Correction: Allergy, Asthma & Clinical Immunology (2022) 18:70 https://doi.org/10.1186/s13223-022-00709-8
Following the publication of our article [1], a previously undetected error in the data set has come to our attention. MedDRA-coded preferred terms (PTs) were not coded in the derived adverse event (AE) data set used for the summary of AEs and AEs of interest. While the overall number of AEs was reported correctly in the published article, three AEs that were originally categorized as ‘other’ have now been re-categorized. Consequently, safety data presented in the Results require correction.
Firstly, in the Safety subsection, the first sentence stated: “In total, 20 AEs of interest (in 15 patients) and 29 other AEs (in 20 patients) were reported (Table 3).”
It should instead read: “In total, 23 AEs of interest (in 16 patients) and 26 other AEs (in 19 patients) were reported (Table 3).”
The referenced Table 3 (Summary of AEs) originally presented the following data:
AEs of interest | Other AEs | SAEsa | ||||
|---|---|---|---|---|---|---|
Patients, n (%) (N = 125) | AEs, n | Patients, n (%) (N = 125) | AEs, n | Patients, n (%) (N = 125) | AEs, n | |
Any AE | 15 (12.0) | 20 | 20 (16.0) | 29 | 5 (4.0) | 5 |
Severity of AEb | ||||||
Mild | 10 (8.0) | 13 | 11 (8.8) | 14 | 0 | 0 |
Moderate | 5 (4.0) | 6 | 6 (4.8) | 12 | 1 (0.8) | 1 |
Severe | 1 (0.8) | 1 | 3 (2.4) | 3 | 4 (3.2) | 4 |
AEs considered related to Ig20Gly | ||||||
Related | 7 (5.6) | 8 | 3 (2.4) | 4 | 0 | 0 |
Possibly related | 5 (4.0) | 5 | 4 (3.2) | 6 | 1 (0.8) | 1 |
Probably related | 2 (1.6) | 2 | 2 (1.6) | 2 | 0 | 0 |
Table 3 should instead present the following corrected data:
AEs of interest | Other AEs | SAEsa | ||||
|---|---|---|---|---|---|---|
Patients, n (%) (N = 125) | AEs, n | Patients, n (%) (N = 125) | AEs, n | Patients, n (%) (N = 125) | AEs, n | |
Any AE | 16 (12.8) | 23 | 19 (15.2) | 26 | 5 (4.0) | 5 |
Severity of AEb | ||||||
Mild | 11 (8.8) | 14 | 10 (8.0) | 13 | 0 | 0 |
Moderate | 5 (4.0) | 8 | 6 (4.8) | 10 | 1 (0.8) | 1 |
Severe | 1 (0.8) | 1 | 3 (2.4) | 3 | 4 (3.2) | 4 |
AEs considered related to Ig20Gly | ||||||
Related | 7 (5.6) | 8 | 3 (2.4) | 4 | 0 | 0 |
Possibly related | 5 (4.0) | 7 | 4 (3.2) | 4 | 1 (0.8) | 1 |
Probably related | 2 (1.6) | 2 | 2 (1.6) | 2 | 0 | 0 |
Safety data in Additional file 2: Table S1 (AEs of interest), referenced in the Safety subsection, were originally presented as follows:
AE of interest | Patients, n (%) (N = 125) | |
|---|---|---|
All causality | Considered related to Ig20Gly | |
Nausea | 2 (1.6) | 1 (0.8) |
Diarrhea | 1 (0.8) | 0 |
Headache | 6 (4.8) | 3 (2.4) |
Cough | 2 (1.6) | 0 |
Stroke | 1 (0.8) | 0 |
Fatigue | 2 (1.6) | 0 |
Infusion-site erythema (redness) | 1 (0.8) | 1 (0.8) |
Infusion-site pain | 3 (2.4) | 3 (2.4) |
Infusion-site pruritus (itchiness) | 1 (0.8) | 0 |
Table S1 should instead present the following corrected data for all causality fatigue:
AE of interest | Patients, n (%) (N = 125) | |
