ArticleBMC infectious diseases2019
Incidence and predictors of major adverse drug events among drug-resistant tuberculosis patients on second-line anti-tuberculosis treatment in Amhara regional state public hospitals; Ethiopia: a retrospective cohort study.
Article in BMC infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 3 of them syntheses that pooled it.
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Who cites it
22 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Variation of adverse drug events in different settings in Africa: a systematic review.European journal of medical research · 2024Pooled it
- Pooled it
- Medication-related problems and adverse drug reactions in Ethiopia: A systematic review.Pharmacology research & perspectives · 2020Pooled it
- Article
- Effectiveness and safety of bedaquiline, pretomanid, linezolid and moxifloxacin in drug-resistant tuberculosis patients in selected public hospitals in Ethiopia: a multicenter retrospective cohort study.BMC infectious diseases · 2026Article
- Article
- Adverse drug reactions and contributing factors in patients with drug-resistant tuberculosis: A 7-year retrospective cohort study in Addis Ababa, Ethiopia.Journal of clinical tuberculosis and other mycobacterial diseases · 2025Article
- Frequency, management and impact of adverse events on treatment outcomes in patients with multidrug resistant tuberculosis in Balochistan, Pakistan.Journal of pharmaceutical policy and practice · 2024Article
- Extrapulmonary and Drug-Resistant Childhood Tuberculosis: Unveiling the Disease to Adopt the Optimal Treatment Strategy.Pathogens (Basel, Switzerland) · 2023Article
- Prevalence of long-term physical sequelae among patients treated with multi-drug and extensively drug-resistant tuberculosis: a systematic review and meta-analysis.EClinicalMedicine · 2023Article
- Magnitude and Impacts of Adverse Events of Injectable Containing Shorter Regimen in Programmatic Management of Multi-Drug Resistant Tuberculosis in Ethiopia: A Retrospective Cohort Study.Therapeutics and clinical risk management · 2023Article
- Incidence of adverse drug events in patients hospitalized in the medical wards of a teaching referral hospital in Ethiopia: a prospective observational study.BMC pharmacology & toxicology · 2022Observational
- Frequency and Management of Adverse Drug Reactions Among Drug-Resistant Tuberculosis Patients: Analysis From a Prospective Study.Frontiers in pharmacology · 2022Article
- A Score to Predict the Risk of Major Adverse Drug Reactions Among Multi-Drug Resistant Tuberculosis Patients in Southern Ethiopia, 2014-2019.Infection and drug resistance · 2022Article
- Predictors for Pulmonary Tuberculosis Outcome and Adverse Events in an Italian Referral Hospital: A Nine-Year Retrospective Study (2013-2021).Annals of global health · 2022Article
- Assessment of Adverse Drug Events, Their Risk Factors, and Management Among Patients Treated for Multidrug-Resistant TB: A Prospective Cohort Study From Pakistan.Frontiers in pharmacology · 2022Article
- Incidence and Predictors of Adverse Drug Events Among People Receiving Drug Resistant Tuberculosis Treatment in Uganda: 8-Year Retrospective Cohort Study.Therapeutics and clinical risk management · 2022Article
- Treatment outcomes of drug resistant tuberculosis patients with multiple poor prognostic indicators in Uganda: A countrywide 5-year retrospective study.Journal of clinical tuberculosis and other mycobacterial diseases · 2021Article
- Effectiveness and Safety of a Shorter Treatment Regimen in a Setting with a High Burden of Multidrug-Resistant Tuberculosis.International journal of environmental research and public health · 2021Article
- Frequency and Factors Associated With Adverse Events Among Multi-Drug Resistant Tuberculosis Patients in Pakistan: A Retrospective Study.Frontiers in medicine · 2021Article
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Authors and funding
6 authors.
Funding
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Abstract
backgroundSecond line anti-tuberculosis drugs are substantially complex, long term, more costly, and more toxic than first line anti-tuberculosis drugs. In Ethiopia, evidence on the incidence and predictors of adverse drug events has been limited. Thus, this study aimed at assessing incidence and predictors of major adverse drug events among drug resistant tuberculosis patients on second line tuberculosis treatment in Amhara Regional State public hospitals, Ethiopia.
methodsA multi-center retrospective cohort study was conducted on 570 drug resistant tuberculosis Patients. Data were entered in to EPI-Data version 4.2.0.0 and exported to Stata version 14 for analysis. Proportional hazard assumption was checked. The univariate Weibull regression gamma frailty model was fitted. Cox-Snell residual was used to test goodness of fit and Akaike Information Criteria (AIC) for model selection. Hazard ratio with 95% CI was computed and variables with P-value < 0.05 in the multivariable analysis were taken as significant predictors for adverse drug event.
resultsA total of 570 patients were followed for 5045.09 person-month (PM) observation with a median follow-uptime of 8.23 months (Inter Quartile Range (IQR) =2.66-23.33). The overall incidence rate of major adverse drug events was 5.79 per 100 PM (95% CI: 5.16, 6.49). Incidence rate at the end of 2nd, 4th, and 6th months was 13.73, 9.25, 5.97 events per 100 PM observations, respectively. Age at 25-49 (Adjusted Hazard Ratio (AHR) = 3.36, 95% CI: 1.36, 8.28), and above 50 years (AHR = 5.60, 95% CI: 1.65, 19.05), co-morbid conditions (AHR = 2.74 CI: 1.12, 6.68), and anemia (AHR = 3.25 CI: 1.40, 7.53) were significant predictors of major adverse drug events.
conclusionThe incidence rate of major adverse drug events in the early 6 months of treatment was higher than that of the subsequent months. Age above 25 years, base line anemia, and co-morbid conditions were independent predictors of adverse drug events. Thus, addressing significant predictors and strengthening continuous follow-ups are highly recommended in the study setting.
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