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Abbreviation : SAEs
Long Form : serious AEs
No. Year Title Co-occurring Abbreviation
2020 151 Confirmed Safety of Deutet.rabenazine for Tardive Dyskinesia in a 3-Year Open-Label Extension Study. AEs, AIMS, TD
2020 A study to evaluate the immunogenicity and shedding of live attenuated influenza vaccine strains in children 24-<48months of age. AEs, HAI
2020 Adverse Events and Discontinuation Rates Associated with Sirolimus Treatment in Adult Renal Transplant Patients in Latin America vs Non-Latin American Countries. EU/ROW, LATAM, NA, TEAEs
2020 Effectiveness and safety of ranibizumab 0.5 mg in treatment-naive patients with diabetic macular edema: Results from the real-world global LUMINOUS study. AEs, DME, VA
2020 Efficacy, immunogenicity and safety of a trivalent live human-lamb reassortant rotavirus vaccine (LLR3) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial. AEs, GMT, RVGE, sRVGE, VE
2020 Everolimus plus exemestane in hormone-receptor-positive, HER2-negative locally advanced or metastatic breast cancer: incidence and time course of adverse events in the phase IIIb BALLET population. AEs, HR, NIP
2020 Initiation of sacubitril/valsartan shortly after hospitalisation for acutely decompensated heart failure in patients with newly diagnosed (de novo) heart failure: a subgroup analysis of the TRANSITION study. ADHF, AEs, HF
2020 Long-Term Safety of Adalimumab in 29,967 Adult Patients From Global Clinical Trials Across Multiple Indications: An Updated Analysis. AEs, CD, HS, Ps, RA, UC, UV
2020 Results from a large post-marketing safety surveillance study in the Republic of Korea with a quadrivalent meningococcal CRM-conjugate vaccine in individuals aged 2 months-55 years. AEs, MAAEs
10  2020 Safety and Cumulative Incidence of Major Cardiovascular Events with Ticagrelor in Taiwanese Patients with Non-ST-Segment Elevation Myocardial Infarction: A 12-Month, Prospective, Phase IV, Multicenter, Single-Arm Study. AEs, CI, CV, KM, NSTEMI
11  2020 Safety and Efficacy of Tumor Necrosis Factor Antagonists in Older Patients With Ulcerative Colitis: Patient-Level Pooled Analysis of Data From Randomized Trials. AEs, TNF, UC
12  2020 Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non-Small-Cell Lung Cancer. ABCP, ACP, AEs, BCP, NSCLC, PROs
13  2020 Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. DCAEs, ECG, TEAEs
14  2020 Safety in moderate-to-severe plaque psoriasis patients with latent tuberculosis treated with guselkumab and anti-tuberculosis treatments concomitantly: results from pooled phase 3 VOYAGE 1 & VOYAGE 2 trials. AEs, AST, IL, LTBI, TB, TNF
15  2020 Safety of Ixekizumab Treatment for up to 5 Years in Adult Patients with Moderate-to-Severe Psoriasis: Results from Greater Than 17,000 Patient-Years of Exposure. IRs, MACE, PY, TEAEs
16  2020 Single-Use Versus Reusable Digital Flexible Ureteroscopes for the Treatment of Renal Calculi: A Prospective Multicenter Randomized Controlled Trial. AEs, CI, F-URS, SFR
17  2020 The Effect of Baseline Rescue Medication Use on Efficacy and Safety of Nebulized Glycopyrrolate Treatment in Patients with COPD from the GOLDEN 3 and 4 Studies. AEs, COPD, EXACT-RS, FEV1, GLY, SGRQ
18  2019 A 6-year Prospective, Observational, Multi-Center Post-Marketing Surveillance of the Safety of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccine in Korea. AEs, Tdap
19  2019 A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan. AEs, BTP, FBSF, PP
20  2019 Acute kidney injury and adverse renal events in patients receiving SGLT2-inhibitors: A systematic review and meta-analysis. AEs, AKI, CI, OR, SGLT2is
21  2019 Adverse Events and Nocebo Effects in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. AE, CD, CI, IBD, RCTs, RD, UC
22  2019 Comparison of the immunogenicity and safety of 3 inactivated hepatitis A vaccines in Korean children aged 12 to 18 months: An open-label, randomized, prospective, multicenter study. AEs, CIs, GMCs, HA, HAV, Ig
23  2019 Effect of smoking status on lung function, patient-reported outcomes, and safety among COPD patients treated with glycopyrrolate inhalation powder: pooled analysis of GEM1 and GEM2 studies. AEs, CAT, FEV1, ICS, PROs, SGRQ, TDI
