article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "Oxaliplatin-induced neurotoxicity is the single main dose-limiting factor in the treatment of colorectal cancer. The degree of neurotoxicity may be either acute and reversible or observed as cumulative and chronic peripheral nerve damage leading to peripheral neuropathy (PNP), walking difficulties, ext... | [
{
"companynumb": "PL-ACCORD-072652",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": "3",
"drug... |
{
"abstract": "Dear Editor, The prevalence of type 2 diabetes (DM-2) in HIV-infected patients and the concomitant use of metformin (MTF) and non-nucleoside reverse transcriptase inhibitors (NRTI) is rising. Through inhibition of NADH dehydrogenase and DNA pol-γ, both drugs hinder oxidative phosphorylation that may le... | [
{
"companynumb": "MX-ALKEM-001296",
"fulfillexpeditecriteria": "1",
"occurcountry": "MX",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LOPINAVIR\\RITONAVIR"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nIndividuals who are exposed to cytotoxic agents are at risk of developing therapyrelated myeloid neoplasms (t-MN). Cytogenetic findings of a neoplasm play an important role in stratifying patients into different risk groups and thus predict the response to treatment and overall survival.\n\... | [
{
"companynumb": "MY-MYLANLABS-2017M1051329",
"fulfillexpeditecriteria": "1",
"occurcountry": "MY",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MITOXANTRONE HYDROCHLORIDE"
},
"drugadditiona... |
{
"abstract": "BACKGROUND\nMethotrexate (MTX) is a cytotoxic antimetabolite. Intravenous (IV) hydration and urine alkalinization with sodium bicarbonate (NaHCO3) can mitigate nephrotoxicity associated with high-dose MTX (HDMTX, doses ≥500 mg/m2). A shortage of IV NaHCO3 in 2017 prompted Alberta Children's Hospital (A... | [
{
"companynumb": "NVSC2021CA043174",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "BACKGROUND\nMultiple myeloma is a hematologic disease with high mortality rates all over the world. The diagnosis has always been challenging since the first case was reported in 1844. For that reason the diagnostic criteria have evolved over years to include the features of the disease more comprehens... | [
{
"companynumb": "GT-FRESENIUS KABI-FK201804909",
"fulfillexpeditecriteria": "1",
"occurcountry": "GT",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ALBUMIN HUMAN"
},
"drugadditional": null... |
{
"abstract": "Physicians should be aware of look-alike/sound-alike (LASA) drug names. Clearly legible drug prescriptions, preferably via electronic drug prescription systems, and the use of Tall Man lettering may help to prevent LASA medication errors.",
"affiliations": "Institute for Clinical Pharmacology Hannove... | [
{
"companynumb": "DE-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-317447",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLOZAPINE"
},
"druga... |
{
"abstract": "OBJECTIVE\nTo report a case of bisphosphonate-induced bilateral anterior uveitis and choroidal effusions with secondary angle closure in a 64-year-old female patient.\n\n\nMETHODS\nObservational case report.\n\n\nRESULTS\nA 64-year-old woman with history of scleroderma and antiphospholipid syndrome, pr... | [
{
"companynumb": "SG-SUN PHARMACEUTICAL INDUSTRIES LTD-2019R1-197594",
"fulfillexpeditecriteria": "1",
"occurcountry": "SG",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ALENDRONATE SODIUM"
},
... |
{
"abstract": "The case of a patient is presented who was undergoing coronary bypass grafting and who, during cardiopulmonary bypass, became severely cyanotic because of methemoglobinemia after intravenous infusion of nitroglycerin. His condition responded promptly and favorably to the withdrawal of the offending age... | [
{
"companynumb": "US-PFIZER INC-2018345534",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DEXTROSE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nBiliary cancers overexpress epidermal growth factor receptor (EGFR), and angiogenesis has been correlated with poor outcome. Erlotinib, an EGFR tyrosine kinase inhibitor, and bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor have each been shown to have activity in biliary c... | [
{
"companynumb": "US-MYLANLABS-2017M1009439",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "BEVACIZUMAB"
},
"drugadditional": null,
... |
{
"abstract": "The novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a pandemic threatening global public health. In the current paper, we describe our successful treatment of three COVID-19 pneumonia patients cases including severe cases and c... | [
{
"companynumb": "CN-ABBVIE-20K-035-3697372-00",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "INTERFERON ALFA-2A OR INTERFERON ALFA-2B"
},
... |
{
"abstract": "Aneurysmal arterial dilatation is an infrequent complication following arteriovenous fistula ligation. Herein, we are describing a case in which a 49-year-old transplanted patient developed a true, symptomatic, brachial artery aneurysm 25 years after transplantation and 12 years after ligation of his r... | [
{
"companynumb": "PHHY2019GR003617",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": "3",
... |
{
"abstract": "Osteopetrosis is a rare hereditary bone dysplasia characterized by insufficient osteoclast activity that results in increased bone mineral density. Hematopoietic stem cell transplantation (HSCT) can reverse skeletal abnormalities and restore hematopoiesis.\n\n\n\nWe present the case of a 3-year and 2-m... | [
{
"companynumb": "MX-AMGEN-MEXSP2021110956",
"fulfillexpeditecriteria": "2",
"occurcountry": "MX",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "BUSULFAN"
},
"drugadditional": null,
... |
{
