article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "OBJECTIVE\nTo report what we believe to be the first 2 cases of long-term (>24 months) intermittent intravenous interleukin-2 receptor antibody (IL-2RA) therapy for maintenance immunosuppression following renal transplantation.\n\n\nMETHODS\nThe first patient is a 52-year-old female with a history of i... | [
{
"companynumb": "US-ROCHE-1037155",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BASILIXIMAB"
},
"drugadditional": "3",
"drug... |
{
"abstract": "Löfgren's syndrome is a rare variant of sarcoidosis characterized by the triad of hilar adenopathy, acute polyarthritis, and erythema nodosum. It can be the first presentation of underlying sarcoidosis. Also, the initial presentation of Löfgren's syndrome may be confused with cellulitis. This is a self... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2016SP016654",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IBUPROFEN"
},
"drugadditional":... |
{
"abstract": "Background Thromboembolic complications after stenting of intracranial aneurysms may be affected by antiplatelet administration. Aims This retrospective study aimed to assess the safety of intravenous tirofiban versus loading dose of oral clopidogrel for preventing thromboembolism in stent-assisted coi... | [
{
"companynumb": "CN-MYLANLABS-2017M1057145",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CLOPIDOGREL BISULFATE"
},
"drugadditional": "... |
{
"abstract": "Bendamustine has been increasingly used for treatment of indolent lymphoma for the past few years. The data on safety profile of this drug is still emerging with the increasing use of this drug. The higher occurrence of CMV reactivation with this drug has been reported in few case reports only. We repo... | [
{
"companynumb": "IN-MYLANLABS-2018M1055566",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BENDAMUSTINE HYDROCHLORIDE"
},
"drugadditiona... |
{
"abstract": "The paper describes the case of a patient affected by a combination of genetic and autoimmune diseases (multiple sclerosis, psoriatic arthritis, Leiden V mutation, and sicca syndrome) and hypertension. The psoriatic arthritis was treated with celecoxib and multiple sclerosis with fingolimod. The patien... | [
{
"companynumb": "PHHY2012CH035758",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "FINGOLIMOD"
},
"drugadditional": "1",
"druga... |
{
"abstract": "Neoadjuvant chemoradiotherapy (CRT) in locally advanced rectal cancer (LARC) does not achieve effective control of distant metastases. Induction chemotherapy is a promising strategy, and bevacizumab (BV) could improve the results of CRT. 5-Fluorouracil, oxaliplatin and irinotecan (FOLFOXIRI) plus BV is... | [
{
"companynumb": "IT-PFIZER INC-2019069761",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BEVACIZUMAB"
},
"drugadditional": null,
... |
{
"abstract": "As left ventricular assist devices (LVADs) become more prevalent, it is increasingly likely that patients with LVADs will require non cardiac procedures. Peri-procedural anticoagulation management is challenging in these patients and requires balancing risks of bleeding and pump thrombosis. We present ... | [
{
"companynumb": "US-MYLANLABS-2019M1102727",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "WARFARIN"
},
"drugadditional": null,
... |
{
"abstract": "Bevacizumab, an inhibitor of vascular endothelial growth factor, is approved for the treatment of various cancers, but the incidence of proteinuria as a side effect has been reported to be 2-64%. We report a case of renal impairment due to thrombotic microangiopathy (TMA) accompanied with glomerular su... | [
{
"companynumb": "JP-ROCHE-1454130",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PACLITAXEL"
},
"drugadditional": null,
"dru... |
{
"abstract": "There are only scattered case reports documenting belatacept use in HIV + kidney transplant recipients. We performed a retrospective review to describe short-term outcomes following conversion to belatacept in a cohort of HIV + patients. Patients were included if they were converted to belatacept betwe... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2021SP001273",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BELATACEPT"
},
"drugadditional"... |
{
"abstract": "The objectives of this study are to carefully describe the context of methotrexate medication errors, to details medical consequences and management approaches, and to determine the rate of fatal outcome.\n\n\n\nData on methotrexate medication errors were obtained from the French network of poison cont... | [
{
"companynumb": "PHHY2019FR127733",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "Encephalopathy, delirium, and agitation are documented symptoms of coronavirus disease (COVID-19) infection, but research into the management of agitation in the setting of COVID-19 and pre-existing neuropsychiatric disease is ongoing. We present a 55-year-old male patient with early-onset Alzheimer di... | [
{
"companynumb": "US-LUPIN PHARMACEUTICALS INC.-2022-04300",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "QUETIAPINE FUMARATE"
},
"druga... |
{
"abstract": "Proton pump inhibitors are widely used, and generally considered safe. In this clinical lesson two cases are presented with a strong suspicion of proton pump inhibitor induced decline of kidney function. This adverse event has only recently been identified in epidemiological studies. Our cases illustra... | [
{
"companynumb": "NL-VALIDUS PHARMACEUTICALS LLC-NL-VDP-2021-014659",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FUROSEMIDE"
},
"druga... |
{
