article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "With growing financial pressure and the range of new and expensive drugs, hospital administrators, clinicians, and pharmacy directors are facing tough decisions on how to manage drug budgets. At a Canadian mother-child hospital, a policy for new and expensive drugs was developed, with the goal of manag... | [
{
"companynumb": "CA-TAKEDA-2021TUS024293",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BORTEZOMIB"
},
"drugadditional": "3",
... |
{
"abstract": "We report a patient who developed metastatic gestational choriocarcinoma following delivery of a normal, healthy child that, however, was anemic and required blood transfusion. The patient developed secondary postpartum hemorrhage over a period of several weeks and required curettage and myometrial con... | [
{
"companynumb": "US-RECORDATI RARE DISEASES-US-R13005-16-00169",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DACTINOMYCIN"
},
"drugad... |
{
"abstract": "OBJECTIVE\nThe immunogenicity of tocilizumab (TCZ) has been poorly studied. We assessed the immunogenicity of TCZ and serum TCZ trough levels in rheumatoid arthritis (RA) patients and the preexisting TCZ-specific CD4+ T cell repertoire in healthy controls.\n\n\nMETHODS\nAnti-drug antibodies (ADAs) to T... | [
{
"companynumb": "FR-ROCHE-1810175",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TOCILIZUMAB"
},
"drugadditional": null,
"dru... |
{
"abstract": "We report on a patient with severe psoriasis vulgaris who developed drug-induced interstitial lung disease (DILD) during treatment with ustekinumab. The diagnosis was based on coincidence with start of therapy, high-resolution computer tomography of the thorax and bronchoalveolar lavage. After disconti... | [
{
"companynumb": "DE-JNJFOC-20180511790",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "USTEKINUMAB"
},
"drugadditional": "1",
... |
{
"abstract": "The health dangers of medicines of unknown identity (MUIs) [loose pharmaceutical units repackaged in individual bags without labelling of their identity] have been suspected in L/MICs. Using visual and analytical tools to identify MUIs, we investigated the frequency of, and factors associated with, adv... | [
{
"companynumb": "LA-ROCHE-2215241",
"fulfillexpeditecriteria": "1",
"occurcountry": "LA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLCOBALAMIN"
},
"drugadditional": "3",
"... |
{
"abstract": "OBJECTIVE\nAs the rates of cesarean births have increased, the type of cesarean anesthesia has gained importance. Here, we aimed to compare the effects of general and spinal anesthesia on maternal and fetal outcomes in term singleton cases undergoing elective cesarean section.\n\n\nMETHODS\nProspective... | [
{
"companynumb": "TR-BAXTER-2015BAX061955",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ATROPINE"
},
"drugadditional": null,
... |
{
"abstract": "We describe the case of a transplanted patient with high-risk HPV infection that manifested as multiple genital condylomas and abnormal Papanicolaou (Pap) smear. Her immunosuppressants were corticosteroids, cyclosporine, and azathioprine. Since gynecologic treatments to eradicate condylomas were comple... | [
{
"companynumb": "HR-MYLANLABS-2018M1051993",
"fulfillexpeditecriteria": "1",
"occurcountry": "HR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": "3",
... |
{
"abstract": "Evolocumab is a recently FDA-approved proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) that reduces the risk of myocardial infarction, stroke, and coronary revascularization in individuals with established atherosclerotic cardiovascular disease. We report an extremely rare possible side... | [
{
"companynumb": "US-AMGEN-USASP2021111611",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "EVOLOCUMAB"
},
"drugadditional": "1",
... |
{
"abstract": "We measured the intracranial pressure, using a subdural catheter in three patients admitted with grade 4 hepatic encephalopathy following paracetamol (aminocetaphen) self poisoning. Acute oliguric renal failure was present in all cases and was treated with daily intermittent machine haemofiltration. Hy... | [
{
"companynumb": "GB-JNJFOC-20210664676",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": null,
... |
{
"abstract": "Malignant hyperthermia (MH) is a rare life threatening inherited disorder that is triggered by drugs used for general anesthesia in susceptible persons. The symptoms include rapid increase of body temperature and severe muscle contractions. The present study includes 3 cases of MH and highlights the ti... | [
{
"companynumb": "CN-MYLANLABS-2016M1050175",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ATROPINE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nEpichaperome network maintenance is vital to survival of tumors that express it. PU-H71 is an epichaperome inhibitor that binds to the ATP-binding site of HSP90 and has demonstrated antitumor activity in breast cancer xenograft models and clinical safety in patients. PU-positron emission tom... | [
{
"companynumb": "US-CELGENEUS-USA-20201205322",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "INVESTIGATIONAL PRODUCT"
},
"drugaddition... |
{
"abstract": "Among women with epilepsy, studies regarding changes in seizure frequency during pregnancy have been limited by the lack of an appropriate nonpregnant comparator group to provide data on the natural course of seizure frequency in both groups.\n\n\n\nIn this prospective, observational, multicenter cohor... | [
{
"companynumb": "US-UCBSA-2021023640",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LACOSAMIDE"
},
"drugadditional": "3",
"dr... |
{
"abstract": "OBJECTIVE\nTo characterize the post-marketing reporting of serotonin syndrome (SS) due to drug-drug interactions (DDIs) with linezolid and investigate the relationship with pharmacokinetic/pharmacodynamic (PK/PD) properties of serotonergic agents.\n\n\nMETHODS\nWe queried the worldwide FDA Adverse Even... | [
