Study ID	Treatment	> 1 dose of study medication available	Any AE	Specific AEs	Serious AEs	AE withdrawal	Other withdrawals/exclusions
Akpunonu 1995	Sumatriptan 6 mg, n = 88 Placebo, n = 48	No	Within 24 hours: 46/88 13/48	No data	No data	No data	No data
Bates 1994	Sumatriptan 6 mg, n = 90 (94 for safety) Placebo, n = 87 (83 forsa- fety)	Yes	Within 24 hours: 43/94 21/83	No data	No data	1/94 0/83	4 participants originally randomised to placebo took only the second injection (suma-triptan) and were included in safety analysis for suma-triptan 6 participants were excluded from the efficacy analyses either because they took the treatments in the wrong order or because they had inadequate diary booklet information
Bousser 1993	Sumatriptan 6 mg, n = 49 (92 for safety) Placebo, n = 47 (89 for efficacy)	Yes	Drug- related, within 24 hours: 34/92 2/89	Drug-related: Injection-site reaction: (1) 12/92; (2) 0/89 Paraesthesiae: (1) 9/92; (2) 0/89 Flushing: (1) 7/92; (2) 0/89 Palpitations/sweating: (1) 6/92; (2) 1/89 Digestive disorders: (1) 4/92; (2) 1/89 Vertigo/malaise: (1) 4/92; (2) 0/89 Nervousness, anxiety, drowsiness: (1) 3/92; (2) 2/89	0/92 2/89	0/92 2/89	Of the 96 participants treating the first attack, 12 did not treat a second attack and were excluded from the cross-over efficacy population: 9 did not experience a second attack 3 withdrew after first attack (2 for adverse events, 1 for pretreatment biological abnormality)
Cady 1991	Study 1 Sumatriptan 6 mg, n = 384 Placebo, n = 190 Study 2 Sumatriptan 6 mg, n = 350 Placebo, n = 180	Yes	Within 48 hours (pooled results for study 1 and study 2): 622/734 197/370	Reported by ≥ 1% of participants after single dose only (pooled results for study 1 and study 2): Flushing: (1) 36/547; (2) 9/370 Hypertension: (1) 4/547; (2) 3/370 Throat symptoms: (1) 18/547; (2) 2/370 Disease of nasal cavity/sinuses: (1) 12/547; (2) 0/370 Nausea and/or vomiting: (1) 68/547; (2) 52/370 Abdominal discomfort: (1) 7/547; (2) 3/370 Injection-site reaction: (1) 321/547; (2) 88/370 Pressure sensation: (1) 39/547; (2) 6/370 Feeling of heaviness (1) 40/547; (2) 4/370 Chest symptoms: (1) 30/547; (2) 5/370 Disorder of mouth/tongue: (1) 27/547; (2) 17/370 Weakness: (1) 27/547; (2) 1/370 Neck pain /stiffness: (1) 26/547; (2) 2/370 Feeling of tightness: (1) 28/547; (2) 1/370 Anxiety: (1) 6/547; (2) 2/370 Drowsiness/sedation: (1) 15/547; (2) 8/370 Dizziness/vertigo: (1) 65/547; (2) 16/370 Malaise/fatigue: (1) 6/547; (2) 3/370 Disturbance of taste: (1) 15/547; (2) 11/370 Burning sensation: (1) 41/547; (2) 1/370 Numbness: (1) 25/547; (2)8/370 Tingling: (1) 74/547; (2) 11/370 Warm/hot sensation: (1) 59/547; (2) 13/370 Sweating: (1) 7/547; (2) 3/370	No data	Pooled results for study 1 and study 2: (1) 6/734 (2) 1/370	No data