"abstract": "A 50-year-old man was treated with trimethoprim-sulfamethoxazole (TMP-SMX) for acute arthritis of his right big toe. Within a few days, he developed dyspnoea, hypoxaemia and diffuse pulmonary infiltrates. Symptoms improved with discontinuation of the antibiotic but worsened again with its reintroductio... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2015US-100245",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": null,
"drugadditional": null,
"drugadministrationroute": ... |
{
"abstract": "We report a case of unusual sexual symptoms in a 43-year-old female patient with schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders, fifth edition), who was being treated with a depot formulation of paliperidone palmitate, an atypical antipsychotic medication. The symptom... | [
{
"companynumb": "TR-MYLANLABS-2018M1032641",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PALIPERIDONE"
},
"drugadditional": "1",
... |
{
"abstract": "Failure of protease-inhibitor (PI)-based second-line antiretroviral therapy (ART) with medication adherence but no protease drug resistance mutations (DRMs) is not well understood. This study investigated the involvement of gp41 and gag as alternative mechanisms, not captured by conventional resistance... | [
{
"companynumb": "US-VIIV HEALTHCARE LIMITED-US2017193288",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DIDANOSINE"
},
"drugadditional"... |
{
"abstract": "BACKGROUND\nVemurafenib is a BRAF kinase inhibitor that improves the survival of patients with metastatic melanoma, who have the V600E BRAF mutation. The development of cutaneous neoplasms, including squamous cell carcinomas (SCCs), keratoacanthomas (KAs), and hyperkeratotic papules is one of the most ... | [
{
"companynumb": "US-ROCHE-1419797",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ACITRETIN"
},
"drugadditional": null,
"druga... |
{
"abstract": "We report the case of a 38-year-old man who presented with severe diarrhea, weight loss of 10 kg, ankles paresthesia and severe motor weakness in the left fibular nerve territory after introduction of azathioprine and corticosteroid for proteinuria. Coloscopy and gastroscopy revealed a typical aspect o... | [
{
"companynumb": "FR-MYLANLABS-2015M1011485",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AZATHIOPRINE"
},
"drugadditional": null,
... |
{
"abstract": "Although a small number of cases of secondary uveitis have been documented in the setting of ibrutinib therapy, panuveitis has not previously been described with this medication. The authors describe a presumed case of panuveitis in a patient on ibrutinib for chronic lymphocytic leukemia. The purpose o... | [
{
"companynumb": "US-ABBVIE-21K-163-3935011-00",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "IBRUTINIB"
},
"drugadditional": null,
... |
{
"abstract": "This case report presents the case of a 29 weeks pregnant woman in her late twenties who was seen at the emergency department of a hospital with a seizure of unknown cause. By anamnesis and hetero-anamnesis the use of illicit gamma-hydroxybutyric acid (GHB) was revealed. Examination showed dilated pupi... | [
{
"companynumb": "NL-MYLANLABS-2020M1003130",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DIAZEPAM"
},
"drugadditional": "1",
... |
{
"abstract": "This open-label, phase 1 study evaluated the safety, pharmacokinetics, and maximum tolerated dose of AMG 232, an investigational oral, selective mouse double minute 2 homolog inhibitor in relapsed/refractory acute myeloid leukemia (AML). AMG 232 was administered orally once daily for 7 days every 2 wee... | [
{
"companynumb": "PHHY2019US180012",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "TRAMETINIB"
},
"drugadditional": null,
"drug... |
{
"abstract": "The Impella devices are percutaneous intravascular ventricular assist devices indicated for use in patients with cardiogenic shock that occurs following acute myocardial infarction (MI) or open heart surgery. These devices must be used with a purge solution that contains heparin per manufacturer recomm... | [
{
"companynumb": "US-PFIZER INC-2020278475",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nWe sought to determine whether empirical nesiritide or milrinone would improve the early postoperative course after Fontan surgery. We hypothesized that compared with milrinone or placebo, patients assigned to receive nesiritide would have improved early postoperative outcomes.\n\n\nRESULTS... | [
{
"companynumb": "US-JNJFOC-20140717743",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "NESIRITIDE"
},
"drugadditional": null,
... |
{
"abstract": "We present a case report of visceral leishmaniasis in an elderly kidney transplant recipient (age, 73 years) with high intermittent fever in the 2 months before admission. Symptoms started 16 years after transplant. The patient received appropriate treatment with liposomal amphotericin and experienced ... | [
{
"companynumb": "IT-ACCORD-026345",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nQurse-e-istisqua (Q-e-I), an Unani medicine commonly prescribed to treat liver disorders.\n\n\nOBJECTIVE\nTo study efficacy and safety of Q-e-I in hepatitis C virus (HCV) infection.\n\n\nMETHODS\nIn this randomized double-blind exploratory study, 60 naive patients of HCV infection were assi... | [
{
"companynumb": "IN-ROCHE-1548177",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "HERBALS"
},
"drugadditional": null,
"drugadm... |
{
"abstract": "BACKGROUND\nSimplifying immunosuppressive therapy after liver transplant may improve patient compliance, thereby preventing acute rejection and graft loss. This phase 4, open-label, single-center study was conducted to evaluate the efficacy and safety of twice-daily to once-daily tacrolimus conversion ... | [
{
"companynumb": "KR-ASTELLAS-2021US045587",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
... |
{
