article dict | reports listlengths 1 3.97k |
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{
"abstract": "BACKGROUND\nPembrolizumab is an anti-programmed death receptor 1 (PD-1) that was shown to have a tolerable safety profile with 17% of grade 3-4 drug-related adverse events, notable response rate of 16% with median duration of response of 8 mo, and median overall survival of 8 mo. Severe mucositis is a ... | [
{
"companynumb": "US-TEVA-2020-US-1848928",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
... |
{
"abstract": "Several studies have shown that NNRTI/PI-based triple therapy could be safely administered as a 4 days (4D) or 5 days (5D) a week maintenance strategy. We report here our experience of using an integrase inhibitor (INSTI)-based 4D/5D regimen in virologically suppressed HIV patients.\n\n\n\nThis cohort ... | [
{
"companynumb": "FR-GLAXOSMITHKLINE-FR2018218987",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LAMIVUDINE"
},
"drugadditional": null,
... |
{
"abstract": "Abstract Serum aminotransferase elevations are a commonly known adverse effect of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) therapy. However, hepatotoxic events have not been widely published with ezetimibe or the combination agent simvastatin-ezetimibe. We describe a 70-year-o... | [
{
"companynumb": "DE-RANBAXY-2013R1-66841",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ENALAPRIL"
},
"drugadditional": null,
... |
{
"abstract": "We report a rare case of lymphangitis carcinomatosa in a 66-year-old man with a relatively long survival of 18 months following chemotherapy.The patient initially presented with dyspnea and lower abdominal pain.Subsequent colonoscopy detected adenocarcinoma of the descending colon, and computed tomogra... | [
{
"companynumb": "JP-ROCHE-1563146",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "IRINOTECAN HYDROCHLORIDE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo describe the association of amnestic nocturnal eating behavior with use of zolpidem for insomnia.\n\n\nBACKGROUND\nSleep-related eating disorder is increasingly recognized in relationship to other diagnosable sleep disorders. Many of these disorders, like restless legs syndrome (RLS), giv... | [
{
"companynumb": "US-APOTEX-2018AP019316",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ROPINIROLE"
},
"drugadditional": "3",
... |
{
"abstract": "Background and Objectives: Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is a viral disease that is spreading worldwide and became a pandemic. Although most of the time, the symptoms of the infection are flu like, a percentage of p... | [
{
"companynumb": "RO-GILEAD-2021-0519395",
"fulfillexpeditecriteria": "1",
"occurcountry": "RO",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "SODIUM CHLORIDE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nPreoperative concurrent chemoradiation therapy (CRT) with either capecitabine or 5-florouracil/leucovorin (5 FU/LV) is the standard of care in locally advanced rectal cancer (LARC). Literature comparing the toxicity and response of these two regimens in Indian patients is sparse. Our object... | [
{
"companynumb": "IN-ROCHE-1936370",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CAPECITABINE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "The inadvertent administration of a concentrated vancomycin solution to a 47 day-old premature male twin resulted in extremely high vancomycin levels and altered renal function. A 1.5 volume exchange transfusion did not change the measured vancomycin level. Multiple doses of oral activated charcoal, 1 ... | [
{
"companynumb": "US-PFIZER INC-2017030244",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "GENTAMICIN SULFATE"
},
"drugadditional": null,... |
{
"abstract": "Porphyrias are rare genetic disorders which cause a deficiency in the enzymes involved in the biosynthesis of heme. The treatment of epilepsy in patients with acute intermittent porphyria can be difficult since many anticonvulsants can increase heme synthesis and trigger porphyric attacks. We report a ... | [
{
"companynumb": "CA-LUNDBECK-DKLU3018932",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TOPIRAMATE"
},
"drugadditional": null,
... |
{
"abstract": "Because of its characteristic features of autoinfection, the parasitic nematode Strongyloides stercoralis can infect patients for years. An acceleration of its autoinfective cycle can be triggered by human T-lymphotropic virus-1 (HTLV-1) infection, mainly by the deviation of the protective Th2- to Th1-... | [
{
"companynumb": "FR-MLMSERVICE-20211006-3154167-1",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ACYCLOVIR"
},
"drugadditional": "4",
... |
{
"abstract": "Immediate hypersensitivity reactions to systemic steroids are reported rarely in the literature. The authors present a case of Behçet's disease-associated panuveitis in a patient with skin test confirmed immunoglobulin E-mediated allergy to methylprednisolone and reported allergic reaction to prednison... | [
{
"companynumb": "US-HIKMA PHARMACEUTICALS USA INC.-US-H14001-21-55470",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"dr... |
{
"abstract": "Laryngospasm is a potential complication after general anesthesia that is universally dreaded because the failure to act swiftly and effectively could be fatal for the patient. This case report involves a morbidly obese male patient who received his first general anesthetic and experienced 4 episodes o... | [
{
"companynumb": "US-HIKMA PHARMACEUTICALS USA INC.-US-H14001-20-05241",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
... |
{