"abstract": "Lactic acidosis is the most severe adverse effect associated with metformin therapy of type 2 diabetes mellitus. The risk increases in patients with impaired renal function, most commonly due to diabetic nephropathy, and may be augmented when concurrent medication with a negative impact on renal functi... | [
{
"companynumb": "CZ-IMPAX LABORATORIES, INC-2017-IPXL-00843",
"fulfillexpeditecriteria": "1",
"occurcountry": "CZ",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
... |
{
"abstract": "Desmoplastic small round cell tumor (DSRCT) is a rare, highly aggressive malignancy with distinctive histological features: a nesting pattern of cellular growth within dense desmoplastic stroma, occurring in young population with male predominance. The mean survival period is only about 1.5-2.5 years. ... | [
{
"companynumb": "CN-PFIZER INC-2021333489",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "An 88-year-old woman was admitted to the emergency department after experiencing syncope while in a sitting position. Electrocardiogram showed advanced degree heart block. She has been on low-dose carbamazepine (200 mg/day) for the last year for trigeminal neuralgia (TN). After discontinuation of carba... | [
{
"companynumb": "TR-VALIDUS PHARMACEUTICALS LLC-TR-2016VAL002113",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CARBAMAZEPINE"
},
"drug... |
{
"abstract": "Globally, there has been increasing attention paid to vitamin D deficiency and its treatment. Vitamin D stosstherapy with high-dose ergocalciferol in a single day is reemerging as a potential treatment option. We present an as yet unreported complication of acute renal injury due to propylene glycol to... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2019R1-200916",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ERGOCALCIFEROL"
},
"... |
{
"abstract": "Thrombocytopenia is one of the most common hematological abnormalities observed during pregnancy, and in rare cases, this may be the first indicator of an underlying hematological malignancy. Hairy cell leukemia (HCL) is an uncommon B-cell lymphoproliferative disorder of which thrombocytopenia is a rec... | [
{
"companynumb": "IE-ACCORD-170926",
"fulfillexpeditecriteria": "1",
"occurcountry": "IE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ALLOPURINOL"
},
"drugadditional": "1",
"drug... |
{
"abstract": "OBJECTIVE\nWe aimed to retrospectively analyze incidence, risk factors, and management of postoperative stent graft (SG) infection after endovascular aneurysm repair (EVAR).\n\n\nMETHODS\nWe evaluated patients who underwent EVAR for infrarenal abdominal aortic aneurysm at our institution between July 2... | [
{
"companynumb": "JP-PFIZER INC-2019289659",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMPICILLIN SODIUM\\SULBACTAM SODIUM"
},
"druga... |
{
"abstract": "Hypernatremia (serum sodium concentration >145 mEq/L) is a common electrolyte disorder with increased morbidity and mortality especially in the elderly and critically ill patients. The review presents the main pathogenetic mechanisms of hypernatremia, provides specific directions for the evaluation of ... | [
{
"companynumb": "GR-VALIDUS PHARMACEUTICALS LLC-GR-2016VAL001454",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SODIUM CHLORIDE"
},
"dr... |
{
"abstract": "Long-term stabilization of advanced renal cell carcinoma (RCC) by the sequence of sorafenib monotherapy followed by sunitinib and everolimus treatments in a man with multiple metastases is reported. A 66-year-old man was diagnosed with advanced RCC in 2005. The patient initially underwent nephrectomy, ... | [
{
"companynumb": "PHHY2015DE021762",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "EVEROLIMUS"
},
"drugadditional": null,
"dru... |
{
"abstract": "The prevalence of serotonin syndrome increases over the past several years as more serotonergic medications are being used in clinical practice. It is a potentially lethal condition caused by excessive serotonergic activity. Common causes of serotonin syndrome are the use of prescription medications, i... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2020SP008447",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ZOLPIDEM TARTRATE"
},
"drugadd... |
{
"abstract": "The computerized antithrombotic risk assessment tool (CARAT) is an online decision-support algorithm that facilitates a systematic review of a patient's stroke risk, bleeding risk, and pertinent medication safety considerations, to generate an individualized treatment recommendation. The CARAT was pros... | [
{
"companynumb": "AU-CIPLA LTD.-2018AU10480",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "WARFARIN"
},
"drugadditional": "3",
... |
{
"abstract": "Hepatitis C virus (HCV) infection is an important cause of liver-related morbidity and mortality in patients with end-stage renal disease (ESRD). Though indicated, antiviral therapy adds to the existing financial burden and is poorly tolerated in these patients. We studied HCV treatment outcomes in pat... | [
{
"companynumb": "IN-ROCHE-1500057",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PEGINTERFERON ALFA-2A"
},
"drugadditional": null,
... |
{
"abstract": "A comparative analysis of those women on Norinyl 1/35 versus those on Lo-Ovral showed those on Norinyl 1/35 were significantly (P less than or equal to 0.05) older than women in the Lo-Ovral group. There were no significant differences (P greater than or equal to 0.05) between the groups for other char... | [
{
"companynumb": "NG-PFIZER INC-2017197178",
"fulfillexpeditecriteria": "1",
"occurcountry": "NG",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ETHINYL ESTRADIOL\\NORGESTREL"
},
"drugadditio... |
{
"abstract": "Rapid Resolution of Symptomatic Hypercalcaemia Abstract. Milk-alkali syndrome consists of the triad of hypercalcaemia, metabolic alkalosis, and renal insufficiency associated with the ingestion of calcium and absorbable alkali. Older patients, those at risk for volume depletion and those on medications... | [
