Table 4.
Adverse events for galcanezumab versus placebo.
| Subgroup | Number of pooled events/participants |
I 2 | Risk ratio (95% CI) | p value | |
|---|---|---|---|---|---|
| Galcanezumb | Placebo | ||||
| Any AE | 913/1435 | 827/1451 | 0% | 1.12 (95% CI = 1.05–1.18) | 0.0002 |
| Any SAE | 24/1435 | 14/1451 | 0% | 1.74 (95% CI = 0.9–3.34) | 0.0989 |
| Discontinuation due to AEs | 36/1435 | 23/1451 | 0% | 1.59 (95% CI = 0.95–2.66) | 0.0808 |
| Injection site pain | 156/1435 | 138/1451 | 0% | 1.14 (95% CI = 0.92–1.42) | 0.2157 |
| Injection site erythema | 49/1435 | 20/1451 | 0% | 2.48 (95% CI = 1.48–4.15) | 0.0005 |
| Injection site pruritus | 39/1435 | 2/1451 | 0% | 15.99 (95% CI = 4.47–57.3) | <00001 |
| Injection site reaction | 67/1435 | 14/1451 | 68.9% | 4.98 (95% CI = 1.35–18.38) | 0.0159 |
| Nasopharyngitis | 83/1435 | 94/1451 | 0% | 0.89 (95% CI = 0.67–1.19) | 0.4402 |
| Upper respiratory tract infection | 53/1435 | 35/1451 | 0% | 1.53 (95% CI = 1.01 –2.33) | 0.0465 |
| Back pain | 23/1435 | 20/1451 | 54,6% | 1.21 (95% CI = 0.48–3.03) | 0.686 |
| Urinary tract infection | 10/1435 | 7/1451 | 0% | 1.43 (95% CI = 0.83–2.44) | 0.1965 |
| Abdominal pain | 10/1435 | 9/1451 | 0% | 1.12 (95% CI = 0.46–2.73) | 0.8079 |
| Fatigue | 23/1435 | 22/1451 | 0% | 1.06 (95% CI = 0.59–1.88) | 0.8523 |
| Diarrhea | 19/1435 | 20/1451 | 0% | 0.96 (95% CI = 0.52–1.79) | 0.8982 |
| Dizziness | 26/1435 | 21/1451 | 0% | 1.26 (95% CI = 0.71–2.22) | 0.4305 |
| Migraine | 16/1435 | 9/1451 | 0% | 1.79 (95% CI = 0.8–4.04) | 0.1582 |
| Influenza | 31/1435 | 22/1451 | 24,8% | 1.43 (95% CI = 0.83–2.45 | 0.1973 |
| Injection site bruising | 6/1435 | 6/1451 | 0% | 1.01 (95% CI = 0.33–3.12) | 0.9805 |
| Neck pain | 14/1435 | 12/1451 | 0% | 1.18 (95% CI = 0.55–2.53) | 0.3849 |
| Nausea | 13/1435 | 15/1451 | 0% | 0.88 (95% CI = 0.42–1.82) | 0.729 |
AE, adverse event; CI, confidence interval; SAE, serious adverse event.