"abstract": "This article describes three complicated cases in rheumatology and pregnancy. The first case elucidates the challenges in treating SLE in conjunction with pulmonary arterial hypertension, while the second case features an SLE-affected pregnancy with development of portal hypertension secondary to porta... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2018SP008206",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"dru... |
{
"abstract": "Atorvastatin and warfarin are commonly prescribed in combination. Acute rhabdomyolysis is a rare but recognized side effect of atorvastatin occurring within a few weeks of initiation. This article presents a case of a 69-year-old man, on stable atorvastatin therapy, who developed acute rhabdomyolysis f... | [
{
"companynumb": "GB-ALKEM LABORATORIES LIMITED-GB-ALKEM-2022-02254",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ATORVASTATIN CALCIUM"
},
... |
{
"abstract": "A 15-day-old boy was admitted to the hospital due to repeated convulsions for 14 days. The main clinical manifestations were uncontrolled seizures, hypoergia, feeding difficulties, limb hypotonia, and bilateral hearing impairment. Clinical neurophysiology showed reduced brainstem auditory evoked potent... | [
{
"companynumb": "CN-UCBSA-2021053084",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "4",
... |
{
"abstract": "To evaluate initial magnetic resonance imaging (MRI) abnormalities in infantile spasms, correlate them to clinical characteristics, and describe repeat imaging findings.\n\n\n\nA retrospective review of infantile spasm patients was conducted, classifying abnormal MRI into developmental, acquired, and n... | [
{
"companynumb": "US-LUNDBECK-DKLU2046741",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VIGABATRIN"
},
"drugadditional": "3",
... |
{
"abstract": "Pharmacological stress tests using dipyridamole are considered to be safe. However, cases of atrioventricular (AV) block have been reported. We retrospectively analyzed ECG at baseline and during dipyridamole stress tests of 2010 consecutive patients (patients with second or third degree AV block were ... | [
{
"companynumb": "IL-OXFORD PHARMACEUTICALS, LLC-2018OXF00049",
"fulfillexpeditecriteria": "1",
"occurcountry": "IL",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DIPYRIDAMOLE"
},
"drugaddit... |
{
"abstract": "We have identified ten children who developed gastritis after prolonged anticonvulsant therapy that included either valproic acid or divalproex sodium. Presenting symptoms were primarily feeding difficulties, including anorexia and refusal to eat. Vomiting was present in two thirds of the patients, wit... | [
{
"companynumb": "US-ABBVIE-17P-163-2186911-00",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VALPROIC ACID"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nTopiramate (TPM), an anti-epileptic drug with >4 million users, increases renal stones in adults. We screened outpatient TPM-treated children without history of stones to estimate the prevalence of renal stones and to characterize urine stone-risk profiles.\n\n\nMETHODS\nChildren taking TPM... | [
{
"companynumb": "US-JNJFOC-20131200490",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TOPIRAMATE"
},
"drugadditional": null,
... |
{
"abstract": "Hypercalcemia is a common electrolyte disorder and is typically caused by parathyroid-dependent and parathyroid-independent causes. The most common parathyroid-independent causes include malignancy, granulomatous diseases, over-supplementation with calcium, and hypervitaminosis D. We present an unusual... | [
{
"companynumb": "US-TEVA-2020-US-1863322",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "QUETIAPINE"
},
"drugadditional": "3",
... |
{
"abstract": "Donor cell leukemia is a very rare cause of relapse after allogeneic hematopoietic cell transplantation (alloHCT). Herein, we describe an unprecedented case of donor cell-derived chronic myelomonocytic leukemia (CMML) presenting seven years after a 51-year-old man received a matched-related alloHCT fro... | [
{
"companynumb": "US-GLENMARK PHARMACEUTICALS-2021GMK051617",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "THYMOCYTE IMMUNE GLOBULIN NOS"
},
... |
{
"abstract": "Immunosuppressed patients such as solid organ transplant and hematologic malignancy patients appear to be at increased risk for morbidity and mortality due to coronavirus disease 2019 (COVID-19) caused by SARS coronavirus 2 (SARS-CoV-2). Convalescent plasma, a method of passive immunization that has be... | [
{
"companynumb": "US-LUPIN PHARMACEUTICALS INC.-2022-06613",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "HYDROXYCHLOROQUINE"
},
"drugad... |
{
"abstract": "One of the standard distinctions between type 1 (non-immune) and type 2 (immune-mediated) heparin-induced thrombocytopenia (HIT) is the transience of thrombocytopenia: type 1 HIT is viewed as early-onset and transient thrombocytopenia, with platelet count recovery despite continuing heparin administrat... | [
{
"companynumb": "CA-PFIZER INC-2017473160",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": "1",
... |
{
"abstract": "Mutations in the gene ACTA2 are a recognized cause of aortic aneurysms with aortic dissection in adulthood. Recently, a specific mutation (Arg179His) in this gene has been associated with multisystem smooth muscle dysfunction presenting in childhood. We describe 3 patients with an R179H mutation, all o... | [
{
"companynumb": "US-ACTELION-A-CH2015-121056",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BOSENTAN"
},
"drugadditional": null,
... |
{
"abstract": "Salicylate-induced acute respiratory syndrome (ARDS) is a well-known entity occurring in 35% of salicylate-intoxicated patient. Careful history taking, physical examination, arterial blood gas analysis, and measurement of serum salicylate concentration will lead to early recognition to initiate appropr... | [
{