{
"companynumb": "CH-MYLANLABS-2019M1053022",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TORSEMIDE"
},
"drugadditional": "1",
... |
{
"abstract": "Dasatinib is a small-molecule tyrosine kinase inhibitor used in the treatment of hematological malignancies. Pulmonary arterial hypertension (PAH) is a rare but known complication. The mainstay of treatment is cessation of Dasatinib, and while clinical improvement is rapid, complete hemodynamic resolut... | [
{
"companynumb": "US-APOTEX-2017AP017710",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional": ... |
{
"abstract": "CONCLUSIONS\nA 39-year-old woman was diagnosed with Systemic lupus erthymatosus (SLE) in 1993, and initially received 30 mg of prednisolone (PSL) daily as treatment. In 2012, the patient was diagnosed with pregnancy-induced hypertension (PIH) complecated with proteinurea, hypertension and pretibial ede... | [
{
"companynumb": "JP-MYLANLABS-2016M1047715",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "In this paper, we report the case of a patient, aged 26, with schizophrenia who was admitted to psychiatric emergencies for catatonia, one week after abrupt discontinuation of clozapine. An improvement was seen after only two days of the reintroduction of clozapine alone. This catatonia is reversible a... | [
{
"companynumb": "FR-MYLANLABS-2017M1001622",
"fulfillexpeditecriteria": "1",
"occurcountry": "MA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CLOZAPINE"
},
"drugadditional": null,
... |
{
"abstract": "Acute tubulointerstitial nephritis (ATIN) has been increasingly recognized as an important manifestation of kidney injury associated with the use of immune checkpoint inhibitors (anti-PD-1 and anti-CTLA-4). While the exact pathophysiology remains unknown, corticosteroids are the mainstay of management.... | [
{
"companynumb": "JP-TEVA-2018-JP-877259",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": null,
"drugadditional": "3",
"drugadministrationroute": "045",
"drugauthoriz... |
{
"abstract": "BACKGROUND\nAbiraterone acetate (AA) has demonstrated improved outcomes in men with metastatic castration-resistant prostate cancer (mCRPC). However, data are lacking on the effect of AA on subsequent efficacy of enzalutamide or docetaxel.\n\n\nMETHODS\nWe included men with mCRPC who received AA and su... | [
{
"companynumb": "US-JNJFOC-20160420150",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ENZALUTAMIDE"
},
"drugadditional": null,
... |
{
"abstract": "Haemolytic uraemic syndrome (HUS) is a rare complication of invasive infection by Streptococcus pneumoniae (SP-HUS), especially in adults. Here we report an unusual case of a 53-year-old man presenting SP-HUS with severe multivisceral involvement. After failure of supportive care and plasma exchanges, ... | [
{
"companynumb": "FR-PFIZER INC-2019314940",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IBUPROFEN"
},
"drugadditional": "3",
... |
{
"abstract": "A two-year-old female child status post-bilateral nephrectomies sustained a cardiac arrest following the central intravenous administration of vancomycin chloride. This report reviews the literature concerning the problems associated with the use of vancomycin chloride in the perioperative period.",
... | [
{
"companynumb": "US-PFIZER INC-2017155722",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "HALOTHANE"
},
"drugadditional": null,
... |
{
"abstract": "Bipolar disorder is a psychiatric illness that is relatively common among patients presenting for treatment in primary care clinics. Physicians in primary care often face difficult decisions about how and when to intervene when a patient is experiencing depressive, manic, or hypomanic episodes consiste... | [
{
"companynumb": "US-OTSUKA-2020_028693",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "The responses to therapy with either clindamycin alone or penicillin plus chloramphenicol in 77 patients with septic abortions were compared in a randomized, double-blind study. Although fever index and duration of hospitalization were similar for both groups of patients, significantly more patients in... | [
{
"companynumb": "US-PFIZER INC-2021814828",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "SODIUM CHLORIDE"
},
"drugadditional": null,
... |
{
"abstract": "Segmental testicular infarction is an uncommon clinical entity marked by acute scrotal pain and swelling. Classically, these appear as wedge-shaped, avascular, hypoechoic lesions on a testicular ultrasound. We present a unique case of testicular infarct caused by an antineutrophil cytoplasmic antibody-... | [
{
"companynumb": "US-TEVA-498129USA",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MINOCYCLINE\\MINOCYCLINE HYDROCHLORIDE"
},
"drugaddit... |
{
"abstract": "The incidence of patients with liver cirrhosis (LC) is increasing. Patients with LC are known to have a greater risk of postoperative morbidity and mortality than patients without LC. A treatment option such as pancreaticoduodenectomy (PD) has not been validated to be safe for these patients, especiall... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2021RR-288440",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "GIMERACIL\\OTERACIL\\TEGAFUR"
... |
{
"abstract": "BACKGROUND\nDIGO or drug-induced gingival overgrowth occurs as a side effect of certain drugs. Until now, the etiology of drug-induced gingival overgrowth is not clearly understood. Among the calcium channel blockers, nifedipine has been shown to be most frequently associated with drug-induced gingival... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-319784",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AMLODIPINE BESYLATE"
},
... |
{