"abstract": "Bilateral adrenal hemorrhage (BAH) is a rare condition, which can easily become a serious threat to life. It is even rarer in the setting of antiphospholipid syndrome (APLS), which in itself is associated with coagulopathy as well as the need for lifelong anticoagulation. Death from BAH is commonly due... | [
{
"companynumb": "GB-TEVA-2022-GB-2011389",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "WARFARIN"
},
"drugadditional": "1",
"... |
{
"abstract": "Central nervous system (CNS) metastasis carries a significant morbidity and mortality in anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC). Next-generation ALK tyrosine kinase inhibitors (TKIs) are highly CNS-penetrant and have demonstrated remarkable intracranial activity ... | [
{
"companynumb": "US-PFIZER INC-2020085410",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "LORLATINIB"
},
"drugadditional": null,
... |
{
"abstract": "PURPOSETO evaluate the efficacy and safety of combined bevacizumab-mitomycin c (MMC) in recurrent cases of pediatric glaucoma.METHODSA prospective non-masked controlled study that included bilateral cases of 12 patients (24 eyes) with recurrent (had previous glaucoma surgery before) pediatric glaucoma.... | [
{
"companynumb": "EG-ROCHE-1704763",
"fulfillexpeditecriteria": "1",
"occurcountry": "EG",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "BEVACIZUMAB"
},
"drugadditional": null,
"dr... |
{
"abstract": "Rothmund-Thomson syndrome (RTS) is characterized by a rash that begins in the first few months of life and eventually develops into poikiloderma. Associated symptoms are alterations in the teeth, sparse hair, thin eyebrows, lack of eyelashes, low stature, bone abnormalities, hematological illnesses, ga... | [
{
"companynumb": "ES-TEVA-2021-ES-1898210",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional":... |
{
"abstract": "Serotonin syndrome is thought to arise from serotonin excess. In many cases, symptoms are mild and self-limiting. But serotonin syndrome can become life threatening, when neuromuscular hyperexcitability spins out of control. Uncontainable neuromuscular hyperexcitability may lead to cardiovascular compl... | [
{
"companynumb": "SE-ALEMBIC PHARMACUETICALS LIMITED-2019SCAL000694",
"fulfillexpeditecriteria": "1",
"occurcountry": "SE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ESCITALOPRAM OXALATE"
},
... |
{
"abstract": "Bupropion overdose in the pediatric setting poses significant potential for toxicity. We present the case of a 15-year-old female patient presenting with intentional bupropion overdose resulting in generalized tonic-clonic seizures, severe acidosis, vomiting, and tachycardia after ingestion of between ... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2019R1-230355",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BUPROPION"
},
"druga... |
{
"abstract": "Patients with current or past hepatitis B virus (HBV) infection are at risk of viral reactivation if they receive immune-modulating treatment or chemotherapy. This can range from subclinical elevation in HBV DNA levels, to abnormal liver function tests, to severe hepatitis with liver failure and risk o... | [
{
"companynumb": "GB-TEVA-524687ISR",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"drugadditional": null,
"dr... |
{
"abstract": "OBJECTIVE\nSpinal subdural hematoma (S-SDH) rarely occurs after aneurysmal subarachnoid hemorrhage (SAH). Little information is known regarding the management and prognosis of patients with both S-SDH and SAH. Here, we present an illustrative case and provide a systematic review of S-SDH in the setting... | [
{
"companynumb": "US-DRREDDYS-USA/USA/19/0111423",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": "1"... |
{
"abstract": "Pancreatic adenocarcinoma commonly presents as metastatic disease and harbors a dire prognosis due to its aggressive behavior, propensity for resistance to therapies, and lack of targetable driver mutations. Additionally, despite advances in other cancers, immunotherapy has been ineffective in this dis... | [
{
"companynumb": "US-CELGENEUS-USA-20210501909",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "NIVOLUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Tenofovir (TDF) is considered the ideal treatment for patients coinfected with human immunodeficiency virus (HIV) and hepatitis B virus (HBV). However, certain coinfected patients exhibit incomplete viral suppression, with persistent, and sometimes transient, bouts of HBV replication. The reasons for t... | [
{
"companynumb": "FR-GILEAD-2014-0108486",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LAMIVUDINE"
},
"drugadditional": null,
... |
{
"abstract": "Quaternary prevention has been commonly defined with the \"primum non nocere\" of classical texts by many authors. The daily life of our primary care consultations are full of patients in which we wondered if we try to obtain the benefit of our intervention will exceed the damage we cause him to interv... | [
{
"companynumb": "ES-TEVA-622895ISR",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYPROTERONE"
},
"drugadditional": null,
"dr... |
{
"abstract": "BACKGROUND\nEuglycaemic ketoacidosis (EKA) is an infrequent but serious condition which usually follows a period of starvation, severe vomiting or illness in individuals with or without diabetes. Ketoacidosis is associated with materno-fetal morbidity and mortality necessitating prompt diagnosis and ma... | [
{
"companynumb": "GB-Merck Healthcare KGaA-9288101",
"fulfillexpeditecriteria": "1",
"occurcountry": null,
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
"drugaddit... |
{
