article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "BACKGROUND\nEptifibatide is a platelet glycoprotein IIb/IIIa (GP IIb/IIIa) receptor antagonist that inhibits fibrinogen binding to the activated GP IIb/IIIa site and prevents platelet-platelet interaction and clot formation. GP IIb/IIIa inhibitors improve outcome in patients undergoing percutaneous cor... | [
{
"companynumb": "US-TEVA-2019-US-1055703",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "EPTIFIBATIDE"
},
"drugadditional": "1",
... |
{
"abstract": "Resistance to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancers (NSCLCs) with activating EGFR mutations generally involve development of acquired secondary or tertiary EGFR mutations, such as T790M or C797S. However, case reports have demonstrated that actionable receptor tyrosine k... | [
{
"companynumb": "GB-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2017-BI-028055",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AFATINIB"
},
"dr... |
{
"abstract": "We present here the first MS-case where rituximab-treatment led to grade IV neutropenia, with hospitalization and treatment of a serious infection with broad-spectrum antibiotics. The neutropenia resolved promptly with granulocyte-colony stimulating factor-treatment and the patient recovered well. Due ... | [
{
"companynumb": "FI-ROCHE-2091280",
"fulfillexpeditecriteria": "1",
"occurcountry": "FI",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": "1",
"drugad... |
{
"abstract": "Proton pump inhibitors (PPIs) are generally safe, and their short-term use commonly does not induce hemolytic anemia. The underlying mechanisms are unknown, and the literature insufficiently explores hemolytic anemia as an adverse event induced by PPIs. In this case study, we report a 31-year-old femal... | [
{
"companynumb": "SA-PFIZER INC-2019253684",
"fulfillexpeditecriteria": "1",
"occurcountry": "SA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PANTOPRAZOLE"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nThe intrauterine device is a popular form of long-acting reversible contraception. Although generally safe, one of the most serious complications of intrauterine device use is uterine perforation. Risk factors for perforation include position of the uterus, force exerted during intrauterine... | [
{
"companynumb": "US-BAYER-2018-111176",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEVONORGESTREL"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nWe investigated the efficacy and safety of metronomic chemotherapy with combined irinotecan and tegafur-gimeracil-oteracil potassium (TS-1) in patients with metastatic and recurrent breast cancer (MRBC), and the association between irinotecan metabolizing enzyme UDP-glucuronosyltransferase ... | [
{
"companynumb": "JP-CIPLA LTD.-2015JP05817",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IRINOTECAN"
},
"drugadditional": null,
... |
{
"abstract": "Real-world data on regimens for relapsed/refractory multiple myeloma (RRMM) are limited. Daratumumab in combination with bortezomib and dexamethasone is a promising new treatment. The aim of this analysis was to assess the outcomes of daratumumab-bortezomib-dexamethasone (DVd) combination for the treat... | [
{
"companynumb": "SK-TAKEDA-2021TUS010766",
"fulfillexpeditecriteria": "1",
"occurcountry": "SK",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DARATUMUMAB"
},
"drugadditional": "3",
... |
{
"abstract": "The antiretroviral regimens including tenofovir and a ritonavir-boosted protease inhibitor (r/PI) have been associated with a reduced bone mineral density (BMD), increased bone turnover markers and renal tubular dysfunction.\n\n\n\nAn observational, prospective study was performed including HIV-1-infec... | [
{
"companynumb": "IT-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-005399",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "NEVIRAPINE"
},
"... |
{
"abstract": "Hypercalcaemia is a rare but potentially life-threatening consequence of malignancies. Solid cancers, such as lymphomas, increase serum calcium primarily through parathyroid hormone-related protein or ectopic production of 1alpha-hydroxylase. We present a case of 56-year-old woman with Sjogren's syndro... | [
{
"companynumb": "US-TEVA-2019-US-1074062",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": "1",
... |
{
"abstract": "Congenital tumors account for 2% to 4% of all pediatric central nervous system tumors. Glioblastoma multiforme (GBM) represents a small subset of these tumors. Despite harboring histologic features similar to older patients, infants with GBM exhibit improved survival and respond more favorably to surge... | [
{
"companynumb": "US-009507513-1609USA007084",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LOMUSTINE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nGabapentin is a commonly used medication for neuropathic pain and epilepsy that is prescribed by a wide range of medical specialties. Adverse effects including asterixis and myoclonus have been described in patients with chronic kidney disease, but myokymia has not been previously reported.... | [
{
"companynumb": "US-CADILA HEALTHCARE LIMITED-US-ZYDUS-062488",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "NORTRIPTYLINE"
},
"drugad... |
{
"abstract": "Small cell lung cancer (SCLC) was highly malignant and lack effective treatment after the failure of radiotherapy and chemotherapy. Antiangiogenic therapy had shown a certain effect in advanced SCLC. Apatinib, a new potent oral small-molecule tyrosine kinase inhibitor targeting the intracellular domain... | [
{
"companynumb": "CN-MYLANLABS-2018M1064097",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": "3",
... |
{