"companynumb": "JP-NOVAST LABORATORIES, LTD-JP-2018NOV000417",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ASPIRIN\\CARISOPRODOL"
},
... |
{
"abstract": "BACKGROUND\nPsoriasis is immune-mediated chronic inflammatory disease with preference for skin and joints. The skin involvement occurs by hyperproliferation and abnormal differentiation of keratinocytes. It is associated with comorbidities, mainly related to the clinical manifestations of the metabolic... | [
{
"companynumb": "BR-JNJFOC-20160725950",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "Valproic acid (VPA) and derivatives are effective anticonvulsants that are also used for numerous mood disorders. VPA toxicity can cause central nervous system (CNS) depression, dose related hyperammonemia, and eventually hepatotoxicity. While traditional treatment of VPA toxicity often includes l-carn... | [
{
"companynumb": "US-MLMSERVICE-20211019-3166003-1",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "4... |
{
"abstract": "Idiopathic Pulmonary Fibrosis (IPF) is a chronic fibrosing lung condition with high morbidity and mortality, accounting for about 25% of the cases of interstitial lung diseases. It usually has a progressive course resulting in death due to respiratory failure. Myasthenia Gravis (MG) is an autoimmune ne... | [
{
"companynumb": "IN-PFIZER INC-2016253444",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": null,
"drugadditional": null,
"drugadministrationroute": null,
"drugautho... |
{
"abstract": "A 2-year-and-7-month-old boy underwent an emergent reconstruction surgery of the right ventricle-pulmonary artery (RV-PA) conduit. Although he was successfully weaned from cardiopulmonary bypass (CPB) after reconstruction of the RV-PA conduit, the bleeding continued despite the massive transfusion of r... | [
{
"companynumb": "JP-WATSON-2016-01097",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "NITRIC OXIDE"
},
"drugadditional": null,
... |
{
"abstract": "Limited data exists regarding toxicity of calcium channel blockers (CCBs) in children. The purpose of this study was to determine the frequency, the range of toxicity, the appropriate observation time, and to assess effective interventions for CCB ingestions in children. A 6-year retrospective review o... | [
{
"companynumb": "US-LUPIN PHARMACEUTICALS INC.-2015-03662",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "AMLODIPINE BESYLATE"
},
"drug... |
{
"abstract": "BACKGROUND\nAnaphylactic shock and pulmonary edema are unusual but life-threatening adverse reactions to drugs. We encountered a case of serious anaphylactic shock and acute pulmonary edema caused by a single oral intake of acetazolamide, a frequently used medication by several medical specialties espe... | [
{
"companynumb": "GR-MYLANLABS-2018M1020556",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAZOLAMIDE"
},
"drugadditional": "3",
... |
{
"abstract": "The impact of selective surgical resection for patients with esophageal cancer treated with definitive chemoradiation has not been clearly evaluated long-term.\n\n\n\nNRG (National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, Gynecologic Oncology Group) Oncology Radiati... | [
{
"companynumb": "PHHY2017US196756",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "GRANULOCYTE COLONY-STIMULATING FACTOR NOS"
},
"drugadd... |
{
"abstract": "We report the case of a 51-year-old woman who had a medical history of diabetes, depression with past suicide attempts, and suicidal ideation. She was found unresponsive in a motel with multiple bottles of medicines (melatonin, carisoprodol, ativan, and clonazepam) and an unopened bottle of wine. She w... | [
{
"companynumb": "US-MYLANLABS-2012040152",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CARISOPRODOL"
},
"drugadditional": null,
... |
{
"abstract": "Immune Reconstitution Inflammatory Syndrome (IRIS) is an inflammatory syndrome in the context of immune restoration directed at a specific infectious antigen despite resolution of infection, often associated with opportunistic infections. IRIS has been reported in 30% to 35% of HIV patients who have cr... | [
{
"companynumb": "US-PFIZER INC-2020221739",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "Concomitant arterial and venous thrombosis is an infrequent event often associated with malignancy, hyperhomocysteinemia, and thrombophilic conditions. Some overlapping pathophysiology mechanisms suggest an association between arterial and venous thrombosis. It is reported that thrombosis in the arteri... | [
{
"companynumb": "US-NATCO PHARMA LIMITED-2118384",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ANASTROZOLE"
},
"drugadditional": null... |
{
"abstract": "BACKGROUND\nPediatric acute-liver-failure due to acetaminophen (APAP) administration at therapeutic dosage is rare, while viral infections and metabolic defects are the prevalent causes. Yet, as acetaminophen is routinely used in febrile illnesses, it may be mistakenly held responsible for the acute li... | [
{
"companynumb": "US-G+W LABS-GW2018US000085",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": "1",
... |
{
"abstract": "Approximately 30-45% of patients with familial Mediterranean fever (FMF) have been reported to have attacks despite colchicine treatment. Currently, data on the treatment of colchicine-unresponsive or colchicine-intolerant FMF patients are limited; the most promising alternatives seem to be anti-interl... | [
{
"companynumb": "PHHY2018TR002726",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CANAKINUMAB"
},
"drugadditional": "3",
"drug... |
{
"abstract": "COVID-19 is a life-threatening infection among elderly patients, comorbid patients, or transplanted patients. Lombardy (region of Italy), accounts for 786,324 cases as of 21 April 2021. We retrospectively describe our single Centre experience in 82 adult kidney-transplant patients with COVID-19 infecti... | [
