article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "BACKGROUND\nRecombinant granulocyte colony-stimulating factors (G-CSFs) such as Filgrastim are used to treat chemotherapy-induced neutropenia. We investigated a new G-CSF, XM02, and compared it to Neupogen after myelotoxic chemotherapy in breast cancer (BC) patients.\n\n\nMETHODS\nA total of 348 patien... | [
{
"companynumb": "DE-AMGEN-DEUSP2021169882",
"fulfillexpeditecriteria": "2",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FILGRASTIM"
},
"drugadditional": "3",
... |
{
"abstract": "We report a 37-year-old man with a history of cirrhosis and methicillin-sensitive staphylococcus aureus (MSSA) bacteremia who presented from a nursing home with 1 week of progressive confusion followed by acute onset of aphasia, forced left eye deviation and right sided weakness. While clinical present... | [
{
"companynumb": "US-BAXTER-2015BAX046599",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "We herein report the first case of purulent pericarditis associated with aortic stent-graft infection in an 80-year-old Japanese man that was caused by methicillin-susceptible Staphylococcus aureus, which appropriate antibiotics failed to treat. The detailed clinical course and autopsy images revealed ... | [
{
"companynumb": "JP-PFIZER INC-2019519709",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MEROPENEM"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nEosinophilic granulomatosis with polyangiitis (EGPA) is a rare multisystem necrotizing vasculitis associated with eosinophilia and extravascular granuloma and classically involving the upper and lower airways. There have only been a few reported cases of gynecologic involvement in EGPA.\n\n... | [
{
"companynumb": "US-PFIZER INC-2019135790",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LIDOCAINE HYDROCHLORIDE"
},
"drugadditional": ... |
{
"abstract": "BACKGROUND\nDolutegravir (DTG), a once-daily, human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, was evaluated for distribution and antiviral activity in cerebrospinal fluid (CSF).\n\n\nMETHODS\nING116070 is an ongoing, single-arm, open-label, multicenter study in antiretroviral therapy-n... | [
{
"companynumb": "US-CIPLA LTD.-2014US01507",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ABACAVIR\\LAMIVUDINE"
},
"drugadditional": nu... |
{
"abstract": ": Dabigatran is a direct thrombin inhibitor that was approved as an alternative to warfarin because it offers the benefit of predictable pharmacokinetic properties, favorable safety profile and ease of administration. Despite the improved safety profile, dabigatran use can lead to bleeding events. The ... | [
{
"companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-056532",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IDARUCIZUMAB"
},
... |
{
"abstract": "Although reproductive-aged women use both menstrual cups and intrauterine devices (IUDs) simultaneously, it is unknown whether concomitant use reduces contraceptive effectiveness. We report seven cases wherein IUD expulsion occurred during concomitant menstrual cup use. Further research is needed to de... | [
{
"companynumb": "US-BAYER-2019-084807",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LEVONORGESTREL"
},
"drugadditional": null,
... |
{
"abstract": "Pseudoseptic arthritis is an increasingly recognised entity. It is an inflammatory arthritis that mimics septic arthritis; however, Gram stain and cultures are persistently negative. It is a diagnosis of exclusion. We present the first case, to date, in which pseudoseptic arthritis led to such severe j... | [
{
"companynumb": "PHHY2016GB160496",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "A woman in her early 60s noticed bilateral breast masses and visited a different hospital. Core needle biopsy showed diffuse large B-cell lymphoma of the right breast and invasive ductal carcinoma of the left breast. After referral to our department, PET-CT was performed. Compared with mild fluorodeoxy... | [
{
"companynumb": "JP-PFIZER INC-2019544105",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "Diamond-Blackfan anemia (DBA) is a rare congenital disease caused by mutations in ribosomal protein genes and is characterized by pure red cell aplasia. While the prognosis is relatively favorable, quality of life (QOL) among DBA patients is negatively impacted by the adverse effects of long-term predn... | [
{
"companynumb": "JP-EDENBRIDGE PHARMACEUTICALS, LLC-JP-2018EDE000003",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE SODIUM PHOSPHATE"
... |
{
"abstract": "BACKGROUND\nBisphosphonates have a widespread indication for osteoporosis and are also applied in cancer patients with skeletal-related conditions. Bisphosphonate-associated osteonecrosis of the jaw (BRONJ) is a feared side effect which is hard to treat and often affects patient's quality of life in an... | [
{
"companynumb": "DE-WATSON-2014-22158",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMINOSALICYLIC ACID"
},
"drugadditional": null,
... |
{
"abstract": "Von Hippel-Lindau (VHL) disease, caused by germline mutations in the VHL gene, is characterized by metachronously occurring tumors including pheochromocytoma, renal cell carcinoma (RCC), and hemangioblastoma. Although VHL disease leads to reduced life expectancy, its diagnosis is often missed and tumor... | [
{
"companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-042563",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TAMSULOSIN HYDROCHLORIDE"
... |
{
"abstract": "Chemotherapy with G-CSF is used to mobilize peripheral stem cells in multiple myeloma (MM) patients, with plerixafor as a rescue strategy for poorly mobilizing patients. Preclinical studies suggested that the nonsteroidal anti-inflammatory drug meloxicam enhances the mobilization of CD34+ cells. In thi... | [
{