"abstract": "Ulcerations under the medial column in patients with acquired neuropathic pes planus may be intractable to conservative techniques such as regular debridement, offloading, bracing, and accommodative shoes. When surgery becomes necessary for these patients, the foot and ankle surgeon has the option of e... | [
{
"companynumb": "US-DRREDDYS-USA/USA/20/0123546",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CIPROFLOXACIN"
},
"drugadditional": "3",... |
{
"abstract": "Fascioliasis is a trematode flatworm infection caused by Fasciola hepatica and F. gigantica. Fasciola hepatica is mesoendemic in Turkey. Six cases of pediatric fascioliasis are presented here. All patients had histories of consumption of various raw vegetables. Four of our patients were at the hepatic ... | [
{
"companynumb": "NVSC2020TR084866",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TRICLABENDAZOLE"
},
"drugadditional": "3",
"... |
{
"abstract": "Russia has one of the highest prevalences of paediatric chronic hepatitis C infection (CHC). Our aim was to provide a detailed characterization of children and adolescents with CHC including treatment outcomes. Thus, an observational study of children with CHC aged <18 years was conducted in three hepa... | [
{
"companynumb": "GB-ROCHE-2361053",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "INTERFERON ALFA-2B"
},
"drugadditional": "3",
... |
{
"abstract": "Generalized morphea is associated with epoxy resin vapors and is characterized by the development of lesions shortly after exposure. Morphea presenting along with eosinophilic fasciitis (EF), or morphea/EF overlap, is rare and an indicator of poor prognosis and resistance to treatment. Here we present ... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2018SP006204",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditiona... |
{
"abstract": "To evaluate the efficacy and safety of pemetrexed, carboplatin and bevacizumab (PCB) followed by maintenance therapy with pemetrexed and bevacizumab (PB) in chemotherapy-naïve patients with stage IV non-squamous non-small cell lung cancer (NSCLC) through the influence of thymidylate synthase (TS) prote... | [
{
"companynumb": "CO-ROCHE-1743132",
"fulfillexpeditecriteria": "1",
"occurcountry": "CO",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BEVACIZUMAB"
},
"drugadditional": null,
"dru... |
{
"abstract": "Short telomere syndromes are a heterogenous spectrum of disorders leading to premature cellular aging. These may involve bone marrow failure, adult-onset idiopathic pulmonary fibrosis, and liver disease, and classical entities such as dyskeratosis congenita. We report a patient who presented with commo... | [
{
"companynumb": "US-AMGEN-USASP2020179581",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
... |
{
"abstract": "Natalizumab significantly reduces the disease activity in patients with relapsing-remitting multiple sclerosis but due to the risk of progressive multifocal leukoencephalopathy it is often discontinued. Fingolimod is seen as an alternative, but there are no long-term analyses of the efficacy of fingoli... | [
{
"companynumb": "CH-BIOGEN-2016BI00185995",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "NATALIZUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Symptomatic Intracerebral hemorrhage (sICH) is a serious complication of recombinant tissue-plasminogen activator (rt-PA) therapy for acute ischemic stroke (AIS).\nTo estimate the prevalence and predictors of sICH in patients after receiving IV rt-PA for AIS.\nConsecutive patients of AIS thrombolysed b... | [
{
"companynumb": "IN-ROCHE-2192663",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "OBJECTIVE\nGemcitabine (G) is standard therapy for pancreatic cancer. Enzastaurin (E) inhibits PKCβ and PI3K/AKT signaling pathways with a dose-dependent effect on growth of pancreatic carcinoma xenografts. Data suggest that the GE combination may improve clinical outcomes.\n\n\nMETHODS\nPrimary object... | [
{
"companynumb": "US-PFIZER INC-2020437798",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GEMCITABINE HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "Angioedema has recently been reported as a side effect associated with the antipsychotic risperidone. We report a case of dystonia with concurrent angioedema due to risperidone. A 40-year-old male with a history of schizophrenia was started on 3 mg of risperidone BID and developed perioral and periorbi... | [
{
"companynumb": "AG-MANKIND-000056",
"fulfillexpeditecriteria": "1",
"occurcountry": "AG",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RISPERIDONE"
},
"drugadditional": "1",
"dru... |
{
"abstract": "Patients with acute liver failure (ALF) have a high risk of death that can be substantially reduced with liver transplantation. It is a challenge to predict which patients with ALF will survive without liver transplant because available prognostic scoring systems are inadequate. We devised a mathematic... | [
{
"companynumb": "US-JNJFOC-20160724006",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nAcute biochemical changes, hepatotoxicity, nephrotoxicity and frequency of infections are common in diffuse large B-cell Lymphoma patients undergoing Cyclophosphamide, Doxorubicin, Oncovin (Vincristine) Prednisone (CHOP) and Rituximab plus CHOP chemo cycles. Eventually, it leads to prolongi... | [
{
"companynumb": "PHHY2018PK039541",
"fulfillexpeditecriteria": "1",
"occurcountry": "PK",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VINCRISTINE SULFATE"
},
"drugadditional": "3",
... |
{
"abstract": "A 74-year-old man presented with abdominal swelling. Computed tomography revealed massive ascites and localized thickening of the small intestinal wall. Enteroscopy showed ulcerative lesions along the circumference of the jejunum. Histological examination showed dense proliferation of large lymphoid at... | [
