{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T11:08:44Z","timestamp":1779361724855,"version":"3.51.4"},"reference-count":23,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2025,8,26]],"date-time":"2025-08-26T00:00:00Z","timestamp":1756166400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Ministry of Education, Culture, Research, and Technology (MOECRT) of the Republic of Indonesia"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["International Journal of Risk &amp; Safety in Medicine"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The treatment of multidrug-resistant (MDR) tuberculosis (TB) requires the long-term administration of multiple second-line drugs in combination therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>We investigated the ADRs to a 9-month all-oral regimen (i.e., pyrazinamide, ethambutol, high-dose isoniazid, levofloxacin, bedaquiline, and clofazimine) and a longer 18-months regimen (i.e., levofloxacin, bedaquiline, linezolid, clofazimine, and cycloserine) for MDR-TB during the first 4\u00a0months of treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method<\/jats:title>\n                    <jats:p>The patients in this cohort study were recruited from three referral hospitals in Indonesia. The inclusion criteria were patients aged \u226518\u00a0years diagnosed with MDR-TB who received either the 9-month all-oral or 18-months regimens. We used the causality assessment categories from the WHO\u2013Uppsala Monitoring Center.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 60 patients were included in this study. The ADRs included nausea and\/or vomiting (48.3%), arthralgia (38.3%), prolonged QTcF interval (30.0%), among others. One case of prolonged QT interval in a grade 3 ADR was observed, in which the 18-month regimen was modified during the first 4\u00a0months of treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In the first 4\u00a0months of treatment, the predominant ADRs were nausea and\/or vomiting, arthralgia, and prolonged QT interval. This study showed that active patient monitoring is needed.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/09246479251370581","type":"journal-article","created":{"date-parts":[[2025,8,26]],"date-time":"2025-08-26T08:54:01Z","timestamp":1756198441000},"page":"235-241","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Adverse drug reactions to the nine-month all-oral and 18-month regimens for multidrug-resistant tuberculosis in Indonesia"],"prefix":"10.1177","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1888-0897","authenticated-orcid":false,"given":"Nina","family":"Mariana","sequence":"first","affiliation":[{"name":"University of Indonesia"},{"name":"National Infectious Disease Center - Sulianti Saroso Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9912-0800","authenticated-orcid":false,"given":"Anggi","family":"Gayatri","sequence":"additional","affiliation":[{"name":"University of Indonesia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7952-2893","authenticated-orcid":false,"given":"Indah Suci","family":"Widyahening","sequence":"additional","affiliation":[{"name":"Faculty of Medicine University of Indonesia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9010-2427","authenticated-orcid":false,"given":"Budiman","family":"Bela","sequence":"additional","affiliation":[{"name":"University of Indonesia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8031-9024","authenticated-orcid":false,"given":"Neni","family":"Sawitri","sequence":"additional","affiliation":[{"name":"Dr. M. Goenawan Partowidigdo Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7317-5619","authenticated-orcid":false,"given":"Soedarsono","family":"Soedarsono","sequence":"additional","affiliation":[{"name":"University of Hang Tuah"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4064-5412","authenticated-orcid":false,"given":"Erni Juwita","family":"Nelwan","sequence":"additional","affiliation":[{"name":"Faculty of Medicine University of Indonesia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3084-3087","authenticated-orcid":false,"given":"Purwantyastuti","family":"Ascobat","sequence":"additional","affiliation":[{"name":"University of Indonesia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,8,26]]},"reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1186\/s40249-023-01107-x"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.12701\/yujm.2020.00626"},{"key":"e_1_3_5_4_2","volume-title":"Global tuberculosis report 2021","author":"World Health Organization","year":"2021","unstructured":"World Health Organization. Global tuberculosis report 2021, 2021."},{"key":"e_1_3_5_5_2","volume-title":"Dashboard Data Kondisi TBC di Indonesia Data Diperbarui","author":"Indonesian Ministry of Health","year":"2025","unstructured":"Indonesian Ministry of Health. Dashboard Data Kondisi TBC di Indonesia Data Diperbarui 3 Februari 2025, 2025."