"abstract": "Devic syndrome or neuromyelitis optica is an autoimmune neurological condition characterized by relapsing symptoms of optic neuritis and transverse myelitis. Women with neuromyelitis optica suffer from adverse pregnancy outcomes and high relapse rates during pregnancy and the postpartum period.\nThis c... | [
{
"companynumb": "CA-PFIZER INC-2020278838",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HUMAN IMMUNOGLOBULIN G"
},
"drugadditional": "... |
{
"abstract": "Primary renal lymphoma is a rare entity, even more so in children. Children with primary renal lymphoma present with variable clinical features such as constitutional signs and symptoms, acute kidney injury, palpable abdominal masses, and gross hematuria. Herein we report a child who presented with see... | [
{
"companynumb": "US-CORDEN PHARMA LATINA S.P.A.-US-2017COR000235",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugaddi... |
{
"abstract": "OBJECTIVE Candida auris (CA) is an emerging multidrug-resistant pathogen associated with increased mortality. The environment may play a role, but transmission dynamics remain poorly understood. We sought to limit environmental and patient CA contamination following a sustained unsuspected exposure. DE... | [
{
"companynumb": "US-009507513-1802USA012692",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CASPOFUNGIN ACETATE"
},
"drugadditional": "3... |
{
"abstract": "Hypersensitivity pneumonitis (HP), also called extrinsic allergic alveolitis, is a respiratory syndrome involving the lung parenchyma and specifically the alveoli, terminal bronchioli, and alveolar interstitium, due to a delayed allergic reaction. Such reaction is secondary to a repeated and prolonged ... | [
{
"companynumb": "IT-AUROBINDO-AUR-APL-2020-001182",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SERTRALINE HYDROCHLORIDE"
},
"drugaddi... |
{
"abstract": "Pleural aspergillosis is a rare fungal infection. We herein report a case of pleuritis clinically diagnosed as aspergillosis without apparent Aspergillus lung lesions. A 75-year-old man receiving immunosuppressive therapy due to microscopic polyangiitis was admitted for treatment of massive pleural eff... | [
{
"companynumb": "JP-ROXANE LABORATORIES, INC.-2016-RO-00084RO",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugaddi... |
{
"abstract": "The SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) coronavirus has emerged as a highly contagious respiratory pathogen causing severe acute lung injury. Extracorporeal membrane oxygenation is a standard tool for the management of life-threatening acute respiratory distress syndrome, but t... | [
{
"companynumb": "US-DRREDDYS-USA/USA/20/0126638",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BIVALIRUDIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nWe have previously reported favorable response and survival rates using drug-eluting beads loaded with doxorubicin (DEBDOX) for unresectable hepatic metastases. This study investigates the quality of life (QoL) impact of DEBDOX for the treatment of unresectable hepatic metastases from melan... | [
{
"companynumb": "US-JNJFOC-20171218278",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional": n... |
{
"abstract": "Levetiracetam (LEV) is a newer second-generation antiepileptic drug that is found to be effective in tonic-clonic seizures, partial onset seizures, and myoclonic seizures. Among antiepileptic drugs, LEV is usually known for fewer adverse drug reactions. Psychiatric disorders after the administration of... | [
{
"companynumb": "TR-HQ SPECIALTY-TR-2019INT000316",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "1... |
{
"abstract": "BACKGROUND\nNeoadjuvant trials conducted using a double HER2 blockade with lapatinib and trastuzumab, combined with different paclitaxel-containing chemotherapy regimens, have shown high pathological complete response (pCR) rates, but at the cost of important toxicity. We hypothesised that this toxicit... | [
{
"companynumb": "FR-CIPLA LTD.-2014FR02665",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TRASTUZUMAB"
},
"drugadditional": null,
... |
{
"abstract": "The spectrum of the mucocutaneous adverse effects of directed oncologic therapies, such as anti-EGFR, anti-VEGF, anti-TK and anti-BRAF, presents similarities but also differences compared to that of the classic chemotherapeutics. This article reviews the dermatological toxicities of the targeted therap... | [
{
"companynumb": "BE-TEVA-2019-BE-1041420",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IMATINIB MESYLATE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nKetamine is a recreational drug widely abused in East Asia and also in certain subpopulations of the United States. Many US clinicians are unaware of abuse symptoms, leading to misdiagnosis and missed opportunities for intervention. We will discuss clinical patterns that should alert a clini... | [
{
"companynumb": "US-PFIZER INC-2017416497",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "KETAMINE HYDROCHLORIDE"
},
"drugadditional": "... |
{
"abstract": "OBJECTIVE\nOsteonecrosis of the jaw (ONJ) is an established side effect of intravenous bisphosphonates and other antiresorptive medications. Although bisphosphonates are frequently prescribed for patients with the skeletal disorder fibrous dysplasia (FD), there are no reports of ONJ in this population.... | [
{
"companynumb": "PHHY2016US067821",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ZOLEDRONIC ACID"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nCanagliflozin is a sodium glucose cotransporter 2 inhibitor developed to treat type 2 diabetes mellitus (T2DM).\n\n\nOBJECTIVE\nThe purpose of this study was to describe the effects of canagliflozin on bone fracture risk.\n\n\nMETHODS\nThis was a randomized phase 3 study in patients with T2... | [
{
