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■ Abbreviation / Long Form : SAEs / serious adverse events

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Abbreviation:   SAEs  (>> Co-occurring Abbreviation)
Long Form:   serious adverse events
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No. Year Title Co-occurring Abbreviation
2020 A 5-year Retrospective Analysis of Drug Survival, Safety, and Effectiveness of the Infliximab Biosimilar CT-P13 in Patients with Rheumatoid Arthritis and Ankylosing Spondylitis. AS, RA, TEAEs
2020 A case study of 10 patients administered HBOC-201 in high doses over a prolonged period: outcomes during severe anemia when transfusion is not an option. EA, Hb, HBOCs, IND
2020 A Comparison of the ARMEO to Tabletop Assisted Therapy Exercises as Supplemental Interventions in Acute Stroke Rehabilitation: A Randomized Single Blinded Study. ARMEO, FIM, FMA, IRF, MAS, ROM, RPE, TAT, ULE
2020 A Phase 1, Randomised, Placebo-Controlled, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Cannabidiol in Fed Healthy Volunteers. AUC, CBD, TEAEs, Tmax
2020 A phase I study of toripalimab, an anti-PD-1 antibody, in patients with refractory malignant solid tumors. PD-L1, TRAEs
2020 A Phase I, Randomized, Single‑Blind, Placebo‑Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist, in Healthy Subjects. DOR, ECG, EEG, s.c
2020 A Randomized Double-Blind Placebo-Controlled First-In-Human Phase 1 Trial of TransCon PTH in Healthy Adults. BSAP, FECa, HP, PD, PK, S-P, sCa, TMP/GFR
2020 A randomized Phase I/II study to evaluate safety and reactogenicity of a heat-stable rotavirus vaccine in healthy adults followed by evaluation of the safety, reactogenicity, and immunogenicity in infants. AEs, HSRV, ICDDR,B, solicited AEs
2020 A Systematic Literature Review and Bucher Indirect Comparison: Tildrakizumab versus Guselkumab. IL-23, PASI
10  2020 A systematic literature review of the recombinant subunit herpes zoster vaccine use in immunocompromised 18-49year old patients. HZ, PRISMA-P, RZV
11  2020 Adjunctive sertraline for asymptomatic cryptococcal antigenemia: A randomized clinical trial. CrAg
12  2020 Alpha Stent for Coiling of Unruptured, Wide-Necked, Distal Internal Carotid Artery Aneurysms: Safety and Effectiveness at 6 Months. ICA
13  2020 Antidepressants for smoking cessation. AEs, CENTRAL, CIs, MAOIs, NRT, RCTs, RR, SSRIs
14  2020 Are the Outcomes of Minimally Invasive Transforaminal/Posterior Lumbar Fusion Influenced by the Patient's Age or BMI? AEs, BMI, MILIF
15  2020 Assessing the risk-benefit profile of ramucirumab in patients with advanced solid tumors: A meta-analysis of randomized controlled trials. CIs, FAEs, HR, MCBS, OS, PFS, QOL, RCTs, RR
16  2020 Assessing the Short-Term Efficacy and Safety of Guselkumab for Moderate-to-Severe Plaque Psoriasis: Meta-Analysis of Randomized Controlled Trials. AEs, CI, ORs, RCTs
17  2020 Baseline characteristics predicting clinical outcomes and serious adverse events in middle-aged hypertensive women: a subanalysis of the SPRINT in women aged <65 years CKD, HR, MI
18  2020 BENEFIT: real-world effectiveness of SB4 after transition from reference etanercept in rheumatoid arthritis and axial spondyloarthritis. axSpA, BASDAI, CI, DAS28, RA
19  2020 Beyond 10 years of levodopa intestinal infusion experience: Analysis of mortality and its predictors. PD
20  2020 Biologics for chronic rhinosinusitis. CI, CT, HRQL, MD, RCTs, RR, VAS
21  2020 Cerebrolysin for acute ischaemic stroke. CI, RCTs, RR
22  2020 Comparative efficacy and safety of 100mg and 200 mg filgotinib administered to patients with active rheumatoid arthritis: A Bayesian network meta-analysis of randomized controlled trials
. CrI, MTX, OR, RA, RCTs, SUCRA
23  2020 Comparative efficacy and safety of 15 and 30 mg upadacitinib administered to patients with active rheumatoid arthritis: aBayesian network meta-analysis of randomized controlled trials. RA, RCTs, SUCRA
24  2020 Comparative efficacy and safety of secukinumab and ixekizumab in patients with active ankylosing spondylitis. AS, ASAS20, CrI, OR, SUCRA