{
"companynumb": "IT-LUPIN PHARMACEUTICALS INC.-2021-22388",
"fulfillexpeditecriteria": "2",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "HYDROXYCHLOROQUINE"
},
"drugad... |
{
"abstract": "Hyperemesis gravidarum is a disabling condition. It is not uncommon that patients request termination of pregnancy because of intolerable symptoms and psychological stress. We report a case in which termination of pregnancy was avoided by the use of ondansetron to treat the hyperemesis gravidarum.",
... | [
{
"companynumb": "PHHY2019HK116121",
"fulfillexpeditecriteria": "1",
"occurcountry": "HK",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METOCLOPRAMIDE"
},
"drugadditional": "3",
"d... |
{
"abstract": "Acute carpal tunnel syndrome is an uncommon diagnosis most often related to blunt trauma requiring immediate surgical decompression to avoid serious sequelae. Patients who present with bleeding-related acute carpal tunnel syndrome tend to have severe pain, rapid onset of swelling, and neurologic sympto... | [
{
"companynumb": "US-BAYER-2015-279303",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": null,
"dru... |
{
"abstract": "OBJECTIVE\nThe impact of donor-specific anti-human leukocyte antigen (HLA) antibodies (DSAs) on living donor liver transplantation (LDLT) is unclear. The aim of this study was to investigate the association between DSAs and short-term outcomes in LDLT recipients, and to clarify the clinical impact of D... | [
{
"companynumb": "JP-ROCHE-2435951",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo present a case of localized retinal detachment and mild vitreous hemorrhage in a patient with oculocutaneous albinism following accidental intraocular injection of botulinum toxin A.\n\n\nMETHODS\nBotulinum toxin A injection were administered to a 5-year old oculocutaneous albinism patien... | [
{
"companynumb": "SA-IPSEN BIOPHARMACEUTICALS, INC.-2021-14360",
"fulfillexpeditecriteria": "1",
"occurcountry": "SA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BOTULINUM TOXIN TYPE A"
},
... |
{
"abstract": "Serotonin syndrome (SS), a potentially life-threatening adverse drug reaction caused by excessive serotonergic agonism in central and peripheral nervous system serotonergic receptors, may be caused by a single drug or a combination of drugs with serotonergic activity. The syndrome results in a variety ... | [
{
"companynumb": "IT-MYLANLABS-2017M1064747",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DARUNAVIR"
},
"drugadditional": null,
... |
{
"abstract": "Among extremely preterm infants, we evaluated whether bevacizumab therapy compared with surgery for retinopathy of prematurity (ROP) is associated with adverse outcomes in early childhood.\n\n\n\nThis study was a retrospective analysis of prospectively collected data on preterm (22-26 + 6/7 weeks' gest... | [
{
"companynumb": "US-ROCHE-2445604",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BEVACIZUMAB"
},
"drugadditional": null,
"dru... |
{
"abstract": "The optimal first-line treatment for advanced-stage Hodgkin's lymphoma (HL) is still a matter of debate. While ABVD is less toxic and as effective as other, more intensive chemotherapy regimens, escalated BEACOPP (BEACOPPesc) is superior to ABVD for initial disease control and prolonged time-to-relapse... | [
{
"companynumb": "NVSC2020US189457",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BLEOMYCIN SULFATE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nPharmacokinetic interaction of high-dose methotrexate (MTX) and other concomitantly administered renally secreted medicinal products may lead to insufficient methotrexate serum level decrease and significant MTX toxicity.\n\n\nMETHODS\nWe report the case of an 18-year-old male patient treat... | [
{
"companynumb": "DE-PFIZER INC-2020350431",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE SODIUM"
},
"drugadditional": "3",... |
{
"abstract": "Risperidone is an atypical antipsychotic agent that was originally approved by the United States Food and Drug Adminstration for the treatment of schizophrenia. There are many side effects that are frequently associated with the use of risperidone. These include weight gain, anxiety, extra-pyramidal si... | [
{
"companynumb": "US-APOTEX-2017AP017715",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RISPERIDONE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nTo report use of intravenous foscarnet or cidofovir for the treatment of refractory acute retinal necrosis (ARN).\n\n\nMETHODS\nRetrospective chart review.\n\n\nRESULTS\nFour immunocompetent men aged 45-90 years presented with ARN from 2008-2014. One patient with two prior episodes of herpes... | [
{
"companynumb": "PHHY2018US065398",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VALACYCLOVIR HYDROCHLORIDE"
},
"drugadditional": "3",
... |
{
"abstract": "Adverse events including intracerebral hemorrhage and reperfusion arrhythmias are well known to occur with thrombolytic therapy. We report a case report of anaphylactic reaction directly attributable to intravenous (IV) recombinant tissue plasminogen activator and identify additional cases through revi... | [
{
"companynumb": "US-ACTAVIS-2015-14476",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LISINOPRIL"
},
"drugadditional": null,
... |
{
"abstract": "Giant cell hepatitis with autoimmune hemolytic anemia (AHA) is a rare disease of infancy characterized by the presence of both Coombs-positive hemolytic anemia and progressive liver disease with giant cell transformation of hepatocytes. Here, we report a case involving a seven-month-old male infant who... | [
{
"companynumb": "KR-CELLTRION INC.-2020KR021997",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": "3",