{
"companynumb": "IT-GLAXOSMITHKLINE-IT2020GSK186625",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BUPROPION HYDROCHLORIDE"
},
"drugadd... |
{
"abstract": "Acute interstitial nephritis (AIN) is characterized by inflammation of the renal interstitium and usually occurs in a temporal relationship with the medication. We present a case of an Asian male who had nephrotic range proteinuria and presented with acute kidney injury. The patient reported an acute c... | [
{
"companynumb": "US-DRREDDYS-USA/USA/15/0053954",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "SILDENAFIL"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nAllopurinol is a urate-lowering agent that is commonly used to prevent chemotherapy-related hyperuricemia. Allopurinol hypersensitivity syndrome (AHS) is a disorder involving multiple organs, which may be accompanied by cutaneous adverse reactions. We identified the characteristics and clini... | [
{
"companynumb": "KR-ACCORD-032519",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ALLOPURINOL"
},
"drugadditional": null,
"dru... |
{
"abstract": "Sleep-wake disorders are a common and debilitating nonmotor manifestation of Parkinson disease (PD), but treatment options are scarce.\n\n\n\nTo determine whether nocturnal administration of sodium oxybate, a first-line treatment in narcolepsy, is effective and safe for excessive daytime sleepiness (ED... | [
{
"companynumb": "CH-JAZZ-2021-CH-006586",
"fulfillexpeditecriteria": "2",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SODIUM OXYBATE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nPyogenic abscess of psoas muscles is a rare condition. Psoas abscess due to methicillin-resistant Staphylococcus aureus is an emerging and rare infection and so far the related data are scarce.\n\n\nMETHODS\nWe report the rare case of primary and bilateral large psoas abscesses due to methi... | [
{
"companynumb": "JO-FRESENIUS KABI-FK201601344",
"fulfillexpeditecriteria": "1",
"occurcountry": "JO",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": n... |
{
"abstract": "OBJECTIVE\nThe number of stroke-related maternal deaths is increasing in Japan. We investigated methods to reduce maternal death from stroke.\n\n\nMETHODS\nWe analyzed stroke-related maternal deaths in Japan reported to the Committee of the Ministry of Health, Labor, and Welfare from 2010 to 2014 inclu... | [
{
"companynumb": "JP-MYLANLABS-2018M1039529",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "KETAMINE"
},
"drugadditional": null,
... |
{
"abstract": "Dysbetalipoproteinemia (DBL) is an uncommon condition characterized by a mixed hyperlipidemia due to accumulation of remnant lipoproteins and is highly atherogenic. Typically, DBL is an autosomal recessive condition requiring an additional metabolic stress with reduced apolipoprotein E (apoE) function.... | [
{
"companynumb": "ZA-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-311651",
"fulfillexpeditecriteria": "1",
"occurcountry": "ZA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "THALIDOMIDE"
},
"dru... |
{
"abstract": "BACKGROUND\nIn 2019, The EWGSOP2 group made updates on the definition and diagnosis of sarcopenia. The aim of this study is to determine the possible risk factors for chemotherapy dose-limiting toxicity (DLT).\n\n\nMETHODS\nNewly diagnosed gastrointestinal (GI) cancer patients were included in this pro... | [
{
"companynumb": "TR-AMGEN-TURSP2022078281",
"fulfillexpeditecriteria": "2",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PANITUMUMAB"
},
"drugadditional": "3",
... |
{
"abstract": "Use of systemic corticosteroids for the treatment for coronavirus disease 2019 (COVID-19) among chronic obstructive pulmonary disease (COPD) patients is not well described. A 58-year-old man with fever and progressive dyspnea was admitted to the Showa University Hospital, and showed severe respiratory ... | [
{
"companynumb": "JP-MYLANLABS-2020M1082890",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LOXOPROFEN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nStaphylococcus infection-associated glomerulonephritis is a rare cause of graft dysfunction in kidney transplant. Suspicion should be high in the setting of elevation of serum creatinine, active urinary sediment, with or without hypocomplementemia, and simultaneous Staphylococcus aureus inf... | [
{
"companynumb": "PT-TEVA-2018-PT-894757",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "In pemphigus, elucidating the disease-causing immune mechanism and developing new therapeutic strategies are needed. In this context, the second messenger 3',5'-cyclic adenosine monophosphate (cAMP) is gaining attention. cAMP is important in hematological and auto-inflammatory disorders. A class of enz... | [
{
"companynumb": "DE-MYLANLABS-2021M1044973",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "APREMILAST"
},
"drugadditional": null,
... |
{
"abstract": "Eosinophilic granulomatosis with polyangiitis is a rare multisystemic disorder, characterized by necrotizing vasculitis affecting small to medium-sized vessels, associated with asthma and eosinophilia. Cardiac involvement is the most important predictor of mortality and it seems to be more frequent in ... | [
{
"companynumb": "PHHY2018PT098463",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUTICASONE"
},
"drugadditional": "3",
"drug... |
{
"abstract": "Outcomes for diffuse large B-cell lymphoma (DLBCL) in sub-Saharan Africa (SSA) are poorly described. We report mature data from one of the first prospective SSA cohorts. Patients aged ≥18 years with DLBCL were enrolled in Malawi 2013-2017. Participants were treated with CHOP (cyclophosphamide, doxorubi... | [