"companynumb": "CH-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-010962",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MELOXICAM"
},
"d... |
{
"abstract": "Although acute hepatitis may be a side effect of many medications, most cases are reversible after treatment interruption, and fulminant hepatic failure (FHF) is rare. Venlafaxine and trazodone are 2 popular antidepressant agents. Alteration of liver enzyme levels has been reported as a side effect of ... | [
{
"companynumb": "BE-MYLANLABS-2010S1001242",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VENLAFAXINE HYDROCHLORIDE"
},
"drugadditional... |
{
"abstract": "OBJECTIVE\nTo determine how often serious or life-threatening medication administration errors with the potential to cause harm (potential adverse drug events) result in actual harm (adverse drug events (ADEs)) in the hospital setting.\n\n\nMETHODS\nRetrospective chart review of clinical events followi... | [
{
"companynumb": "US-TEVA-568039USA",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE SODIUM SUCCINATE"
},
"drugadditio... |
{
"abstract": "OBJECTIVE\nTo illustrate the potential value of pharmacogenetic testing to identify patients at risk for nonsteroidal anti-inflammatory drug-induced gastropathy.\n\n\nMETHODS\nCase report.\n\n\nMETHODS\nWe report a case encountered in an outpatient setting for pain management.\n\n\nMETHODS\nWe present ... | [
{
"companynumb": "US-LUPIN PHARMACEUTICALS INC.-2015-01940",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CELECOXIB"
},
"drugadditional"... |
{
"abstract": "Maple Syrup Urine Disease (MSUD) is a rare inherited disorder of branched chain amino acid metabolism characterized by cerebral edema and death in uncorrected metabolic crisis. It is conventionally treated with intensive nutritional therapy to prevent and correct metabolic crisis. This paper reports th... | [
{
"companynumb": "US-MYLANLABS-2021M1007206",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEXTROSE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nThe benefits of adjuvant chemotherapy for elderly patients with gastric cancer (GC) remain unknown because elderly patients are underrepresented in most clinical trials. This study aimed to evaluate the effectiveness and complications of adjuvant chemotherapy in patients > 65 years of age a... | [
{
"companynumb": "CN-ACCORD-219089",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CAPECITABINE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "BACKGROUND\nThe FOLFOX regimen, i.e., folinic acid (FOL), fluorouracil (F) and oxaliplatin (OX), is a drug cocktail that is used to treat gastric and colorectal cancers. Despite the concomitant improvements in response rate, duration of response and patient survival, reports of serious toxic pulmonary ... | [
{
"companynumb": "BE-FRESENIUS KABI-FK201708130",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LEUCOVORIN CALCIUM"
},
"drugadditional":... |
{
"abstract": "There is an unmet need for a treatment for psoriasis that results in complete skin clearance with a reliably quick response. Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. We aimed to compare the efficacy and safety of bimekizumab with pl... | [
{
"companynumb": "DE-JNJFOC-20210543993",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "USTEKINUMAB"
},
"drugadditional": "3",
... |
{
"abstract": "Splenic marginal zone lymphoma (SMZL) accounts for only 1-2.7% of all lymphomas. Almost all patients have bone marrow (BM) involvement but only one-third has liver involvement. The higher prevalence of hepatitis C virus (HCV) infection in these patients has led to the hypothesis of viral involvement in... | [
{
"companynumb": "PT-CELLTRION HEALTHCARE HUNGARY KFT-2021PT015921",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VINCRISTINE"
},
"druga... |
{
"abstract": "Extracorporeal membrane oxygenation is considered a relative contraindication for patients with severe neurological injury manifested by fixed and dilated pupils. The inability to provide adequate cardiopulmonary support while attempting to treat the underlying neurologic disease results in a fatal out... | [
{
"companynumb": "US-PFIZER INC-2021195114",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VENLAFAXINE HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "Purpose: Defining the risk of neoplasia associated with gender-affirming hormone therapy (GAHT) is a priority for transgender medical research. The purposes of this article are to present a unique case of breast neoplasia in a transgender individual and to review the existing evidence base on GAHT as a... | [
{
"companynumb": "US-MYLANLABS-2018M1009863",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TAMSULOSIN"
},
"drugadditional": null,
... |
{
"abstract": "Both developmental and acquired stuttering are related to the function of the basal ganglia-thalamocortical loop, which includes the putamen. Here, we present a case of stuttering- and palilalia-like dysfluencies that manifested as an early symptom of multiple system atrophy-parkinsonian type (MSA-P) a... | [
{
"companynumb": "JP-IMPAX LABORATORIES, INC-2018-IPXL-00149",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "CARBIDOPA\\LEVODOPA"
},
"dru... |
{
"abstract": "We retrospectively studied the long-term (2-year) outcome of 50 consecutive patients admitted to our inpatient headache program because of chronic daily headache (CDH) associated with the overuse of analgesics, ergotamine, or both. They had been detoxified, given repetitive intravenous dihydroergotamin... | [
{
"companynumb": "US-PFIZER INC-2015436478",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CAFFEINE"
},
"drugadditional": null,
... |
{