{
"companynumb": "JP-ACCORD-220264",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"drugadditional": "3",
"drug... |
{
"abstract": "We herein report a unique case of type B2 thymoma-associated myasthenia gravis which was ameliorated by immunosuppressive therapy in combination with chemotherapy. However, the patient subsequently developed pure red cell aplasia and marked lymphocytosis after additional chemotherapy aimed at improveme... | [
{
"companynumb": "JP-MYLANLABS-2018M1064945",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "We report a case of a male, term newborn with known left congenital diaphragmatic hernia (CDH) who presented with circulatory compromise requiring maximal inotropic support in the first 24 hours of life. Repeat X-ray at 24 hours showed pneumatosis intestinalis. Emergency laparotomy was performed for su... | [
{
"companynumb": "AU-ACTELION-A-CH2018-176428",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BOSENTAN"
},
"drugadditional": "3",
... |
{
"abstract": "Organophosphorus (OP) pesticides are commonly used in agricultural fields to control pests in India. However, exposure to it can cause poisoning in humans and animals, or it can be taken intentionally as poison to commit suicide. We present a case of a 35-year-old suicidal man who developed prolonged a... | [
{
"companynumb": "IN-ALEMBIC PHARMACUETICALS LIMITED-2016SCAL000567",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PENTAZOCINE"
},
"dru... |
{
"abstract": "OBJECTIVE\nTo improve the effect of allogeneic stem-cell transplantation by sequential use of intensive chemotherapy, reduced-intensity conditioning (RIC), and prophylactic donor lymphocyte transfusions (pDLTs) in high-risk acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).\n\n\nMETHODS\n... | [
{
"companynumb": "DE-SA-2014SA109547",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FLUDARABINE PHOSPHATE"
},
"drugadditional": null,
... |
{
"abstract": "We sought to evaluate whether combining a humanized antidisialoganglioside mAb (hu14.18K322A) with induction chemotherapy improves early responses and outcomes in children with newly diagnosed high-risk neuroblastoma.\n\n\n\nWe conducted a prospective nonrandomized, single-arm, two-stage, phase II clin... | [
{
"companynumb": "US-OTSUKA-2019_036081",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MELPHALAN"
},
"drugadditional": null,
"... |
{
"abstract": "Since the inception of pancreas transplant as a treatment for type 1 diabetes mellitus, there has been considerable debate about the best way to manage exocrine secretions and monitor patients for graft rejection. For patients who undergo bladder exocrine drainage of a pancreatic allograft, a bladder-t... | [
{
"companynumb": "US-ASTELLAS-2019US022649",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": "3",
... |
{
"abstract": "Adverse reactions to medications are extremely common and display a characteristic clinical morphology such as fixed drug eruption (FDE), Stevens-Johnson syndrome, urticaria, morbilliform exanthem, hypersensitivity syndrome, pigmentary changes, lichenoid, dermatitis, acute generalized exanthematous pus... | [
{
"companynumb": "TR-PFIZER INC-2013144055",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CIPROFLOXACIN"
},
"drugadditional": "3",
... |
{
"abstract": "This paper discusses the case of a pregnant woman with polychemotherapy during the second trimester of pregnancy for rhabdomyosarcoma of the face and cessation of fetal growth with disappearance of amniotic fluid after the first course of therapy.",
"affiliations": "Department of Obstetrics and Gynec... | [
{
"companynumb": "FR-RECORDATI RARE DISEASES-FR-R13005-16-00173",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DACTINOMYCIN"
},
"drugad... |
{
"abstract": "BACKGROUND\nWe studied the toxicity of cyclosporin (CsA), azathioprine, and mesalamine in 94 patients with inflammatory bowel disease (IBD).\n\n\nMETHODS\n63 treatments with CsA (2mg/kg intravenously or 5 mg/kg orally); 57 with azathioprine (2 mg/kg); and 44 with mesalamine (3.2-4.8 gr) were included. ... | [
{
"companynumb": "IT-TEVA-588466ISR",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": null,
"d... |
{
"abstract": "BACKGROUND\nMedulloblastoma, an embryonal neuroectodermal tumor of the cerebellum, is the most common malignant brain tumor in children. There are approximately 15 cases diagnosed in the Czech Republic each year. The recent World Health Organization classification recognizes several histopathological s... | [
{
"companynumb": "CZ-ACCORD-038857",
"fulfillexpeditecriteria": "1",
"occurcountry": "CZ",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VINCRISTINE"
},
"drugadditional": null,
"dru... |
{
"abstract": "OBJECTIVE\nMetaplastic carcinoma of the breast (MCB) is a rare cancer characterized by the histologic presence of two or more histological cell types originating from epithelial and mesenchymal stem cells. Patients with metastatic MCB have a low response rate to conventional chemotherapy and poor survi... | [
{
"companynumb": "TW-FRESENIUS KABI-FK201909920",
"fulfillexpeditecriteria": "1",
"occurcountry": "TW",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "BUPARLISIB HYDROCHLORIDE"
},
"drugadditi... |
{
"abstract": "Pleuropulmonary blastoma (PPB) is a very rare, malignant aggressive primary lung tumor, which occurs mainly in children less than 5 years old. Due to its poor prognosis, it is aggressively treated with multimodal therapy including surgery and chemotherapy. We present a case of PPB in a 2-year-old girl ... | [
{
"companynumb": "RO-BAXTER-2020BAX011577",
"fulfillexpeditecriteria": "1",
"occurcountry": "RO",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional":... |
{