Cady 1993	Sumatriptan 6 mg, n = 166 Placebo, n = 144	No	Within 72 hours (data from 4 attacks pooled): 152/166 62/144	Data from 4 attacks pooled: Injection-site reaction: (1) 131/166; (2) 34/144 Nausea and/or vomiting: (1) 38/166; (2) 14/144 Tingling: (1) 38/166; (2) 2/144 Warm/hot sensation: (1) 31/166; (2) 1/144 Chest symptoms: (1) 26/166; (2) 0/144 Flushing: (1) 25/166; (2) 2/144 Pressure sensation: (1) 23/166; (2) 3/144 Feeling of tightness: (1) 22/166; (2) 0/144 Migraine: (1) 21/166; (2) 4/144 Disorder of mouth/tongue: (1) 20/166; (2) 3/144 Numbness: (1) 9/166; (2) 3/144 Disease of nasal cavity/sinuses: (1) 8/166; (2) 2/144 Hypertension: (1) 6/166; (2) 2/144	Data from 4 attacks pooled: 5/166 3/144	Data from 4 attacks pooled: 3/166 0/144	47 participants withdrawn due to failure to treat all 4 attacks in cross-over study
Cady 1998	Sumatriptan 6 mg, n = 67 Placebo, n = 68	Yes	Within 14 days: 35/67 14/68	Experienced by > 5% of participants in suma-triptan group Warm or hot sensation: (1) 10/67; (2) 1/68 Nausea and vomiting: (1) 7/67; (2) 2/68 Dizziness: (1) 5/67; (2) 2/68 Injection-site reaction: (1) 5/67; (2) 2/68 Pressure sensation: (1) 5/67; (2) 0/68 Chest tightness: (1) 4/67; (2) 0/68 Tingling: (1) 4/67; (2) 0/68	No data	0/67 0/68	3 participants randomised to placebo were excluded from the efficacy analyses: 1 failed to return to the clinic 2 did not use treatment in accordance with the study protocol
Dahlof 1992	Sumatriptan 8 mg, n = 27 Placebo, n = 27	No	No data	No data	No data	No data	No data
Dahlof 1998	Sumatriptan 6 mg, n = 47 Naratriptan 0.5 mg, n = 60 Naratriptan 1 mg, n = 55 Naratriptan 2.5 mg, n = 42 Naratriptan 5 mg, n = 34 Naratriptan 10 mg, n = 34 Placebo, n = 63	No	Within 5 days: 25/47 20/60 16/55 18/42 20/34 24/34 14/63	Occurring in ≥ 7 participants in any naratriptan treatment group: Malaise/fatigue: (1) 4/47; (2) 4/60; (3) 2/55; (4) 4/42; (5) 6/34; (6) 12/34; (7) 2/63 Feeling of heaviness: (1) 8/47; (2) 3/60; (3) 3/55; (4) 4/42; (5) 6/34; (6) 7/34; (7) 3/63 Injection-site reaction: (1) 6/47; (2) 2/60; (3) 3/55; (4) 3/42; (5) 4/34; (6) 7/34; (7) 3/63 Warm/hot sensation: (1) 4/47; (2) 2/60; (3) 1/55; (4) 2/42; (5) 3/34; (6) 9/34; (7) 1/63 Tingling: (1) 4/47; (2) 2/60; (3) 3/55; (4) 1/42; (5) 2/34; (6) 6/34; (7) 2/63 Dizziness/vertigo: (1) 2/47; (2) 2/60; (3) 3/55; (4) 0/42; (5) 2/34; (6) 3/34; (7) 1/63 Pressure sensation: (1) 3/47; (2) 0/60; (3) 1/55; (4) 1/42; (5) 3/34; (6) 4/34; (7) 0/63 Nausea/vomiting: (1) 1/47; (2) 1/60; (3) 2/55; (4) 2/42; (5) 0/34; (6) 3/34; (7) 5/63 Chest pressure: (1) 2/47; (2) 1/60; (3) 0/55; (4) 3/42; (5) 0/34; (6) 3/34; (7) 1/63	No data	0/47 No data 0/60 0/55 0/42 0/34 0/34 0/63	No data