24  2019 Effectiveness on high-grade cervical abnormalities and long-term safety of the quadrivalent human papillomavirus vaccine in Japanese women. AEs, CIN, EGLs, qHPV
25  2019 Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course in healthy Korean infants: phase III, randomized study. AEs, FHA, PRN, PT
26  2019 Long-term safety and effectiveness of tocilizumab in patients with rheumatoid arthritis and inadequate responses to csDMARDs and/or TNF inhibitors: an open-label study close to clinical practice. ACR, AEs, csDMARDs, DAS28, LTE, PROs, PY, RA, TCZ
27  2019 MF59-adjuvanted seasonal trivalent inactivated influenza vaccine: Safety and immunogenicity in young children at risk of influenza complications. AEs, GMTs
28  2019 Nocebo response in Parkinson's disease: A systematic review and meta-analysis. AEs
29  2019 Novel Tretinoin 0.05% Lotion for Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris in a Hispanic Population acne, AEs, EGSS
30  2019 Novel Tretinoin 0.05% Lotion for the Once-daily Treatment of Moderate-to-Severe Acne Vulgaris in an Adult and Adolescent Female Population acne, AEs, EGSS
31  2019 Novel Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris in an Asian Population AEs, EGSS, QOL
32  2019 Persistence and 4-year boosting of the bactericidal response elicited by two- and three-dose schedules of MenB-FHbp: A phase 3 extension study in adolescents. AEs, FHbps, LLOQ, MAEs, mITT, NDCMCs
33  2019 Phase 2, randomized, open-label study on catheter-directed thrombolysis with plasmin versus rtPA and placebo in acute peripheral arterial occlusion. aPAO, BOC, CDT, rt-PA, TEAEs
34  2019 Phase I, Open-Label, Dose-Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2879552 in Relapsed/Refractory SCLC. AEs, PD, PK
35  2019 Post-marketing surveillance to assess the safety and tolerability of a combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP-IPV) in Korean children. ADRs, AEs, DTaP-IPV, PMS
36  2019 Putting in harm to cure: Drug related adverse events do not affect outcome of patients receiving treatment for multidrug-resistant Tuberculosis. Experience from a tertiary hospital in Italy. AEs, MDR-TB
37  2019 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Clinical Effect of Danirixin in Adults With Acute, Uncomplicated Influenza. AEs, DNX, OSV
38  2019 Real-World Safety And Effectiveness Of OnabotulinumtoxinA Treatment Of Crow's Feet Lines And Glabellar Lines: Results Of A Korean Postmarketing Surveillance Study. AEs, CFL, GL
39  2019 Safety and immunogenicity of VAQTA in children 12-to-23 months of age with and without administration of other US pediatric vaccines. AE
40  2019 Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease. AE, G/P, HCV, PK, SVR12
41  2019 Safety and tolerability of linaclotide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: pooled Phase 3 analysis. AE, CIC, IBS-C, LTS, RCTs, TEAEs
42  2019 Safety of a quadrivalent human papillomavirus vaccine in a Phase 3, randomized, double-blind, placebo-controlled clinical trial among Chinese women during 90 months of follow-up. AEs, qHPV, VRCs
43  2019 Safety of bazedoxifene in Korean women with post-menopausal osteoporosis: a post-marketing surveillance study (PMSS). ADRs, AEs, PMSS, SADRs
44  2019 Safety of guselkumab in patients with moderate-to-severe psoriasis treated through 100 weeks: a pooled analysis from the randomized VOYAGE 1 and VOYAGE 2 studies. AEs, MACEs, NMSCs, PYs, SIs
45  2019 Safety of tiotropium in patients with asthma. AE, ICS, LAMAs
46  2019 Safety of two doses of an inactivated hepatitis a vaccine given 6 months apart in healthy toddlers, children, and adolescents aged 12 months to 15 years in China: a phase IV study. AEs, HAV
47  2019 Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials. AEs, pIMDs, RZV
48  2019 The effectiveness and safety of full-dose versus half-dose corticosteroid plus renin-angiotensin system blockers for IgA nephropathy. AEs, CS, eGFR, full CS, IgAN, RASB, UP
49  2019 Tiotropium add-on therapy is safe andreduces seasonal worsening in paediatricasthma patients. AEs
50  2019 Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis: Final Results from a Set of Multi-National Non-Interventional Studies. AEs, PY, TCZ