"abstract": "Solid organ transplant recipients have an increased incidence of skin infections resulting from immunosuppression. Common pathogens include herpes simplex virus, varicella zoster virus, Gram-positive bacteria and dermatophytes; however, the contribution of multicellular parasitic organisms to dermatolo... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2017SP000065",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditiona... |
{
"abstract": "A 47-year-old woman with a large ostium secundum atrial septal defect (ASD) and severe pulmonary artery hypertension underwent device closure of ASD under transesophageal echocardiography guidance. She developed a massive esophageal hematoma which was diagnosed 4 days after the procedure. The use of du... | [
{
"companynumb": "IN-DRREDDYS-USA/IND/16/0068234",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CLOPIDOGREL BISULFATE"
},
"drugadditiona... |
{
"abstract": "PURPOSE We investigated the effect on minimal residual disease, by qualitative and real-time quantitative polymerase chain reaction (RQ-PCR), of a consolidation regimen that included bortezomib, thalidomide, and dexamethasone (VTD) in patients with multiple myeloma (MM) responding to autologous stem-ce... | [
{
"companynumb": "IT-TAKEDA-2017MPI007091",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "BORTEZOMIB"
},
"drugadditional": null,
... |
{
"abstract": "As a result of infection control regulations during the coronavirus disease 2019 (COVID-19) pandemic, anticoagulation clinics have been required to adjust their practices in order to continue providing safe and effective services for their patients. In accordance with a guidance document issued by the ... | [
{
"companynumb": "US-MYLANLABS-2021M1093661",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "WARFARIN"
},
"drugadditional": "1",
... |
{
"abstract": "Cytomegalovirus (CMV) is a common posttransplant infection, most commonly seen in settings of excessive immunosuppression. Before the advent of CMV specific antiviral therapies, the standard treatment approaches for CMV disease were immunosuppression reductions to let the transplant recipient mount an ... | [
{
"companynumb": "US-APOTEX-2020AP006798",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "3",... |
{
"abstract": "Chronic granulomatous disease (CGD) is a genetic disease caused by structural mutations in the enzyme NADPH oxidase that results in severe immunodeficiency. End-stage renal disease occurs in this patient population and is attributed to various factors, including infections, amyloidosis, and nephrotoxic... | [
{
"companynumb": "TR-SUN PHARMACEUTICAL INDUSTRIES LTD-2015RR-106657",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
... |
{
"abstract": "Systemic capillary leak syndrome is a rare, underdiagnosed and life-threatening disease characterized by periodic episodes of hypovolaemic shock due to leakage of plasma from the intravascular to the extravascular space. It is associated with haemoconcentration, hypoalbuminaemia and generalized oedema.... | [
{
"companynumb": "PT-PURDUE-GBR-2019-0070964",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "THEOPHYLLINE ANHYDROUS"
},
"drugadditional":... |
{
"abstract": "To describe the presentation and management of a patient with epithelial versus fibrous downgrowth following trabeculectomy surgery and review relevant literature regarding this complication after intraocular surgery.\nA 52-year-old monocular African-American woman was referred for management of presum... | [
{
"companynumb": "US-ROCHE-2963305",
"fulfillexpeditecriteria": "1",
"occurcountry": null,
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BEVACIZUMAB"
},
"drugadditional": "4",
"drug... |
{
"abstract": "Tuberous sclerosis complex (TSC) is a rare autosomal dominant genetic disease with many manifestations, and it involves any organ. In this study, we report a TSC patient with new type skin lesions.\n\n\n\nA 7-month-old TSC boy with multiple cutaneous nodules was admitted in our hospital. We collected t... | [
{
"companynumb": "CN-GLAXOSMITHKLINE-CN2020GSK120074",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LAMOTRIGINE"
},
"drugadditional": nu... |
{
"abstract": "We aim to evaluate the efficacy of 2 different 1-week quadruple therapies given back-to-back consecutive therapy in patients with difficult-to-treat Helicobacter pylori infection.\n\n\n\nPatients with proven H. pylori infection were recruited after >3 failed standard quadruple eradication. They receive... | [
{
"companynumb": "CN-ALKEM LABORATORIES LIMITED-CN-ALKEM-2021-05523",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ESOMEPRAZOLE MAGNESIUM"
},
... |
{
"abstract": "Enterovesical fistula (EVF) is a rare complication of diverticulitis, as well as Crohn's disease, intestinal malignancy, radiotherapy and trauma. EVF formation is associated with inflammation of the involved bowel segments. The current study presents the case of a 35-year-old man with non-Hodgkin's lym... | [
{
"companynumb": "TW-BAUSCH-BL-2016-016246",
"fulfillexpeditecriteria": "1",
"occurcountry": "TW",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": null,
... |
{
"abstract": "We describe a case of atrial fibrillation in which an intracardiac thrombus that could not be prevented with \"low-dose\" dabigatran treatment was resolved by switching to apixaban treatment. Thrombolysis using direct oral anticoagulants (DOACs) could be a therapeutic option for patients with intracard... | [
{
"companynumb": "JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-14913NB",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "RISEDRONATE SODIUM"
},
... |
{
"abstract": "A 46-year-old woman was referred to the endocrinology clinic for evaluation of progressive fatigue, dizziness and treatment-resistant hypothyroidism. Initial laboratory results revealed hypothyroidism, hyponatraemia and hyperkalaemia. Liothyronine sodium (Cytomel) was initiated, which exacerbated her f... | [