Diener 1999	Sumatriptan 6 mg, n = 114 (116 for safety) Intravenous acetyl-salicylic acid lysinate 1.8 g, n = 119 Placebo, n = 42 (43 for safety)	No	Within 48 hours: 38/116 9/119 4/43	Only reported as number of events occurring rather than number of participants with specific AEs	No data	No data	3 participants (2 from suma-triptan group and 1 from placebo group) excluded from efficacy analyses due to violation of exclusion criteria
Diener 2001	Sumatriptan 6 mg, n = 317 Alniditan 1.4 mg, n = 309 Alniditan 1.8 mg, n = 141 Placebo, n = 157	No	Within 48 hours: 210/317 214/309 91/141 62/157	Occurring in > 5% of all participants: Headache: (1) 74/317; (2) 60/309; (3) 38/141; (4) 5/157 Paraesthesia: (1) 40/317; (2) 59/309; (3) 27/141; (4) 9/157 Fatigue: (1) 46/317; (2) 47/309; (3) 21/141; (4) 10/157 Chest pain: (1) 28/317; (2) 36/309; (3) 25/141; (4) 2/157 Application site reaction: (1) 46/317; (2) 22/309; (3) 6/141; (4) 10/157 Change in temperature sensation: (1) 29/317; (2) 17/309; (3) 11/141; (4) 8/157 Nausea: (1) 29/317; (2) 19/309; (3) 11/141; (4) 2/157	0/317 0/309 1/141 1/157	No data	3 participants withdrew before trial completion: 1 subject on alniditan 1.4 mg and 1 on sumatriptan were lost to follow-up, whilst 1 on placebo was noncom-pliant All participants included in both efficacy and safety analyses
Facchinetti 1995	Sumatriptan 6 mg, n = 115 Placebo, n = 111	Yes	Within 24 hours: 54/115 34/111	Reported most frequently: Dizziness/vertigo: (1) 12/115; (2) 5/111 Nausea/vomiting: (1) 10/115; (2) 3/111 Paraesthesia: (1) 10/115; (2) 3/111 Tingling: (1) 8/115; (2) 3/111 Warm/hot sensations: (1) 8/115; (2) 1/111 Injection-site reaction: (1) 7/115; (2) 5/111 Throat symptoms: (1) 7/115; (2) 1/111 Neck pain/stiffness: (1) 5/115; (2) 2/111 Sweating: (1) 5/115; (2) 0/111 Pressure sensation: (1) 2/115; (2) 5/111	No data	3/115 2/111	47 participants were excluded from the efficacy analyses due to treating a migraine attack outside of the menstrual window (-3 to +5 days): 32 from the sumatriptan group and 15 from the placebo group A further 10 participants were excluded from primary efficacy analyses due to insufficient baseline pain intensity: 6 from the sumatriptan group and 4 from the placebo group
Ferrari 1991	Sumatriptan 6 mg, n = 423 Sumatriptan 8 mg, n = 110 Placebo, n = 106	Yes	No data	Most frequently reported after a single dose only: Injection-site reaction: (1) 26/203; (2) 6/60; (3) 0/13 Nausea or vomiting: (1) 12/203; (2) 4/60; (3) 0/13 Flushing: (1) 10/203; (2) 4/60; (3) 2/13 Warm or hot sensation: (1) 22/203; (2) 6/60; (3) 0/13 Feeling of heaviness: (1) 24/203; (2) 10/60; (3) 2/13 Pressure sensation: (1) 18/203; (2) 4/60; (3) 1/13 Weakness: (1) 6/203; (2) 4/60; (3) 1/13 Drowsiness/sedation: (1) 2/203; (2) 0/60; (3) 0/13 Dizziness or vertigo: (1) 2/203; (2) 3/60; (3) 0/13 Malaise or fatigue: (1) 8/203; (2) 4/60; (3) 2/13 Paraesthesia (1) 6/203; (2) 4/60; (3) 0/13 Tingling: (1) 6/203; (2) 3/60; (3) 1/13 Headache: (1) 1/203; (2) 2/60; (3) 0/13	No data	No data	3 participants were excluded from efficacy analyses due to insufficient baseline pain intensity or taking other medications before or during the study 2 other participants were excluded from efficacy analyses after 1 hour due to erroneous treatment with open-label sumatriptan at 1 hour