"abstract": "Ketamine is known within the medical field for its anesthetic properties, yet its unique psychedelic and antidepressant properties are being increasingly recognized. We document the case of a patient with bipolar I disorder and an extensive history of substance dependence who used large doses of ketami... | [
{
"companynumb": "US-DRREDDYS-USA/USA/14/0044085",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "GABAPENTIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nRituximab induces a rapid remission in most patients with pemphigus.\n\n\nOBJECTIVE\nOur aim was to assess the long-term efficacy of rituximab in this disease.\n\n\nMETHODS\nWe conducted a retrospective study of 59 patients with pemphigus treated with rituximab and observed over a median pe... | [
{
"companynumb": "DE-MYLANLABS-2020M1053375",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "Teriparatide is a synthetic polypeptide hormone that contains the 1-34 amino acid fragment of the recombinant human parathyroid hormone that stimulates bone formation. Currently, it is approved only for the treatment of osteoporosis. The outcomes of daily teriparatide injections for the treatment of bi... | [
{
"companynumb": "JP-WATSON-2016-08143",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ALENDRONIC ACID"
},
"drugadditional": null,
... |
{
"abstract": "Metformin is increasingly used to treat gestational diabetes and type 2 diabetes in pregnancy, and in attempts to improve pregnancy outcomes in polycystic ovary syndrome and obesity. It passes across the placenta with possible long-term consequences for the offspring. We previously explored the effect ... | [
{
"companynumb": "NO-ALKEM LABORATORIES LIMITED-NO-ALKEM-2018-01523",
"fulfillexpeditecriteria": "1",
"occurcountry": "NO",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
... |
{
"abstract": "Pseudoxanthoma Elasticum-like Papillary Dermal Elastolysis (PXE-PDE) is a peculiar idiopathic elastolytic disorder that clinically resembles Psudoxanthoma elasticum(PXE). It is histologically characterized by a total or partial loss of elastic fibers in the papillary dermis. It more often affects elder... | [
{
"companynumb": "PHHY2015IT042162",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo evaluate the impact on mortality of anti-tumor necrosis factor (anti-TNF) treatment of rheumatoid arthritis-associated interstitial lung disease (RA-ILD).\n\n\nMETHODS\nWe retrospectively reviewed the medical records of 100 RA-ILD patients who visited our tertiary care medical center betw... | [
{
"companynumb": "KR-ABBVIE-08P-090-0490146-00",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "SULFASALAZINE"
},
"drugadditional": null,... |
{
"abstract": "BACKGROUND\nThe aim of this study was to evaluate the outcome of congenital cytomegalovirus (CMV) infection identified on urine-filter screening assay at >2 years' follow up, and to observe the clinical outcomes after anti-CMV treatment.\n\n\nMETHODS\nSixty of 72 congenital CMV patients were enrolled a... | [
{
"companynumb": "JP-CLINIGEN GROUP PLC/ CLINIGEN HEALTHCARE LTD-JP-CLGN-18-00158",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "VALGANCICLOVIR"
... |
{
"abstract": "HBV eradication in chronic hepatitis B (CHB) subjects is rarely achieved with either nucleos(t)ide analogues (NA) or pegylated interferon (Peg-IFN), which both have a limited effect in restoring immune responses. Thirty CHB subjects on long-term treatment with tenofovir (TDF) and HBV suppression were e... | [
{
"companynumb": "IT-ROCHE-2116032",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TENOFOVIR"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "The BK virus (BKV) is a member of the polyomaviridae family of DNA viruses. BKV reactivates under a highly immunosuppressed state and causes renal dysfunction. In renal transplant patients, BKV infection leads to tubular impairment and loss of transplanted kidney grafts. However, few studies have repor... | [
{
"companynumb": "JP-TEVA-2019-JP-1118403",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "1"... |
{
"abstract": "Hashimoto's thyroiditis (HT) or chronic lymphocytic thyroiditis is the most common form of primary hypothyroidism. Muscular manifestations like weakness, pain, stiffness and elevated muscle enzymes have been noticed in hypothyroidism. Statins are also known to cause myositis and rhabdomyolysis. This is... | [
{
"companynumb": "IN-PFIZER INC-2018091620",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ATORVASTATIN CALCIUM"
},
"drugadditional": "1"... |
{
"abstract": "5-Fluorouracil is a first-line agent in several cancer-therapy regimens. Cardiotoxicity is common, with coronary artery disease being an important risk factor. We report the case of an acute coronary syndrome presumably induced by 5-FU, in a patient with previously unknown and asymptomatic coronary art... | [
{
"companynumb": "PT-MYLANLABS-2018M1082013",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": null,
... |
{
"abstract": "The occurrence of major neurologic disturbances is a rare complication of intrathecal cytotoxic drug administration. We describe the case of a 30-year old man with relapsed lymphoblastic lymphoma and CNS involvement who was treated by systemic chemotherapy (ESHAP) and intrathecal injections of methotre... | [
{
"companynumb": "US-PFIZER INC-2016496496",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYTARABINE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nTo assess the activity of laparoscopic Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in women with recurrent, platinum-resistant ovarian cancer.\n\n\nMETHODS\nProspective case series using repeated courses q 28-42 days of PIPAC containing cisplatin 7.5 mg/m(2) and doxorubicin 1.5 ... | [
{