25  2020 Cost-effectiveness analysis of treatment sequences containing tofacitinib for the treatment of rheumatoid arthritis in Spain. HAQ, LTE, MTX, QALY, RA
26  2020 Does Carboplatin Rapid Desensitization Change Its Adverse Drug Reactions Other than Hypersensitivity and Efficacy in Patients With Ovarian Cancer? ADRs, OS, TTP
27  2020 Does N-Terminal Pro-B-Type Natriuretic Peptide Improve the Risk Stratification of Emergency Department Patients With Syncope? CSRS, ED, NT-proBNP
28  2020 Dual HER2 Blockade in Neoadjuvant Treatment of HER2+ Breast Cancer: A Meta-Analysis and Review. CI, HER2, pCR, RCTs, RR
29  2020 Early Safety Indicators of COVID-19 Convalescent Plasma in 5,000 Patients. TACO, TRALI
30  2020 Early safety indicators of COVID-19 convalescent plasma in 5000 patients. COVID-19
31  2020 Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. AE, PK, V/F
32  2020 Effect of Aspiration Therapy on Obesity-Related Comorbidities: Systematic Review and Meta-Analysis. AT, EWL, HbA1c, MD, TWL
33  2020 Effect of Maternal Docosahexaenoic Acid (DHA) Supplementation on Offspring Neurodevelopment at 12 Months in India: A Randomized Controlled Trial. DASII, DHA, DQ
34  2020 Effect on efficacy and safety trial outcomes of also enrolling patients on ongoing glucocorticoid therapy in rheumatoid arthritis clinical trials of tocilizumab or adalimumab or methotrexate monotherapy. ADA, GCs, MTX, RA, TCZ
35  2020 Effectiveness and safety of opicapone in Parkinson's disease patients with motor fluctuations: the OPTIPARK open-label study. CGIC, NMSS, PGIC, TEAEs, UPDRS
36  2020 Effectiveness and safety of opicapone in Parkinson's disease patients with motor fluctuations: the OPTIPARK open-label study. CGIC, NMSS, PGIC, TEAEs, UPDRS
37  2020 Effects of the Proteasome Inhibitor Bortezomib in Combination with Chemotherapy for the Treatment of Mantle Cell Lymphoma: A Meta-analysis CI, HR, MCL, ORR, OS, PFS
38  2020 Efficacy and Safety of Bevacizumab Combined With First-Line Chemotherapy in Elderly (≥75 Years) Patients With Metastatic Colorectal Cancer: A Real-World Study. CI, CRC, mCRC, OS, PFS
39  2020 Efficacy and safety of biological agents in patients with giant cell arteritis: A meta-analysis of randomized trials. CI, GCA, OR, RCTs, TNF
40  2020 Efficacy and safety of FOLFIRINOX as salvage treatment in advanced biliary tract cancer: an open-label, single arm, phase 2 trial. BTC, GemCis, OS, PFS
41  2020 Efficacy and safety of pulsed radiofrequency as a method of dorsal root ganglia stimulation for treatment of non-neuropathic pain: a systematic review. DRG, LBP, PRF, ROBINS-I
42  2020 Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials. HZ, pIMDs, RZV
43  2020 Efficacy, Safety, and Tolerability of Treatments for Systemic Sclerosis-Related Interstitial Lung Disease: A Systematic Review and Network Meta-Analysis. DLCO, FVC, NMA, SMD, SSc-ILD
44  2020 Evaluation of Serious Adverse Event Reporting Forms for Clinical Trials: A Comparative Korean Study. IRBs, RECs
45  2020 Factors associated with severity of adverse events following yellow fever vaccination during the biggest outbreak of the disease recorded in Brazil, 2016-2017. NSAE, OR, SI-PNI
46  2020 First-in-Human Randomized Study to Assess the Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus (RSV) Vaccine Based on Chimpanzee-Adenovirus-155 Viral Vector-Expressing RSV Fusion, Nucleocapsid, and Antitermination Viral Proteins in Healthy Adults. Ig, PBMCs, RSV
47  2020 Fourteen small molecule and biological agents for psoriatic arthritis: A network meta-analysis of randomized controlled trials. CIs, ETN, GOL, IFX, NMA, ORs, PASI75, PsA, SUCRA
48  2020 Frequency and Clinical Impact of Serious Adverse Events on Post-Stroke Recovery with NeuroAiD (MLC601) versus Placebo: The CHInese Medicine Neuroaid Efficacy on Stroke Recovery Study. CHIMES
49  2020 Fully covered self-expanding metal stents for benign biliary stricture after orthotopic liver transplant: 5-year outcomes. BBS, CDM, CI, FCSEMSs, OLT