{
"companynumb": "PHHY2019MW042461",
"fulfillexpeditecriteria": "1",
"occurcountry": "MW",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": null,
... |
{
"abstract": "Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a novel class of drugs that lower glucose by inducing renal glycosuria. We aimed to explore whether SGLT2 inhibitor added to the usual care for patients with type 2 diabetes mellitus (T2DM) and biopsy-proven nonalcoholic steatohepatitis (NASH) will ... | [
{
"companynumb": "MY-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2019-BI-005289",
"fulfillexpeditecriteria": "1",
"occurcountry": "MY",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "INSULIN NOS"
},
... |
{
"abstract": "A 60-year-old man who abused corticosteroids developed thoracic-distribution zoster. Varicella zoster virus (VZV) DNA was found in non-healing skin 3 months later. He died suddenly 2 months later. Skin was ulcerated and necrotic. VZV was widespread in organs and arteries, particularly coronary arteries... | [
{
"companynumb": "PHHY2015US058269",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
"dru... |
{
"abstract": "OBJECTIVE\nThis retrospective study aimed to compare the efficacy of and tolerance to two center-related conventional transarterial chemoembolization (TACE) strategies in the management of unresectable hepatocellular carcinoma (HCC).\n\n\nMETHODS\nAll HCC patients in whom TACE was initiated in the two ... | [
{
"companynumb": "FR-FRESENIUS KABI-FK201506134",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "EPIRUBICIN"
},
"drugadditional": null,
... |
{
"abstract": "We present the case of a 29-year-old woman who initially presented to her GP with a short history of non-pruritic annular skin lesions with central clearing. A month later, she developed signs and symptoms of bone marrow failure with bruising, epistaxis and fatigue. After urgent review of a blood film,... | [
{
"companynumb": "GB-TEVA-2021-GB-1887584",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MITOXANTRONE HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "To assess possible adverse effects on breastfed infants of mothers receiving monoclonal antibodies (MAbs) during pregnancy and/or lactation.\n\n\n\nWe identified 23 patients from the German Multiple Sclerosis and Pregnancy Registry (DMSKW) who received MAbs (17 natalizumab and 6 anti-CD20) during lacta... | [
{
"companynumb": "DE-CELLTRION INC.-2020DE022324",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": "3",
... |
{
"abstract": "Iodine-123/iodine-131 (123I/131I)-metaiodobenzylguanidine (mIBG) scan is an established tool for the localization and treatment of neuroendocrine tumors such as paragangliomas (PGL). To minimize thyroid irradiation by the radioactive iodine in the mIBG preparation, blockade of thyroidal iodine uptake w... | [
{
"companynumb": "US-GE HEALTHCARE LIFE SCIENCES-2020CSU003728",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "IOBENGUANE I-123"
},
"drug... |
{
"abstract": "OBJECTIVE Postoperative cerebral venous sinus thrombosis (CVST) is an uncommon complication of posterior fossa surgery. The true incidence of and optimal management strategy for this entity are largely unknown. Herein, the authors report their institutional incidence and management experience of postop... | [
{
"companynumb": "US-TEVA-2019-US-1146560",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ENOXAPARIN SODIUM"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nAnaphylaxis to teicoplanin appears to be extremely rare, with only one confirmed case report worldwide. Two anaesthetic allergy clinics in the UK have received a number of suspected cases referred for investigation, and we present here the first case series of teicoplanin allergy.\n\n\nMETH... | [
{
"companynumb": "GB-WATSON-2016-00895",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "MIDAZOLAM\\MIDAZOLAM HYDROCHLORIDE"
},
"drugaddit... |
{
"abstract": "To report the incidence of endophthalmitis after the use of intravitreal injection for anti-vascular endothelial growth factor therapy.\n\n\n\nThis was a single-centre retrospective study conducted at the Aga Khan University Hospital, Pakistan. A total of 11 128 injections were administered to 2054 pat... | [
{
"companynumb": "PK-REGENERON PHARMACEUTICALS, INC.-2018-22767",
"fulfillexpeditecriteria": "1",
"occurcountry": "PK",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "AFLIBERCEPT"
},
"drugaddi... |
{
"abstract": "To explore the pharmacodynamics of mycophenolic acid (MPA) through inosine monophosphate dehydrogenase (IMPDH) capacity measurement and purine levels in peripheral blood mononuclear cells (PBMC) longitudinally during the first year after renal transplantation (TX).\n\n\n\nPBMC were isolated from renal ... | [
{
"companynumb": "NVSC2020NO045721",
"fulfillexpeditecriteria": "1",
"occurcountry": "NO",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nSCN1A is the gene that codes for the neuronal voltage-gated sodium-channel alpha-subunit 1. It is generally considered that an SCN1A truncating mutation causes the severe phenotype of Dravet syndrome.\n\n\nMETHODS\nWe describe 11- and 4-year-old male patients presenting with mild Dravet syn... | [
{
"companynumb": "JP-CIPLA LTD.-2017JP30681",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LAMOTRIGINE"
},
"drugadditional": "3",
... |
{
"abstract": "We present a case of a male kidney transplant patient harbouring two kidney grafts of which one is functional. In the failed graft, he developed urothelial cell carcinoma with cells containing XX-chromosome, and female tumour cells were also found in the bladder. The patient underwent donor nephrectomy... | [
{