{
"companynumb": "US-PFIZER INC-2019392287",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "LEVOTHYROXINE SODIUM"
},
"drugadditional": nul... |
{
"abstract": "We report the case of a 43-year-old woman presenting with nocturnal episodes of pain and screaming during sleep starting at age 30. There was no childhood or family history of parasomnia. The events had gradually become more frequent over the years, occurring in the first half of the night within 2 h o... | [
{
"companynumb": "GB-GLENMARK PHARMACEUTICALS INC, USA.-2015GMK014998",
"fulfillexpeditecriteria": "2",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "GABAPENTIN"
},
"dru... |
{
"abstract": "Objective: To describe a temporal association between COVID-19 vaccine administration and multiple sclerosis (MS) relapses. Methods: This case series study was collected in four MS Centres in Central Italy, using data from 16 MS patients who received COVID-19 vaccination and presented both clinically a... | [
{
"companynumb": "IT-PFIZER INC-202101625315",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DIMETHYL FUMARATE"
},
"drugadditional": "3",... |
{
"abstract": "A woman aged 44 underwent elective standard abdominoplasty and bilateral mastopexy (superiorly based pedicle with vertical scar) following weight loss of 8.5 stone (53.9 kg) over a 5-year period. She had type 2 diabetes and her antidiabetic medications included metformin, liraglutide and empagliflozin.... | [
{
"companynumb": "GB-NOVOPROD-559656",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LIRAGLUTIDE"
},
"drugadditional": "3",
"dr... |
{
"abstract": "BACKGROUND\nMycophenolate mofetil (MMF) is recommended as a first-line immunosuppressant to treat lupus nephritis (LN). Prognosis and therapeutic response in LN are known to vary depending on race. We investigated the benefits of MMF and therapeutic drug monitoring (TDM) in the treatment of Japanese LN... | [
{
"companynumb": "JP-ALKEM LABORATORIES LIMITED-JP-ALKEM-2018-04108",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
... |
{
"abstract": "BACKGROUND\nIntravenous lipid emulsion (ILE) has gained favor as a rescue treatment for cardiovascular collapse due to intravenous local anesthetic overdose, however, goals of ILE therapy are still being defined. We describe a case of a girl given 66 mL/kg of 20% lipid emulsion (ILE) in the treatment o... | [
{
"companynumb": "US-DENTSPLY-2018SCDP000527",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MEPIVACAINE\\MEPIVACAINE HYDROCHLORIDE"
},
"... |
{
"abstract": "Between 1982 and 1986, 326 evaluable patients with acute myeloid leukemia (AML) were randomized to receive cytarabine (Ara-C) at 200 mg/m2 (A200) or 100 mg/m2 (A100) for induction and maintenance therapy. Cycle 1 of induction therapy consisted of 7 days of continuous intravenous (IV) Ara-C and 3 days o... | [
{
"companynumb": "US-PFIZER INC-2021594820",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CYTARABINE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo compare the retinal and choroidal microvasculature quantitatively via optical coherence angiography (OCTA) in children with attention deficit hyperactivity disorder (ADHD) who were under methylphenidate (MFD) treatment or newly diagnosed as ADHD and were not taking any medication.\n\n\nME... | [
{
"companynumb": "TR-JNJFOC-20200523568",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPHENIDATE HYDROCHLORIDE"
},
"drugadditional... |
{
"abstract": "Recent advances in systemic sclerosis (SSc) show that it involves a T-helper type-2-oriented immune response with interleukin (IL)-4 and IL-13. Romilkimab is an engineered, humanised, bispecific immunoglobulin-G4 antibody that binds and neutralises IL-4/IL-13 making it ideal for exploration in fibrosis... | [
{
"companynumb": "FR-ROCHE-2724998",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nSynovial sarcomas are uncommon malignancies that mainly affect adolescents and young adults. Most arise from the deep soft tissues of the extremities, but they can occur in other parts of the body such as the lung. Synovial sarcomas after radiation therapy are rare, in contrast with other s... | [
{
"companynumb": "US-MALLINCKRODT-T201501922",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "SODIUM IODIDE I-131"
},
"drugadditional": nu... |
{
"abstract": "The combination of lenalidomide (Revlimid® , R) and dexamethasone (d) is a standard regimen for patients with relapsed/refractory multiple myeloma (rrMM). With this regimen, only a small fraction of patients will achieve high quality responses [≥ very good partial response (VGPR)]. The combination of b... | [
{
"companynumb": "CH-CELGENEUS-151-21880-14072993",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BENDAMUSTINE"
},
"drugadditional": "3",... |
{
"abstract": "We reported a case of a 6-month-old baby girl who was hospitalized in the pediatric emergency for central nervous system disorders then coma. Toxicology analysis showed the presence of amitriptyline (AMI) and its metabolite nortriptyline (NOR) in blood and urine of the baby. Additional investigations s... | [
{
"companynumb": "FR-MYLANLABS-2016M1017149",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "KETAMINE"
},
"drugadditional": null,
... |
{
"abstract": "Ergotism is a toxic condition resulting from overexposure to the ergot compounds produced by various fungi of the genus Claviceps. Traditionally, such exposure was due to ingestion of infected grains, but long-term or excessive use of medications containing ergot derivatives or drug-drug interactions b... | [
{
"companynumb": "TH-WATSON-2014-20621",
"fulfillexpeditecriteria": "1",
"occurcountry": "TH",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "INDINAVIR\\RITONAVIR"
},
"drugadditional": null,
... |
{