Gross 1994	Sumatriptan 6 mg, n = 60 Placebo, n = 26	Yes	Within 24 hours: 33/60 4/26	Most commonly reported after a single dose only: Injection site: (1) 4/40; (2) 0/2 Nausea and vomiting: (1) 2/40; (2) 0/2 Headache: (1) 2/40; (2) 0/2 Flushing: (1) 3/40; (2) 0/2 Burning sensation: (1) 1/40; (2) 0/2 Tingling: (1) 3/40; (2) 0/2 Chest symptoms: (1) 2/40; (2) 0/2 Numbness: (1) 3/40; (2) 0/2 Paraesthesia: (1) 3/40; (2) 0/2 Warm/hot sensation: (1) 3/40; (2) 0/2	No data	1 participant discontinued (group not reported)	1 participant discontinued treatment because of a dislike of injections
Henry 1993	Sumatriptan 6 mg, n = 37 Placebo, n = 39	Yes	Drug- related, within 24 hours: 10/37 1/39	Notified as drug-related: Flushing: (1) 1/37; (2) 0/39 Injection-site reaction: (1) 1/37; (2) 1/39 Sickness/vertigo/hypothymia: (1) 6/37; (2) 0/39 Paraesthesia: (1) 0/37; (2) 1/39 Drowsiness: (1) 1/37; (2) 0/39 Thoracic discomfort/laryngeal oppression: (1) 4/37; (2) 0/39 Muscular weakness: (1) 1/37; (2) 0/39 Nausea: (1) 2/37; (2) 0/39 Headache: (1) 1/37; (2) 0/39	No data	0/37 0/39	No data
Jensen 1995	Sumatriptan 6 mg, n = 117 attacks (108 for cross-over efficacy analysis) Placebo, n = 109 attacks (108 for cross-over efficacy analysis)	Yes	Within 24 hours: 36/108 10/108	Only reported as number of events occurring rather than number of participants with specific AEs	No drug-related serious AEs	( 6/117 1/109	10 participants treated only 1 attack and were excluded from the cross-over efficacy analyses
Mathew 1992	Sumatriptan 1 mg, n = 30 Sumatriptan 2 mg, n = 30 Sumatriptan 3 mg, n = 30 Sumatriptan 4 mg, n = 30 Sumatriptan 6 mg, n = 30 Sumatriptan 8 mg, n =30 Placebo, n = 62	No	Within 24 hours: 19/30 20/30 24/30 25/30 26/30 29/30 34/62	Most common events: Flushing: (1) 0/30; (2) 1/30; (3) 2/30; (4) 1/30; (5) 7/30; (6) 3/30; (7) 1/62 Throat symptoms: (1) 0/30; (2) 1/30; (3) 2/30; (4) 1/30; (5) 1/30; (6) 1/30; (7) 0/62 Nausea and/or vomiting: (1) 3/30; (2) 4/30; (3) 1/30; (4) 6/30; (5) 6/30; (6) 5/30; (7) 10/62 Injection-site reaction: (1) 15/30; (2) 17/30; (3) 19/30; (4) 20/30; (5) 18/30; (6) 25/30; (7) 21/62 Pressure sensation: (1) 0/30; (2) 1/30; (3) 2/30; (4) 3/30; (5) 2/30; (6) 1/30; (7) 0/62 Feeling of heaviness: (1) 0/30; (2) 0/30; (3) 1/30; (4) 1/30; (5) 1/30; (6) 4/30; (7) 1/62 Chest symptoms: (1) 2/30; (2) 0/30; (3) 1/30; (4) 1/30; (5) 0/30; (6) 3/30; (7) 1/62 Disorder of mouth/tongue: (1) 2/30; (2) 1/30; (3) 1/30; (4) 1/30; (5) 2/30; (6) 2/30; (7) 1/62 Weakness: (1) 0/30; (2) 0/30; (3) 