"abstract": "BACKGROUND\nReal-life long-term data on infliximab treatment in ulcerative colitis are limited.\n\n\nOBJECTIVE\nTo study the long-term efficacy and safety of infliximab in chronic active ulcerative colitis and possible predictors of colectomy and response were also examined.\n\n\nMETHODS\nA retrospecti... | [
{
"companynumb": "SE-JNJFOC-20170116548",
"fulfillexpeditecriteria": "1",
"occurcountry": "SE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AZATHIOPRINE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nAnticoagulant-related nephropathy (ARN) is a form of acute kidney injury that mainly occurs in patients with previously unrecognized glomerular disease in addition to excessive anticoagulation. Since a renal biopsy is not performed in most cases, the diagnosis is often presumptive.\n\n\nMET... | [
{
"companynumb": "SI-JNJFOC-20210527178",
"fulfillexpeditecriteria": "1",
"occurcountry": "SI",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RIVAROXABAN"
},
"drugadditional": "1",
... |
{
"abstract": "N-methyl-D-aspartate receptor (NMDAR) encephalitis is a rare antibody-mediated autoimmune encephalitis often associated with an ovarian teratoma in adolescent females. Here we present a 17-year-old girl with only and unusual psychiatric symptoms as part of her NMDAR encephalitis in combination with a v... | [
{
"companynumb": "DE-SHIRE-DE201930273",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"drugadditional": "1",
... |
{
"abstract": "Cushing's syndrome causes increased morbidity and mortality due to cardiovascular and infectious diseases. Exogenous Cushing's syndrome can render the adrenal glands unable to cope with severe infections and may result in Addisonian crisis, which can be fatal if not properly diagnosed and treated. Duri... | [
{
"companynumb": "IT-TEVA-2022-IT-1999032",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nTo assess the safety and efficacy of antithrombotic therapy (ATT) for secondary stroke prevention of childhood bacterial meningitis.\n\n\nMETHODS\nA retrospective study of cases of stroke associated with bacterial meningitis in 2 pediatric hospitals during a period of 15 years. Patients were... | [
{
"companynumb": "CA-BAYER-2014-177385",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": null,
"dr... |
{
"abstract": "To examine the behavioral functioning of children prenatally exposed to carbamazepine (CBZ), lamotrigine (LTG), levetiracetam (LEV), or valproate (VPA) monotherapy.\n\n\n\nIn collaboration with the European Registry of Antiepileptic Drugs and Pregnancy (EURAP), the Dutch EURAP & Development study was d... | [
{
"companynumb": "NL-UCBSA-2019037099",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "3",
... |
{
"abstract": "A 52-year-old man known for a recent cardiac transplantation presented with 6 weeks of incapacitating left shoulder pain with normal x-rays and CT scans. MRI revealed bone edema of the coracoid and glenoid neck with a supraspinatus abscess. Biopsy of the coracoid demonstrated Aspergillus osteomyelitis ... | [
{
"companynumb": "CA-TEVA-2021-CA-1885261",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "3",
... |
{
"abstract": "Mutations in the epidermal growth factor receptor (EGFR) are drivers for a subset of lung cancers. Osimertinib is a third-generation tyrosine kinase inhibitor (TKI) recently approved for the treatment of T790M-positive non-small cell lung cancer (NSCLC); however, acquired resistance to osimertinib is e... | [
{
"companynumb": "US-MYLANLABS-2017M1056119",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BEVACIZUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Pneumocystis pneumonia (PCP) is a life-threatening fungal infection occurring in immunocompromised patients such as HIV-positive patients with low CD4 cell count or patients under heavy immunosuppressive therapy. We report the case of a 59-year-old male with severe diffuse cutaneous systemic sclerosis ... | [
{
"companynumb": "BE-VISTA PHARMACEUTICALS INC.-2084300",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM"
},
... |
{
"abstract": "Percutaneous reverse Potts shunt improves right ventricular function in patients with suprasystemic idiopathic pulmonary arterial hypertension. There are no data regarding the anesthesia in this high-risk procedure. We report our experience of the anesthetic management for the creation of percutaneous ... | [
{
"companynumb": "FR-AUROBINDO-AUR-APL-2021-032360",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BOSENTAN"
},
"drugadditional": "4",
... |
{
"abstract": "BACKGROUND Myxedema coma is an uncommon severe thyroid disorder that is fatal in 25-60% of cases. Although the differential diagnosis for altered mental status is extensive, including many more common causes such as infection, medication changes, electrolyte abnormalities, and exacerbation of chronic i... | [
{
"companynumb": "US-HIKMA PHARMACEUTICALS USA INC.-US-H14001-20-52468",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AMIODARONE"
},
"dr... |
{
"abstract": "Infection is a common cause of morbidity and mortality in immunocompromised patients for whom diagnosis and management require scrupulous attention to detail and a continuing awareness of the micro-organisms causing infection in a particular environment in different groups of patients. Although uncommo... | [
{
"companynumb": "JP-JNJFOC-20160905016",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "3",
... |
{
"abstract": "Thirty-six patients with stage III-IV ovarian cancer, bulky disease, were treated with adriamycin and cyclophosphamide administered in two different dosages. Three or four cycles of chemotherapy were administered before the first surgery to facilitate the surgical debulking. After surgery, 6 additional... | [
{