"companynumb": "NL-ASTELLAS-2017US047790",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ATORVASTATIN"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nWe investigated selumetinib (AZD6244, ARRY-142886), an oral, potent, and highly selective, allosteric MEK1/2 inhibitor, plus platinum-doublet chemotherapy for patients with advanced/metastatic non-small cell lung cancer.\n\n\nMETHODS\nIn this Phase I, open-label study (NCT01809210), treatme... | [
{
"companynumb": "GB-PFIZER INC-2017430264",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "Eczema in children is a chronic disabling condition. The impact of this condition on the lives of families is often underestimated by conventional physicians. As a consequence parents may investigate complementary treatment options. Close monitoring by a paediatrician is essential, considering that a v... | [
{
"companynumb": "NL-BAUSCH-BL-2017-017169",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": "1",
... |
{
"abstract": "Therapeutic plasma exchange (TPE) has been demonstrated to be of significant clinical value in a number of diseases and conditions, with well-established guidelines and recommendations. However, technical support in providing this procedure for pregnant patients is largely absent from these recommendat... | [
{
"companynumb": "US-OCTA-LIT19718US",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HUMAN IMMUNOGLOBULIN G"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nBrugada syndrome may be unmasked by non-antiarrhythmic pharmaceuticals or drugs. Lacosamide is an antiepileptic agent with a novel mechanism of sodium channel inhibition and has the potential to cause cardiac sodium channel blockade.\nIn this report, we describe the case of patient with a h... | [
{
"companynumb": "US-UCBSA-2021023446",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "3",
... |
{
"abstract": "This study was aimed at determining if the myocardial performance index (MPI) is altered in well-controlled gestational diabetics and if so whether it is predictive of adverse perinatal outcome. In a prospective cross-sectional study, 54 consecutive women with well-controlled gestational diabetes contr... | [
{
"companynumb": "ZA-ALKEM LABORATORIES LIMITED-ZA-ALKEM-2019-07378",
"fulfillexpeditecriteria": "1",
"occurcountry": "ZA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
... |
{
"abstract": "BACKGROUND\nPerioperative epirubicin, cisplatin, and capecitabine (ECC) chemotherapy was evaluated in patients who underwent esophageal resection for adenocarcinoma of the esophagus or gastroesophageal junction (GEJ).\n\n\nMETHODS\nA cohort of 93 consecutive patients was analyzed. The median follow-up ... | [
{
"companynumb": "NL-CIPLA LTD.-2015NL00524",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUOROURACIL"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND As an uncommon malignancy with the highest prevalence in the elderly population, blastic plasmacytoid dendritic cell neoplasm or BPDCN is a hematologic disorder with unknown pathogenesis and devastating outcomes. This neoplasm usually manifests in the skin but can also involve the bone marro... | [
{
"companynumb": "US-CIPLA LTD.-2021US06771",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nHighly active antiretroviral therapy (HAART) is recommended to control the infection of HIV-1. HIV-1 drug resistance becomes an obstacle to HAART due to the accumulation of specific mutations in the RT coding region. The development of resistance mutations may be more complex than previousl... | [
{
"companynumb": "CN-CIPLA LTD.-2015CN08957",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "EFAVIRENZ"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nAcute portal vein thrombosis is a rare medical event usually seen in liver disease, but it can also occur due to any inherited or acquired procoagulable state that triggers venous occlusion. Hormonal therapies have been associated with an increased risk of prothrombotic states. This case re... | [
{
"companynumb": "US-ENDO PHARMACEUTICALS INC-2021-009884",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TESTOSTERONE"
},
"drugadditiona... |
{
"abstract": "Kava is an herbal remedy popular for centuries among native Pacific Islanders for its sedative effects and use in religious ceremonies. Kava gained popularity in Western countries due to its anxiolytic properties; however, very little is known about potential adverse reactions to kava other than report... | [
{
"companynumb": "US-GLAXOSMITHKLINE-B1025026A",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ROPINIROLE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nWe retrospectively evaluated the clinical outcomes of patients with histologic variants of muscle invasive bladder cancer (MIBC) treated with trimodal bladder-preserving therapy (TMT).\n\n\nMETHODS\nAmong 148 patients with clinical T2-3N0M0 MIBC treated with TMT at Tsukuba University Hospit... | [
{
"companynumb": "JP-HEALTHCARE PHARMACEUTICALS LTD.-2082095",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditi... |
{
"abstract": "BACKGROUND\nEosinophilic pneumonias are characterized by an increase in lung eosinophils. These disorders can be induced by drug reactions.\n\n\nMETHODS\nA 57-year-old woman suffering from bipolar disorder and treated by sodium divalproate for more than 2 years was hospitalised in the department of res... | [
{
"companynumb": "FR-SUN PHARMACEUTICAL INDUSTRIES LTD-2020R1-256997",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DIVALPROEX SODIUM"
},
... |
{
"abstract": "A 56-year-old woman with advanced gastric cancer with peritoneal metastasis was successfully treated with multidisciplinary therapy. Gastrectomy and total resection of the peritoneal metastasis were performed initially. Subsequently, combined chemotherapy with S-1/polysaccharide-Kureha( PSK) and intrap... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2016R1-110105",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "IRINOTECAN"