1/30; (4) 0/30; (5) 3/30; (6) 2/30; (7) 0/62 Neck pain/stiffness: (1) 1/30; (2) 1/30; (3) 2/30; (4) 1/30; (5) 3/30; (6) 1/30; (7) 1/62 Feeling of tightness: (1) 0/30; (2) 0/30; (3) 1/30; (4) 0/30; (5) 2/30; (6) 3/30; (7) 0/62 Myalgia: (1) 0/30; (2) 0/30; (3) 0/30; (4) 0/30; (5) 0/30; (6) 3/30; (7) 0/62 Migraine: (1) 1/30; (2) 1/30; (3) 0/30; (4) 4/30; (5) 2/30; (6) 1/30; (7) 0/62 Drowsiness/sedation: (1) 2/30; (2) 0/30; (3) 0/30; (4) 2/30; (5) 0/30; (6) 0/30; (7) 0/62 Dizziness/vertigo: (1) 1/30; (2) 3/30; (3) 2/30; (4) 2/30; (5) 3/30; (6) 2/30; (7) 6/62 Malaise/fatigue: (1) 0/30; (2) 1/30; (3) 1/30; (4) 2/30; (5) 1/30; (6) 0/30; (7) 1/62 Feeling strange: (1) 1/30; (2) 1/30; (3) 2/30; (4) 0/30; (5) 0/30; (6) 1/30; (7) 0/62 Burning sensation: (1) 1/30; (2) 1/30; (3) 2/30; (4) 2/30; (5) 2/30; (6) 2/30; (7) 0/62 Numbness: (1) 1/30; (2) 1/30; (3) 0/30; (4) 1/30; (5) 3/30; (6) 1/30; (7) 2/62 Tingling: (1) 1/30; (2) 1/30; (3) 2/30; (4) 3/30; (5) 7/30; (6) 4/30; (7) 3/62 Cold sensation: (1) 0/30; (2) 0/30; (3) 0/30; (4) 2/30; (5) 1/30; (6) 2/30; (7) 1/62 Warm/hot sensation: (1) 0/30; (2) 3/30; (3) 2/30; (4) 2/30; (5) 5/30; (6) 3/30; (7) 2/62 Headache: (1) 0/30; (2) 0/30; (3) 1/30; (4) 0/30; (5) 1/30; (6) 4/30; (7) 0/62 Sweating: (1) 0/30; (2) 0/30; (3) 1/30; (4) 0/30; (5) 3/30; (6) 1/30; (7) 0/62	No data	No data	No data
Mushet 1996	Study 1 Sumatriptan 6 mg, n = 40 Placebo, n = 39 Study 2 Sumatriptan 6 mg, n = 40 Placebo, n = 39	No	No data	Occurring in ≥ 5% of participants in any treatment group within 24 hours (results from study 1 and study 2 pooled): Injection-site reaction: (1) 27/79; (2) 14/79 Nausea/vomiting: (1) 10/79; (2) 11/79 Migraine: (1) 10/79; (2) 7/79 Tingling: (1) 8/79; (2) 4/79 Warm/hot sensation: (1) 5/79; (2) 3/79 Disease of nasal cavity: (1) 3/79; (2) 4/79 Disorder of mouth/tongue: (1) 5/79; (2) 2/79 Flushing: (1) 4/79; (2) 2/79 Malaise/fatigue: (1) 3/79; (2) 3/79 Dizziness/vertigo: (1) 3/79; (2) 2/79 Chest symptoms: (1) 5/79; (2) 0/79 Feeling of heaviness: (1) 5/79; (2) 0/79 Headache: (1) 4/79; (2) 1/79 Joint symptoms: (1) 3/79; (2) 0/79 Weakness: (1) 3/79; (2) 0/79 Burning sensation: (1) 4/79; (2) 0/79 Neck pain/stiffness: (1) 2/79; (2) 1/79 Muscle cramps: (1) 1/79; (2) 2/79 Numbness: (1) 2/79; (2) 0/79 Feeling of tightness: (1) 2/79; (2) 0/79	0/79 0/79	0/79 0/79	No participant discontinued the study
Pfaffenrath 1991	Sumatriptan 6 mg, n = 155 Placebo, n = 80	Yes	Within 24 hours: 60/155 15/80	Most commonly reported after a single dose only: Flushing: (1) 7/107; (2) 0/20 Nausea/vomiting: (1) 7/107; (2) 0/20 Injection-site reaction: 11/107; 0/20 Neck pain/stiffness: (1) 5/107; (2) 0/20 Migraine: (1) 0/107; (2) 1/20 Dizziness/vertigo: (1) 7/107; (2) 0/20 Malaise/fatigue: (1) 4/107; (2) 1/20 Numbness: (1) 3/107; (2) 0/20 Feeling of heaviness: (1) 3/107; (2) 1/20	No data	3/155 0/80	13 participants were excluded from the efficacy analyses (7 from suma-triptan group and 6 from placebo group): 2 did not provide diary card data 11 failed to use the auto-injector properly