"companynumb": "IT-PFIZER INC-2020521166",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "Patients with tachyarrythmias as a result of thyroid storm have been typically treated with beta-blockers to decrease the heart rate and alleviate beta-receptor mediated symptoms such as anxiety and tremulousness. We report an unusual case of a previously well young man presenting to the emergency depa... | [
{
"companynumb": "SG-PFIZER INC-2018022187",
"fulfillexpeditecriteria": "1",
"occurcountry": "SG",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PROPRANOLOL HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "Acetaminophen is one of the most widely prescribed analgesic drugs. Fixed drug eruption, especially the pigmenting type, is reported in literature as a possible adverse event to acetaminophen in child. We hereby present a case of generalized fixed drug eruption due to acetaminophen intake in a 5-year-o... | [
{
"companynumb": "IT-MYLANLABS-2020M1073404",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": "1",
... |
{
"abstract": "The ALK inhibitors are promising therapeutic agents against lung cancer harboring ALK fusion genes and are currently under development up to the third generation. However, its therapeutic effects are reported to be affected by differences in ALK variants and co-occurrent mutations. Materials and Method... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2021RR-322863",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PEMETREXED"
},
"drug... |
{
"abstract": "Ciprofloxacin, a very common antibiotic used in our day-to-day practice can cause adverse cutaneous reactions in 1-2% of patients. Photosensitivity, urticaria and maculopapular rash are the usual skin reactions. Fixed drug eruption (FDE) is an uncommon side effect of ciprofloxacin. Ciprofloxacin-induce... | [
{
"companynumb": "PHHY2018IN030853",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CIPROFLOXACIN"
},
"drugadditional": "1",
"dr... |
{
"abstract": "Clinical trials and real-world data have proven that hepatitis C virus (HCV) in most infected patients can be eradicated by direct-acting antivirals (DAAs). However, the proper retreatment regimen for hemodialysis patients with HCV infection who have previously failed to respond to DAAs has not been cl... | [
{
"companynumb": "JP-ABBVIE-18K-087-2502938-00",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "GLECAPREVIR\\PIBRENTASVIR"
},
"drugadditio... |
{
"abstract": "Pemphigus vulgaris (PV) is an autoimmune blistering skin disease that may require multiagent immunosuppressive drug therapies in severe cases. In addition to the well-established corticosteroid sparing agents azathioprine, mycophenolate mofetil, and methotrexate, rituximab is being increasingly used al... | [
{
"companynumb": "TR-ACCORD-109934",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "HUMAN IMMUNOGLOBULIN G"
},
"drugadditional": null,
... |
{
"abstract": "Treatment strategies for acute toxicity following massive ingestion of warfarin are not well described in the literature. Warfarin is the primary oral anticoagulation agent used in the treatment of thromboembolic disease, and patients with acute toxicity are at risk for life-threatening hemorrhages. Tr... | [
{
"companynumb": "US-ROCHE-1877595",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "3",
... |
{
"abstract": "For an assessment of the efficacy of clindamycin in preventing bowel necrosis (intestinal gangrene or perforation), 42 premature infants with radiographically confirmed necrotizing enterocolitis (NEC) (pneumatosis, intraportal gas, or both) were randomly assigned to receive parenterally either ampicill... | [
{
"companynumb": "US-PFIZER INC-2019512462",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLINDAMYCIN"
},
"drugadditional": "3",
... |
{
"abstract": "Ribociclib is an orally bioavailable cyclin-dependent kinase 4/6 inhibitor. In combination with aromatase inhibitor letrozole, it has approval for treatment of hormone receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. First-line therapy with r... | [
{
"companynumb": "DE-SUN PHARMACEUTICAL INDUSTRIES LTD-2021RR-312210",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "RIBOCICLIB"
},
"drug... |
{
"abstract": "BACKGROUND Thrombolysis with rtPA is the only accepted drug therapy for acute ischemic stroke. Since acute cerebral stroke is so pervasive, newly developed recanalization methods have the potential for wide-ranging impacts on patient health and safety. We explored the efficacy and safety of Solitaire s... | [
{
"companynumb": "CN-ROCHE-1779002",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"drugadditional": null,
"druga... |
{
"abstract": "BACKGROUND\nMycobacterium tuberculosis causes infection in approximately one-third of the world's population. Arthritis due to Mycobacteriurn tuberculosis usually presents as a chronic, slowly progressive, monoarticular infection that predominantly involves the weight-bearing joints and the spine. The ... | [
{
"companynumb": "ID-ACCORD-156019",
"fulfillexpeditecriteria": "1",
"occurcountry": "ID",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,
"dr... |
{
"abstract": "The GETUG 13 phase III trial tested personalised chemotherapy based on tumour marker decline in patients with poor-prognosis germ-cell tumour (GCT) and demonstrated that a dose-dense regimen improves progression-free survival in patients with an unfavourable decline. We investigated the pattern of rela... | [
{
"companynumb": "FR-CIPLA LTD.-2018FR07085",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": null,
... |
{
"abstract": "Patients with pulmonary arterial hypertension (PAH) and distal chronic thromboembolic pulmonary hypertension (CTEPH) who still reveal risk factors of worse prognosis on double combination therapy may benefit from add-on therapy with the novel oral selective prostacyclin receptor agonist selexipag.\n\n\... | [