"companynumb": "US-JNJFOC-20151205570",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CANAGLIFLOZIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nWe conducted a phase I trial of gemcitabine (gem) with concurrent radiotherapy in patients with muscle-invasive bladder cancer (BC) ineligible for surgery or cisplatin or refusing organ loss.\n\n\nMETHODS\nPatients with urothelial cancer, cT2-T4, cN0-1, M0, ineligible for surgery due to loc... | [
{
"companynumb": "AT-CIPLA LTD.-2016AT09358",
"fulfillexpeditecriteria": "1",
"occurcountry": "AT",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "GEMCITABINE\\GEMCITABINE HYDROCHLORIDE"
},
"... |
{
"abstract": "Cornelia de Lange syndrome (CdLS) is a rare dominantly inherited genetic multisystem developmental condition with considerable phenotypic and allelic heterogeneity. Missense and in-frame deletions within the SMC1A gene can be associated with epilepsy and milder craniofacial features. We report two fema... | [
{
"companynumb": "US-JNJFOC-20151118874",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVOCARNITINE"
},
"drugadditional": null,
... |
{
"abstract": "We report a case of severe generalised muscle weakness in a 66-year-old man who underwent revision of left knee arthroplasty. On postoperative day 1, he developed non-focal muscle weakness and shortness of breath which progressed over a 6-hour period. Serum phosphorus level was severely low at 0.5 mg/d... | [
{
"companynumb": "US-MYLANLABS-2018M1025999",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ATORVASTATIN"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo properly assess the guidance for perioperative management, we undertook a clinical epidemiology study with the primary aim of evaluating the incidence of perioperative vascular complications and their associated factors in a cohort of Japanese patients who underwent non-cardiac surgery in... | [
{
"companynumb": "JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-27077GD",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DIPYRIDAMOLE"
},
... |
{
"abstract": "Hemophilia A is an X-linked recessive disorder characterized by defective synthesis of Factor VIII protein. Depending on the level of FVIII activity, patients may present with easy bruising, inadequate clotting of traumatic or mild injury, or in severe hemophilia, spontaneous hemorrhage. Ulcerative col... | [
{
"companynumb": "US-TAKEDA-2022TUS024004",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT"
},
"d... |
{
"abstract": "Posaconazole is a broad-spectrum antifungal used for prophylaxis and treatment of invasive fungal infections. There is no published data to inform prescribers on dosing of the intravenous (IV) formulation in the pediatric population. We describe our experience including dosing, serum concentrations, an... | [
{
"companynumb": "US-009507513-1801USA005047",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "POSACONAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "While methimazole (MMI) is the first line treatment for hyperthyroidism, this medication is not devoid of adverse effects. In this article, we present a 70-year-old male who admitted the hospital with right lower extremity pain and rash. The patient was recently treated with MMI for hyperthyroidism. Im... | [
{
"companynumb": "US-PFIZER INC-2018379037",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "GENTAMICIN"
},
"drugadditional": null,
... |
{
"abstract": "Increased susceptibility to 5-fluorouracil (5-FU)/capecitabine can lead to rapidly occurring toxicity caused by impaired clearance, dihydropyrimidine dehydrogenase deficiency, and other genetic variations in the enzymes that metabolize 5-FU. Life-threatening 5-FU overdoses occur because of infusion pum... | [
{
"companynumb": "US-BAUSCH-BL-2016-024128",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "FLUOROURACIL"
},
"drugadditional": null,
... |
{
"abstract": "We report a case of a 31-year-old man with metastatic fibrolamellar hepatocellular carcinoma (FLHCC) treated with gemcitabine and oxaliplatin complicated by hyperammonemic encephalopathy biochemically consistent with acquired ornithine transcarbamylase deficiency. Awareness of FLHCC-associated hyperamm... | [
{
"companynumb": "US-FRESENIUS KABI-FK201701093",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nDrug-induced kidney injury (DIKI) may affect patients regardless of their baseline kidney function. Therefore, this study evaluated DIKI in patients with or without previous chronic kidney disease (CKD).\n\n\nMETHODS\nPotential DIKI cases were ascertained using the network of the Berlin Case... | [
{
"companynumb": "DE-TEVA-2018-DE-864177",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROCHLOROTHIAZIDE\\OLMESARTAN MEDOXOMIL"
},
"d... |
{
"abstract": "Immunotherapy directed at the programmed cell death-1 receptor (PD-1) or its ligand PD-L1 has proven effective in solid malignancies such as melanoma, non-small cell lung cancer (NSCLC), urothelial cancer, renal cell carcinoma, and head and neck cancer. Compared with cytotoxic chemotherapy, radiotherap... | [
{
"companynumb": "IT-TEVA-2021-IT-1938133",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "VINCRISTINE"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nTelaprevir-induced rash is a common, therapy-limiting adverse drug event (ADE) for patients with hepatitis c virus (HCV) infection. Given the similarity between telaprevir and simeprevir, real-world management of rash during treatment with an NS3/4A protease inhibitor and its implications a... | [
{
"companynumb": "US-VERTEX PHARMACEUTICALS INC-2014-003698",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PEGINTERFERON ALFA-2A OR PEGINTERFERON ALFA-2B"
... |
{
"abstract": "T-cell prolymphocytic leukemia (T-PLL) is a rare and aggressive T-lymphoid malignancy usually refractory to current treatment strategies and associated with short overall survival. By applying next-generation functional testing of primary patient-derived lymphoma cells using a library of 106 US Food an... | [