|---|---|---|
All causality | Considered related to Ig20Gly | |
Nausea | 2 (1.6) | 1 (0.8) |
Diarrhea | 1 (0.8) | 0 |
Headache | 6 (4.8) | 3 (2.4) |
Cough | 2 (1.6) | 0 |
Stroke | 1 (0.8) | 0 |
Fatigue | 3 (2.4) | 0 |
Infusion-site erythema (redness) | 1 (0.8) | 1 (0.8) |
Infusion-site pain | 3 (2.4) | 3 (2.4) |
Infusion-site pruritus (itchiness) | 1 (0.8) | 0 |
Safety data in Additional file 2: Table S4 (AEs by mode of Ig20Gly administration), referenced in the Subgroup analysis by mode of administration at 12 months subsection, were originally presented as follows:
AEs of interest | Other AEs | SAEs | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Infusion pump | Manual | Infusion pump | Manual | Infusion pump | Manual | |||||||
Patients, n (%) (N = 71) | AEs, n | Patients, n (%) (N = 54) | AEs, n | Patients, n (%) (N = 71) | AEs, n | Patients, n (%) (N = 54) | AEs, n | Patients, n (%) (N = 71) | AEs, n | Patients, n (%) (N = 54) | AEs, n | |
Any AE | 6 (8.5) | 9 | 9 (16.7) | 11 | 12 (16.9) | 13 | 8 (14.8) | 16 | 5 (7.0) | 5 | 0 | 0 |
Severity of AE | ||||||||||||
Mild | 4 (5.6) | 7 | 6 (11.1) | 6 | 6 (8.5) | 7 | 5 (9.3) | 7 | 0 | 0 | 0 | 0 |
Moderate | 1 (1.4) | 1 | 4 (7.4) | 5 | 3 (4.2) | 3 | 3 (5.6) | 9 | 1 (1.4) | 1 | 0 | 0 |
Severe | 1 (1.4) | 1 | 0 | 0 | 3 (4.2) | 3 | 0 | 0 | 4 (5.6) | 4 | 0 | 0 |
AEs considered related to Ig20Gly | ||||||||||||
Related | 3 (4.2) | 3 | 4 (7.4) | 5 | 2 (2.8) | 3 | 1 (1.9) | 1 | 0 | 0 | 0 | 0 |
Possibly related | 2 (2.8) | 2 | 3 (5.6) | 3 | 2 (2.8) | 2 | 2 (3.7) | 4 | 1 (1.4) | 1 | 0 | 0 |
Probably related | 1 (1.4) | 1 | 1 (1.9) | 1 | 0 | 0 | 2 (3.7) | 2 | 0 | 0 | 0 | 0 |
Table S4 should instead present the following corrected data for the manual administration subgroup:
AEs of interest | Other AEs | SAEs | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Infusion pump | Manual | Infusion pump | Manual | Infusion pump | Manual | |||||||
Patients, n (%) (N = 71) | AEs, n | Patients, n (%) (N = 54) | AEs, n | Patients, n (%) (N = 71) | AEs, n | Patients, n (%) (N = 54) | AEs, n | Patients, n (%) (N = 71) | AEs, n | Patients, n (%) (N = 54) | AEs, n | |
Any AE | 6 (8.5) | 9 | 10 (18.5) | 14 | 12 (16.9) | 13 | 7 (13.0) | 13 | 5 (7.0) | 5 | 0 | 0 |
Severity of AE | ||||||||||||
Mild | 4 (5.6) | 7 | 7 (13.0) | 7 | 6 (8.5) | 7 | 4 (7.4) | 6 | 0 | 0 | 0 | 0 |
Moderate | 1 (1.4) | 1 | 4 (7.4) | 7 | 3 (4.2) | 3 | 3 (5.6) | 7 | 1 (1.4) | 1 | 0 | 0 |
Severe | 1 (1.4) | 1 | 0 | 0 | 3 (4.2) | 3 | 0 | 0 | 4 (5.6) | 4 | 0 | 0 |
AEs considered related to Ig20Gly | ||||||||||||
Related | 3 (4.2) | 3 | 4 (7.4) | 5 | 2 (2.8) | 3 | 1 (1.9) | 1 | 0 | 0 | 0 | 0 |
Possibly related | 2 (2.8) | 2 | 3 (5.6) | 5 | 2 (2.8) | 2 | 2 (3.7) | 2 | 1 (1.4) | 1 | 0 | 0 |
Probably related | 1 (1.4) | 1 | 1 (1.9) | 1 | 0 | 0 | 2 (3.7) | 2 | 0 | 0 | 0 | 0 |
Finally, safety data in Additional file 2: Table S6 (AEs by indication), referenced in the Subgroup analysis by indication at 12 months subsection, were originally presented as follows:
