Accumulated safety data of recombinant human growth hormone therapy in Korean children over a 10-year period: interim results from the LG Growth Study

Background: Cancer chemotherapeutic drugs are commonly associated with serious adverse effect which contributes to increase in the duration of hospitalisation and economic burden. Aim: The aim of this study was to characterise the seriousness and outcome of adverse drug reactions (ADRs) produced by chemotherapy drugs in cancer patients. Materials and Methods: Patient's demographic characteristics and ADRs due to chemotherapeutic drugs were documented inpatient case report form. Frequencies of the seriousness of the ADRs, its outcome and preventability were studied using descriptive statistics. Proportion of life-threatening ADRs and ADRs linked to increase in duration of hospitalisation were studied. Factors associated with serious ADRs and patient characteristics were studied using calculation of odds ratio (OR) at 95% confidence interval (P < 0.5). Results: A total of 412 ADRs were noted in selected 120 patients received chemotherapy drugs. Majority of ADRs (61%) were linked to increase in duration of hospital admission. Some ADRs (12%) were noted as life-threatening to the patients. OR 1.58 was found on the association between patient age group and serious ADRs (P = 0.02). Association of preventability of ADRs and serious ADRs shows OR of 3.65 (P = 0.0001). Common serious ADRs were noted as anaemia, neutropenia, fever, thrombocytopenia, diarrhoea, mucositis and nausea and vomiting. Conclusion: The incidence of serious ADRs due to chemotherapy drugs amongst cancer patients is high. Studies on the nature of seriousness of ADRs, outcome and its triggering factors may help to prevent them. Early identification of serious ADRs may support to reduce hospital stay and economic burden.

The A1chieve study: Mapping the Ibn Battuta trail

ObjectiveThe aim of this study was to assess the safety and effectiveness of palivizumab for the prevention of lower respiratory tract infection (LRI) caused by respiratory syncytial virus (RSV) in children with immunocompromised conditions or Down syndrome.MethodsIn this multicenter, post-marketing surveillance study (December 2013 to December 2015), children aged ≤24 months with immunocompromised conditions or Down syndrome (without hemodynamically significant congenital heart disease) receiving palivizumab immunoprophylaxis during two RSV seasons were observed until 30 days after the final palivizumab injection. Safety [adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs)] and effectiveness (frequency, incidence, and duration of hospitalization due to RSV infections) were assessed.ResultsOf 304 patients receiving palivizumab, 167 (54.9%) had immunocompromised conditions, and 138 (45.4%) had Down syndrome; 260 (85.5%) completed palivizumab immunoprophylaxis. The annual mean (±standard deviation) number of doses was 5.3 (±2.4) per season. Overall, 220 AEs occurred in 99 patients (32.6%), including 89 SAEs in 53 patients (17.4%). Of these, 33 AEs in 25 patients (8.22%) were considered ADRs, and 13 ADRs in 11 patients (3.62%) were considered SADRs. In four patients, five SADRs (nephroblastoma and asthma in the same patient, septic shock, device-related infection, and drug-induced liver injury) were previously unreported; however, none were considered drug-related. During the observation period, five RSV infections occurred and two patients required hospitalization.ConclusionPalivizumab was generally safe and effective for the prevention of LRI caused by RSV in newborns, infants, and children with immunocompromised conditions or Down syndrome up to the age of 24 months.Electronic supplementary materialThe online version of this article (doi:10.1007/s40272-017-0264-y) contains supplementary material, which is available to authorized users.

Objective:To evaluate the long-term safety and efficacy of glycopyrronium (GLY) in patients with COPD in a real-world setting in Japan.Methods:This 52-week, multicentre, post-marketing surveillance conducted in Japan, between February 2013 and August 2019, included patients using GLY for the first time for the relief of airway obstructive disorder-related symptoms. Safety outcomes included incidence of adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs) and priority variables included cardiovascular/cerebrovascular (CCV) AEs and anticholinergic AEs during the 52-week period. Safety outcomes were also assessed in elderly patients. Efficacy outcomes included physician’s global assessment, COPD assessment test (CAT) and lung function test.Results and Discussion:Of the 1,331 patients registered for this surveillance, safety and efficacy outcomes were evaluated in 1,277 patients. In the safety analysis population, the incidence of AEs was 15.51%, SAEs 4.70%, ADRs 5.01% and SADRs 0.31%. The CCV AEs and anticholinergic AEs were reported by 0.70% and 2.58% patients, respectively. Physician’s global assessment showed that the overall response rate at the last assessment was 70%. The mean (95% CI) CAT scores decreased from the start of treatment to Week 52 with GLY, (−6.2 [−7.0 to −5.4]). Lung function in terms of trough FEV1 and FVC improved over time from the start of GLY to Week 52.Conclusion:GLY demonstrated an acceptable long-term safety profile with no new safety concerns in a real-life setting. It demonstrated improvement in lung function and symptom control in Japanese COPD patients.