{
"companynumb": "CH-ACTELION-A-CH2018-173842",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "SITAGLIPTIN PHOSPHATE"
},
"drugadditional"... |
{
"abstract": "Perampanel (PER) is approved in Italy as an adjunctive treatment for focal-onset seizures (FOS) and generalized tonic-clonic seizures (GTCs), and it could be an alternative to valproate in young women diagnosed with idiopathic generalized epilepsy. Nevertheless, clinical data about the outcome of pregn... | [
{
"companynumb": "US-UCBSA-2022006657",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": null,
... |
{
"abstract": "This report describes a case of persistent rhinorrhea caused by donepezil and successfully treated with azelastine in an 84-year-old male treated with donepezil for Alzheimer's disease (AD) who experienced excessive rhinorrhea. After initiation of donepezil for AD the patient showed increased discomfor... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2020SP000164",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": ... |
{
"abstract": "The prevalence of takotsubo syndrome (TTS) in patients with subarachnoid hemorrhage (SAH) is much higher than in the general population. Clinical and experimental observations confirm secondary to brain damage catecholamine-mediated cardiac injury resulting in reversible left ventricular (LV) dysfuncti... | [
{
"companynumb": "PL-SUN PHARMACEUTICAL INDUSTRIES LTD-2020R1-263634",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "NIMODIPINE"
},
"drug... |
{
"abstract": "OBJECTIVE\nThe aim of the present study was to emphasize the critical importance of the clinician's awareness of signet-ring cell carcinoma (SRCC) of the urinary bladder, a rare and aggressive disease entity.\n\n\nMETHODS\nA review of the current literature was conducted and a classic case of advanced ... | [
{
"companynumb": "DK-ACCORD-069288",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": null,
"drugad... |
{
"abstract": "A ten-year-old female was admitted with syncope and a myocardial infarction, was resuscitated, and was diagnosed with anomalous left coronary artery from right aortic sinus. After initial stabilization, she was on bed rest in the intensive care unit awaiting surgery and experienced sudden arrest and co... | [
{
"companynumb": "US-BAXTER-2015BAX024877",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DOPAMINE HYDROCHLORIDE"
},
"drugadditional": n... |
{
"abstract": "Gastrointestinal complications are a frequent cause of morbidity after transplantation and may affect up to 40% of kidney transplant recipients. Here we report a rare case of idiopathic giant esophageal ulcer in a kidney transplant recipient. A 37-year-old female presented with a one-week history of od... | [
{
"companynumb": "IT-ACCORD-039960",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nHemophagocytic lymphohistiocytosis is a rare hematological syndrome characterized by excessive and uncontrolled activation of the immune system. The often nonspecific nature of early symptoms and the potential for progression to multiorgan failure and death if appropriate therapy is not sta... | [
{
"companynumb": "US-JUBILANT CADISTA PHARMACEUTICALS-2019JUB00453",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CHOLECALCIFEROL"
},
"... |
{
"abstract": "We present the first cirrhotic patient who underwent liver transplantation (LT) and presented a hepatic artery thrombosis of the graft due to Aspergillus fumigatus, within the first month of LT. This culminated in graft loss, re-transplant with multiple biliary and infectious complications. To our know... | [
{
"companynumb": "CO-PFIZER INC-2018336416",
"fulfillexpeditecriteria": "1",
"occurcountry": "CO",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE SODIUM SUCCINATE"
},
"druga... |
{
"abstract": "Collapsing glomerulopathy has been described in settings of viral infections, drug, genetic, ischemic, renal transplant, and idiopathic conditions. It has a worse prognosis than other morphologic variants of focal segmental glomerulosclerosis, and may be treated with aggressive immunosuppression. In th... | [
{
"companynumb": "US-PFIZER INC-2019188221",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PAMIDRONATE DISODIUM"
},
"drugadditional": nul... |
{
"abstract": "A clinical case of cutaneous T-cell lymphoma is presented in this paper - Mycosis fungoides, a tumorous stage that developed in a patient who suffered as a result of the Chornobyl accident. The most likely development of this di- sease is due to the influence of the radiation factor, which led to the a... | [
{
"companynumb": "UA-PFIZER INC-2020340859",
"fulfillexpeditecriteria": "1",
"occurcountry": "UA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHOTREXATE SODIUM"
},
"drugadditional": "1",... |
{
"abstract": "Purple glove syndrome is a rare and poorly understood complication of phenytoin use, occurring almost always with its intravenous formulation. This syndrome comprises of pain, purple discoloration, and edema distal to the site of intravenous administration of phenytoin. We hereby report an unusual case... | [
{
"companynumb": "IN-IMPAX LABORATORIES, INC-2015-IPXL-01326",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugaddi... |
{
"abstract": "OBJECTIVE\nTo evaluate the association between cumulative dose of haloperidol and next-day diagnosis of delirium in a cohort of older medical ICU patients, with adjustment for its time-dependent confounding with fentanyl and intubation.\n\n\nMETHODS\nProspective, observational study.\n\n\nMETHODS\nMedi... | [
{
