Table 3.
Major adverse events (includes treatment-emergent adverse events)
| Outcomes | Number of studies | Number of adverse events/participants | I2 | Risk ratio (RR) | 95% CI | P value | |
|---|---|---|---|---|---|---|---|
| Galcanezumab | Placebo | ||||||
| Injection-site pain | 5 | 205/1579 | 149/1419 | 60% | 1.43 | 0.99–2.06 | 0.04 |
| Nasopharyngitis | 5 | 106/1579 | 104/1419 | 19% | 0.91 | 0.67–1.24 | 0.56 |
| Upper respiratory tract infection | 4 | 93/1153 | 55/987 | 0% | 1.33 | 0.97–1.83 | 0.08 |
| Injection-site erythema | 4 | 54/1306 | 20/1275 | 0% | 2.44 | 1.46–4.06 | 0.0006 |
| Back pain | 4 | 47/1125 | 36/958 | 15% | 1.03 | 0.64–1.66 | 1.03 |
| Sinusitis | 4 | 39/1125 | 26/958 | 0% | 1.33 | 0.81–2.19 | 0.26 |
| Influenza | 4 | 34/1472 | 23/1309 | 0% | 1.36 | 0.79–2.33 | 0.26 |
| Neck pain | 4 | 21/1125 | 14/958 | 0% | 1.27 | 0.64–2.53 | 0.49 |
| Dizziness | 3 | 31/987 | 24/1003 | 0% | 1.31 | 0.77–2.22 | 0.32 |
| Nausea | 3 | 24/806 | 29/679 | 0% | 0.74 | 0.43–1.27 | 0.27 |
| Injection site pruritus | 3 | 39/1199 | 2/1172 | 0% | 13.42 | 3.70–48.62 | < 0.0001 |
| Injection site reaction | 3 | 67/1199 | 14/1172 | 73% | 4.87 | 1.20–19.85 | 0.03 |
| Urinary tract infection | 3 | 35/1018 | 23/848 | 0% | 1.39 | 0.83–2.35 | 0.21 |
| Abdominal pain | 2 | 16/426 | 12/389 | 0% | 1.21 | 0.58–2.55 | 0.61 |
| Arthralgia | 2 | 12/426 | 12/389 | 0% | 0.95 | 0.43–2.09 | 0.90 |
| Dysmenorrhea | 2 | 12/699 | 2/569 | 0% | 3.32 | 0.80–13.71 | 0.10 |
| Migraine | 2 | 16/745 | 9/711 | 0% | 1.66 | 0.74–3.73 | 0.22 |
| Oropharyngeal pain | 2 | 14/745 | 6/711 | 0% | 2.20 | 0.85–5.68 | 0.10 |
| Weight increased | 2 | 13/745 | 10/711 | 0% | 1.23 | 0.54–2.80 | 0.63 |
| Fatigue | 2 | 23/773 | 22/740 | 0% | 0.99 | 0.55–1.76 | 0.97 |
| Diarrhea | 2 | 19/773 | 20/740 | 0% | 0.90 | 0.48–1.60 | 0.74 |
| Bronchitis | 2 | 15/699 | 6/569 | 0% | 1.92 | 0.74–4.95 | 0.18 |
| Rash | 1 | 5/107 | 0/110 | – | 11.31 | 0.63–201.99 | 0.10 |
| Hypertension | 1 | 5/107 | 0/110 | – | 11.31 | 0.63–201.99 | 0.10 |
| Pain in extremity | 1 | 4/107 | 5/110 | – | 0.82 | 0.23–2.98 | 0.77 |
| Toothache | 1 | 4/107 | 1/110 | – | 4.11 | 0.47–36.20 | 0.20 |
| Viral gastroenteritis | 1 | 2/107 | 4/110 | – | 0.51 | 0.10–2.75 | 0.44 |
| Cough | 1 | 10/426 | 7/432 | – | 1.45 | 0.56–3.77 | 0.45 |
| Pruritus | 1 | 8/426 | 1/432 | – | 8.11 | 1.02–64.58 | 0.05 |
| Injection site bruising | 1 | 6/426 | 6/432 | – | 1.01 | 0.33–3.12 | 0.98 |
| Nasal congestion | 1 | 6/426 | 4/432 | – | 1.52 | 0.43–5.35 | 0.51 |
| Vertigo | 1 | 6/426 | 2/432 | – | 3.04 | 0.62–14.99 | 0.17 |
| Contusion | 1 | 5/426 | 5/432 | – | 1.01 | 0.30–3.48 | 0.98 |
| Injection site swelling | 1 | 6/454 | 0/461 | – | 13.20 | 0.75–233.63 | 0.08 |
| Pyrexia | 1 | 6/319 | 2/279 | – | 2.62 | 0.53–12.9 | 0.24 |
| Pain in extremity | 1 | 3/273 | 1/137 | – | 1.51 | 0.16–14.34 | 0.72 |