To investigate the association between recombinant human growth hormone (rhGH) therapy and ocular biometric and refractive characteristics in Korean children with idiopathic short stature (ISS). This cross-sectional study compared ocular parameters between children receiving rhGH therapy for ISS (GH group) and age- and sex-matched healthy controls. Comprehensive ophthalmologic assessments were performed, including axial length (AL), spherical equivalent refraction (SER), peripapillary retinal nerve fiber layer (pRNFL), and ganglion cell-inner plexiform layer (GC-IPL) thickness. The GH group showed significantly more myopic SER than controls (-1.68 ± 1.68 D vs. - 1.15 ± 1.17D, p = 0.048). Although mean AL was slightly longer in the GH group, the difference was not statistically significant (23.65 ± 1.10mm vs. 23.43 ± 0.98mm, p = 0.290). Sectoral pRNFL analysis revealed temporal thickening (p < 0.001) in the GH group. In multivariable analyses within the GH group, longer treatment duration was significantly associated with more myopic SER (P = 0.009). Although treatment duration was also associated with longer AL in the primary model (P = 0.041), this association became attenuated after exclusion of age from the model (P = 0.249). Exploratory analyses additionally demonstrated significant associations between thinner GC-IPL thickness and both more myopic SER (P = 0.010) and longer AL (P = 0.029) in the GH group. RhGH therapy in children with ISS was associated with more myopic refraction and distinct ocular structural characteristics in this cross-sectional analysis. The association between longer rhGH treatment duration and more myopic SER may suggest a possible relationship between prolonged rhGH exposure and refractive status. These findings should be interpreted cautiously, and further longitudinal studies are needed to clarify the long-term relationship between rhGH exposure and ocular growth.

ABSTRACTBackground:Adverse drug reactions (ADRs) are a significant cause of preventable morbidity and mortality. They account for 10–20% of hospital admissions and have a high economic impact on healthcare infrastructure. This study aims to provide information about the pattern, causality, severity, seriousness, and preventability of an ADR reported during the study period.Material and Methods:This was an observational, rétrospective, record-based study to analyze all submitted spontaneous Individual Case Safety Reports (ICSRs) during three years (April 2020–March 2023) at the ADR monitoring center under PvPI. Data obtained from ICSRs were carefully evaluated for quality, based on their essential elements. The ADR outcome was categorized into recovered, recovering, not recovered upon discharge, fatal, and unknown. The information in the ICSRs was used to assess the causality, preventability, severity, and seriousness of the ADRs.Results:Out of 380 Individual Case Safety Reports (ICSRs) from April 2020 to March 2023, 313 fully completed ICSRs were analyzed. The number of adverse drug reactions was higher in males (n = 166; 53%) than in females (n = 145; 47%). The highest number of ADRs was reported in the age group of 31–40 years (n = 72; 23%), followed by 21–30 years (n = 68; 21.72%). Most ADRs (83.38%) had recovered. The severity of ADRs was mostly mild (87.53%), with only 2.55% being serious. 37.6% of ADRs were preventable, and 62.3% were not preventable. Concerning the seriousness of ADRs by PvPI criteria, 97.76% were ‹non-serious›, while only 2.23% were serious.Conclusion:Adverse drug reactions (ADRs) are a global problem and a major concern for patient safety. Monitoring and reporting ADRs is crucial to reduce their incidence and enhance pharmacovigilance. There is a need to increase awareness among patients, clinicians, and staff members about reporting and preventing ADRs.

