Correction to: BMC Neurol
https://doi.org/10.1186/s12883-020-1609-7
Following publication of the original article [1], the authors noticed an error in the values for ‘Hypersensitivity SMQ’ and ‘Rash’ in Table 7. The data presented for ‘Hypersensitivity SMQ’ and ‘Rash’ were inadvertently the events that were potentially hypersensitivity rather than the events that were likely hypersensitivity after medical review. The table legend and discussion of the data in the text were and are correct.
Table 7.
Percentage of patients in integrated double-blind studies who experienced a hypersensitivity eventa,b
| Galcanezumab | |||
|---|---|---|---|
| Placebo N = 1451 n (%) |
120 mg N = 705 n (%) |
240 mg N = 730 n (%) |
|
| Hypersensitivity SMQ | 40 (2.8) | 34 (4.8)c | 32 (4.4)c |
| Rash | 15 (1.0) | 5 (0.7) | 7 (1.0) |
| Injection site rash | 2 (0.1) | 6 (0.9)c | 4 (0.6) |
| Dermatitis contact | 4 (0.3) | 3 (0.4) | 4 (0.6) |
| Rhinitis allergic | 3 (0.2) | 3 (0.4) | 4 (0.6) |
| Hypersensitivity | 0 (0.0) | 3 (0.4)c | 2 (0.3)c |
| Injection site hypersensitivity | 0 (0.0) | 1 (0.1) | 3 (0.4)c |
| Dermatitis allergic | 0 (0.0) | 3 (0.4)c | 0 (0.0) |
| Eczema | 3 (0.2) | 1 (0.1) | 2 (0.3) |
| Rash pruritic | 0 (0.0) | 2 (0.3)c | 1 (0.1) |
| Urticaria | 5 (0.3) | 2 (0.3) | 1 (0.1) |
| Injection site urticaria | 1 (0.1) | 1 (0.1) | 1 (0.1) |
| Rash generalized | 1 (0.1) | 1 (0.1) | 1 (0.1) |
| Rash papulosquamous | 0 (0.0) | 1 (0.1) | 1(0.1) |
| Dermatitis atopic | 1 (0.1) | 0 (0.0) | 1(0.1) |
| Eye allergy | 0 (0.0) | 1 (0.1) | 0 (0.0) |
| Pruritus allergic | 0 (0.0) | 1 (0.1) | 0 (0.0) |
| Rash erythematous | 1 (0.1) | 0 (0.0) | 1 (0.1) |
| Rash maculo-papular | 1 (0.1) | 1 (0.1) | 0 (0.0) |
| Bronchospasm | 1 (0.1) | 0 (0.0) | 0 (0.0) |
| Conjunctivitis allergic | 1 (0.1) | 0 (0.0) | 0 (0.0) |
| Drug hypersensitivity | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Abbreviations: MedDRA Medical Dictionary for Regulatory Activities, N number of patients in the analysis population, n number of patients within each specific category, SMQ standardized MedDRA query
aThese are likely events per medical review
bCategorized by narrow standardized MedDRA®b (v.19.1) query search terms. MedDRA®, the certified Medical Dictionary for Regulatory Activities terminology, is the international medical terminology developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
cIndicates a statistically significant difference (P < 0.05) compared with placebo
Reference
- 1.Bangs ME, Kudrow D, Wang S, Oakes TM, Terwindt GM, Magis D, Yunes-Medina L, Stauffer VL. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020;20:25. doi: 10.1186/s12883-020-1609-7. [DOI] [PMC free article] [PubMed] [Google Scholar]