"companynumb": "US-JNJFOC-20150419554",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HALOPERIDOL"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nWhereas the incidence of endophthalmitis after compounded intravitreal bevacizumab is known to be low, the rates of endophthalmitis after intravitreal injection of compounded ranibizumab and aflibercept are not known. The purpose of this study was to determine the incidence of endophthalmiti... | [
{
"companynumb": "CA-ROCHE-1960639",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BEVACIZUMAB"
},
"drugadditional": "3",
"drug... |
{
"abstract": "Neutropenic enterocolitis (NEC) is a life-threatening bowel condition, usually resulting from chemotherapy, with a mortality rate thought to be as high as 50%. Markers of poor prognosis include gastrointestinal perforation and bowel wall thickness radiologically detected to be greater than 10 mm. NEC i... | [
{
"companynumb": "GB-HIKMA PHARMACEUTICALS USA INC.-GB-H14001-21-55501",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"d... |
{
"abstract": "Organising pneumonia (OP) is usually promptly responsive to corticosteroid treatment. We describe a series of 3 cases of severe, progressive, biopsy-proven fibrosing OP causing respiratory failure. All cases presented with peribronchial and subpleural consolidations, had a fibro-inflammatory infiltrati... | [
{
"companynumb": "CA-ACCORD-047370",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": null,
... |
{
"abstract": "Elizabethkingia meningoseptica (E. meningoseptica) is a non-fermenting gram negative organism that is commonly detected in the soil and water but is rarely reported to cause human infection. However it is emerging as a nosocomial pathogen in patients admitted in intensive care units (ICUs). Infections ... | [
{
"companynumb": "IN-MYLANLABS-2018M1068507",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TIGECYCLINE"
},
"drugadditional": null,
... |
{
"abstract": "Solid organ transplant (SOT) recipients have a high risk for developing invasive fungal infections (IFI). Treatment is difficult due to the interaction between the antifungal and immunosuppressant drugs, as well as the risk of hepatotoxicity and kidney failure associated with voriconazole and amphoteri... | [
{
"companynumb": "ES-FRESENIUS KABI-FK202010799",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": ... |
{
"abstract": "We report the cases of 3 patients with hematological malignancies and complex karyotypes involving der(5; 17) (p10;q10), which results in the loss of 5q and 17p. Although deletions of 5q and 17p are recurrent abnormalities in hematological disease, only about 20 cases harboring der(5; 17) (p10;q10) hav... | [
{
"companynumb": "JP-CELGENEUS-087-21880-14093860",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LENALIDOMIDE"
},
"drugadditional": null... |
{
"abstract": "Background: Palm and sole skin eruptions have a broad differential diagnosis. It is particularly important to recognize common causes as well as their association with certain chemotherapy regimens such as Capecitabine. Case report: A 79-year-old woman presented with a painful rash on her hands and fee... | [
{
"companynumb": "US-TEVA-2018-US-882684",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CAPECITABINE"
},
"drugadditional": "1",
... |
{
"abstract": "OBJECTIVE\nVedolizumab is increasingly used to treat patients with ulcerative colitis (UC) and Crohn's disease (CD), however, its safety during the perioperative period remains unclear. We compared the 30-day postoperative complications among patients treated preoperatively with vedolizumab, anti-tumor... | [
{
"companynumb": "KR-TAKEDA-2020TUS014475",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VEDOLIZUMAB"
},
"drugadditional": "3",
... |
{
"abstract": "A 57-year-old woman with invasive breast cancer was referred for adjuvant chemotherapy after undergoing breast conservative therapy and axillary dissection. A port was inserted in the contralateral subclavian vein and epirubicin, cyclophosphamide and 5-fluorouracil was the treatment of choice. After th... | [
{
"companynumb": "DE-BAXTER-2014BAX066776",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": null,
... |
{
"abstract": "Diarrhoea is an adverse drug reaction of the angiotensin receptor neprilysin inhibitor (ARNI) sacubitril + valsartan. It was also described with olmesartan and more recently with other angiotensin receptor blockers. The study was performed to compare diarrhoea reports in pharmacovigilance databases wit... | [
{
"companynumb": "FR-NOVARTISPH-NVSC2022FR129465",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SACUBITRIL\\VALSARTAN"
},
"drugadditiona... |
{
"abstract": "Coccidioidomycosis is a fungal infection that usually presents as a primary lung infection. The fungus is endemic to the Southwest United States of America, northern Mexico and parts of Central and South America the infection is rare outside these areas. However, some patients develop disseminated infe... | [
{
"companynumb": "DK-SA-2017SA029123",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLOMIPHENE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "A need exists for reduced toxicity conditioning regimens that offer less toxicity while maintaining myeloablation, especially for primary immune deficiencies where myeloablation or high donor myeloid chimerism is required to achieve cure. We adapted a busulfan and fludarabine regimen by Gungor et al. f... | [
{
"companynumb": "US-TEVA-2021-US-1924673",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BUSULFAN"
},
"drugadditional": null,
... |
{
"abstract": "To interpret postmortem toxicology results, reference concentrations for non-toxic and toxic levels are needed. Usually, measurements are performed in blood, but because of postmortem redistribution phenomena this may not be optimal. Rather, measurement in the target organ of psychoactive drugs, the br... | [