Concerns have been raised of increased mortality risk in adulthood in certain patients who received growth hormone treatment during childhood. This study evaluated the safety of growth hormone treatment in childhood in everyday practice. NordiNet(®) International Outcome Study (IOS) is a noninterventional, observational study evaluating safety and effectiveness of Norditropin(®) (somatropin; Novo Nordisk A/S, Bagsvaerd, Denmark). Long-term safety data (1998-2013) were collected on 13 834 growth hormone treated pediatric patients with short stature. Incidence rates (IRs) of adverse events (AEs) defined as adverse drug reactions (ADRs), serious ADRs (SADRs), and serious AEs (SAEs) were calculated by mortality risk group (low/intermediate/high). The effect of growth hormone dose on IRs and the occurrence of cerebrovascular AEs were investigated by the risk group. We found that 61.0% of patients were classified as low-risk, 33.9% intermediate-risk, and 5.1% high-risk. Three hundred and two AEs were reported in 261 (1.9%) patients during a mean (s.d.) treatment duration of 3.9 (2.8) years. IRs were significantly higher in the high- vs the low-risk group (high risk vs low risk-ADR: 9.11 vs 3.14; SAE: 13.66 vs 1.85; SADR: 4.97 vs 0.73 events/1000 patient-years of exposure; P < 0.0001 for all). Except for SAEs in the intermediate-risk group (P = 0.0486) in which an inverse relationship was observed, no association between IRs and growth hormone dose was found. No cerebrovascular events were reported. We conclude that safety data from NordiNet(®) IOS do not reveal any new safety signals and confirm a favorable overall safety profile in accordance with other pediatric observational studies. No association between growth hormone dose and the incidence of AEs during growth hormone treatment in childhood was found.

Rituximab, a chimeric human/mouse monoclonal antibody targeting CD-20 antigens, has been used recently for various rheumatological and autoimmune diseases, including autoimmune neurological disorders. We aimed to study the frequency, seriousness, causality, and preventability of adverse drug reactions (ADRs) of rituximab in Iranian patients with autoimmune neurological diseases. In this cross-sectional observational study, patients with autoimmune neurological diseases who had an indication for rituximab treatment were enrolled.Naranjo adverse drug reaction probability scale was used to assess the causality of ADRs, and the preventability of the ADRs was determined by P-Method. The seriousness of ADRs was also determined. A total of 264 ADRs were recorded from 97 patients. The Median (min-max) number of ADRs experienced by patients was 3 (1-7) events. 11.3% of patients experienced serious ADRs. 18.2% and 26.9% of ADRs were Definite and Probable, respectively. Only 5% of the ADRs were ''preventable". The most frequent ADRs were rituximab infusion-related reactions. Rituximab had an acceptable safety profile in our study patients. However, there must be certain cautions regarding the use of the medication for the elderly or patients with a compromised immune system. Timely detection and management of ADRs would also be crucial to prevent severe and permanent damages. Moreover, considering that rituximab is used as an off-label treatment for autoimmune neurological diseases, a risk-benefit assessment would be necessary before deciding on the treatment choice.

Adverse drug reactions (ADRs) are a source of concern in healthcare as they negatively affect patients. Serious adverse drug reactions (SADRs) have an even greater impact on patients and the system in terms of morbidity and financial burden. The establishment of National Pharmacovigilance Centers (NPCs) has enhanced ADR reporting in Africa. The Nigerian Pharmacovigilance Centre has been collecting ADR reports using VigiFlow since 2004. The aim of this study was to identify and analyze SADR reports in the Nigerian VigiFlow database in order to profile the patients with SADRs, the medicines most implicated, system organ classes (SOCs) affected, outcome of such reactions, including fatalities, and ADR reporting trends over the years. We also looked at the data elements provided in the reports as a proxy measure of report quality. We retrospectively assessed all individual case safety reports (ICSRs) received by the NPC in Nigeria and entered into VigiFlow as SADR reports between September 2004 and December 2016. We defined SADR as any untoward reaction to any medicine dose that resulted in death, required in-patient hospitalization or prolongation of existing hospitalization, resulted in congenital anomaly, persistent or significant disability/incapacity or was life-threatening. The suspected SADRs were analyzed at the Medical Dictionary for Regulatory Activities SOC and Preferred Term levels. A total of 11,222 ICSRs were entered into VigiFlow during the study period, of which 298 (3%) were classified as SADR reports. Adults were the most affected (244/282; 87%). The median number of medicines per report was 3 (interquartile range = 2-4.75). Nevirapine (36/336; 11%), as a single entity, was the most reported medicine. Human immunodeficiency virus (HIV) infection affected 128/232 (55%) of those with SADRs. There was no statistically significant association between the number of reactions per report and sex of the patients (p = 0.280), their age groups (p = 0.670), or the number of medicines per report (p = 0.640). Hospitalization was the most frequently cited reason for classifying a report as serious (151/276; 53%) and death was reported in 48 cases (48/283; 17%). Based on the SOC, skin and subcutaneous tissue disorders (139/550; 25%) was the most affected, while anemia (55/550; 10%) was the most reported specific reaction. A substantial number of patients (107/256; 42%) either recovered fully or were recovering from the SADRs. The number of SADR reports received varied by year with no consistent trend. There is under-reporting of ADRs in the Nigerian VigiFlow® database, particularly SADRs and those involving pediatric and geriatric age groups. Given that over half of the SADR reports involved antiretroviral drugs, it is imperative to increase the surveillance of ADRs related to this class of drugs through regular clinical assessment of reports and provision of feedback on the findings to healthcare providers. Direct consumer reporting should also be encouraged as a means of increasing ADR reporting.