... |
{
"abstract": "Norovirus gastroenteritis in immunocompromised hosts can result in a serious and prolonged diarrheal illness. We present a case of chronic norovirus disease during rituximab-bendamustine chemotherapy for non-Hodgkin's lymphoma. We show for the first time a correlation between norovirus strain-specific ... | [
{
"companynumb": "US-PFIZER INC-2017127686",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": "3",
... |
{
"abstract": "A 22-year-old female student presented with a history of recurrent pancreatitis. The commonest causes of pancreatitis, including drugs, gallstones, corticosteroids, excess alcohol and hypertriglyceridaemia, were excluded. She was found to have an elevated serum calcium level that was considered to be t... | [
{
"companynumb": "GB-MYLANLABS-2020M1093012",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "3",
"activesubstance": {
"activesubstancename": "CINACALCET HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "In this retrospective study, 71 patients with secondary hormone-refractory prostatic carcinomas were treated with estramustine phosphate (EMP), at three different dosages (280, 560, 840 mg orally). All patients were completely followed up until cancer-induced death. In 12 cases of further progression p... | [
{
"companynumb": "AT-PFIZER INC-202200641941",
"fulfillexpeditecriteria": "1",
"occurcountry": "AT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ESTRAMUSTINE PHOSPHATE"
},
"drugadditional":... |
{
"abstract": "Eighty-three patients with intermediate- or high-grade non-Hodgkin's lymphoma were treated with CEPP(B) (cyclophosphamide, etoposide [VP-16], procarbazine, and prednisone with or without bleomycin) chemotherapy at Stanford University Medical Center (Stanford, CA) from January 1982 through June 1989. Si... | [
{
"companynumb": "US-BAXTER-2021BAX010536",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": null,
... |
{
"abstract": "Wilms tumor (WT) is a disease with a good prognosis. The aim of this study was to evaluate the outcome of patients with WT, treated according to the SIOP-2001 strategy.\n\n\n\nA retrospective analysis of 141 consecutive patients with WT diagnosed at our institution between December 2001 and 2013 was pe... | [
{
"companynumb": "AR-JNJFOC-20161224107",
"fulfillexpeditecriteria": "1",
"occurcountry": "AR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional": "... |
{
"abstract": "We report a case of a 66-year-old diabetic patient who presented with muscle weakness 2 weeks after kidney transplantation. Her immunosuppressive regimen included tacrolimus, mycophenolate mofetil, and steroids. She was found to have hyperkalemia and normal anion gap metabolic acidosis. Tacrolimus leve... | [
{
"companynumb": "IN-ACCORD-040148",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
"d... |
{
"abstract": "CONCLUSIONS\nGrade ≥ 3 mucositis/stomatitis and inability to feed orally were problematic for patients undergoing cetuximab-based bioradiotherapy (BRT) as well as platinum-based chemoradiotherapy (CRT). Severe mucositis/stomatitis and radiation dermatitis should be addressed carefully in patients under... | [
{
"companynumb": "JP-MYLANLABS-2016M1052749",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "Carisoprodol is a noncontrolled skeletal muscle relaxant whose active metabolite is meprobamate, a Schedule IV controlled substance. Although several case reports have shown that carisoprodol has abuse potential, it continues to be widely prescribed. The usage patterns of 40 patients who had taken cari... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2016SP013856",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARISOPRODOL"
},
"drugadditiona... |
{
"abstract": "Reactive arthritis, formerly called Reiter's syndrome, is one of the rare complications following intravesical instillation of Bacillus Calmette Guerin (BCG). A 58-year-old man was admitted to our hospital because of fever, hyperemia of conjunctiva, and arthralgia following the second course of intrave... | [
{
"companynumb": "JP-SA-2018SA027103",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BACILLUS CALMETTE-GUERIN ANTIGEN, UNSPECIFIED SUBSTRAIN"
},
... |
{
"abstract": "Several case reports of transient drug-induced myopia have been reported, mainly due to sulfa drugs. We present a case of a sudden and significant increase in myopia associated with initiation of Sulfasalazine for long-standing ulcerative colitis in an adult Caucasian female.\nOur patient presented to ... | [
{
"companynumb": "IL-HERITAGE PHARMACEUTICALS-2019HTG00316",
"fulfillexpeditecriteria": "1",
"occurcountry": "IL",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SULFASALAZINE"
},
"drugadditio... |
{
"abstract": "Acute hemophagocytic lymphohistiocytosis (HLH) is a life-threatening disease, with an annual incidence of 1 : 800,000 people. The disease is characterized by a cytokine storm, with concomitant macrophage and natural killer (NK) cell activation; death can occur from multiple organ failure or complicatio... | [
{
"companynumb": "CH-SUN PHARMACEUTICAL INDUSTRIES LTD-2021RR-316976",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "NOREPINEPHRINE"
},
"... |
{
"abstract": "BACKGROUND\nRenal medullary carcinoma (RMC) is a rare and lethal renal cell carcinoma characterized by the loss of tumor suppressor SMARCB1. Molecular profiling studies have suggested that RMC cells may be vulnerable to therapies that generate DNA damage, such as the combination of the nucleoside analo... | [
{
"companynumb": "US-009507513-2203USA010164",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TEMOZOLOMIDE"
},
"drugadditional": "4",
... |
{