"companynumb": "DE-PFIZER INC-2015290120",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "Immobilisation is a risk factor for the development of deep venous thrombosis and pulmonary embolism. We present a case-study in which a patient developed a pulmonary embolism after being immobilised after a short period while subjected to physical restraint. We discuss the risk factors involved and st... | [
{
"companynumb": "BE-LUPIN PHARMACEUTICALS INC.-2015-01898",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "RISPERIDONE"
},
"drugaddition... |
{
"abstract": "OBJECTIVE\nTo see if methemoglobin could potentially be misdiagnosed and the limitation of present cooximeters.\n\n\nMETHODS\nA 17-year-old girl who overingested a combination of cimetidine, acetaminophen, ibuprofen, and naproxen in a suicide attempt.\n\n\nMETHODS\nUse of pulse co-oximeters to aid in t... | [
{
"companynumb": "US-PFIZER INC-2019469098",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CIMETIDINE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nResistant lupus nephritis (LN) has been associated with the persistence of long-lived plasma cells. Preliminary studies identified bortezomib as a potential treatment option for patients with refractory LN. The aim of this study was to analyze the efficacy and safety of bortezomib in the tre... | [
{
"companynumb": "ES-PBT-000010",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "3",
... |
{
"abstract": "This study was carried out to determine changes over time in use of folic acid, anti-epileptic drugs (AED), seizures during pregnancy and malformation rate over two decades in women with epilepsy enrolled in the Kerala registry of Epilepsy and Pregnancy (KREP).\n\n\n\nAll completed pregnancies with kno... | [
{
"companynumb": "IN-UCBSA-2019041437",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "3",
... |
{
"abstract": "Gastric cancer (GC) is the second most common cancer in China. The ToGA study showed that trastuzumab in combination with fluoropyrimidine plus cisplatin prolonged overall survival (OS) in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced GC (AGC). However, some patients m... | [
{
"companynumb": "CN-SA-2020SA357952",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DOCETAXEL"
},
"drugadditional": null,
"dru... |
{
"abstract": "Background Hepatic infarction is an exceedingly rare complication of hemolysis, elevated liver enzymes, and low platelets syndrome. Few cases have been described in the medical literature and the true incidence remains unknown. It can lead to fulminant liver failure, liver transplant, or death if not ... | [
{
"companynumb": "US-TEVA-2019-US-1049595",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LABETALOL\\LABETALOL HYDROCHLORIDE"
},
"drugadd... |
{
"abstract": "Although it is known that hematopoietic stem cell transplantation (HSCT) survivors are at risk of nonmelanoma skin cancer (NMSC), there is limited literature on the incidence of NMSC during childhood in this population. We present 4 HSCT patients ages 13 to 20 years diagnosed with NMSC in our clinic ov... | [
{
"companynumb": "US-PFIZER INC-2018244779",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "3... |
{
"abstract": "Clinically significant liver damage in patients taking therapeutic doses of paracetamol is very rare. We report two cases of fulminant hepatic failure caused by therapeutic (4 g x day(-1)) paracetamol administration on our Intensive Care Unit. Both patients had a muscular dystrophy and presented with a... | [
{
"companynumb": "GB-JNJFOC-20080100188",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": null,
... |
{
"abstract": "We present a case of rapidly growing disseminated Mycobacterium tuberculosis (MTB) that presented as an empyema necessitans (EN) in a 65-year-old woman with a single right lung transplant admitted for progressive dyspnea. While hospitalized, she had daily fevers and was found to have a right-sided ches... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2021-06069",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ISONIAZID"
},
"drugad... |
{
"abstract": "BACKGROUND\nThromboembolic events are infrequent but serious complications of transcatheter aortic valve implantation (TAVI), occurring in 2.3-10% of the patients. However, the cause of post-TAVI stroke is unclear.\n\n\nMETHODS\nA 90-year-old female underwent transfemoral-TAVI for severe aortic stenosi... | [
{
"companynumb": "JP-BAYER-2018-060762",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": null,
"drugadditional": null,
"drugadministrationroute": null,
"drugauthoriza... |
{
"abstract": "Three patients under hemodialysis (HD) with relapsed/refractory multiple myeloma (MM) were administered panobinostat/bortezomib/dexamethasone (FVD). Case 1: The patient was a 66-year-old male with BJP-κ. FVD was effective, but HD could not be discontinued. He developed Grade 3 adverse events (AEs), inc... | [
{
"companynumb": "JP-BAUSCH-BL-2017-009666",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "BORTEZOMIB"
},
"drugadditional": null,
... |
{
"abstract": "Atorvastatin is a commonly used oral cholesterol-lowering agent. Side effects associated with statin therapy include arthralgia, myalgia, dyspepsia, weakness, and headache. Prospective and retrospective studies of drug-induced liver injury have identified statin-induced hepatotoxicity, with atorvastati... | [
{
"companynumb": "US-ACCORD-175308",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ATORVASTATIN CALCIUM"
},
"drugadditional": "1",
... |
{
"abstract": "Sickle cell disease and Sarcoidosis are conditions that are more common in the African American population. In this report we share an unfortunate patient who had hepatic sarcoidosis but could not receive steroids since that precipitated acute liver failure. We have discussed potential therapy options ... | [
{