ObjectiveThis Italian survey aims to evaluate real-life long-term efficacy and safety of recombinant human growth hormone (rhGH) therapy in children with short stature homeobox-containing gene deficiency disorders (SHOX-D) and to identify potential predictive factors influencing response to rhGH therapy.Design and methodsThis is a national retrospective observational study collecting anamnestic, anthropometric, clinical, instrumental and therapeutic data in children and adolescents with a genetic confirmation of SHOX-D treated on rhGH. Data were collected at the beginning of rhGH therapy (T0), yearly during the first 4 years of rhGH therapy (T1, T2, T3 and T4) and at near-final height (nFH) (T5), when available.ResultsOne hundred and seventeen SHOX-D children started rhGH therapy (initial dose 0.23 ± 0.04 mg/kg/week) at a mean age of 8.67 ± 3.33 years (74% prepubertal), 99 completed the first year of treatment and 46 reached nFH. During rhGH therapy, growth velocity (GV), standard deviation score (SDS) and height (H) SDS improved significantly. Mean H SDS gain from T0 was +1.14 ± 0.58 at T4 and +0.80 ± 0.98 at T5. Both patients carrying mutations involving intragenic SHOX region (group A) and ones with regulatory region defects (group B) experienced a similar beneficial therapeutic effect. The multiple regression analysis identified the age at the start of rhGH treatment (β = −0.31, P = 0.030) and the GV during the first year of rhGH treatment (β = 0.45, P = 0.008) as main independent predictor factors of height gain. During rhGH therapy, no adverse event of concern was reported.ConclusionsOur data confirm the efficacy and safety of rhGH therapy in SHOX-D children, regardless the wide variety of genotype.Significance StatementAmong children with idiopathic short stature, the prevalence of SHOX-D is near to 1/1000–2000 (1.1–15%) with a wide phenotypic spectrum. Current guidelines support rhGH therapy in SHOX-D children, but long-term data are still few. Our real-life data confirm the efficacy and safety of rhGH therapy in SHOX-D children, regardless of the wide variety of genotypes. Moreover, rhGH therapy seems to blunt the SHOX-D phenotype. The response to rhGH in the first year of treatment and the age when rhGH was started significantly impact the height gain.

To analyze the real-world characteristics and patterns of adverse drug reactions (ADRs) associated with tislelizumab, providing valuable insights for clinical practice. We conducted a comprehensive analysis of tislelizumab-related ADR reports within the pharmacovigilance system of Guangxi, China, spanning from 01/04/2021-31/08/2024. Our analysis focused on population characteristics, temporal distribution of ADR occurrences, system organ classes (SOCs) of serious adverse drug reactions (SADRs), profiles of major SOCs, and factors influencing SADRs and blood and lymphatic system disorders (BLSDs). This study analyzed 507 tislelizumab ADR reports (698 events), including 282 SADRs (356 events), with no deaths reported. Pharmacists were the primary reporters (60.55% of reports). Most patients were aged 46-75 years (77.32%), male (72.58%), and of Han ethnicity (75.54%), and 1.78% (9/507) were of Zhuang ethnicity. A total of 86.19% of ADRs occurred within 30 days of medication. Among the SADRs, there were 83 PTs and 17 SOCs, with the most common SOCs being blood and lymphatic system disorders (15.47%, 108/698), investigations (14.90%, 104/698), hepatobiliary disorders (4.15%, 29/698), and skin and subcutaneous tissue disorders (3.15%, 22/698). Logistic regression analysis showed that chemotherapy was a significant risk factor for SADRs (OR = 4.634, 95%CI: 2.871-7.917, P < 0.001). The risk of BLSDs - related ADRs was 5.545 times higher in the chemotherapy-incorporating group than in the monotherapy group (95%CI: 3.423-8.701, P < 0.001). Close monitoring, particularly in patients receiving chemotherapy-incorporating regimens, is crucial during the first 30 days post-tislelizumab treatment to manage SADR risks. Proactive measures should be implemented if SADR occur.