"abstract": "We herein report the case of a patient with human immunodeficiency virus infection and acquired immune deficiency syndrome who was diagnosed with drug-induced pure red cell aplasia consequent to lamivudine treatment. The patient was admitted to our hospital for treatment of increasing shortness of brea... | [
{
"companynumb": "JP-VIIV HEALTHCARE LIMITED-B0551326A",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "ABACAVIR SULFATE"
},
"drugaddition... |
{
"abstract": "Coronavirus Disease 2019 (COVID-19) has become a pandemic since March 2020. We describe here 2 cases of COVID-19 infection in a posttransplant setting. First one is a 59-year-old renal transplant recipient; the second is a 51-year-old allogeneic bone marrow transplant recipient. Both patients were on i... | [
{
"companynumb": "CN-TEVA-2020-CN-1812473",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MOXIFLOXACIN"
},
"drugadditional": null,
... |
{
"abstract": "The development of Angular Cheilitis and the reactivation of Herpes Simplex Virus, could be related to a decrease in the resistance of the immune system in the infected host, being common in cancer patients receiving antineoplastic chemotherapy. The objective of the present manuscript is to report Anti... | [
{
"companynumb": "BR-FRESENIUS KABI-FK201603257",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": n... |
{
"abstract": "Although levetiracetam is the antiepileptic of choice in patients after hepatic transplantation and patients with hepatic dysfunction, we report a patient in whom levetiracetam was the most probable cause of hepatic dysfunction. Treatment of this hepatic dysfunction is to have a high degree of suspicio... | [
{
"companynumb": "IN-CIPLA LTD.-2020IN06674",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "1",
... |
{
"abstract": "Despite the development of new treatment options based on the molecular characterization of colorectal cancer, 20% of patients present de novo metastatic disease, whereas 30-40% of patients who receive curative treatment relapse during follow up. Herein, we report 2 cases with rectal cancer that develo... | [
{
"companynumb": "GR-SA-2020SA004387",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUOROURACIL\\LEUCOVORIN"
},
"drugadditional": "3",
... |
{
"abstract": "To evaluate postpartum blood loss in women with treated intrahepatic cholestasis of pregnancy.\n\n\n\nIn a retrospective case-control study, 15,083 deliveries including 348 women with intrahepatic cholestasis of pregnancy (2.3%) were analyzed from 2004 to 2014. To adjust for differences in baseline cha... | [
{
"companynumb": "CH-ALLERGAN-1813252US",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "URSODIOL"
},
"drugadditional": "3",
"dr... |
{
"abstract": "The transdermal fentanyl patch (TDF) can be used when switching from other opioids; therefore, little is known about the efficacy and safety of TDF patches applied for opioid initiation. However, TDF patches have been applied for opioid initiation in gastrointestinal cancer patients with gastrointestin... | [
{
"companynumb": "JP-JNJFOC-20141207756",
"fulfillexpeditecriteria": "2",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FENTANYL"
},
"drugadditional": null,
"d... |
{
"abstract": "OBJECTIVE\nPaclitaxel (Taxol) is an antineoplastic agent approved in the United States for the treatment of lung, breast, cervical, pancreatic cancers and Kaposi sarcoma. Paclitaxel does not cross the blood brain barrier, so central nervous system adverse effects are uncommon.\n\n\nMETHODS\nWe describe... | [
{
"companynumb": "US-PFIZER INC-2019384209",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PIPERACILLIN SODIUM\\TAZOBACTAM SODIUM"
},
"d... |
{
"abstract": "BACKGROUND\nAmphetamines have been reported to cause myocardial infarct, cerebral hemorrhage, aortic dissection, hypertension, vasculitis, aneurysms, and, occasionally, death from direct toxicity. To date, there have been no reports of coronary intimal hyperplasia in an amphetamine user.\n\n\nMETHODS\n... | [
{
"companynumb": "US-RANBAXY-2013US-70032",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METHYLPHENIDATE"
},
"drugadditional": null,
... |
{
"abstract": "Gitelman syndrome is an autosomal recessive genetic disease caused by pathogenic variants in SLC12A3 resulting in the loss of function of the Na-Cl co-transporter (NCC) in the distal tubules. Hypokalemia and diuretic effects can cause secondary type 2 diabetes and renal function decline. Here, we prese... | [
{
"companynumb": "JP-LUPIN PHARMACEUTICALS INC.-2022-07953",
"fulfillexpeditecriteria": "2",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "POTASSIUM CHLORIDE"
},
"drugad... |
{
"abstract": "The authors report a case of intraoperative sinus arrest in an otherwise healthy patient undergoing craniotomy for aneurysm clipping after mild subarachnoid hemorrhage. The sinus arrest was precipitated by a rapid infusion of 1500 mg phenytoin and was successfully treated with standard resuscitative me... | [
{
"companynumb": "US-PFIZER INC-001-0073-990073",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "MEPERIDINE"
},
"drugadditional": null,
... |
{
"abstract": "We report the case of metformin-associated lactic acidosis (MALA) exacerbated by acute kidney injury (AKI) in a 65-year-old Asian American woman who was an overseas traveler. She had vomiting and diarrhea before arriving in Osaka, Japan, from the Philippines. She suffered from worsening respiratory dis... | [
{
"companynumb": "JP-IPCA LABORATORIES LIMITED-IPC-2021-JP-002046",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
... |
{
"abstract": "Although the majority of indolent lymphomas (focusing on follicular lymphoma [FL]) have a prolonged waxing and waning course, a portion of patients experience histologic transformation (HT) to either diffuse large B-cell lymphoma or a higher-grade morphology, often with acquisition of MYC and BCL2 and/... | [