},
"drug... |
{
"abstract": "A 48-year old female patient was admitted to the emergency department with upper gastrointestinal bleeding. Endoscopy showed large esophageal varices that were treated with band ligation. She had been treated with cyclophosphamide, melphalan, lenalidomide and corticosteroids for POEMS syndrome (polyneu... | [
{
"companynumb": "PT-CELGENEUS-PRT-2017032112",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LENALIDOMIDE"
},
"drugadditional": "3",
... |
{
"abstract": "Following its discovery in Wuhan, China, in December 2019, COVID-19 has attained pandemic status in mere months. It is caused by SARS-CoV-2, an enveloped beta coronavirus. This infection causes a prothrombogenic state by interplay of inflammatory mediators, and endothelial, microvascular, and possible ... | [
{
"companynumb": "NVSC2020US331723",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HYDROXYCHLOROQUINE"
},
"drugadditional": null,
... |
{
"abstract": "Hypereosinophilic syndrome is characterized by an overproduction of eosinophils that infiltrate and damage multiple organs. Cardiac dysfunction occurs frequently and is a main cause of morbidity and mortality. We describe the case of a middle-aged man diagnosed with a myeloproliferative neoplasm associ... | [
{
"companynumb": "PHHY2018PT102751",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "IMATINIB"
},
"drugadditional": null,
"drugad... |
{
"abstract": "Purpose: This open-label, multicenter, dose-finding, phase Ib study (NCT01546038) evaluated the safety, pharmacokinetics, pharmacodynamics, and clinical activity of the novel Hedgehog pathway Smoothened inhibitor glasdegib (PF-04449913) in patients (N = 52) with acute myeloid leukemia (AML) or high-ris... | [
{
"companynumb": "US-PFIZER INC-2012303670",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AMPHOTERICIN B"
},
"drugadditional": "1",
... |
{
"abstract": "Ruxolitinib side effects include the most frequent hematological toxicity along with a more recently evidenced immunosuppressive activity, interfering both with the innate and adaptive immunity, and several cases of reactivation of latent infections by opportunistic agents in patients in treatment with... | [
{
"companynumb": "IT-LUPIN PHARMACEUTICALS INC.-2021-17905",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "RIFAMPIN"
},
"drugadditional":... |
{
"abstract": "The opioid epidemic has led to increased availability of organs for liver transplantation. The success of direct-acting antiviral therapy for hepatitis C (HCV) has led to the acceptance of HCV viremic donor organs. Nucleic acid testing (NAT) has led to increased detection of HCV and hepatitis B (HBV) i... | [
{
"companynumb": "US-009507513-2112USA005470",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RIBAVIRIN"
},
"drugadditional": "3",
... |
{
"abstract": "Kaposi sarcoma (KS) is an angioproliferative disease associated with human herpesvirus 8 (HHV-8). We report the case of a 10-year-old male from a high HHV-8 prevalence area, diagnosed with severe aplastic anemia who underwent an upfront hematopoietic stem cell transplantation (HSCT). Five months after ... | [
{
"companynumb": "ES-TEVA-2022-ES-2028291",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": "1",
... |
{
"abstract": "We retrospectively examined 106 cases of tapentadol use in Japan in August 2014 for cancer pain at our hospital.The advantage of the opioid medication tapentadol is that its introduction is suitable in patients undergoing anti-cancer treatment because of the low incidence of gastrointestinal symptoms, ... | [
{
"companynumb": "JP-COLLEGIUM PHARMACEUTICAL, INC.-JP-2019COL000890",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FENTANYL CITRATE"
},
... |
{
"abstract": "BACKGROUND\nNo data is available regarding the safety of bevacizumab, an anti-vascular endothelial growth factor-A (VEGF-A) antibody, in patients with pulmonary arterial hypertension (PAH), a condition in which VEGF seems to play a significant and probably protective role.\n\n\nMETHODS\nWe report a pat... | [
{
"companynumb": "FR-ACTELION-A-CH2017-164009",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BOSENTAN"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nNeuroendocrine tumors are rare, heterogeneous neoplasms that produce a wide variety of clinical symptoms. Diarrhea in neuroendocrine tumors is incredibly common and is usually benign in nature. We report two extreme cases of diarrhea in metastatic neuroendocrine tumors that threatened fatal... | [
{
"companynumb": "AU-LUPIN PHARMACEUTICALS INC.-2022-06231",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HYDROCORTISONE BUTYRATE"
},
"d... |
{
"abstract": "Ursodeoxycholic acid (UDCA) is commonly used to treat several liver disorders in adults and children, including primary sclerosing cholangitis (PSC) for which it is not U.S. Food and Drug Administration approved. UDCA treatment has an uncertain impact on disease outcomes and has been reported in high d... | [
{
"companynumb": "US-ALLERGAN-1937671US",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "UNSPECIFIED INGREDIENT"
},
"drugadditional": nul... |
{
"abstract": "Multifocal lymphangioendotheliomatosis with thrombocytopenia (MLT) is a recently described glucose transporter 1-negative multifocal vascular disorder with significant morbidity and mortality. However, data are lacking on the clinical spectrum, long-term prognosis, and treatment of MLT. It is often con... | [
{
"companynumb": "PHHY2015FR081481",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OCTREOTIDE"
},
"drugadditional": null,
"drug... |
{
"abstract": "OBJECTIVE\nAccidental extravasation is a serious iatrogenic injury among patients receiving anthracycline-containing chemotherapy. The aim of this work is to present a combination therapy for chest wall reconstruction following epirubicin extravasation.\n\n\nMETHODS\nHerein, we report a 68-year-old wom... | [