Moxifloxacin, a fluoroquinolone antibiotic, is used for the treatment of respiratory tract, pelvic inflammatory disease, skin, and intra-abdominal infections. Its safety profile is considered favorable in most reviews but has been challenged with respect to rare but potentially fatal toxicities (e.g. hepatic, cardiac, or skin reactions). To analyze and compare the safety profile of moxifloxacin versus comparators in the entire clinical database of the manufacturer. Data on the valid-for-safety population from phase II–IV actively controlled studies (performed between 1996 and 2010) were analyzed. Studies were either double blind (n = 22 369) or open label (n = 7635) and included patients with indications that have been approved in at least one country [acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia, uncomplicated pelvic inflammatory disease, complicated and uncomplicated skin and skin structure infections, and complicated intra-abdominal infections] (n = 27 824) and patients with other indications (n = 2180), using the recommended daily dose (400 mg) and route of administration (oral, intravenous/oral, intravenous only). The analysis included patients at risk (age ≥65 years, diabetes mellitus, renal impairment, hepatic impairment, cardiac disorders, or body mass index <18 kg/m2). Patients with known contraindications were excluded from enrollment by study protocol design, but any patient having entered a study, even if inappropriately, was included in the analysis. Crude incidences and relative risk estimates (Mantel-Haenszel analysis) of patients with any adverse event (AE), adverse drug reaction (ADR), serious AE (SAE), serious ADR (SADR), treatment discontinuation due to an AE or ADR, and fatal outcomes related to an AE or ADR. Overall incidence rates of AEs were globally similar in the moxifloxacin and comparator groups. By filtering the data for differences in disfavor of moxifloxacin (i) at ≥2.5% for events with an incidence ≥2.5% or at ≥2-fold for events with an incidence <2.5% in one or both groups and (ii) affecting ≥10 patients in either group, we observed slightly more (i) AEs in double-blind intravenous-only and open-label oral studies, (ii) SAEs in double-blind intravenous-only studies, (iii) ADRs and SADRs in open-label oral studies, (iv) SADRs in open-label intravenous/oral studies, and (v) premature discontinuation due to AEs in open-label intravenous-only studies. The actual numbers of SADRs (in all studies) were small, with clinically relevant differences noted only in intravenous/oral studies and mainly driven by 'gastrointestinal disorders' (15 versus 7 patients) and 'changes observed during investigations' (23 versus 7 patients [asymptomatic QT prolongation: 11 versus 4 patients in double-blind studies]). Analysis by comparator (including another fluoroquinolone) did not reveal medically relevant differences, even in patients at risk. Incidence rates of hepatic disorders, tendon disorders, clinical surrogates of QT prolongation, serious cutaneous reactions, and Clostridium difficile-associated diarrhea were similar with moxifloxacin and comparators. The safety of moxifloxacin is essentially comparable to that of standard therapies for patients receiving the currently registered dosage and for whom contraindications and precautions of use (as in the product label) are taken into account.

ABSTRACTObjectives: Bazedoxifene was found to be effective and well tolerated for the treatment and prevention of osteoporosis in postmenopausal women. This post-marketing surveillance study (PMSS) examined the safety of bazedoxifene in postmenopausal Korean women with osteoporosis, in a real-world setting.Methods: This PMSS was conducted from 2013 to 2017. A total of 3,423 subjects from 68 centers were enrolled and monitored for about 3 months (± 2 weeks). Bazedoxifene was prescribed at a dose of 20 mg/day. The safety of bazedoxifene was evaluated based on the number and nature of adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs) and serious ADRs (SADRs) in routine medical practice.Results: The mean age of study subjects was 69.51 years. The incidence of AEs and ADRs was 6.11% and 3.86%, respectively, and significantly decreased with increasing age (p= 0.0007). AE and ADR rates with bazedoxifene treatment of 3 months or more were significantly lower than those of less than 3 months (AE, 3.64% vs 30.00%, p < 0.0001; ADR, 1.74% vs 24.38%, p < 0.0001).Conclusion: In this study, bazedoxifene was well tolerated in the management of postmenopausal osteoporosis in Korean women, including those aged 70 years or more.