Parameter, n (%) | AEs of interest | Other AEs | SAEs | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
PID | SID | PID | SID | PID | SID | |||||||
Patients, n (%) (N = 61) | AEs, n | Patients, n (%) (N = 64) | AEs, n | Patients, n (%) (N = 61) | AEs, n | Patients, n (%) (N = 64) | AEs, n | Patients, n (%) (N = 61) | AEs, n | Patients, n (%) (N = 64) | AEs, n | |
Any AE | 10 (16.4) | 15 | 5 (7.8) | 5 | 8 (13.1) | 14 | 12 (18.8) | 15 | 1 (1.6) | 1 | 4 (6.3) | 4 |
Severity of AE | ||||||||||||
Mild | 7 (11.5) | 10 | 3 (4.7) | 3 | 6 (9.8) | 8 | 5 (7.8) | 6 | 0 | 0 | 0 | 0 |
Moderate | 3 (4.9) | 4 | 2 (3.1) | 2 | 2 (3.3) | 6 | 4 (6.3) | 6 | 0 | 0 | 1 (1.6) | 1 |
Severe | 1 (1.6) | 1 | 0 | 0 | 0 | 0 | 3 (4.7) | 3 | 1 (1.6) | 1 | 3 (4.7) | 3 |
AEs considered related to Ig20Gly | ||||||||||||
Related | 5 (8.2) | 6 | 2 (3.1) | 2 | 2 (3.3) | 2 | 1 (1.6) | 2 | 0 | 0 | 0 | 0 |
Possibly related | 3 (4.9) | 3 | 2 (3.1) | 2 | 2 (3.3) | 2 | 2 (3.1) | 4 | 1 (1.6) | 1 | 0 | 0 |
Probably related | 1 (1.6) | 1 | 1 (1.6) | 1 | 1 (1.6) | 1 | 1 (1.6) | 1 | 0 | 0 | 0 | 0 |
Table S6 should instead present the following corrected data:
Parameter, n (%) | AEs of interest | Other AEs | SAEs | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
PID | SID | PID | SID | PID | SID | |||||||
Patients, n (%) (N = 61) | AEs, n | Patients, n (%) (N = 64) | AEs, n | Patients, n (%) (N = 61) | AEs, n | Patients, n (%) (N = 64) | AEs, n | Patients, n (%) (N = 61) | AEs, n | Patients, n (%) (N = 64) | AEs, n | |
Any AE | 11 (18.0) | 16 | 5 (7.8) | 7 | 7 (11.5) | 13 | 12 (18.8) | 13 | 1 (1.6) | 1 | 4 (6.3) | 4 |
Severity of AE | ||||||||||||
Mild | 8 (13.1) | 11 | 3 (4.7) | 3 | 5 (8.2) | 7 | 5 (7.8) | 6 | 0 | 0 | 0 | 0 |
Moderate | 3 (4.9) | 4 | 2 (3.1) | 4 | 2 (3.3) | 6 | 4 (6.3) | 4 | 0 | 0 | 1 (1.6) | 1 |
Severe | 1 (1.6) | 1 | 0 | 0 | 0 | 0 | 3 (4.7) | 3 | 1 (1.6) | 1 | 3 (4.7) | 3 |
AEs considered related to Ig20Gly | ||||||||||||
Related | 5 (8.2) | 6 | 2 (3.1) | 2 | 2 (3.3) | 2 | 1 (1.6) | 2 | 0 | 0 | 0 | 0 |
Possibly related | 3 (4.9) | 3 | 2 (3.1) | 4 | 2 (3.3) | 2 | 2 (3.1) | 2 | 1 (1.6) | 1 | 0 | 0 |
Probably related | 1 (1.6) | 1 | 1 (1.6) | 1 | 1 (1.6) | 1 | 1 (1.6) | 1 | 0 | 0 | 0 | 0 |
Please note that the conclusions made in the original publication are unaffected by the errors identified.
Reference
Keith PK, Cowan J, Kanani A, Kim H, Lacuesta G, Lee JK, Chen J, Park M, Gladiator A. Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study. Allergy Asthma Clin Immunol. 2022;18:70. https://doi.org/10.1186/s13223-022-00709-8.
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Keith, P.K., Cowan, J., Kanani, A. et al. Correction: Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real‑world study. Allergy Asthma Clin Immunol 19, 54 (2023). https://doi.org/10.1186/s13223-023-00805-3
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DOI: https://doi.org/10.1186/s13223-023-00805-3