{
"companynumb": "US-ROCHE-2747785",
"fulfillexpeditecriteria": "1",
"occurcountry": null,
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": null,
"druga... |
{
"abstract": "The increasing use of 3,4-methylenedioxymethamphetamine (MDMA, \"ecstasy\") and tendency of users to combine MDMA with pharmaceutical agents (especially serotonergic medication) warrants a thorough understanding of MDMA's toxicity profile and potential for drug interactions. This study examined the inv... | [
{
"companynumb": "AU-PFIZER INC-2011115204",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ALCOHOL"
},
"drugadditional": null,
... |
{
"abstract": "A 49-year-old female with biopsy proven primary vitreoretinal lymphoma and primary central nervous system lymphoma (PCNSL) presented with asymmetric involvement of both eyes. Right eye had primarily retinal and optic nerve involvement with no light perception while the left eye had purely vitreal form ... | [
{
"companynumb": "IN-MYLANLABS-2015M1040815",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,
... |
{
"abstract": "Acquired hemophilia is a rare autoimmune bleeding disorder related to the production of autoantibodies that inhibit clotting factor VIII or IX. The underlying cause can be autoimmune disease, malignancy, pregnancy, or medications, but it is most commonly idiopathic. Here we present the case of an 81-ye... | [
{
"companynumb": "GR-GYP-000001",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": null,
"d... |
{
"abstract": "This is a preliminary, multicenter, retrospective cohort study, including 272 consecutive patients with COVID-19 admitted to hospitals in Buenos Aires Province, between May 15th and July 1st, 2020, included in an expanded access program to convalescent plasma. Our objectives were to analyze mortality a... | [
{
"companynumb": "AR-ABBVIE-20K-007-3562923-00",
"fulfillexpeditecriteria": "1",
"occurcountry": "AR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LOPINAVIR\\RITONAVIR"
},
"drugadditional":... |
{
"abstract": "Multidrug-resistant tuberculosis (MDR-TB) is a global public health problem affecting women of childbearing age. Little is known, however, about the safety of the drugs used to treat MDR-TB during pregnancy. We describe 7 patients who were treated for MDR-TB during pregnancy. These patients had chronic... | [
{
"companynumb": "PHBS2004US13757",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CLOFAZIMINE"
},
"drugadditional": null,
"dru... |
{
"abstract": "Saccharomyces cerevisiae is an emerging pathogen within the immunocompromised. We present a 4-year-old boy with acute lymphoblastic leukemia presenting with polymerase chain reaction-confirmed hepatosplenic S. cerevisiae infection and significant immune reconstitution symptoms. We explore the challenge... | [
{
"companynumb": "GB-TEVA-2020-GB-1220047",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VINCRISTINE"
},
"drugadditional": "3",
... |
{
"abstract": "A 64-year-old woman who complained of abdominal pain underwent right radical nephrectomy under the clinical diagnosis of renal cell carcinoma in January, 2006. The pathological diagnosis was leiomyosarcoma originating from the kidney. Follow-up computed tomography revealed 2 small nodules in the left l... | [
{
"companynumb": "JP-CIPLA LTD.-2018JP10148",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "GEMCITABINE\\GEMCITABINE HYDROCHLORIDE"
},
"d... |
{
"abstract": "Hypoparathyroidism is a rare endocrine disease with insufficient parathyroid hormone levels. Replacing the missing hormone is not yet a standard therapy. The objective of this retrospective cohort study was to evaluate if the usual therapy regimens of postsurgical hypoparathyroidism with calcitriol hav... | [
{
"companynumb": "BE-VALIDUS PHARMACEUTICALS LLC-BE-2019VAL000875",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CALCITRIOL"
},
"drugadd... |
{
"abstract": "Riluzole is a glutamate-modulating agent with neuroprotective properties approved for use in amyotrophic lateral sclerosis. The efficacy and safety of riluzole vs placebo as an adjunct to antidepressant medication in outpatients with major depressive disorder (MDD) was examined in a 3-site, 8-week, ran... | [
{
"companynumb": "US-CIPLA LTD.-2017US23107",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SERTRALINE HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "We present the case of a 12-year-old-girl who developed lichenoid dermatitis approximately 1 year after starting leflunomide for juvenile idiopathic arthritis. The eruption resolved promptly with discontinuation of the suspected culprit agent, supportive of a lichenoid drug eruption, but she subsequent... | [
{
"companynumb": "PHHY2017US110901",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEFLUNOMIDE"
},
"drugadditional": "1",
"drug... |
{
"abstract": "Fluoroquinolones are a class of popular outpatient antimicrobial agents with a wide spectrum of therapeutic indications for respiratory and genitourinary infections. Though the most common side effects are gastrointestinal, fluoroquinolones have been increasingly associated with neurotoxicity including... | [
{
"companynumb": "US-PFIZER INC-2017478885",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LEVOFLOXACIN"
},
"drugadditional": null,
... |
{
"abstract": "Adverse drug events (ADEs) are a significant cause of emergency department (ED) visits, with a major impact on healthcare resource utilization. A multicentre observational study, aimed to describe frequency, seriousness and preventability of ADEs reported in four EDs, was performed in Sicily (Italy) ov... | [
{
"companynumb": "IT-JNJFOC-20190530529",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TRAMADOL HYDROCHLORIDE"
},
"drugadditional": "3",... |
{