51  2019 Tumor treating fields in combination with gemcitabine or gemcitabine plus nab-paclitaxel in pancreatic cancer: Results of the PANOVA phase 2 study. AEs, OS, PDAC, PFS, TTFields
52  2018 A Multi-Center, Open-Label, Prospective Study of Cannula Injection of Small-Particle Hyaluronic Acid Plus Lidocaine (SPHAL) for Lip Augmentation. AEs, GAIS, HA, IREs, MLFS, SPHAL, SPHAL, TEAEs
53  2018 A Safety and Immunogenicity Study of a Single Dose of a Meningococcal (Groups A, C, W, and Y) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MEN-ACWY-D) in Healthy Japanese Participants. AEs
54  2018 Association of homogeneous inflamed gene signature with a better outcome in patients with metastatic melanoma treated with MAGE-A3 immunotherapeutic. AEs, GS, PFS, TTF
55  2018 Comparison of Serious Adverse Event Profiles Among Antirheumatic Agents Using Japanese Adverse Drug Event Report Database. AEs, IL-6-Is, JADER, MTX, TNF-Is
56  2018 Dapagliflozin in patients with type 2 diabetes mellitus: A pooled analysis of safety data from phase IIb/III clinical trials. AEs, DKA, T2DM, UTIs
57  2018 Immunogenicity and safety of the quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine (MenACWY-TT) in splenectomized or hyposplenic children and adolescents: Results of a phase III, open, non-randomized study. AEs, MenACWY-TT, MenACWY-TT, NOCIs, VRRs
58  2018 Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience. AEs, T2DM, TEAEs
59  2018 Long-term safety and survival with gefitinib in select patients with advanced non-small cell lung cancer: Results from the US IRESSA Clinical Access Program (ICAP). AEs, EGFR, ICAP, NSCLC
60  2018 Multicenter experience from the UK and Ireland of use of lumen-apposing metal stent for transluminal drainage of pancreatic fluid collections. AEs, LAMS, WON
61  2018 Oxcarbazepine oral suspension in young pediatric patients with partial seizures and/or generalized tonic-clonic seizures in routine clinical practice in China: a prospective observational study. AEs, GTCS, OXC, PS
62  2018 Palivizumab Prophylaxis Against Respiratory Syncytial Virus Infection in Children with Immunocompromised Conditions or Down Syndrome: A Multicenter, Post-Marketing Surveillance in Japan. ADRs, AEs, LRI, RSV, SADRs
63  2018 Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza Vaccines FLUAD and VANTAFLU in South Korean Subjects Aged ≥65 Years. AEs
64  2018 Psychiatric and cognitive adverse events: A pooled analysis of three phase III trials of adjunctive eslicarbazepine acetate for partial-onset seizures. AEs, C-CASA, C-SSRS, ESL, POS, TEAEs
65  2018 Safety Experience During Real-World Use of Injectable Artesunate in Public Health Facilities in Ghana and Uganda: Outcomes of a Modified Cohort Event Monitoring Study (CEMISA). AEs, CI, Inj AS, IQR, UMC, WHO
66  2018 Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials. AEs, CI, COPD, MACE, RR
67  2018 Single-dose intravenous diclofenac for acute postoperative pain in adults. AEs, CI, NNTB, NNTp, NSAIDs
68  2018 Successful administration of BI 695501, an adalimumab biosimilar, using an autoinjector (AI): results from a Phase II open-label clinical study (VOLTAIRE-RL). AAP, AEs, AI, PFS, RA
69  2018 Systematic review of the real-world evidence of adalimumab safety in psoriasis registries. AEs, NMSC, PY
70  2018 Tolerability of adjunctive eslicarbazepine acetate according to concomitant lamotrigine or carbamazepine use: A subgroup analysis of three phase III trials in adults with focal (partial-onset) seizures. AEDs, CBZ, ESL, LTG, partial-onset, PHT, TEAEs
71  2018 Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis. AEs, PMS, RA, RRs
72  2017 A 5-year randomized trial on the safety and efficacy of pimecrolimus in atopic dermatitis: a critical appraisal. AD, AEs, IGA, TCS
73  2017 A Phase 2a Randomized Study to Evaluate the Safety and Immunogenicity of the 1790GAHB Generalized Modules for Membrane Antigen Vaccine against Shigella sonnei Administered Intramuscularly to Adults from a Shigellosis-Endemic Country. AEs, GMC, GMMA, IgG, LPS, OAg
74  2017 A randomised double-blind, placebo-controlled, long-term extension study of the efficacy, safety and tolerability of fixed-dose combinations of aclidinium/formoterol or monotherapy in the treatment of chronic obstructive pulmonary disease. AB/FF, AEs, COPD, MACE