50  2020 GLP-1 receptor agonists for Parkinson's disease. CENTRAL, CI, GLP-1, HRQoL, MCID, MD, MDS-UPDRS, PD, PDQ, RCTs, RR, SI, VAS
51  2020 Hemodynamic effects of Vernakalant in cardio-surgical ICU-patients treated for recent-onset postoperative atrial fibrillation. POAF, SR
52  2020 HITM-SURE: Hepatic immunotherapy for metastases phase Ib anti-CEA CAR-T study utilizing pressure enabled drug delivery. CAR-T, CEA, HAI, PEDD
53  2020 Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors in Patients with Renal Anemia: A Meta-Analysis of Randomized Trials. AEs, CKD, Hb, HIF-PHIs, RCTs, RR, WMD
54  2020 Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: a randomized, double-blind, controlled phase III clinical trial in children aged 6-35 months in China. GMT, HI, QIVs, TIVs
55  2020 Immunogenicity and safety of concurrent or sequential administration of live, attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) and measles-mumps-rubella vaccine in infants 9-12months of age in the Philippines: A non-inferiority Phase 4 randomized clinical trial. AEs, ELISA, EPI, IgG, JE, MMR, PRNT, WHO
56  2020 Immunogenicity and safety of the AS04-HPV-16/18 and HPV-6/11/16/18 human papillomavirus vaccines in asymptomatic young women living with HIV aged 15-25 years: A phase IV randomized comparative study. CI, HPV, LL, PBNA, WLWH
57  2020 Immunosuppressive Drug-Associated Adverse Event Profiles in De Novo Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses. AEs, BAS, CMV, EVR, MPS, rATG
58  2020 Intracranial bailout stenting with the Acclino (Flex) Stent/NeuroSpeed Balloon Catheter after failed thrombectomy in acute ischemic stroke: a multicenter experience. AIS, ICS, mENR, mRS, MT, sICH
59  2020 Iron deficiency is associated with higher mortality in patients undergoing cardiac surgery: a prospective study. MACCEs
60  2020 Local prolonged release of antibiotic for prevention of sternal wound infections postcardiac surgery-A novel technology. SOC, SWI
61  2020 Long-term antibody persistence after a booster dose of quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine in healthy 5-year-old children. GMTs, IMD
62  2020 Long-term safety and immunogenicity of a tetravalent dengue vaccine candidate in children and adults: a randomized, placebo-controlled, phase 2 study. ---
63  2020 Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52-Week Extension Trial. AST, TEAEs
64  2020 Low blood pressure and adverse outcomes in acute stroke: HeadPoST study explanations. BP, HeadPoST, mRS
65  2020 Lower vsHigher Fluid Volumes During Initial Management of Sepsis: A Systematic Review With Meta-Analysis and Trial Sequential Analysis. RR, TSA
66  2020 Metformin monotherapy for adults with type 2 diabetes mellitus. CIs, CVM, ESRD, HRQoL, MDs, NFMI, NFS, RCTs, RRs, T2DM
67  2020 Operative Fixation of Hip Fractures in Nonagenarians: Is It Safe? RR
68  2020 Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis. 5-ASA, AEs, RCTs, RR, UC
69  2020 Oral Janus kinase inhibitors for maintenance of remission in ulcerative colitis. AEs, JAK, RR, UC
70  2020 Outpatient Yttrium-90 microsphere radioembolization: assessment of radiation safety and quantification of post-treatment adverse events causing hospitalization. AEs
71  2020 Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial. AEs, CI
72  2020 Pangenotypic direct acting antivirals for the treatment of chronic hepatitis C virus infection: A systematic literature review and meta-analysis. DAAs, DAEs, HCV, SVR12
73  2020 Perioperative safety after cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy for pseudomyxoma peritonei from appendiceal origin: Experience on 254 patients from a single center. CRS, HIPEC, PMP, PSOGI
74  2020 Physical activity and serious adverse events in patients with atrial fibrillation and/or atrial flutter treated with catheter ablation. AF, AFL, IPAQ, PA
75  2020 Predictors of Medical Serious Adverse Events in Hip Fracture Patients Treated With Arthroplasty. BMI, HR
76  2020 Primary efficacy of netakimab, a novel interleukin-17 inhibitor, in the treatment of active ankylosing spondylitis in adults. AEs, AS, NSAID, NTK, PK