"abstract": "OBJECTIVE\nTo report the occurrence of fatal acute liver failure following addition of levothyroxine to a regimen of sunitinib and acetaminophen.\n\n\nMETHODS\nA 57-year-old woman who started sunitinib treatment for relapsed metastatic gastrointestinal stromal tumor after imatinib failure had disease s... | [
{
"companynumb": "US-JNJFOC-20150913999",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": null,
... |
{
"abstract": "We evaluated the safety and efficacy of plerixafor, subsequent to disease-specific chemotherapy followed by granulocyte-colony stimulating factor (G-CSF), in 37 multiple myeloma (MM) or lymphoma patients, who were candidates for autologous stem cell transplantation (ASCT) predicted as poor mobilizers (... | [
{
"companynumb": "IT-AMGEN-ITASP2021040365",
"fulfillexpeditecriteria": "2",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FILGRASTIM"
},
"drugadditional": null,
... |
{
"abstract": "Leishmaniasis is a protozoan disease caused by parasites of the genus Leishmania, transmitted to humans by sandflies. The diagnosis of leishmaniasis is often challenging as it mimics many other infectious or malignant diseases. The disease can present in three ways: cutaneous, mucocutaneous, or viscera... | [
{
"companynumb": "BE-AMGEN-BELSP2017113150",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ETANERCEPT"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND Vertical diplopia that follows local anesthesia is usually due to inferior rectus muscle fibrosis. Here, we report a rare case of acquired Brown syndrome following local anesthesia. CASE REPORT A 36-year-old woman underwent right inferior orbital fat decompression under local anesthesia. On ... | [
{
"companynumb": "SA-B.BRAUN MEDICAL INC.-2089143",
"fulfillexpeditecriteria": "1",
"occurcountry": "SA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "BUPIVACAINE HYDROCHLORIDE"
},
"drugadd... |
{
"abstract": "Methotrexate (MTX) is an effective but potentially toxic treatment for psoriasis. We describe a patient who administered 20 mg daily of MTX for 5 d and presented with ulcerated and necrotic lesions on the psoriatic plaques, mouth erosions and hair loss. However, his psoriatic plaques and ulcerations to... | [
{
"companynumb": "PHHY2013TR101232",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,
"dr... |
{
"abstract": "BACKGROUND\nPeptic ulcer disease (PUD) is a rare condition in children. Perforated peptic ulcer (PPU), a complication of PUD has an estimated mortality between 1.3% and 20%. We evaluate incidence and outcomes of PPU in children using an administrative database, perform a review of the literature, and r... | [
{
"companynumb": "US-PFIZER INC-2019104893",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IBUPROFEN"
},
"drugadditional": "3",
... |
{
"abstract": "A 63-year-old man was admitted to our hospital for further investigation and management of brain metastases. The patient was initially presented with a 4-day history of confusion. On the day of admission, the patient was confused, agitated, disorientated in place and time, and had visual disturbances. ... | [
{
"companynumb": "GR-SA-2017SA241740",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "AMLODIPINE BESYLATE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTreatment options for corticosteroid-refractory and/or high-grade checkpoint inhibitor (CPI)-induced cutaneous adverse events (CAEs) are limited; however, anecdotal reports of biologic therapies have been successful. We aim to characterize the appropriate treatment scenarios and safety and e... | [
{
"companynumb": "US-009507513-2201USA005623",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PEMBROLIZUMAB"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nThe prognosis of refractory or relapsed pediatric solid tumors is very poor, and there is no standard treatment for this condition. The combination of irinotecan and temozolomide has proved useful in adults as a second-line treatment of different solid tumors. In pediatric patients, this co... | [
{
"companynumb": "ES-PFIZER INC-2014215312",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TEMOZOLOMIDE"
},
"drugadditional": null,
... |
{
"abstract": "Bilateral thalamic infarcts are uncommon posterior circulation strokes. The artery of Percheron (AOP) is a rare anatomical variant involving a singular arterial supply to both thalami and occlusion leads to bilateral thalamic infarction.We report the case of a 71-year-old man who presented with decreas... | [
{
"companynumb": "GB-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-019821",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DABIGATRAN ETEXILATE MESYLATE"
... |
{
"abstract": "Systemic amyloidosis is a clinical manifestation of the accumulation of amyloid fibrils in tissues because of persistent acute phase elevation and chronic inflammation. Its most common causes are inflammatory diseases and malignancies. Here, we present a 12-year-old girl diagnosed with systemic amyloid... | [
{
"companynumb": "TR-ALKEM LABORATORIES LIMITED-TR-ALKEM-2019-04876",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "COLCHICINE"
},
"druga... |
{
"abstract": "A man, aged 61 years, with a history of hypogonadism and family history of cancer experienced persistent urinary difficulties with no visible prostate abnormalities. Laboratory testing and diagnostic imaging revealed a primary lesion in the prostate with lymph node involvement and multiple bone metasta... | [
{
"companynumb": "US-TEVA-2019-US-1074020",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LEUPROLIDE"
},
"drugadditional": null,
... |
{
"abstract": "Osteonecrosis of the jaw may be caused by many different triggers. One of them is described to be the drug or medication related osteonecrosis of the jaw. Since many years bisphosphonates induced the dreaded diagnosis. Recently a drug named denosumab is reported to show similar effects on the jaw. In t... | [
