Correction to: Adv Ther (2019) 36:923–949 https://doi.org/10.1007/s12325-019-0895-1
In the original article, the Table 6 was published with some errors. The correct Table 6 is below.
Original
Table 6 Adverse drug reactions of special interest
STELLA-LONG TERM (safety analysis set n = 11,051) | Pre-approval clinical trials | ||||||
---|---|---|---|---|---|---|---|
Total number of patients experiencing an ADR | Serious | Non-serious | Total (n = 1669) | ||||
All ADRs | 1616 | (14.6) | 107 | (0.97) | 1539 | (13.9) | (32.9) |
ADRs of special interest | |||||||
Polyuria/pollakiuria | 571 | (5.2) | 1 | (0.01) | 570 | (5.2) | (10.0) |
Volume depletion-related events, including dehydration | 196 | (1.8) | 9 | (0.08) | 189 | (1.7) | (4.5) |
Skin complications | 166 | (1.5) | 4 | (0.04) | 162 | (1.5) | (4.0) |
Genital infection | 135 | (1.2) | 2 | (0.02) | 133 | (1.2) | (2.0) |
Urinary tract infection | 115 | (1.0) | 5 | (0.05) | 110 | (1.0) | (1.8) |
Renal disorder | 115 | (1.0) | 3 | (0.03) | 112 | (1.0) | (4.8) |
Hepatic disorder | 82 | (0.74) | 6 | (0.05) | 78 | (0.71) | (1.0) |
Hypoglycemia | 39 | (0.35) | 3 | (0.03) | 36 | (0.33) | (1.4) |
Cardiovascular diseasea | 30 | (0.27) | 19 | (0.17) | 11 | (0.10) | (1.0) |
Cerebrovascular diseaseb | 23 | (0.21) | 20 | (0.18) | 3 | (0.03) | (0.2) |
Malignant tumor | 22 | (0.20) | 19 | (0.17) | 3 | (0.03) | (0.2) |
Ketoacidosis, events related to ketone-body increase | 3 | (0.03) | 0 | (0.00) | 3 | (0.03) | (1.0) |
Fracture | 2 | (0.02) | 1 | (0.01) | 1 | (0.01) | 0 |
Corrected
Table 6 Adverse drug reactions of special interest
STELLA-LONG TERM (safety analysis set n = 11,051) | Pre-approval clinical trials | ||||||
---|---|---|---|---|---|---|---|
Total number of patients experiencing an ADR | Serious | Non-serious | Total (n = 1669) | ||||
All ADRs | 1616 | (14.6) | 107 | (0.97) | 1539 | (13.9) | (32.9) |
ADRs of special interest | |||||||
Polyuria/pollakiuria | 571 | (5.2) | 1 | (0.01) | 570 | (5.2) | (10.0) |
Volume depletion-related events, including dehydration | 196 | (1.8) | 9 | (0.08) | 189 | (1.7) | (4.5) |
Skin complications | 166 | (1.5) | 4 | (0.04) | 162 | (1.5) | (3.5) |
Genital infection | 135 | (1.2) | 2 | (0.02) | 133 | (1.2) | (2.0) |
Urinary tract infection | 115 | (1.0) | 5 | (0.05) | 110 | (1.0) | (1.8) |
Renal disorder | 115 | (1.0) | 3 | (0.03) | 112 | (1.0) | (4.6) |
Hepatic disorder | 82 | (0.74) | 6 | (0.05) | 78 | (0.71) | (1.0) |
Hypoglycemia | 39 | (0.35) | 3 | (0.03) | 36 | (0.33) | (1.4) |
Cardiovascular diseasea | 30 | (0.27) | 19 | (0.17) | 11 | (0.10) | (1.0) |
Cerebrovascular diseaseb | 23 | (0.21) | 20 | (0.18) | 3 | (0.03) | (0.2) |
Malignant tumor | 22 | (0.20) | 19 | (0.17) | 3 | (0.03) | (0.2) |
Ketoacidosis, events related to ketone-body increase | 3 | (0.03) | 0 | (0.00) | 3 | (0.03) | (0.7) |
Fracture | 2 | (0.02) | 1 | (0.01) | 1 | (0.01) | 0 |
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Nakamura, I., Maegawa, H., Tobe, K. et al. Correction to: Safety and Effectiveness of Ipragliflozin for Type 2 Diabetes in Japan: 12-Month Interim Results of the STELLA-LONG TERM Post-Marketing Surveillance Study. Adv Ther 38, 4599–4601 (2021). https://doi.org/10.1007/s12325-021-01813-8
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DOI: https://doi.org/10.1007/s12325-021-01813-8