{
"companynumb": "DE-CIPLA LTD.-2017DE21410",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "EPIRUBICIN"
},
"drugadditional": "3",
... |
{
"abstract": "Because of the limited geographic distribution, there have been insufficient data regarding hepatitis C virus (HCV) genotype 6 in Korea. This study aimed to investigate the clinical characteristics and available treatment outcomes of patients with genotype 6 HCV in Korea.\nFrom 2004 to 2014, data were ... | [
{
"companynumb": "KR-ROCHE-1038068",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PEGINTERFERON ALFA-2B"
},
"drugadditional": "3",
... |
{
"abstract": "Male-to-female transsexual persons use oestrogens + antiandrogens to adapt their physical bodies to the female sex. Doses are usually somewhat higher than those used by hypogonadal women receiving oestrogen replacement. Particularly in cases of self-administration of cross-sex hormones, doses may be ve... | [
{
"companynumb": "PHHY2015BR094203",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ESTRADIOL ENANTHATE"
},
"drugadditional": null,
... |
{
"abstract": "Diagnosis of aortic dissection complicating cerebral ischemic stroke is difficult. A 60-year-old patient presented at an emergency department of a hospital with a sudden development of left-sided weakness, but without chest pain. During administration of recombinant tissue plasminogen activator with di... | [
{
"companynumb": "JP-ROCHE-1866110",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "We present a case of pediatric ALF, secondary to hepatic HL, who underwent a successful ABOi living donor liver transplant. We believe this is the first such case reported in academic literature. HL with liver involvement is extremely rare and is not considered an indication for transplantation. The 12... | [
{
"companynumb": "ZA-PFIZER INC-2020297517",
"fulfillexpeditecriteria": "1",
"occurcountry": "ZA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
... |
{
"abstract": "Metronidazole is a very widely used drug for the treatment of multiple ailments caused by anaerobic bacteria as well as some protozoan parasites. Though its usual side effects are not very serious, yet sometimes it may cause profound adverse effects like neurotoxicity. We present here a case of liver a... | [
{
"companynumb": "IN-VIVIMED-2017SP015260",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "Lupus nephritis (LN) requires renal replacement therapy in 10%-30% of patients. About 30% of these patients receive a kidney transplant. Belatacept is a second-generation, selective, T-cell co-stimulator blocker (inhibits cytotoxic, T-lymphocyte antigen 4, CTLA-4) used as an alternative to calcineurin ... | [
{
"companynumb": "ES-SUN PHARMACEUTICAL INDUSTRIES LTD-2020R1-236886",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drug... |
{
"abstract": "Marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) is associated with chronic inflammatory disorders. We present an indolent pancolonic MALT lymphoma occurring in a 39-year-old female with history of autoimmune hepatitis requiring liver transplant in 1997 and ulcerative colitis... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2017US-156197",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drug... |
{
"abstract": "We present a series of 12 patients with telaprevir-induced skin toxicity. Some patients presented eczematous lesion, while others presented nonscaling macular lesions that became more purpuric in the lower limbs. Seven of the 12 patients had skin lesions affecting more than 50% of the body surface area... | [
{
"companynumb": "ES-VERTEX PHARMACEUTICALS-2014-004757",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "RIBAVIRIN"
},
"drugadditional": n... |
{
"abstract": "A 49-year-old woman was admitted to our hospital because of a tumor in her right breast. The tumor was localized to the C area and was approximately 3 cm in size. A right axillary lymphadenopathy was also found. Histopathological examination and needle biopsy of the breast tumor revealed invasive lobul... | [
{
"companynumb": "JP-ROCHE-2896083",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "NIVOLUMAB"
},
"drugadditional": null,
"drug... |
{
"abstract": "Duodenal adenocarcinoma (DA) is a subtype of small bowel adenocarcinoma (SBA). Compared with gastrointestinal cancers such as colorectal cancer and gastric cancer, SBA is less common. For patients with advanced and metastatic DA, chemotherapies are usually extrapolated from colorectal cancer and gastri... | [
{
"companynumb": "CN-MLMSERVICE-2021090930976361",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nThe optimal chemotherapy regimen for treating HIV associated NHL in low resource settings is unknown. We conducted a retrospective study to describe survival rates, treatment response rates and adverse events in patients with HIV associated NHL treated with CHOP and dose adjusted-EPOCH regi... | [
{
"companynumb": "UG-EDENBRIDGE PHARMACEUTICALS, LLC-UG-2020EDE000040",
"fulfillexpeditecriteria": "1",
"occurcountry": "UG",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
... |
{
"abstract": "BACKGROUND\nIn cases of loop diuretic resistance in the intensive care unit (ICU), recommendations for a specific second-line thiazide agent are lacking.\n\n\nOBJECTIVE\nTo compare the effects of intravenous chlorothiazide (CTZ) and enteral metolazone (MET) on urine output (UOP) when added to furosemid... | [
{
"companynumb": "US-UCBSA-2017010312",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FUROSEMIDE"
},
"drugadditional": "3",
"dr... |
{
"abstract": "Intravenous immunoglobulin therapy is FDA approved for the immune-mediated peripheral nerve disorders Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy. Immunoglobulin therapy has been used increasingly with significant efficacy in the treatment... | [