"companynumb": "US-WEST-WARD PHARMACEUTICALS CORP.-US-H14001-17-01200",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
... |
{
"abstract": "Cariprazine (CAR) is a strong inhibitor of the Dhcr7 enzyme, the last enzyme in the cholesterol biosynthesis pathway. We assessed the effects of CAR on maternally exposed Dhcr7+/- and wild-type mouse offspring, and tested the biochemical effects of CAR in human serum samples. Dhcr7+/- and wild-type tim... | [
{
"companynumb": "US-OTSUKA-2021_011595",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "A case report of coinfection with Talaromyces marneffei (T. marneffei) and Cryptococcus neoformans (C. neoformans) is presented in a 57-year-old woman with hemolytic anemia who received dexamethasone for 8 years. To the best of our knowledge, this patient was successfully treated with voriconazole. Thi... | [
{
"companynumb": "CN-SUN PHARMACEUTICAL INDUSTRIES LTD-2019R1-232251",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"d... |
{
"abstract": "Tocilizumab (TCZ) is used to treat rheumatoid arthritis and other systemic inflammatory disorders. There is some evidence suggesting the occurrence of pancreatitis following TCZ use. We aimed to determine the reporting of pancreatitis following TCZ use in comparison with other drugs using the United St... | [
{
"companynumb": "IN-ROCHE-2928245",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TOCILIZUMAB"
},
"drugadditional": "3",
"drug... |
{
"abstract": "Fludarabine-based therapy is widely approved as a first-line treatment for chronic lymphocytic leukemia (CLL). This treatment is occasionally associated with prolonged myelosuppression. We herein describe the cases of CLL who underwent fludarabine, cyclophosphamide and rituximab (FCR) therapy. Bone mar... | [
{
"companynumb": "PHHY2013JP081006",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": null,
... |
{
"abstract": "BRAF inhibitory therapy is the mainstream treatment for BRAF mutant advanced melanoma. However vemurafenib, a type I mutant BRAF V600 inhibitor, induces an array of proliferative skin disorders from keratosis pilaris-like and keratoacanthoma-like lesions to locally aggressive cutaneous squamous cell ca... | [
{
"companynumb": "CH-ROCHE-1539663",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "VEMURAFENIB"
},
"drugadditional": null,
"dru... |
{
"abstract": "OBJECTIVE\nThe aim of present study was to investigate the feasibility of a densified sequence of FEC75 (5-fluorouracil 600 mg/m2, epirubicin 75 mg/m2, cyclophosphamide 600 mg/m2) and docetaxel 100 mg/m2 (D100) in patients with primary operable high-risk breast cancer.\n\n\nMETHODS\nFifty-one consecuti... | [
{
"companynumb": "IT-CIPLA LTD.-2015IT04156",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "EPIRUBICIN"
},
"drugadditional": null,
... |
{
"abstract": "Refractory Kawasaki disease (KD) is related to a major risk of coronary arteries abnormalities and its treatment is not standardized. In this regard, anakinra (ANA), an interleukin (IL)-1 receptor antagonist, represents an emerging therapeutic option. We report two cases of children, diagnosed with KD,... | [
{
"companynumb": "IT-TAKEDA-2021TUS027432",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "HUMAN IMMUNOGLOBULIN G"
},
"drugadditional": nu... |
{
"abstract": "BACKGROUND\nUstekinumab is a fully human monoclonal antibody against the p40 subunit of interleukin (IL) 12 and 23 which is involved in the pathogenesis of several inflammatory diseases. Ustekinumab is approved for psoriasis and psoriatic arthritis treatment and has been successfully evaluated in phase... | [
{
"companynumb": "FR-JNJFOC-20171033721",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "USTEKINUMAB"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nCinacalcet is a new effective treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients (HP), but the alterations of parathyroid gland (PTG) hyperplasia determined by cinacalcet and vitamin D have not been extensively investigated in humans.\n\n\nMETHODS\nWe performed histo... | [
{
"companynumb": "IT-AMGEN-ITASP2019193703",
"fulfillexpeditecriteria": "2",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CINACALCET HYDROCHLORIDE"
},
"drugadditional":... |
{
"abstract": "Psoriasis is a chronic, relapsing, inflammatory disease that has been associated with Metabolic Syndrome (MS), a cluster of cardiovascular risk factors mainly hypertension, obesity, diabetes mellitus and hyperlipidemia. A 49-year-old male patient presented with extensive plaque psoriasis from past 13 y... | [
{
"companynumb": "IN-CIPLA LTD.-2017IN14002",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMLODIPINE BESYLATE"
},
"drugadditional": "3"... |
{
"abstract": "BACKGROUND\nNonsteroidal anti-inflammatory drugs can increase bleeding and thrombosis, but little is known about the cerebrovascular safety of these drugs, especially among healthy people.\n\n\nOBJECTIVE\nThe aim of this study was to examine the risk of ischemic and hemorrhagic stroke associated with t... | [
{
"companynumb": "DK-ROCHE-616953",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "NAPROXEN"
},
"drugadditional": null,
"drugadm... |
{
"abstract": "A 22-year-old morbidly obese, nonpregnant woman presented with left ileofemoral deep vein thrombosis (DVT) presenting as low back pain and bilateral, left greater than right, leg swelling and pain for 2 days. While on heparin, she developed compartment syndrome in her left leg and had evidence of dead ... | [
{
"companynumb": "US-WEST-WARD PHARMACEUTICALS CORP.-US-H14001-16-00334",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
... |
{