},{"key":"e_1_3_5_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijtb.2020.09.027"},{"key":"e_1_3_5_7_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-0040-1722535"},{"key":"e_1_3_5_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(00)02799-9"},{"key":"e_1_3_5_9_2","volume-title":"StatPearls","author":"Kommu S","year":"2024","unstructured":"Kommu S, Carter CWP. Adverse drug reactions. In: StatPearls. StatPearls Publishing, 2024. Available from: https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK599521\/.2024"},{"key":"e_1_3_5_10_2","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.12722"},{"key":"e_1_3_5_11_2","first-page":"194","article-title":"The use of the WHO-UMC system for standardized case causality assessment","volume":"48","author":"World Health Organization","year":"2014","unstructured":"World Health Organization. The use of the WHO-UMC system for standardized case causality assessment. Uppsala Uppsala Monit Cent 2014; 48: 194\u2013203.","journal-title":"Uppsala Uppsala Monit Cent"},{"key":"e_1_3_5_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.rcsop.2021.100064"},{"key":"e_1_3_5_13_2","first-page":"1","article-title":"Adverse drug reactions related to treatment of drug-susceptible tuberculosis in Brazil: a prospective cohort study","volume":"2","author":"Sant\u00b4Anna FM","year":"2021","unstructured":"Sant\u00b4Anna FM, Ara\u00fajo-Pereira M, Schmaltz CAS, et al. Adverse drug reactions related to treatment of drug-susceptible tuberculosis in Brazil: a prospective cohort study. Front Trop Dis 2021; 2: 1\u201310.","journal-title":"Front Trop Dis"},{"key":"e_1_3_5_14_2","volume-title":"Petunjuk teknis monitoring dan manajemen efek samping obat secara aktif (MESO aktif) pada pengobatan TBC resistan obat di Indonesia","author":"Kementerian Kesehatan RI","year":"2022","unstructured":"Kementerian Kesehatan RI. Petunjuk teknis monitoring dan manajemen efek samping obat secara aktif (MESO aktif) pada pengobatan TBC resistan obat di Indonesia. Kementerian Kesehatan RI, 2022."},{"key":"e_1_3_5_15_2","volume-title":"Common Terminology criteria for adverse events (CTCAE) v.5.0","author":"U.S. Department of Health and Human Services","year":"2017","unstructured":"U.S. Department of Health and Human Services. Common Terminology criteria for adverse events (CTCAE) v.5.0. U.S. Departement of Health and Human Services, 2017."},{"key":"e_1_3_5_16_2","doi-asserted-by":"publisher","DOI":"10.1177\/20503121231171350"},{"key":"e_1_3_5_17_2","first-page":"e30764","article-title":"Adverse drug reaction monitoring in multidrug-resistant tuberculosis patients receiving bedaquiline and delamanid-based regimen","volume":"14","author":"Paikray E","year":"2022","unstructured":"Paikray E, Das P, Pattnaik M, et al. Adverse drug reaction monitoring in multidrug-resistant tuberculosis patients receiving bedaquiline and delamanid-based regimen. Cureus 2022; 14: e30764.","journal-title":"Cureus"},{"key":"e_1_3_5_18_2","doi-asserted-by":"publisher","DOI":"10.3390\/tropicalmed7090244"},{"key":"e_1_3_5_19_2","unstructured":"US Food and Drug Administration Center for drug evaluation and research. Bedaquiline. US food and drug administration center; 2012."},{"key":"e_1_3_5_20_2","doi-asserted-by":"publisher","DOI":"10.4103\/jfmpc.jfmpc_831_21"},{"key":"e_1_3_5_21_2","first-page":"1","article-title":"Pharmacovigilance: reporting requirements throughout a product\u2019s lifecycle","volume":"13","author":"Sylvia L","year":"2022","unstructured":"Sylvia L, Jessica A, Timothy RS, et al. Pharmacovigilance: reporting requirements throughout a product\u2019s lifecycle. Ther Adv Drug Saf 2022; 13: 1\u201316.","journal-title":"Ther Adv Drug Saf"},{"key":"e_1_3_5_22_2","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics14050990"},{"key":"e_1_3_5_23_2","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.00040-2016"},{"key":"e_1_3_5_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijid.2014.12.001"}],"container-title":["International Journal of Risk &amp; Safety in Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/09246479251370581","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/09246479251370581","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/09246479251370581","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T10:59:18Z","timestamp":1779361158000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/09246479251370581"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,26]]},"references-count":23,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,5]]}},"alternative-id":["10.1177\/09246479251370581"],"URL":"https:\/\/doi.org\/10.1177\/09246479251370581","relation":{},"ISSN":["0924-6479","1878-6847"],"issn-type":[{"value":"0924-6479","type":"print"},{"value":"1878-6847","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,26]]}}}