BackgroundMoxifloxacin, a fluoroquinolone antibiotic, is used for the treatment of respiratory tract, pelvic inflammatory disease, skin, and intra-abdominal infections. Its safety profile is considered favorable in most reviews but has been challenged with respect to rare but potentially fatal toxicities (e.g. hepatic, cardiac, or skin reactions).ObjectiveTo analyze and compare the safety profile of moxifloxacin versus comparators in the entire clinical database of the manufacturer.SettingData on the valid-for-safety population from phase II–IV actively controlled studies (performed between 1996 and 2010) were analyzed. Studies were either double blind (n = 22 369) or open label (n = 7635) and included patients with indications that have been approved in at least one country [acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia, uncomplicated pelvic inflammatory disease, complicated and uncomplicated skin and skin structure infections, and complicated intra-abdominal infections] (n = 27 824) and patients with other indications (n = 2180), using the recommended daily dose (400 mg) and route of administration (oral, intravenous/oral, intravenous only). The analysis included patients at risk (age ≥65 years, diabetes mellitus, renal impairment, hepatic impairment, cardiac disorders, or body mass index <18 kg/m2). Patients with known contraindications were excluded from enrollment by study protocol design, but any patient having entered a study, even if inappropriately, was included in the analysis.Main Outcome MeasureCrude incidences and relative risk estimates (Mantel-Haenszel analysis) of patients with any adverse event (AE), adverse drug reaction (ADR), serious AE (SAE), serious ADR (SADR), treatment discontinuation due to an AE or ADR, and fatal outcomes related to an AE or ADR.ResultsOverall incidence rates of AEs were globally similar in the moxifloxacin and comparator groups. By filtering the data for differences in disfavor of moxifloxacin (i) at ≥2.5% for events with an incidence ≥2.5% or at ≥2-fold for events with an incidence <2.5% in one or both groups and (ii) affecting ≥10 patients in either group, we observed slightly more (i) AEs in double-blind intravenous-only and open-label oral studies, (ii) SAEs in double-blind intravenous-only studies, (iii) ADRs and SADRs in open-label oral studies, (iv) SADRs in open-label intravenous/oral studies, and (v) premature discontinuation due to AEs in open-label intravenous-only studies. The actual numbers of SADRs (in all studies) were small, with clinically relevant differences noted only in intravenous/oral studies and mainly driven by ‘gastrointestinal disorders’ (15 versus 7 patients) and ‘changes observed during investigations’ (23 versus 7 patients [asymptomatic QT prolongation: 11 versus 4 patients in double-blind studies]). Analysis by comparator (including another fluoroquinolone) did not reveal medically relevant differences, even in patients at risk. Incidence rates of hepatic disorders, tendon disorders, clinical surrogates of QT prolongation, serious cutaneous reactions, and Clostridium difficile-associated diarrhea were similar with moxifloxacin and comparators.ConclusionThe safety of moxifloxacin is essentially comparable to that of standard therapies for patients receiving the currently registered dosage and for whom contraindications and precautions of use (as in the product label) are taken into account.

IntroductionSafety data can be collected through prospective and retrospective methods during post-marketing surveillance (PMS). This study aimed to compare prospective and retrospective methods in terms of examining safety data from PMS of tigecycline.MethodsThis PMS study was an open-label, noncomparative, observational, noninterventional and multicenter study of patients who received tigecycline for infections. From July 2007 to April 2015, 3172 patients were included in this study, of which 738 were enrolled prospectively and 2434 retrospectively. To reduce selection bias, demographic and baseline characteristics were adjusted using 1:2 propensity score matching.ResultsAfter propensity score matching, data from 1446 patients were analyzed. The incidences of adverse events (AEs) and serious AEs (SAEs) were determined to be significantly higher in the prospective method compared with those of the retrospective method (P < 0.001 and P = 0.004, respectively). However, no significant differences in the incidences of adverse drug reactions (ADRs) and serious ADRs (SADRs) were detected between the two groups (P = 0.09 and P = 0.33, respectively). In a subgroup analysis of 360 patients from 14 hospitals involved in both prospective and retrospective methods, the incidence of AEs was found to be significantly higher using the prospective method compared with when the retrospective method was used (P < 0.001), but there were no significant differences in ADRs (P = 0.14), SAEs (P = 0.24) and SADRs.ConclusionIn general, the prospective method can detect safety data effectively in a PMS study, whereas retrospective data collection may be an alternative option in collecting ADR data when a prospective PMS study is not deemed feasible.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40121-021-00398-7.