"abstract": "Acquired perforating calcific collagenosis (APCC), which is characterized by the calcification of dermal collagen fibers with subsequent transepidermal elimination and perforation, is an extremely rare entity. Thus far, it has only been reported in a patient with direct contact exposure to calcium chlo... | [
{
"companynumb": "TW-PFIZER INC-2019138531",
"fulfillexpeditecriteria": "1",
"occurcountry": "TW",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMPHETAMINE"
},
"drugadditional": "3",
... |
{
"abstract": "The Glivec International Patient Assistance Programme makes Glivec (Imatinib mesylate) available to Philadelphia chromosome/BCR-ABL1 positive patients with chronic myeloid leukaemia (CML) in Lower and Middle Income Countries (LMIC). We have established a large cohort of 211 CML patients who are eligibl... | [
{
"companynumb": "PHHY2017NP057208",
"fulfillexpeditecriteria": "1",
"occurcountry": "NP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "IMATINIB MESYLATE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nStress echocardiography is the current standard for cardiac risk stratification of patients undergoing orthotopic liver transplantation (OLT). We aim to evaluate the role of dobutamine stress echocardiography (DSE) in predicting perioperative major adverse cardiac event (MACE) in patients un... | [
{
"companynumb": "US-PFIZER INC-2018339908",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOBUTAMINE HYDROCHLORIDE"
},
"drugadditional":... |
{
"abstract": "Fentanyl, and the numerous drugs derived from it, are contributing to the opioid overdose epidemic currently underway in the USA. To identify human exposure to these growing public health threats, an LC-MS-MS method for 5 μL dried blood spots (DBS) was developed. This method was developed to detect exp... | [
{
"companynumb": "US-JNJFOC-20191006181",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "SUFENTANIL"
},
"drugadditional": null,
... |
{
"abstract": "Survivors of childhood cancers are at increased risk of developing secondary gastrointestinal cancers, including colorectal cancer, later in life, possibly from exposure to abdominopelvic radiotherapy and/or alkylating chemotherapy. Profuse gastrointestinal polyposis is associated with rare, inherited ... | [
{
"companynumb": "US-ROXANE LABORATORIES, INC.-2014-BI-48166GD",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PROCARBAZINE"
},
"drugadd... |
{
"abstract": "Very late antibody-mediated rejection (AMR) in heart transplant patients (over 10 years post-transplant) is very rare. It is associated with high mortality, graft dysfunction, and fulminant coronary artery vasculopathy (CAV) and should remain in the differential for patients presenting with late graft ... | [
{
"companynumb": "US-TEVA-2019-US-1160102",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
... |
{
"abstract": "We report a case of severe choroidal detachments (CDs) in both eyes caused by systemic lupus erythematosus (SLE).\nThe patient was a 50-year-old woman who presented with conjunctival edema in both eyes, visual dysfunction, and generalized fatigue. At the first visit, the best corrected visual acuity (B... | [
{
"companynumb": "JP-SGP-000035",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "BACKGROUND\nDermatologic adverse events (dAEs) of anticancer therapies may negatively impact dosing and quality of life. While therapy interruption patterns due to dAEs have been studied in hospitalized cancer patients, similar outcomes in outpatient oncodermatology are lacking.\n\n\nOBJECTIVE\nTo anal... | [
{
"companynumb": "US-AMGEN-USASP2020110367",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PANITUMUMAB"
},
"drugadditional": "3",
... |
{
"abstract": "Cardiac tumors can lead to distinct electrocardiographic changes and ventricular arrhythmias. Benign and malignant cardiac tumors have been associated with ventricular tachycardia. When possible, benign tumors should be resected when ventricular arrhythmias are intractable. Chemotherapy can shrink mali... | [
{
"companynumb": "US-FRESENIUS KABI-FK201506602",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AMIODARONE HYDROCHLORIDE"
},
"drugadditio... |
{
"abstract": "BACKGROUND\nChlamydia pneumoniae is a common cause of atypical community acquired pneumonia (CAP). The diagnostic approach of chlamydial infections remains a challenge. Diagnosis of delayed chlamydial-associated complications, involving complex autoimmune pathophysiological mechanisms, is still more ch... | [
{
"companynumb": "GR-MYLANLABS-2021M1093684",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "IBUPROFEN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nIntrapleural hyperthermic chemotherapy (IPHC) is the preferred method to locally treat lung cancer with pleural seeding. Anesthetic management during IPHC is a very challenging task for the anesthesiologist because of the hemodynamic instability associated with the procedure; however, there... | [
{
"companynumb": "KR-ACCORD-069286",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "THIOPENTAL"
},
"drugadditional": null,
"dru... |
{
"abstract": "Isoniazid is an effective antituberculosis drug. Isoniazid poisoning produces a characteristic clinical syndrome that occurs 30 to 120 minutes after ingestion and includes seizures, metabolic acidosis, and in severe cases, coma. Rhabdomyolysis is one of the reported complications of isoniazid poisoning... | [
{
"companynumb": "TR-WATSON-2014-18803",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PYRIDOXINE"
},
"drugadditional": null,
... |
{
"abstract": "We describe a 22-year-old previously healthy primigravida who presented with spontaneous rupture of membranes at 40 weeks of gestation. Because of her history of inadequate prenatal care, a chemoprophylaxis regimen against group B streptococcal infection was prescribed upon admission. Within a few minu... | [
