Correction: Long-term safety and efficacy of ropeginterferon alfa-2b in Japanese patients with polycythemia vera
Keita Kirito, Yuka Sugimoto, Akihiko Gotoh, Katsuto Takenaka, Michiko Ichii, Tadaaki Inano, Shuichi Shirane, Masafumi Ito, Oleh Zagrijtschuk, Albert Qin, Hiroaki Kawase, Toshiaki Sato, Norio Komatsu, Kazuya Shimoda
Abstract
Genes, proteins, chemicals, diseases, species, mutations and cell lines named across the full text — each resolved to its canonical identifier and authoritative record.
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Taxonomy
TopicsMyeloproliferative Neoplasms: Diagnosis and Treatment · Eosinophilic Disorders and Syndromes · Cytokine Signaling Pathways and Interactions
Correction: International Journal of Hematology (2024) 120:675–683 10.1007/s12185-024-03846-5
In Table 1 of this article, the data in the “Psychiatric disorders” headed “Phase 2 study [15] …” were incorrect and should have been “1 (3.4)”. The entire row ‘Suicidal ideation’ should be deleted under ‘Psychiatric disorders’.
Uncorrected version of Table 1
Table 1. Summary of TEAEs and ADRs at 12 months [15]^a^ vs those occurring from >12–36 months^b^ (safety population)Phase 2 study [15] (up to 12 months) (N = 29)Extension study (> 12–36 months) (N = 27)At least one ADR29 (100)25 (92.6)At least one grade 1 ADR20 (69.0)15 (55.6)At least one grade 2 ADR9 (31.0)8 (29.6)At least one grade ≥ 3 ADR02 (7.4)At least one serious TEAE1 (3.4)3 (11.1)At least one TEAE of special interest9 (31.0)7 (25.9)ADR leading to treatment discontinuation1 (3.4)0ADRs occurring in ≥ 10% of patients (in either study) by Preferred TermAlopecia16 (55.2)1 (3.7)Fatigue8 (27.6)1 (3.7)Influenza-like illness8 (27.6)0Alanine aminotransferase increased6 (20.7)1 (3.7)Beta-2 microglobulin urine increased6 (20.7)7 (25.9)Aspartate aminotransferase increased5 (17.2)1 (3.7)Diarrhea5 (17.2)1 (3.7)Liver function test abnormal4 (13.8)1 (3.7)Myalgia4 (13.8)3 (11.1)Pyrexia4 (13.8)2 (7.4)Anemia3 (10.3)5 (18.5)Arthralgia3 (10.3)0Gamma glutamyl transferase increased3 (10.3)0White blood cell count decreased07 (25.9)Injection site reaction3 (10.3)0Malaise3 (10.3)3 (11.1)TEAEs of special interest by System Organ Class and Preferred TermEndocrine disorders3 (10.3)2 (7.4) Hypothyroidism2 (6.9)2 (7.4) Silent thyroiditis1 (3.4)0Psychiatric disorders2 (6.9)0 Anxiety1 (3.4)0 Suicidal ideation1 (3.4)0Eye disorders1 (3.4)1 (3.7) Retinal hemorrhage1 (3.4)1 (3.7)Data are n (%)Number and percentage of TEAEs in the present study represent new events confirmed during the extension study (i.e., from > 12–36 months); events that occurred during the original 12-month study were not included. Patients who experienced an event during the original study that resolved and then experienced another event during the extension study were included.ADR adverse drug reaction, TEAE treatment-emergent adverse event^a^Medical Dictionary for Regulatory Activities, v23.0^b^Medical Dictionary for Regulatory Activities, v26.0
Corrected version of Table 1Table 1. Summary of TEAEs and ADRs at 12 months [15]^a^ vs those occurring from > 12–36 months^b^ (safety population)Phase 2 study [15] (up to 12 months) (N = 29)Extension study (> 12–36 months) (N = 27)At least one ADR29 (100)25 (92.6)At least one grade 1 ADR20 (69.0)15 (55.6)At least one grade 2 ADR9 (31.0)8 (29.6)At least one grade ≥ 3 ADR02 (7.4)At least one serious TEAE1 (3.4)3 (11.1)At least one TEAE of special interest9 (31.0)7 (25.9)ADR leading to treatment discontinuation1 (3.4)0ADRs occurring in ≥ 10% of patients (in either study) by Preferred TermAlopecia16 (55.2)1 (3.7)Fatigue8 (27.6)1 (3.7)Influenza-like illness8 (27.6)0Alanine aminotransferase increased6 (20.7)1 (3.7)Beta-2 microglobulin urine increased6 (20.7)7 (25.9)Aspartate aminotransferase increased5 (17.2)1 (3.7)Diarrhea5 (17.2)1 (3.7)Liver function test abnormal4 (13.8)1 (3.7)Myalgia4 (13.8)3 (11.1)Pyrexia4 (13.8)2 (7.4)Anemia3 (10.3)5 (18.5)Arthralgia3 (10.3)0Gamma glutamyl transferase increased3 (10.3)0White blood cell count decreased07 (25.9)Injection site reaction3 (10.3)0Malaise3 (10.3)3 (11.1)TEAEs of special interest by System Organ Class and Preferred TermEndocrine disorders3 (10.3)2 (7.4) Hypothyroidism2 (6.9)2 (7.4) Silent thyroiditis1 (3.4)0Psychiatric disorders**1 (3.4)**0 Anxiety1 (3.4)0Eye disorders1 (3.4)1 (3.7) Retinal hemorrhage1 (3.4)1 (3.7)Data are n (%)Number and percentage of TEAEs in the present study represent new events confirmed during the extension study (i.e., from > 12–36 months); events that occurred during the original 12-month study were not included. Patients who experienced an event during the original study that resolved and then experienced another event during the extension study were includedADR adverse drug reaction, TEAE treatment-emergent adverse event^a^Medical Dictionary for Regulatory Activities, v23.0^b^Medical Dictionary for Regulatory Activities, v26.0