58/251 (2) 55/242 (3) 43/250 (4) 36/242 |
None | None | None reported |
TRX109011/13 2010 | (1) suma/naprox 85/500 mg, n = 317 (2) BCM, n = 392 (3) placebo, n = 320 |
AE for safety population reported within 72 h: (1) 36/406 (2) 21/392 (3) 28/405 |
(1) 2 (breast cancer diagnosis, chest pain, and hypertension) (2) 0 (3) 1 (intestinal mass and viral meningitis) None considered related to study medication |
(1) 3, (2) 0, (3) 1 | 4 in total; pregnancy (2), breast cancer diagnosis (1), and use of prohibited medication (1) |
AE: adverse event; BCM: barbiturate‐containing medication; h: hour; naprox: naproxen; ITT: intention to treat; SAE: serious adverse event; suma: sumatriptan; suma/naprox: sumatriptan plus naproxen. |