{
"companynumb": "US-OCTA-LIT04119US",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HUMAN IMMUNOGLOBULIN G"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nEszopiclone, sold under the brand name Lunesta, is a new type of non-benzodiazepine hypnotic. Eszopiclone is a zopiclone dextrorotation, which is classified as a cyclopyrrolone. It functions by binding gamma-aminobutyric acid (GABA) receptors. Compared with benzodiazepines hypnotics, eszopi... | [
{
"companynumb": "CN-ACCORD-231030",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ESZOPICLONE"
},
"drugadditional": "1",
"drug... |
{
"abstract": "We report 17 cases of glucose-6-phosphate dehydrogenase (G6PD) deficiency with drug-induced haemolytic anaemia. In most cases the drug involved was an antimalarial. However, we also found two cases in which other drugs could have been responsible for the haemolysis. The degree of severity of haemolysis... | [
{
"companynumb": "IN-SA-2018SA005270",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PRIMAQUINE PHOSPHATE"
},
"drugadditional": "3",
... |
{
"abstract": "5-Fluorouracil (5-FU) based chemotherapy has been commonly used to treat metastatic or advanced colon cancer as an adjuvant chemotherapy. Although the side effects of 5-FU such as gastrointestinal problems and neutropenia and thrombocytopenia are common, not many cases of 5-FU related encephalopathy ar... | [
{
"companynumb": "KR-SPECTRUM PHARMACEUTICALS, INC.-16-F-KR-00053",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "FLUOROURACIL"
},
"druga... |
{
"abstract": "Plasma cell myeloma (PCM) is rare in children and young adults and therefore may be difficult to diagnose. Here we report the clinicopathologic findings of 4 patients under the age of 30 diagnosed with PCM at our institution and summarize the literature about 48 other cases of PCM in this age group. Th... | [
{
"companynumb": "US-009507513-1708USA010156",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LENALIDOMIDE"
},
"drugadditional": "3",
... |
{
"abstract": "Pain is a prevalent condition in patients with cancer, particularly in advanced stages of cancer. Although strong opioids are the mainstay of cancer pain management protocols, patients are often undertreated. Transdermal buprenorphine is currently available for the treatment of moderate to severe cance... | [
{
"companynumb": "PHHY2015BE152857",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FENTANYL"
},
"drugadditional": null,
"druga... |
{
"abstract": "Progressive multifocal leukoencephalopathy (PML) is a rare opportunistic brain infection caused by the human polyomavirus JC (JCPyV). A particular problem with the drug cladribine seems to be prolonged suppression of the CD4+ T-cells, a well-known risk factor for PML.\n\n\n\nA 67-year-old male presente... | [
{
"companynumb": "NO-FRESENIUS KABI-FK201701183",
"fulfillexpeditecriteria": "1",
"occurcountry": "NO",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CLADRIBINE"
},
"drugadditional": null,
... |
{
"abstract": "Statins, which are used as first-line drugs in the prevention of cardiovascular disease, are usually safe, but in some cases there may be muscular toxicity. Statin-associated myopathy, can present as myalgia, myositis or rhabdomyolysis. Only 0.44 per 10,000 treated and per year, develop rhabdomyolysis.... | [
{
"companynumb": "ES-LUPIN PHARMACEUTICALS INC.-2016-03789",
"fulfillexpeditecriteria": "2",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "FENOFIBRATE"
},
"drugadditiona... |
{
"abstract": "The horizontal transfer of a plasmid bearing the blaKPC-2 gene from K. pneumoniae to E. cloacae infecting the respiratory tract of a patient during meropenem therapy was elucidated. This finding is particularly worrisome, since these drugs are of last resort for multidrug-resistant Gram-negative pathog... | [
{
"companynumb": "BR-PFIZER INC-2017SE67357",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PIPERACILLIN SODIUM\\TAZOBACTAM SODIUM"
},
"... |
{
"abstract": "Restoration of immune response by highly active antiretroviral therapy (HAART) effectively improved the overall prognosis of HIV infection. However, 25%-31.7% of patients experience paradoxical worsening of pre-existing infections or unmasking of subclinical infections after starting HAART therapy, whi... | [
{
"companynumb": "US-TEVA-2018-US-882683",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOLUTEGRAVIR"
},
"drugadditional": "3",
... |
{
"abstract": "Topiramate, which interacts with multiple neurotransmitter and enzyme systems, is approved by the Food and Drug Administration to treat seizure disorder, prevent migraine, and (in combination with phentermine) reduce weight. Topiramate has also been shown in multiple studies to reduce heavy drinking. T... | [
{
"companynumb": "US-JNJFOC-20141004238",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TOPIRAMATE"
},
"drugadditional": null,
... |
{
"abstract": "Dysphagia is listed as a 'rare' side effect following clozapine treatment. In this case report, we describe how significant clozapine-induced dysphagia has led to significant reduction of nutritional intake with subsequent substantial weight loss. An 18-year-old single man with an established diagnosis... | [
{
"companynumb": "IE-MYLANLABS-2016M1039638",
"fulfillexpeditecriteria": "1",
"occurcountry": "IE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLOZAPINE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nLong-acting depot preparations of antipsychotics are the mainstay of treatment for patients with schizophrenia who show nonadherence to their medications. Olanzapine pamoate is one of the recently approved long-acting depot psychotropic preparations that have shown its efficacy both in clini... | [