{
"companynumb": "AT-MYLANLABS-2018M1002005",
"fulfillexpeditecriteria": "1",
"occurcountry": "AT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PIXANTRONE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo report a case of pancytopenia following colchicine overdose and to discuss the use of granulocyte colony-stimulating factor (G-CSF) for treating this severe complication.\n\n\nMETHODS\nA 19-year-old man developed pancytopenia four days after ingestion of approximately 50-60 0.6-mg colchic... | [
{
"companynumb": "US-TAKEDA-2017TUS005697",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "COLCHICINE"
},
"drugadditional": "3",
... |
{
"abstract": "We report the case of an 82-year-old woman who developed pneumothorax during treatment for nontuberculous mycobacterium (NTM). In year X, she was diagnosed with NTM at another hospital after abnormalities were pointed out on a chest X-ray. She received no treatment for NTM at that time. Antibiotic trea... | [
{
"companynumb": "US-SA-2019SA145354",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ERYTHROMYCIN"
},
"drugadditional": "3",
"d... |
{
"abstract": "Typical survival with common 1(st)-line regimens for pancreatic cancer range from 6-11 months. We report a case of a patient with stage IVB pancreatic adenocarcinoma treated with gemcitabine and erlotinib who stopped therapy after 3 months without achieving a response due to intolerance. To decide upon... | [
{
"companynumb": "US-CIPLA LTD.-2016US05217",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ERLOTINIB"
},
"drugadditional": null,
... |
{
"abstract": "A 44-year-old woman, chronic smoker with Graves' disease was treated with radioactive iodine ablation (RAI). One week after the treatment, she presented with severe pain in the anterior neck with radiation to the angle of the jaw associated with fatigue, tremor and odynophagia. Physical examination dem... | [
{
"companynumb": "US-DRREDDYS-USA/USA/15/0045841",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PROPRANOLOL\\PROPRANOLOL HYDROCHLORIDE"
},
... |
{
"abstract": "OBJECTIVE\nTo describe the clinical features and risk factors of and optimal antifungal therapy for Purpureocillium lilacinum keratitis.\n\n\nMETHODS\nRetrospective case series in a quaternary referral hospital setting.\n\n\nMETHODS\nComprehensive chart review of patients diagnosed with P. lilacinum ke... | [
{
"companynumb": "ALCN2016AU009028",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": "3",
"dr... |
{
"abstract": "BACKGROUND Cardiac amyloidosis is an infiltrative cardiomyopathy caused by the extracellular deposition of insoluble precursor protein amyloid fibrils. These depositions of protein amyloid fibrils are found on the atria and ventricles and can cause a wide array of arrhythmias; however, sustained ventri... | [
{
"companynumb": "US-MYLANLABS-2021M1031259",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LIDOCAINE"
},
"drugadditional": null,
... |
{
"abstract": "We report a case of persistent Rhodopseudomonas bacteremia in a patient two months after an allogeneic bone marrow transplant for acute myeloid leukemia. The bacteremia persisted until IV catheter removal. To our knowledge, this is the first report of Rhodopseudomonas causing infection in humans.",
"... | [
{
"companynumb": "US-ACCORD-059942",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ONDANSETRON"
},
"drugadditional": null,
"dr... |
{
"abstract": "Lupus nephritis (LN) can be complicated with requirement for kidney replacement therapy and death. Efficacy of induction therapies using mycophenolate mofetil (MMF) or intravenous cyclophosphamide (IVCYC) has been reported from studies, but there is limited data in Africans comparing both treatments in... | [
{
"companynumb": "ZA-ROCHE-2803462",
"fulfillexpeditecriteria": "1",
"occurcountry": "ZA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": null,
... |
{
"abstract": "A young adult man with 4-years history of lepromatous leprosy (received irregularly multidrug therapy) presented with two and half years history of symptoms suggestive of chronic erythema nodosum leprosum (ENL), initially responded to steroids and thalidomide, but later on failed. During the last 2-mon... | [
{
"companynumb": "IN-CELGENEUS-IND-20170903412",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "RIFAMPIN"
},
"drugadditional": null,
... |
{
"abstract": "Management of drug-influenced gingival enlargement is challenging, and surgery is most often indicated. However, because of a unique mechanism of action, azithromycin helps in the management of gingival enlargement caused by cyclosporine. An incidental observation of the effect of azithromycin in the c... | [
{
"companynumb": "US-MYLANLABS-2020M1085003",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "... |
{
"abstract": "The prognosis of metastatic melanoma is poor. Pre-targeted treatment era, the combination of interferon-α (IF-α) plus chemotherapy had been used and have generally short response duration. Herein, we present a metastatic melanoma case that achieved long-term durable complete response (CR) IF-α plus che... | [
{
"companynumb": "TR-BAYER-2015-411872",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DACARBAZINE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nDrug reaction with eosinophilia and systemic symptoms (DRESS) is a potentially fatal condition caused by drug exposure resulting in hypersensitivity reaction with involvement of different organ systems.\n\n\nMETHODS\nWe present a case of a 65-year-old man with a recent history of right tota... | [
{