"abstract": "OBJECTIVE\nClinical trials have documented the efficacy and good tolerability of tapentadol prolonged released (PR) for severe chronic pain. This study investigated routine long-term administration by pain specialists.\n\n\nMETHODS\nThe effectiveness analysis included prospective data collected over a ... | [
{
"companynumb": "DE-JNJFOC-20141001248",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HYDROMORPHONE"
},
"drugadditional": null,
... |
{
"abstract": "The coronavirus disease 2019 pandemic has had an impact on system processes, with airway management being significantly affected. A 37-year-old woman diagnosed with stroke was found to have a filling defect at the origin of the right internal carotid artery. She was taken to the operating room urgently... | [
{
"companynumb": "US-009507513-2011USA007539",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "SUGAMMADEX"
},
"drugadditional": null,
... |
{
"abstract": "Candida dubliniensis is an emerging pathogen implicated in a variety of infections in immunocompromised hosts. A 79-year-old male with autoimmune pancytopenia on chronic oral steroid therapy was admitted for suspected sepsis and started on empirical antibiotics and micafungin. He developed floaters and... | [
{
"companynumb": "US-TEVA-2021-US-1895834",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": "3",
... |
{
"abstract": "Rhodotorula is emerging as an important cause of nosocomial and opportunistic infections. We present two cases of Rhodotorula mucilaginosa fungemia diagnosed at our hospital during the last decade. The first case was of a term neonate who presented congenital heart disease (interventricular communicati... | [
{
"companynumb": "TN-VALIDUS PHARMACEUTICALS LLC-TN-2016VAL001489",
"fulfillexpeditecriteria": "1",
"occurcountry": "TN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AMIKACIN SULFATE"
},
"d... |
{
"abstract": "BACKGROUND\nAmbulatory surgery has the advantages of shortening the waiting time for hospitalization and reducing medical expenses. It has been more and more widely used in recent years in China. The patients admitted in Ambulatory Surgery Center are generally in good condition (ASA I-II), with clear d... | [
{
"companynumb": "CN-JNJFOC-20201010488",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PROPOFOL"
},
"drugadditional": null,
"d... |
{
"abstract": "Accidental poisoning or overdoses occur frequently in children. These are difficult to recognise because young children cannot communicate their symptoms; this means that specific symptoms can be missed, which can delay the diagnosis. A 5-month-old boy was accidently given a tenfold dose of digoxin for... | [
{
"companynumb": "NL-IMPAX LABORATORIES, INC-2015-IPXL-00604",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DIGOXIN"
},
"drugadditional... |
{
"abstract": "OBJECTIVE\nNecrosis of the central nervous system (CNS) is a known complication of craniospinal irradiation (CSI) in children with medulloblastoma and similar tumors. We reviewed the incidence of necrosis in our prospective treatment series.\n\n\nMETHODS\nBetween 1996 and 2009, 236 children with medull... | [
{
"companynumb": "US-MYLANLABS-2017M1009831",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "Steroid-sensitive nephrotic syndrome (SSNS) is, in most patients, a chronic disease with 80% experiencing at least one relapse after first flare. B cell depletion using rituximab is effective in preventing relapse in steroid-dependent (SDNS) patients but fails to maintain long-term remission following ... | [
{
"companynumb": "FR-MYLANLABS-2020M1100019",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "OFATUMUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Toxic epidermal necrolysis-like acute cutaneous lupus erythematosus (TEN-like ACLE) is a rare manifestation of systemic lupus erythematosus (SLE). Because of its rarity, little is known about this entity. In this report, we describe a case of two women previously diagnosed with SLE that presented TEN-l... | [
{
"companynumb": "MA-SA-2021SA293287",
"fulfillexpeditecriteria": "1",
"occurcountry": "MA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ISONIAZID"
},
"drugadditional": "1",
"drug... |
{
"abstract": "Bloodstream infection with carbapenem-resistant Klebsiella pneumoniae (CRKP) is a severe and challenging complication in the early post-transplantation period. Pulmonary infection secondary to sepsis caused by CRKP has been reported only rarely in kidney transplant recipients. Here we report an interes... | [
{
"companynumb": "CN-STRIDES ARCOLAB LIMITED-2020SP015081",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional... |
{
"abstract": "A 12 ½ year old male with cystic fibrosis presented with growth failure after itraconazole was added to a treatment regimen including inhaled and intranasal glucocorticoids. Investigations showed severe adrenal suppression. This case demonstrates the potential for exogenous glucocorticoids to accumulat... | [
{
"companynumb": "PHHY2015NZ096872",
"fulfillexpeditecriteria": "1",
"occurcountry": "NZ",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ITRACONAZOLE"
},
"drugadditional": null,
"dr... |
{
"abstract": "Single agent studies targeting the tumor microenvironment in central nervous system (CNS) tumors have largely been disappointing. Combination therapies targeting various pathways and cell types may be a more effective strategy. In this phase I study, we evaluated the combination of dasatinib, lenalidom... | [
{
"companynumb": "US-MYLANLABS-2018M1036904",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DASATINIB"
},
"drugadditional": "3",
... |
{
"abstract": "A man in his 30s who presented with an enlarged right testicle was diagnosed with a germ cell tumor via orchiectomy. Adjuvant chemotherapy with cisplatin, etoposide and bleomycin(BEP)was initiated. He developed a headache 8 days later, followed by neurological deficits 10 days later. Magnetic resonance... | [