{
"companynumb": "IN-JUBILANT CADISTA PHARMACEUTICALS-2019JUB00127",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "OLANZAPINE"
},
"drugad... |
{
"abstract": "We describe the third case report of seroconversion with multidrug resistant (MDR)-HIV despite pre-exposure prophylaxis (PrEP) with emtricitabine (FTC) and tenofovir (TFV) disoproxil (TDF).\n\n\n\nCase report.\n\n\n\nPrEP adherence was assessed via self-report, pharmacy records, and measuring TFV/FTC l... | [
{
"companynumb": "US-GILEAD-2018-0325420",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "EMTRICITABINE\\TENOFOVIR DISOPROXIL FUMARATE"
},
... |
{
"abstract": "A 62-year-old white man with a 10-year history of treatment-refractory Sweet's syndrome was admitted to the hospital with the onset of purpuric lesions. Methylprednisolone and infliximab were administered. Our patient developed disseminated Nocardia infection and eventually succumbed. Opportunistic inf... | [
{
"companynumb": "US-JNJFOC-20140902900",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "Refractory ventricular fibrillation occurs when there are three or more episodes of ventricular fibrillation within a 24-hour period. We report the first case of a 35-year-old woman without prior medical or family cardiac history who sustained refractory ventricular fibrillation while taking Lamictal f... | [
{
"companynumb": "US-UNICHEM PHARMACEUTICALS (USA) INC-UCM201807-000162",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LAMOTRIGINE"
},
"... |
{
"abstract": "The coronavirus disease 2019 (COVID-19) pandemic has been an enormous public health challenge. The pursuit for an effective therapy led to the use of the antiviral drug Remdesivir for hospitalized patients with severe COVID-19 pneumonia. We reported two cases of patients with severe COVID-19 pneumonia ... | [
{
"companynumb": "QA-GILEAD-2021-0545478",
"fulfillexpeditecriteria": "1",
"occurcountry": "QA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "REMDESIVIR"
},
"drugadditional": "1",
... |
{
"abstract": "Severe coronavirus disease 2019 (COVID-19) has been increasingly recognized as a multisystem disease. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can infect literally any cell type that expresses its target receptor angiotensin-converting enzyme 2. However, COVID-19-associated organ dy... | [
{
"companynumb": "CH-LUPIN PHARMACEUTICALS INC.-2021-26217",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugad... |
{
"abstract": "We report a case of a 5-year-old girl with persistent fetal vasculature who presented with unilateral acute angle closure caused by aqueous misdirection syndrome that was apparently associated with regression of cycloplegia. Initial treatment with topical steroids, anti-glaucomatous drops, and atropine... | [
{
"companynumb": "BR-LANNETT COMPANY, INC.-BR-2018LAN000020",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ATROPINE SULFATE\\DIPHENOXYLATE HYDROCHLORIDE"
... |
{
"abstract": "OBJECTIVE\nTo investigate the clinical efficacy of haploid hematopoietic stem cells (haplo-HSC) combined with third-party umbilical cord blood (tpCB) transplantation in the treatment of X-linked chronic granulomatous disease (X-CGD).\n\n\nMETHODS\nThe clinical data of 26 boys with X-CGD were retrospect... | [
{
"companynumb": "NVSC2019CN033139",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": null,
... |
{
"abstract": "Synchronous quadriceps tendon rupture is rare. A 29-year-old man, an amateur weight lifter, taking androgenic-anabolic steroids (AAS), developed sudden onset bilateral pain and swelling of his anterior thighs when attempting to squat 280 kg (620 lb). Examination revealed gross swelling superior to the ... | [
{
"companynumb": "IE-ENDO PHARMACEUTICALS INC-2016-004186",
"fulfillexpeditecriteria": "1",
"occurcountry": "IE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TESTOSTERONE"
},
"drugadditiona... |
{
"abstract": "Gemtuzumab ozogamicin (GO) remained available to US clinicians through an open-label expanded-access protocol (NCT02312037) until GO was reapproved. Patients were aged ≥3 months with relapsed/refractory (R/R) acute myeloid leukemia (AML), high-risk myelodysplastic syndrome, or acute promyelocytic leuke... | [
{
"companynumb": "US-CORDEN PHARMA LATINA S.P.A.-US-2020COR000020",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"d... |
{
"abstract": "Acute promyelocytic leukemia (APL) is characterized by fusion of PML/RARα genes as a result of t(15;17)(q24;q21). APL is now one of the curable hematological malignancies thanks to molecularly targeted therapies based on all-trans retinoic acid (ATRA) and arsenic trioxide (ATX). Extramedullary (EM) rel... | [
{
"companynumb": "IT-PFIZER INC-2019338697",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TRETINOIN"
},
"drugadditional": "3",
... |
{
"abstract": "The use of concurrent doublet chemotherapy with radiation for locoregionally advanced cervical cancer (LACC) is limited by gastrointestinal and hematologic toxicity. By reducing radiation dose to bowel and bone marrow, image guided intensity modulated radiation therapy (IG-IMRT) may improve chemotherap... | [
{
"companynumb": "US-MYLANLABS-2020M1080734",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "GEMCITABINE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nClinical indications of immune checkpoint inhibitors have expanded to a variety of malignancies. Nearly 50% of patients with advanced cutaneous squamous cell carcinoma, respond to the programmed-death 1 inhibitor cemiplimab. To date, insulin-dependent diabetes mellitus has been documented w... | [
{
"companynumb": "US-SA-2021SA400238",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CEMIPLIMAB-RWLC"
},
"drugadditional": "1",
... |
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