"companynumb": "US-MLMSERVICE-20210907-3093652-1",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LISINOPRIL"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nRandomized-controlled trials and claims databases suggest that antiepileptic drug (AED) use may increase the risk of suicide attempts (SA). The present case-control study explores the impact of underlying indications on this potential association.\n\n\nMETHODS\nPhysicians collected the medic... | [
{
"companynumb": "FR-ROCHE-1931530",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARBAMAZEPINE"
},
"drugadditional": "3",
"dr... |
{
"abstract": "OBJECTIVE\nThe purpose of this investigation was to identify and characterize post-marketing reports of cardiotoxicity, including torsades de pointes (TdP), associated with loperamide use.\n\n\nMETHODS\nWe searched the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database fo... | [
{
"companynumb": "US-JNJFOC-20170124150",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ALFUZOSIN"
},
"drugadditional": null,
"... |
{
"abstract": "A 78-year-old man, with a 6-year history of stable chronic myelomonocytic leukaemia (CMML), presented with general deterioration and worsening pancytopenia. Bone marrow biopsy showed that his disease had transformed into acute myeloid leukaemia (AML). He was started on a supportive transfusion regimen ... | [
{
"companynumb": "GB-FRESENIUS KABI-FK201705973",
"fulfillexpeditecriteria": "2",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DEXTROSE"
},
"drugadditional": null,
... |
{
"abstract": "Angioedema is an uncommon, yet morbid, adverse reaction to recombinant tissue plasminogen activator (rtPA) administration for ischemic stroke. Orolingual edema may preclude completion of rtPA therapy and cause potential airway compromise. Few case reports and case series have examined the incidence of ... | [
{
"companynumb": "US-TEVA-499892USA",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLOPIDOGREL BISULFATE"
},
"drugadditional": null,
... |
{
"abstract": "Decreased engagement in beneficial physical activity and increased levels of sedentary behavior and unhealthy weight are a continued public health concern in adolescents. Adolescents with autism spectrum disorder may be at an increased risk compared with their typically developing peers. Weekly physica... | [
{
"companynumb": "US-OTSUKA-2020_008083",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nFungal peritonitis (FP) is a rare but devastating complication in peritoneal dialysis (PD), accounting for high rates of technique failure, morbidity and mortality. This study was conducted to investigate FPs with regard to peritonitis rate, microbiology testing, patient characteristics, cli... | [
{
"companynumb": "CN-PFIZER INC-2019106013",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": "3",
... |
{
"abstract": "Transcatheter arterial chemoembolization (TACE) has been used widely to treat patients with unresectable hepatocellular carcinoma. However, this method can induce various adverse events caused by necrosis of the tumor itself or damage to nontumor tissues. In particular, neurologic side effects such as ... | [
{
"companynumb": "KR-SUN PHARMACEUTICAL INDUSTRIES LTD-2022R1-329937",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"dru... |
{
"abstract": "Calciphylaxis is a rare disease characterized by calcification of small- to medium-sized blood vessels in the dermis and subcutaneous fat, resulting in cutaneous necrosis. Although most commonly shown in patients with end-stage kidney disease, it has also been reported in patients with other diseases, ... | [
{
"companynumb": "US-MYLANLABS-2021M1037601",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MIDODRINE"
},
"drugadditional": "3",
... |
{
"abstract": "During labour, remifentanil patient-controlled analgesia is used as an alternative to neuraxial analgesia. Remifentanil is associated with hypoventilation and respiratory depression but the frequency of serious maternal and neonatal adverse events is unknown. The aim of this study was to estimate the n... | [
{
"companynumb": "NL-MYLANLABS-2019M1072547",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "OXYTOCIN"
},
"drugadditional": null,
... |
{
"abstract": "Drug-induced lupus (DIL) is a drug-mediated immune reaction with the same symptoms as that of lupus erythematosus. We herein report the first case of tocilizumab-induced lupus syndrome presenting with cardiac tamponade. A 65-year-old man presented with cough, exertional dyspnea, and chest pain after 2 ... | [
{
"companynumb": "JP-DSJP-DSJ-2021-136506",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PRASUGREL HYDROCHLORIDE"
},
"drugadditional": "... |
{
"abstract": "BACKGROUND\nSunitinib is a tyrosine kinase inhibitor that binds to vascular endothelial factor receptor currently used for the treatment of renal cell carcinoma, as well as for several other conditions such as gastrointestinal stromal tumors and pancreatic neuroendocrine tumors. We present a patient wi... | [
{
"companynumb": "TR-SUN PHARMACEUTICAL INDUSTRIES LTD-2022RR-328632",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SUNITINIB"
},
"druga... |
{
"abstract": "Hyperammonemic encephalopathy secondary to the use of valproate is rare without evidence of hepatotoxicity, and it usually presents with confusion, agitation, irritability, cognitive disturbances, lethargy, coma, and death. We present the case of a 21-year-old woman presenting with catatonia as a manif... | [
{
"companynumb": "MX-ALLERGAN-1823158US",
"fulfillexpeditecriteria": "1",
"occurcountry": "MX",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "FLUOXETINE HYDROCHLORIDE"
},
"drugadditional": "1... |
{
"abstract": "Second-line chemotherapy in patients with gemcitabine-refractory advanced pancreatic cancer has shown disappointing survival outcomes due to rapid disease progression and performance deterioration. The aim of this phase II trial was to evaluate the efficacy and safety of adoptive immunotherapy using ex... | [