{
"companynumb": "DE-AMGEN-DEUSP2015115937",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DENOSUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Secondary hyperparathyroidism (SHPT) occurs in patients with chronic renal failure complicated with renal bone disease and soft tissue/vascular calcification. In dialysis patients with severe SHPT, medical treatment may fail and parathyroidectomy (PTX) is indicated for definitive treatment. Severe hypo... | [
{
"companynumb": "MN-STRIDES ARCOLAB LIMITED-2018SP000920",
"fulfillexpeditecriteria": "1",
"occurcountry": "MN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CINACALCET"
},
"drugadditional... |
{
"abstract": "Fanconi syndrome (FS) is a severe grade of drug-induced proximal tubule toxicity. There are numerous causes for acquired FS, and drug toxicity is one of the most common. FS is known to be associated with the nucleoside reverse transcriptase inhibitor (NRTI) tenofovir disoproxil fumarate (TDF). TDF is o... | [
{
"companynumb": "US-AVET LIFESCIENCES LTD-2021-AVET-000041",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditiona... |
{
"abstract": "BACKGROUND\nSevere hypercalcemia is rare in newborns; even though often asymptomatic, it may have important sequelae. Hypophosphatemia can occur in infants experiencing intrauterine malnutrition, sepsis and early high-energy parenteral nutrition (PN) and can cause severe hypercalcemia through an unknow... | [
{
"companynumb": "IT-MYLANLABS-2021M1093483",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FUROSEMIDE"
},
"drugadditional": "4",
... |
{
"abstract": "Pseudoporphyria (PP) is used to describe a photodistributed bullous disorder with clinical and histologic features of porphyria cutanea tarda (PCT) but without accompanying biochemical porphyrin abnormalities. Medications, excessive sun and ultraviolet radiation exposure, have all been reported to deve... | [
{
"companynumb": "IN-ROXANE LABORATORIES, INC.-2015-RO-02108RO",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PARICALCITOL"
},
"drugadd... |
{
"abstract": "Varenicline is a smoking cessation agent. Varenicline acts as a partial agonist of α4β2 neuronal nicotinic acetylcholine receptor and prevents nicotine binding to the same. It also causes dopamine (DA) stimulation that decreases craving and symptoms of dependence. A 40-year-old male diagnosed with alco... | [
{
"companynumb": "IN-PFIZER INC-2015453426",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "VARENICLINE TARTRATE"
},
"drugadditional": nul... |
{
"abstract": "A 67-year-old man with castration-resistant prostate cancer associated with multiple bone metastases had been treated with zoledronic acid and docetaxel. Although there was no evidence of damage around the right lower jaw bone, the patient complained of pain in May 2011, which worsened during the next ... | [
{
"companynumb": "JP-CIPLA LTD.-2018JP10168",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DOCETAXEL"
},
"drugadditional": null,
... |
{
"abstract": "Symptoms of psychotic disorders can complicate efforts to accurately evaluate patients' medication ingestion. The digital medicine system (DMS), composed of antipsychotic medication co-encapsulated with an ingestible sensor, wearable sensor patches, and a smartphone application, was developed to object... | [
{
"companynumb": "US-OTSUKA-2021_010022",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "In burnt or skeletonized bodies dental hard tissue sometimes is the only remaining specimen available. Therefore, it could be used as an alternative matrix in post mortem toxicology. Additionally, analysis of dental tissues could provide a unique retrospective window of detection. For forensic interpre... | [
{
"companynumb": "DE-WATSON-2016-08646",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DIACETYLMORPHINE"
},
"drugadditional": null,
... |
{
"abstract": "Our report describes the case of patient with hypersensitive reaction regularly arising early after initiation of haemodialysis. This characteristic reaction with pletoric face coloration, bronchospasm, increase of blood pressure, anxiety and decrease of blood oxygen saturation at the consequence and c... | [
{
"companynumb": "PHHY2015CZ090696",
"fulfillexpeditecriteria": "1",
"occurcountry": "CZ",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ENOXAPARIN"
},
"drugadditional": null,
"drug... |
{
"abstract": "Objectives: Hepatitis E virus (HEV) infection is a pandemic with regional outbreaks, including in industrialized countries. HEV infection is usually self-limiting but can progress to chronic hepatitis E in transplant recipients and HIV-infected patients. Whether other immunocompromised hosts, including... | [
{
"companynumb": "FR-TEVA-2019-FR-1052619",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": "3",
... |
{
"abstract": "To characterize the use and safety of newer disease-modifying therapies (DMTs) in children with multiple sclerosis (MS) and clinically isolated syndrome (CIS) treated under 18 years of age.\n\n\n\nThis is a cohort study including children with MS or CIS followed at 12 outpatient practices participating... | [
{
"companynumb": "PHHY2019US001191",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "FINGOLIMOD HYDROCHLORIDE"
},
"drugadditional": null,
... |
{
"abstract": "Cancers can develop the ability to evade immune recognition and destruction. Immune checkpoint inhibitors (ICIs) are drugs targeting these immune evasion mechanisms. ICIs have significantly improved outcomes in several cancers including metastatic melanoma. However, data on toxicities associated with a... | [
{
"companynumb": "GB-TEVA-2021-GB-1902215",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "1"... |
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