{
"companynumb": "US-CASPER PHARMA LLC-2021CAS000691",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PENICILLIN G BENZATHINE"
},
"drugadd... |
{
"abstract": "We present the case of a 71-year-old man with longstanding, previously well-controlled type 1 diabetes who developed acute hyperglycemia. His insulin requirements, via his insulin pump, increased to nearly five times his typical daily dose. The patient was admitted for evaluation and treatment and star... | [
{
"companynumb": "PHHY2019US030497",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "INSULIN NOS"
},
"drugadditional": "3",
"drug... |
{
"abstract": "Management of acute venous thromboembolism (VTE) with anticoagulants in elderly patients and those with chronic kidney disease poses special challenges. The RE-COVER and RE-COVER II trials showed that dabigatran 150 mg twice daily was as effective as warfarin over 6 months in preventing recurrent VTE, ... | [
{
"companynumb": "US-CIPLA LTD.-2018US07940",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "WARFARIN"
},
"drugadditional": null,
... |
{
"abstract": "The risk of use of immune-mediated diarrhea and colitis (imDC) in patients with preexisting inflammatory bowel disease (IBD) is not fully understood. We report the incidence of imDC in these patients, and compare with a matched cohort of patients with cancer and without IBD.\n\n\n\nPatients with IBD fr... | [
{
"companynumb": "US-009507513-2110USA006351",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PEMBROLIZUMAB"
},
"drugadditional": "3",
... |
{
"abstract": "Anastrozole is an aromatase inhibitor that has been used more frequently over the last decade especially for oestrogen receptor-positive breast cancer. It has a relatively safe side effect profile. However, occasionally it has been associated with serious adverse events. Here, we present the case of a ... | [
{
"companynumb": "US-CIPLA LTD.-2018US11810",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PROBIOTICS NOS"
},
"drugadditional": null,
... |
{
"abstract": "Neonatal abstinence syndrome (NAS) is common, expensive, and hurts opioid addicted women and their families. Current treatments do not sufficiently address comorbid addictions, especially tobacco use, among pregnant buprenorphine-maintained women.\n25 consecutive admissions of pregnant, opioid addicted... | [
{
"companynumb": "US-TEVA-2020-US-1863251",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CLONAZEPAM"
},
"drugadditional": null,
... |
{
"abstract": "Methadone, a long-acting opiate agonist, and naltrexone, an opiate receptor antagonist, are both commonly used to treat patients with morphine and heroin addiction. We present a rare case of methadone-induced persistent bilateral sensorineural hearing loss (SNHL) after chronic naltrexone use and review... | [
{
"companynumb": "US-VISTAPHARM, INC.-VER201911-001360",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHADONE HYDROCHLORIDE"
},
"druga... |
{
"abstract": "Long-term use of paracetamol (at therapeutic doses) can cause the accumulation of endogenous organic pyroglutamate, resulting in metabolic acidosis with an elevated anion gap. This occurs in the presence of malnutrition, infection, antibiotic use, renal failure and pregnancy. Given the prevalence of th... | [
{
"companynumb": "GB-FRESENIUS KABI-FK201702137",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FLUCLOXACILLIN"
},
"drugadditional": nul... |
{
"abstract": "BACKGROUND\nPatient comfort and safety are prerequisites for office procedures.\n\n\nOBJECTIVE\ncomparison of the fentanyl transdermal patch with injection of local anesthesia for intraoperative/postoperative pain from in-office Thermachoice III ablations.\n\n\nMETHODS\nSingle-center prospective random... | [
{
"companynumb": "US-JNJFOC-20140812672",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FENTANYL"
},
"drugadditional": null,
"d... |
{
"abstract": "Cannabidiol (CBD), a major purified nonpsychoactive component of cannabis with anticonvulsant properties, was approved by the U.S. Food and Drug Administration (FDA) in June 2018 as an adjuvant treatment for refractory epilepsy (Epidiolex; GW Pharmaceuticals). CBD is metabolized by cytochrome P450 (CYP... | [
{
"companynumb": "US-PFIZER INC-2018224987",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nPharmacomechanical thrombolysis (PMT) and catheter-directed thrombolysis (CDT) are commonly used for the treatment of iliofemoral deep venous thrombosis (DVT). The purpose of this study was to examine the short- and long-term venous patency and venous valvular function as well as clinical ou... | [
{
"companynumb": "US-ROCHE-1447951",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"drugadditional": null,
"drug... |
{
"abstract": "Introduction: Heparin-induced thrombocytopenia (HIT) is known for its strong association with thrombosis and distinct pathogenesis involving anti-PF4/polyanion antibodies that activate platelets strongly through clustering of platelet FcγIIa receptors. Autoimmune HIT (aHIT) refers to a subgroup of pati... | [
{
"companynumb": "CA-PFIZER INC-2019336475",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": "3",
... |
{
"abstract": "Pseudocirrhosis is a rare form of liver disease that can cause clinical symptoms and radiographic signs of cirrhosis; however, its histologic features suggest a distinct pathologic process. In the setting of cancer, hepatic metastases and systemic chemotherapy are suspected causes of pseudocirrhosis. H... | [
{
"companynumb": "US-TEVA-2021-US-1989694",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FLUOROURACIL"
},
"drugadditional": "4",
... |
{