{
"companynumb": "KP-CIPLA LTD.-2014KP01357",
"fulfillexpeditecriteria": "1",
"occurcountry": "KP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "GEMCITABINE\\GEMCITABINE HYDROCHLORIDE"
},
"... |
{
"abstract": "Alternative transition protocols from methadone to buprenorphine in the treatment of opioid use disorder (OUD) are needed to reduce the risk of precipitated withdrawal and opioid use during induction.\n\n\n\nCase report (n = 1).\n\n\n\nOne patient with OUD underwent a rapid microinduction outpatient pr... | [
{
"companynumb": "US-TEVA-2021-US-1946938",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BUPRENORPHINE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo review and report the history and clinical presentation of a cohort of health care professionals (HCPs) who have abused the drug propofol.\n\n\nMETHODS\nThe authors queried a clinical database (the HCP Database) that contained information about HCPs treated at a large addiction center bet... | [
{
"companynumb": "US-PFIZER INC-2014003368",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PROPOFOL"
},
"drugadditional": "3",
... |
{
"abstract": "Genicular nerve radiofrequency ablation (RFA) is an intervention to treat patients with chronic knee pain who have failed previous conservative, pharmacologic, and surgical interventions. Vascular complications following interventional procedures of the knee are extremely rare. A delay in diagnosis may... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2020SP012570",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "TRAMADOL"
},
"drugadditional":... |
{
"abstract": "To explore primary care polymyalgia rheumatica (PMR) patient beliefs about the causes of their PMR.\n\n\n\nQualitative content analysis was conducted on patients' written responses to the question of what they thought had caused their PMR. All data were coded and emergent categories of causal beliefs i... | [
{
"companynumb": "GB-MYLANLABS-2018M1005274",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ATORVASTATIN"
},
"drugadditional": "2",
... |
{
"abstract": "A 76-year-old Japanese man was admitted to our department because of aphasia and right hemiparesis. Brain magnetic resonance imaging showed cerebral infarction caused by occlusion of the left middle cerebral artery, and alteplase therapy was started. Thrombectomy was subsequently performed, resulting i... | [
{
"companynumb": "JP-TEVA-2018-JP-991658",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"drugadditional": "3",
"... |
{
"abstract": "Mixed phenotype acute leukemia (MPAL) accounts for 2-5% of leukemia in children. MPAL are at higher risk of induction failure. Lineage switch (B to M or vice versa) or persistence of only the lymphoid or myeloid clone is frequently observed in biphenotypic/bilineal cases, highlighting their lineage pla... | [
{
"companynumb": "FR-AMGEN-FRASP2021044561",
"fulfillexpeditecriteria": "2",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ONDANSETRON"
},
"drugadditional": null,
... |
{
"abstract": "Deliberate self-harm, including intentional self-poisoning, remains a major health concern in South Africa. Increasing number of cases place a significant burden on our Emergency Centres (EC's). Paracetamol remains the most frequent drug ingested in intentional self-poisoning. As an antidote, N-acetylc... | [
{
"companynumb": "ZA-SUN PHARMACEUTICAL INDUSTRIES LTD-2020RR-262294",
"fulfillexpeditecriteria": "1",
"occurcountry": "ZA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"d... |
{
"abstract": "Hepatic sinusoidal obstructive syndrome (HSOS) is a frequent complication in patients undergoing haematopoietic stem cell transplant (HSCT), and more rarely, in paediatric patients receiving conventional chemotherapy for solid tumours. Its diagnosis relies on a combination of clinical signs and symptom... | [
{
"companynumb": "IT-TEVA-592467ISR",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VINCRISTINE"
},
"drugadditional": null,
"dr... |
{
"abstract": "As of mid-April 2020, the coronavirus disease of 2019 (COVID-19) pandemic has affected more than 2 million people and caused 135 000 deaths worldwide. Not much is known about the effect of this disease in immunosuppressed children with renal transplantation (RT). Here we report a 13-year-old child with... | [
{
"companynumb": "US-ASTELLAS-2020US018975",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
... |
{
"abstract": "We report on a 14-year-old boy with focal atrial tachycardia. After failure of catheter ablation and medical therapy he received 2 g omega-3 fatty acid supplementation while waiting on repeat ablation. Focal atrial tachycardia disappeared 4 weeks later and antiarrhythmic therapy was terminated. We disc... | [
{
"companynumb": "DE-MYLANLABS-2019M1101265",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METOPROLOL"
},
"drugadditional": null,
... |
{
"abstract": "We describe a case of fatal acute appendicitis in a neonate associated with congenital cardiac disease requiring staged surgery. Neonatal appendicitis is extremely rare and usually associated with prematurity and congenital abdominal conditions. This report serves to highlight the risk of this disease ... | [
{
"companynumb": "AU-AXELLIA-001117",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"drugadditional": null,
"dru... |
{
"abstract": "This multi-center, retrospective study aimed to clarify retention rates and reasons for discontinuation of 7 biological disease-modifying antirheumatic drugs (bDMARDs) and tofacitinib (TOF), one of the janus kinase inhibitors, in bDMARDs-naïve and bDMARDs-switched patients with rheumatoid arthritis (RA... | [
{
"companynumb": "JP-UCBSA-2018014594",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "3",
"... |
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