{
"companynumb": "JP-HQ SPECIALTY-JP-2017INT000319",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": null,
... |
{
"abstract": "A 52-year-old woman undergoing azathioprine treatment for rheumatoid arthritis developed acute retinal necrosis a month after intravitreal dexamethasone (Ozurdex ®) implantation for posterior uveitis in the left eye. Varicella zoster virus (VZV) DNA was detected in the anterior chamber and vitreous sam... | [
{
"companynumb": "TR-ALLERGAN-1509203US",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": null,
... |
{
"abstract": "Despite central nervous system (CNS) relapse occurring in >10% of high-risk diffuse large B-cell lymphoma (DLBCL) patients, the role of CNS-directed prophylaxis is controversial in the absence of randomized controlled trials. In this retrospective study, we aimed to evaluate the safety and efficacy of ... | [
{
"companynumb": "KR-ROCHE-2841363",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "Aortic dissection after orthotopic heart transplantation is a rare condition, and a limited number of reports have been published in the literature. Herein, we report a case of Type A aortic dissection 16 years after heart transplantation.",
"affiliations": "Department of Cardiac Surgery, \"Louis Pra... | [
{
"companynumb": "FR-ASTELLAS-2018US053843",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": nu... |
{
"abstract": "Two licensed reconstitution volumes may be used to achieve the recommended abobotulinumtoxinA (ABO) dose for glabellar line correction.\n\n\n\nComparison of efficacy, safety, and subject satisfaction concerning treatment of moderate to severe glabellar lines with 2 different ABO reconstitution volumes.... | [
{
"companynumb": "US-IPSEN BIOPHARMACEUTICALS, INC.-2019-05745",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ABOBOTULINUMTOXINA"
},
"dr... |
{
"abstract": "Dilated cardiomyopathy is an etiologically heterogeneous disorder. Early diagnosis and prompt treatment of the underlying disease are of great significance. Primary and secondary adrenal insufficiency are considered quite rare causes of dilated cardiomyopathy. However, to the best of our knowledge, no ... | [
{
"companynumb": "CN-ALVOGEN-2021-ALVOGEN-117850",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": "3",... |
{
"abstract": "TBC1D24 is a newly recognized gene in which variations lead to variable clinical phenotypes including drug-resistant epilepsy. We report four patients with novel variants of TBC1D24 demonstrating drug-resistant focal epilepsy, developmental delays, and head growth deceleration. All patients had seizure... | [
{
"companynumb": "US-APOTEX-2017AP019047",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MIDAZOLAM HYDROCHLORIDE"
},
"drugadditional": nu... |
{
"abstract": "Secondary acute lymphoblastic leukemia (sALL) following chemotherapy and/or radiotherapy of previous malignancies represents 2-10% of all cases of ALL. A 72-year-old female patient was diagnosed with acute lymphoblastic leukemia following chemotherapy for a diffuse large B cell lymphoma. Banding cytoge... | [
{
"companynumb": "FR-BAXTER-2020BAX026976",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nSeizures are common in juvenile Huntington's disease (HD), but considered to be rare in adult-onset HD. We studied the occurrence of epilepsy and seizures in a nationwide cohort of Finnish patients with adult-onset HD.\n\n\nMETHODS\nPatients with HD and their diagnoses of epilepsy or seizur... | [
{
"companynumb": "FI-MYLANLABS-2017M1034592",
"fulfillexpeditecriteria": "1",
"occurcountry": "FI",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLOZAPINE"
},
"drugadditional": "3",
... |
{
"abstract": "James is a 7½-year-old boy born in Vietnam to a mother with mental illness. Little is known about his early history; he spent the first 6 months of his life in an orphanage, followed by foster care and a disrupted adoption. He moved to the U.S. at age 1½ and joined his current adoptive family at age 4 ... | [
{
"companynumb": "US-APOTEX-2020AP010029",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RISPERIDONE"
},
"drugadditional": null,
... |
{
"abstract": "Pseudotumor cerebri (PTC), also known as idiopathic or benign intracranial hypertension, is characterized by elevated intracranial pressure without any evidence of organic central nervous system disorders. PTC is a rare but well-known adverse event associated with all-trans retinoic acid (ATRA) treatme... | [
{
"companynumb": "JP-ZO SKIN HEALTH-2019ZOS00010",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ARSENIC TRIOXIDE"
},
"drugadditional": ... |
{
"abstract": "Malignant spinal cord compression syndrome (MSCCS) occurs in 2.5 to 5% of all oncological patients. In 20% of the cases, it is the initial manifestation. This syndrome is a rare event among germ cell tumors (GCT), occurring in only 1.7% of the patients. We present the case of a 24-year-old man who arri... | [
{
"companynumb": "MX-ACCORD-118286",
"fulfillexpeditecriteria": "1",
"occurcountry": "MX",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BLEOMYCIN SULFATE"
},
"drugadditional": null,
... |
{
"abstract": "Nontuberculous mycobacteria (NTM) are a rare cause of infectious tenosynovitis of the upper extremity. Using molecular methods, clinical microbiology laboratories are increasingly reporting identification down to the species level. Improved methods for speciation are revealing new insights into the cli... | [
{
"companynumb": "US-MLMSERVICE-20210907-3087306-1",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LINEZOLID"
},
"drugadditional": null,
... |
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