75  2017 A randomized lot-to-lot immunogenicity consistency study of the candidate zoster vaccine HZ/su. AEs, gE, HZ, pIMDs, VZV
76  2017 Adjunctive eslicarbazepine acetate: A pooled analysis of three phase III trials. AEDs, ESL, POS, SSF, TEAEs
77  2017 Biological Response Modifiers in Rheumatoid Arthritis: Systematic Review and Meta-analysis of Safety. AE, NNH, RA, RR, RR
78  2017 Celecoxib for osteoarthritis. CENTRAL, NSAID, OA, RCTs, tNSAID, VAS, WOMAC
79  2017 Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial. AEs, RVGE, VE
80  2017 Efficacy and safety of micafungin for the treatment of patients with proven or probable invasive aspergillosis: A non-comparative, multicenter, phase IV, open-label study. ADRs, CI, IA, TEAEs
81  2017 Efficacy and safety of tadalafil 5 mg once daily in the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia in men aged ≥75 years: integrated analyses of pooled data from multinational, randomized, placebo-controlled clinical studies. AEs, ED, IPSS, LUTS/BPH, TEAEs
82  2017 Efficacy of erlotinib as first-line maintenance therapy in patients with locally advanced or metastatic nonsmall cell lung cancer who have not experienced disease progression or unacceptable toxicity during chemotherapy. AEs, NSCLC, ORR, OS, PFS, PFSR
83  2017 House dust mite sublingual tablet is effective and safe in patients with allergic rhinitis. AASS, AEs, AR, HDM, IR, JRQLQ
84  2017 Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial. AEs
85  2017 Immunogenicity, safety and reactogenicity of the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in 2-17-year-old children with asplenia or splenic dysfunction: A phase 3 study. AEs, OPA
86  2017 Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials. AEs, ILD
87  2017 Long-Term Maintenance of Certolizumab Pegol Safety and Efficacy, in Combination with Methotrexate and as Monotherapy, in Rheumatoid Arthritis Patients. AEs, CZP, ER, MTX, OLE, PYs, RA, RCTs
88  2017 Long-term safety of icatibant treatment of patients with angioedema in real-world clinical practice. AEs, IOS
89  2017 Lot-to-lot consistency, safety and immunogenicity of 3 lots of Haemophilus influenzae type b conjugate vaccine: results from a phase III randomized, multicenter study in infants. AEs, Hib
90  2017 Post-licensure, phase IV, safety study of a live attenuated Japanese encephalitis recombinant vaccine in children in Thailand. AEs
91  2017 Rheumatoid arthritis triple therapy compared with etanercept: difference in infectious and gastrointestinal adverse events. AEs, GI, IRRs, NAEs
92  2017 Safety and tolerability of cariprazine in the long-term treatment of schizophrenia: results from a 48-week, single-arm, open-label extension study. AEs, CGI-S, PANSS
93  2017 Safety and tolerability of fingolimod in patients with relapsing-remitting multiple sclerosis: results of an open-label clinical trial in Italy. AEs, RRMS
94  2017 SAFETY AND TOLERABILITY OF VANDETANIB IN JAPANESE PATIENTS WITH MEDULLARY THYROID CANCER: A PHASE I/II OPEN-LABEL STUDY. AE, MTC, ORR, PFS, PK
95  2017 Similar efficacy and tolerability of raltegravir-based antiretroviral therapy in HIV-infected patients, irrespective of age group, burden of comorbidities and concomitant medication: Real-life analysis of the German 'WIP' cohort. AEs, ART, BL, HIV, RAL
96  2017 Six-Month Safety Data of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein Vaccine in a Phase 3 Double-Blind, Placebo-Controlled Randomized Study in Healthy Adults. AEs, PFU
97  2017 Six-year multi-centre, observational, post-marketing surveillance of the safety of the HPV-16/18 AS04-adjuvanted vaccine in women aged 10-25years in Korea. ADRs, AEs, CI
98  2017 The adverse event profile of brivaracetam: A meta-analysis of randomized controlled trials. AEs, BRV, PAEs, RCTs
99  2017 Transaminase Levels and Hepatic Events During Tocilizumab Treatment: Pooled Analysis of Long-Term Clinical Trial Safety Data in Rheumatoid Arthritis. AEs, AST, DMARDs, ULN
100  2016 A phase 1/2 study of intrathecal heparan-N-sulfatase in patients with mucopolysaccharidosis IIIA. AEs, CSF, IDDD, rhHNS