{
"companynumb": "DK-LANNETT COMPANY, INC.-DK-2017LAN000482",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DIAZEPAM"
},
"drugadditional"... |
{
"abstract": "Serum sickness is an immune-complex-mediated hypersensitivity reaction that was first noted in the early 1900s in patients receiving heterologous antisera, such as horse antitetanus or antidiphtheria serum. This condition is primarily self-limited; however, in its acute state, it can cause severe sympt... | [
{
"companynumb": "US-SA-2021SA167563",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "Central airway stenosis is extremely rare in pregnancy and could lead to respiratory and cardiovascular embarrassment, especially at the time of delivery. Initially, patients may not show obvious signs of respiratory difficulty. Early recognition of the disease and anticipatory management of a complica... | [
{
"companynumb": "US-APOTEX-2018AP006465",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "AZITHROMYCIN ANHYDROUS"
},
"drugadditional": nul... |
{
"abstract": "Fluoroquinolones are widely used antibiotics; however, numerous side effects have been reported in published studies, including a spectrum of tendinopathies, affecting numerous anatomic sites. Several risk factors have been identified, including advanced age (>60 years), corticosteroid use, renal failu... | [
{
"companynumb": "LB-OTONOMY INC.-2016OTO00008",
"fulfillexpeditecriteria": "1",
"occurcountry": "LB",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "We report the first two cases of posttransplant lymphoproliferative disorder (PTLD) in recipients of islet transplants worldwide. First, a 44-year-old recipient of three islet infusions developed PTLD 80 months after his initial transplantation, presenting with abdominal pain and diffuse terminal ileum... | [
{
"companynumb": "CA-SUN PHARMACEUTICAL INDUSTRIES LTD-2017US-152236",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ALEMTUZUMAB"
},
"dru... |
{
"abstract": "There is little data specifically dedicated to the long-term outcomes of the hepatitis-associated variant of aplastic anemia (HAAA). A majority of patients with nonsevere (moderate) aplastic anemia progress to severe aplastic anemia, and severe aplastic anemia typically results in death if left untreat... | [
{
"companynumb": "US-TEVA-2021-US-1950054",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMOXICILLIN"
},
"drugadditional": "3",
... |
{
"abstract": "QX003S is a biosimilar candidate for the reference tocilizumab, Actemra®. We investigated the tolerance, variability, and pharmacokinetics (PK) of QX003S biosimilar in healthy Chinese male subjects.\n\n\n\nA randomised, double-blind, two-arm, parallel study was performed to examine the bioequivalence o... | [
{
"companynumb": "CN-ROCHE-2783079",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TOCILIZUMAB"
},
"drugadditional": "3",
"drug... |
{
"abstract": "IVIg therapy has potentially been related to arterial and venous therapy. We performed an Ovid review focusing on IVIg and thrombotic events. While a few case reports were reviewed case series and case control studies were particularly reviewed in relation to thrombotic events. Outcomes demonstrate a c... | [
{
"companynumb": "US-BIOTEST-T 480/15",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TESTOSTERONE"
},
"drugadditional": null,
... |
{
"abstract": "Excessive exogenous thyroid hormone ingestion may lead to severe thyrotoxicosis and cause potential harm. We have reviewed the literature and suggested that thyroid hormone supplementation should not be used to alleviate nonspecific complaints in patients with normal endogenous thyroid function. Failur... | [
{
"companynumb": "US-PFIZER INC-2020349170",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEVOTHYROXINE SODIUM"
},
"drugadditional": "1"... |
{
"abstract": "BACKGROUND\nPituitary apoplexy is a rare complication of the initial administration of leuprolide acetate.\n\n\nMETHODS\nWe present the case of a 63-year-old man who experienced headache, blurred vision, and loss of consciousness after initial leuprolide treatment for prostate carcinoma. Neuroimaging s... | [
{
"companynumb": "US-TOLMAR, INC.-2016US012557",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEUPROLIDE ACETATE"
},
"drugadditional": "... |
{
"abstract": "Adverse drug reactions (ADRs) contribute to poorer patient outcomes and additional burden to the healthcare system. However, data on the true burden, relevant types and drugs causing ADRs are lacking. The aim of this study was to determine the prevalence of ADR-related hospitalization in the general ad... | [
{
"companynumb": "SG-JNJFOC-20161208637",
"fulfillexpeditecriteria": "1",
"occurcountry": "SG",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": "3",
... |
{
"abstract": "A modification of the SMILE regimen with dexamethasone, methotrexate, ifosfamide, L-asparaginase, etoposide (mSMILE) followed by Intensity-Modulated Radiotherapy (IMRT) at lower than usual dose, has been adopted as standard of care for extranodal NK-/T-cell lymphoma (ENKL) at our institution. mSMILE is... | [
{
"companynumb": "US-CADILA HEALTHCARE LIMITED-US-ZYDUS-062153",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadd... |
{
"abstract": "Dizziness and ataxia are known adverse effects of pregabalin, but characteristic oculomotor signs in pregabalin intoxication have not been reported. Here we describe a patient who displayed perverted head-shaking and positional downbeat nystagmus after prescription of a high dosage of pregabalin. Since... | [
{
"companynumb": "KR-WATSON-2014-23869",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PREGABALIN"
},
"drugadditional": null,
"... |
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