"abstract": "Recipients of renal transplant are at increased risk of developing various malignancies, especially post-transplant lymphoproliferative disorder (PTLD) and skin cancers. Neuroendocrine tumours (NET) of the gastrointestinal tract have not been reported in this setting. Here we describe the case of a 75-... | [
{
"companynumb": "PHHY2016IN058722",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
"dr... |
{
"abstract": "BACKGROUND\nNevirapine (NVP) is widely used in antiretroviral treatment (ART) of HIV-1 globally. The primary objective of the AA5208/OCTANE trial was to compare the efficacy of NVP-based versus lopinavir/ritonavir (LPV/r)-based initial ART.\n\n\nRESULTS\nIn seven African countries (Botswana, Kenya, Mal... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2016SP019278",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "NEVIRAPINE"
},
"drugadditional"... |
{
"abstract": "Lithium treatment in pregnancy represents a significant dilemma for women and treating health professionals alike. The complexity of risk-benefit analysis is impacted by limited information.\n\n\n\nA cohort study of 33 women with severe mental illness, who were prescribed lithium at any time during the... | [
{
"companynumb": "AU-HERITAGE PHARMACEUTICALS-2018HTG00253",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LITHIUM CARBONATE"
},
"drugadd... |
{
"abstract": "Candida auris has become a great challenge in diagnostic, therapeutic and hospital environmental adaptation. With a prevalence of 5.3% in intensive care unit (ICU) acquired candidemia in India, its colonization is very rapid which hastens hospital transmission. Strict surveillance and preventive measur... | [
{
"companynumb": "IN-BAYER-2018-110774",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CIPROFLOXACIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nIn early 2005 the UK Committee on Safety of Medicines (CSM) announced gradual withdrawal of the analgesic co-proxamol because of its adverse benefit/safety ratio, especially its use for intentional and accidental fatal poisoning. Prescriptions of co-proxamol were reduced in the 3-year withd... | [
{
"companynumb": "GB-JNJFOC-20140817994",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": null,
... |
{
"abstract": "Tumor genome sequencing has become an invaluable resource in determining targets for new therapies. In this report, we describe the case of a patient with metastatic urothelial carcinoma with sarcomatoid features. Sarcomatoid differentiation is a rare histologic subtype that confers a more aggressive c... | [
{
"companynumb": "US-DRREDDYS-USA/USA/18/0102411",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "To compile and assess data about complication and success rates for in vitro fertilization (IVF) of women with systemic lupus erythematosus (SLE) and/or antiphospholipid syndrome (APS). To date, such data are sparse.\n\n\n\nThis retrospective study described women with SLE and/or APS who have had at le... | [
{
"companynumb": "FR-CONCORDIA PHARMACEUTICALS INC.-GSH201705-003218",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROXYCHLOROQUINE"
},
... |
{
"abstract": "Transplanted patients are particularly exposed to a major risk of infectious diseases due to prolonged immunosuppressive treatment. Over the last decade, the growing migration flows and the transplant tourism have led to increasing infections caused by geographically restricted organisms. Malaria is an... | [
{
"companynumb": "IT-TEVA-2021-IT-1958319",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": "1",
... |
{
"abstract": "Autism spectrum disorder is commonly co-diagnosed intellectual disability, language disorder, anxiety, and epilepsy, however, symptom management is difficult due to the complex genetic nature of ASD.\n\n\n\nWe present a next-generation sequencing-based case study with both de novo and inherited genetic... | [
{
"companynumb": "US-OTSUKA-2019_032263",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CLONIDINE HYDROCHLORIDE"
},
"drugadditional": nu... |
{
"abstract": "BACKGROUND Tumor treatment is the mainstay of therapy for paraneoplastic neurologic disorders (PNDs), but it is only effective in some cases and other treatment options are limited. OBJECTIVE To evaluate the short-term use of a combination of prednisone and tacrolimus for acute neurologic worsening in ... | [
{
"companynumb": "US-MYLANLABS-2017M1005873",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nFatal familial insomnia (FFI) is a human prion disease that is characterized by sleep-wake cycle deterioration, loss of slow-wave sleep, and motor overactivation over the daily 24-hour period.\nHere, we report the case of a 57-year-old man who had an irregular sleep-wake cycle and exhibited... | [
{
"companynumb": "KR-PFIZER INC-2018205460",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "THYMOCYTE IMMUNE GLOBULIN NOS"
},
"drugadditio... |
{
"abstract": "BACKGROUND\nDrug reaction with eosinophilia and systemic symptoms (DRESS) may relapse following introduction of drugs structurally unrelated to the initial culprit drug.\n\n\nOBJECTIVE\nTo assess the frequency and characteristics of recurrent drug eruptions in patients with history of DRESS.\n\n\nMETHO... | [
{
"companynumb": "PHHY2015FR044443",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"drugadditional": null,
"drug... |
{
"abstract": "To compare the metabolic changes between men with advanced prostate cancer commenced on a gonadotropin-releasing hormone (GnRH) agonist and those treated with orchiectomy.\n\n\n\nFifty-eight hormone-naive men with advanced prostate cancer were randomly assigned (1:1) to either subcapsular orchiectomy o... | [
{
"companynumb": "DK-ARBOR PHARMACEUTICALS, LLC-DK-2019ARB000644",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TRIPTORELIN"
},
"drugadd... |
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