Russell 1994	Sumatriptan 6 mg, n = 209 Placebo, n = 209	Yes	Within 24 hours (after 1 dose only): 35/102 1/41	Most frequent events after single dose only: Injection-site reaction: (1) 3/102; (2) 0/41 Tachycardia: (1) 4/102; (2) 0/41 Chest symptoms: (1) 2/102; (2) 0/41 Dizziness/vertigo: (1) 7/102; (2) 0/41 Nausea and/or vomiting: (1) 2/102; (2) 0/41 Headache: (1) 2/102; (2) 0/41 Paraesthesia: (1) 7/102; (2) 0/41 Pressure sensation: (1) 4/102; (2) 0/41 Dyspnoea: (1) 2/102; (2) 0/41 Discomfort: (1) 2/102; (2) 0/41	1/224 0/220	3/224 0/220	21 participants were excluded from the cross-over efficacy analyses: 16 treated only 1 attack (10 with sumatriptan and 6 with placebo) 5 had missing diary data for 1 or both attacks
S2BL99	Sumatriptan 6 mg, n = 125 Oral ASA 1000 mg + MCP 10 mg, n = 130	Yes	Within 24 hours: 59/125 27/130	Malaise/fatigue: 12/125; 4/130 Throat symptoms: (1) 7/125; (2) 0/130 Tingling: (1) 7/125; (2) 0/130 Dizziness/vertigo: (1) 6/125; (2) 1/130 Nausea and/or vomiting: (1) 6/125; (2) 9/130 Burning sensation: (1) 5/125; (2) 0/130 Flushing: (1) 5/125; (2) 0/130 Injection-site reaction: (1) 5/125; (2) 1/130 Warm/hot sensation: (1) 5/125; (2) 0/130 Pruritis: (1) 4/125; (2) 1/130 Chest symptoms: (1) 4/125; (2) 0/130 Neck pain /stiffness: (1) 4/125; (2) 0/130 Paraesthesia: (1) 4/125; (2) 0/130 Drowsiness/sedation: (1) 2/125; (2) 6/130 Disease of nasal cavity/sinuses: (1) 2/125; (2) 1/130 Dyspnoea: (1) 2/125; (2) 1/130 Abdominal discomfort: (1) 1/125; (2) 3/130 Diarrhoea: (1) 1/125; (2) 2/130 Palpitations: (1) 1/125; (2) 1/130 Gastric symptoms: (1) 1/125; (2) 1/130 Disorder of mouth/tongue: (1) 1/125; (2) 1/130 Feeling of heaviness: (1) 0/125; (2) 1/130	0/125 1/130	6/125 1/130	Withdrawals due to lack of efficacy: 2/125* 0/130 Other withdrawals: 2/125 7/130 *One subject withdrew due to both AE and lack of efficacy and is counted in both groups
S2BM03	Sumatriptan 6 mg (+ placebo at 4 h) , n = 106 (90 for cross-over efficacy analysis, of which 87 had moderate or severe baseline pain intensity) Placebo (+ sumatriptan 6 mg at 4 h), n = 106 (90 for cross-over efficacy analysis, of which 81 had moderate or severe baseline pain intensity)	Yes	No useable data	No useable data	0/106 0/106	0/106 0/106	Withdrawn for other reasons after randomisation (some before taking study medication): 17/106 19/106
S2BS78	Sumatriptan 6 mg, n =236 Placebo, n = 117	Yes	No useable data	No useable data	0/236 0/117	15/236 4/117	Withdrawn for other reasons after randomisation (some before taking study medication): 28/249 14/122