77  2020 Prophylactic use of acid suppressants in adult acutely ill hospitalised patients: A systematic review with meta-analysis and trial sequential analysis. GI, H2RAs, HRQoL, PPIs, SUP, TSA
78  2020 Prospective evaluation of fexapotide triflutate injection treatment of Grade Group 1 prostate cancer: 4-year results. AS, FT
79  2020 Real-World Effectiveness and Safety of a Single-Pill Combination of Olmesartan/Amlodipine/Hydrochlorothiazide in Korean Patients with Essential Hypertension (RESOLVE): A Large, Observational, Retrospective, Cohort Study. AEs, DBP, SBP, SPC, UAEs
80  2020 Real-world non-interventional long-term post-authorisation safety study of ruxolitinib in myelofibrosis. ADRs
81  2020 Real-World Safety of an Implantable Continuous Glucose Sensor Over Multiple Cycles of Use: A Post-Market Registry Study. AEs, CGM, PMCF, PYs, T1D, T2D
82  2020 Reducing Uninformative IND Safety Reports: A List of Serious Adverse Events anticipated to Occur in Patients with Lung Cancer. SCRT
83  2020 Rheumatoid arthritis patients on persistent moderate disease activity on biologics have adverse 5-year outcome compared to persistent low-remission status and represent a heterogeneous group. pMDA, RA
84  2020 Risk for non-home discharge following surgery for ischemic mitral valve disease. adjOR, CI, IMR, NHD, QOL
85  2020 Risk of Systemic Adverse Events Following Intravitreal Bevacizumab, Ranibizumab, and Aflibercept in Routine Clinical Practice. CVD, DRD, MI, nAMD, RVO
86  2020 Safety and continued use of the levonorgestrel intrauterine system as compared with the copper intrauterine device among women living with HIV in South Africa: A randomized controlled trial. AOR, ART, C-IUD, CI, gVL, IPC, IUC, LNG-IUS, PID, pVL, RTIs, WLHIV
87  2020 Safety and Effectiveness of an Intragastric Balloon as an Adjunct to Weight Reduction in a Post-Marketing Clinical Setting. IGB
88  2020 Safety and efficacy of coblopasvir and sofosbuvir in patients with genotypes 1, 2, 3 and 6 HCV infections without or with compensated cirrhosis. AEs, HCV, ITT, SVR, SVR12
89  2020 Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. AEs, ALC, ARR, DMF, EDSS, LLN, MRI, PBO
90  2020 Safety and Efficacy of Otaplimastat in Patients with Acute Ischemic Stroke Requiring tPA (SAFE-TPA): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study. mRS, PH, rt-PA
91  2020 Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a double blind, phase III randomized clinical trial in healthy Serbian adults. AEs, GMT, HAI, TIV
92  2020 Safety and immunogenicity of the RTS,S/AS01 malaria vaccine in infants and children identified as HIV-infected during a randomized trial in sub-Saharan Africa. CS
93  2020 Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4-17 Years) With Focal Seizures. ESL, TEAEs
94  2020 Safety of BRAF+MEK Inhibitor Combinations: Severe Adverse Event Evaluation. adj. ROR, FAERS
95  2020 Safety of intrathecal delivery of recombinant human arylsulfatase A in children with metachromatic leukodystrophy: Results from a phase 1/2 clinical trial. ASA, CSF, EOW, MLD
96  2020 Safety of retigabine in adults with partial-onset seizures after long-term exposure: focus on unexpected ophthalmological and dermatological events. POS, TEAEs
97  2020 Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12-15 years: end-of-study results from a community-randomized study up to 6.5 years. CI, HPV, NOADs
98  2020 Safety profiles of biologic agents for inflammatory bowel diseases: a prospective pharmacovigilance study in Southern Italy. ADA, AEs, GOL, IBDs, IFX, UST, VED
99  2020 Safety, tolerability and efficacy of repeated intravenous infusions of KHK4083, a fully human anti-OX40 monoclonal antibody, in Japanese patients with moderate to severe atopic dermatitis. AD, AEs, EASI, IGA, TARC
100  2020 SAGE-217, A Novel GABAA Receptor Positive Allosteric Modulator: Clinical Pharmacology and Tolerability in Randomized Phase I Dose-Finding Studies. GABAA, MAD, MTD, PK, SAD