Sang 2004	Sumatriptan 6 mg, n = 15 Intravenous LY293558 1.2 mg/kg, n = 13 Placebo, n = 16	No	Within 24 hours: 8/15 2/13 5/16	Reported by > 10% of participants: Chest/throat symptoms: (1) 2/15; (2) 0/13; (3) 0/16 Disorientation: (1) 4/15; (2) 1/13; (3) 1/16 Dizziness: (1) 4/15; (2) 2/13; (3) 2/16 Heaviness/tingling: (1) 5/15; (2) 0/13; (3) 0/16 Sedation/drowsiness: (1) 5/15; (2) 2/13; (3) 4/16 Visual symptoms: (1) 4/15; (2) 1/13; (3) 1/16 Warmth: (1) 5/15; (2) 1/13; (3) 1/16	No data	No data	1 participant randomised to LY293558 withdrew before receiving treatment
Schulman 2000	Sumatriptan 6 mg, n = 79 Placebo, n = 40	No	Drug- related within 24 hours: 15/79 3/40	No data	0/79 0/40	1/79 0/40	3 participants were excluded from the efficacy analyses (all in suma-triptan group) due to incomplete diary data
SUM40286	Sumatriptan 6 mg, n = 146 (145 for efficacy) Placebo, n = 153 (152 for efficacy)	Yes	Up to final visit: 36/146 21/153	Nausea: (1) 9/146; (2) 3/153 Other pressure/tightness: (1) 9/146; (2) 0/153 Injection-site reaction: (1) 8/146; (2) 3/153 Dizziness: (1) 6/146; (2) 0/153 Chest symptoms: (1) 5/146; (2) 0/153 Temperature sensation: (1) 5/146; (2) 2/153 Paraesthesia: (1) 3/146; (2) 2/153 Migraine: (1) 3/146; (2) 1/153 Burning/stinging sensation: (1) 2/146; (2) 1/153 Headache: (1) 2/146; (2) 1/153 Disturbance of sense of taste: (1) 0/146; (2) 1/153 Malaise and fatigue: (1) 0/146; (2) 1/153 Nasal inflammation: (1) 0/146; (2) 1/153 Sinusitis: (1) 0/146; (2) 1/153 Temperature regulation disturbances: (1) 0/146; (2) 1/153 Throat and tonsil discomfort and pain: (1) 0/146; (2) 1/153	0/146 0/153	0/146 0/153	Withdrawn for other reasons after randomisation (some before taking study medication): 29/175 30/182
SUM40287	Sumatriptan 6 mg, n = 149 (148 for efficacy) Placebo, n = 139	Yes	Up to final visit: (1)45/149 13/139	Injection-site reaction: (1) 7/149; (2) 2/139 Temperature sensation: (1) 7/149; (2) 0/139 Nausea: (1) 6/149; (2) 3/139 Paraesthesia: (1) 6/149; (2) 1/139 Dizziness: (1) 5/149; (2) 3/139 Chest symptoms: (1) 4/149; (2) 2/139 Malaise and fatigue: (1) 2/149; (2) 0/139 Breathing disorder: (1) 1/149; (2) 0/139 Headache: (1) 1/149; (2) 0/139 Nasal signs and symptoms: (1) 1/149; (2) 0/139 Other pressure/tightness: (1) 1/149; (2) 0/139 Sweating: (1) 1/149; (2) 2/139 Tachycardia: (1) 1/149; (2) 1/139 Temperature regulation disturbances: (1) 1/149; (2) 0/139 Vomiting: (1) 1/149; (2) 2/139 Disturbance of sense of taste: (1) 0/149; (2) 1/139 Drowsiness: (1) 0/149; (2) 1/139 Somnolence: (1) 0/149; (2) 1/139	0/149 0/139	0/149 0/139	Withdrawn for other reasons after randomisation (some before taking study medication): 28/177 36/174
Thomson 1993	Sumatriptan 4 mg, n = 28 Placebo, n = 23	No	Within 24 hours: 23/28 4/23	No data	0/28 0/23	No data	1 participant was excluded from efficacy analyses because of protocol violation (use of ergotamine within 24 hours)
Touchon 1996	Sumatriptan 6 mg, n = 278 DHE nasal spray 1 mg, n = 277	Yes	Within 24 hours: 120/278 62/277	No data	No data	3/278 1 /277	12 participants with-drawn after treating first attack (including 4 adverse event withdrawals) 11 participants failed to treat a second attack, therefore 266 participants evaluable for cross-over efficacy analyses
Visser 1992	Sumatriptan 1 mg, n = 170 Sumatriptan 2 mg, n = 171 Sumatriptan 3 mg, n = 172 Placebo, n = 172	Yes	Only pooled results for all 3 doses of sumatriptan versus placebo given	Only pooled results for all 3 doses of sumatriptan versus placebo given	0/170 0/171 0/172 0/172	0/170 0/171 0/172 0/172	No data
Wendt 2006	Sumatriptan 4 mg, n = 384 Placebo, n = 193	No	Within 24 hours: 265/384 75/193	Occurring in ≥ 1% of participants in either treatment group: Injection-site reaction: (1) 165/384; (2) 28/193 Tingling: (1) 45/384; (2) 6/193 Dizziness or vertigo: (1) 40/384; (2) 10/193 Warm or hot sensation: (1) 30/384; (2) 4/193 Nausea and/or vomiting: (1) 28/384; (2) 15/193 Pressure sensation: (1) 22/384; (2) 2/193 Burning sensation: (1) 20/384; (2) 1/193 Chest symptoms: (1) 20/384; (2) 2/193 Feeling of heaviness: (1) 20/384; (2) 1/193 Disorder of mouth or tongue: (1) 17/384; (2) 2/193 Numbness: (1) 12/384; (2) 5/193 Drowsiness or sedation: (1) 11/384; (2) 4/193 Flushing: (1) 10/384; (2) 7/193 Malaise/fatigue: (1) 9/384; (2) 3/193 Disturbance of hearing: (1) 8/384; (2) 0/193 Feeling strange: (1) 7/384; (2) 3/193 Neck pain or stiffness: (1) 7/384; (2) 1/193 Cold sensation: (1) 7/384; (2) 0/193 Sweating: (1) 6/384; (2) 1/193 Nasal or sinus discomfort: (1) 5/384; (2) 2/193 Tight feeling in head: (1) 5/384; (2) 0/193 Weakness: (1) 5/384; (2) 3/193 Anxiety: (1) 4/384; (2) 0/193 Throat symptoms: (1) 4/384; (2) 0/193	1/384 5/193	No data	No data
Winner 1996	Sumatriptan 6 mg, n = 158 Subcutaneous dihy-droergotamine (DHE) mesylate 1 mg, n = 152	Yes	Only number of events reported rather than number of participants with event	Clinically relevant AEs occurring within 24 hours: Nausea: (1) 9/158; (2) 24/152 Vomiting: (1) 6/158; (2) 10/152 Chest pain: (1) 9/158; (2) 1/152	0/158 0/152	0/158 2/152	No data
Winner 2006	Study 1 Sumatriptan 6 mg, n = 146 Placebo, n= 153 Study 2 Sumatriptan 6 mg, n = 149 Placebo, n = 139	Yes	Drug- related (results from study 1 and study 2 pooled): 71/295 18/292	Most commonly reported: Nausea: Study 1 (1) 9/146; (2) 3/153 Study 2 (1) 6/149; (2) 3/139 Injection-site reaction: Study 1 (1) 7/146; (2) 3/153 Study 2 (1) 7/149; (2) 1/139	Study 1 0/146 0/153 Study 2 0/149 0/139	Study 1 0/146 0/153 Study 2 0/149 0/139	5 participants excluded from efficacy analysis: 3 did not return evaluable data 2 did not have sufficient baseline pain intensity (1 from suma-triptan and one from placebo group in study 1)