article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "A 62-year-old man was admitted to the emergency department (ED) with the complaint of intense hematemesis. He was admitted to intensive care unit because of acute esophageal variceal hemorrhage. He underwent sclerotherapy followed by a slow infusion of intravenous octreotide. Complete heart block occur... | [
{
"companynumb": "PHHY2019TR065509",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "OCTREOTIDE"
},
"drugadditional": null,
"drug... |
{
"abstract": "Alemtuzumab is an anti-CD52 monoclonal antibody used to treat relapsing-remitting multiple sclerosis following failure of second-line medications. It is administered intravenously in 2 treatment sequences 1 year apart. This drug is frequently associated with mild infusion reactions within days of admin... | [
{
"companynumb": "US-SA-2021SA230971",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ALEMTUZUMAB"
},
"drugadditional": null,
"d... |
{
"abstract": "Autoimmune polyendocrine syndrome type II (APS-2) is a rare constellation of autoimmune hypoadrenalism, thyroid dysfunction and/or type 1 diabetes (T1DM), usually occurring in the 3rd or 4th decades and associated with a human leukocyte antigen (HLA) DR3 or DR4 serotype. We detail the first report of a... | [
{
"companynumb": "AU-009507513-1910AUS007288",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PEMBROLIZUMAB"
},
"drugadditional": "1",
... |
{
"abstract": "Alopecia areata (AA) is the most common immune-mediated hair loss disorder with a life-time prevalence of 2%. The pathogenesis of AA is not completely understood, but interferon gamma (INF-γ) and Janus kinases (JAK) may play a key role. Here, we present a case involving a male patient with psoriasis an... | [
{
"companynumb": "DK-TEVA-2020-DK-1851063",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nRecent clinical evidence supports a targeted therapeutic approach for genetic epileptic encephalopathies based on the molecular dysfunction.\nA 2-day-old male infant presented with epileptic encephalopathy characterized by burst-suppression EEG background and tonic-clonic migrating partial ... | [
{
"companynumb": "US-UCBSA-2016044391",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": null,
... |
{
"abstract": "A 30-year-old man was admitted to the intensive care unit after a suicide attempt with respiratory difficulties, tremor, sinus tachycardia and significant hypokalemia. On examination, the patient was lucid, fully conscious and did not exhibit positive symptoms. Sings were not typical for overdosing ola... | [
{
"companynumb": "PL-ACTAVIS-2016-10647",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CLENBUTEROL"
},
"drugadditional": null,
... |
{
"abstract": "An 80-year-old man was admitted to our hospital with 24 hours of epigastric pain. The pain was described as sharp, episodic, nonradiating, and without an identifiable provoking factor. Associated symptoms included nausea and nonbloody vomiting. He denied dyspnea, angina, fevers, chills, dysphagia, diar... | [
{
"companynumb": "US-TOLMAR, INC.-19US001359",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CARVEDILOL"
},
"drugadditional": null,
... |
{
"abstract": "The clinicopathological breast cancer subtypes are used in clinical practice to better anticipate biological behaviour and guide systemic treatment strategy. In the adjuvant setting, genomic assay recurrence scores became widely available for luminal-like disease. Recently, next-generation sequencing (... | [
{
"companynumb": "PT-MLMSERVICE-20211014-3169990-1",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": "3",... |
{
"abstract": "Dear Editor, The ongoing pandemic of coronavirus disease 2019 (COVID-19) was declared by the World Health Organization on March 11, 2020, and remains a global challenge. COVID-19 is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), transmitted primarily through respiratory droplet... | [
{
"companynumb": "HR-ACCORD-238982",
"fulfillexpeditecriteria": "1",
"occurcountry": "HR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nSolid organ transplantation is associated with a higher risk of Epstein-Barr virus (EBV)-related lymphoproliferative disease due to immunosuppressive regimen. Little evidence is currently available on post-transplant lymphoproliferative disorders (PTLDs) in the lung transplant (LuTx) settin... | [
{
"companynumb": "IT-PFIZER INC-2019065533",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "Iron chelation is controversial in higher risk myelodysplastic syndromes (HR-MDS), outside the allogeneic transplant setting. We conducted a retrospective, multicentre study in 51 patients with transfusion-dependent, intermediate-to-very high risk MDS, according to the revised international prognostic ... | [
{
"companynumb": "PHHY2017IT059519",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEFERASIROX"
},
"drugadditional": "3",
"drug... |
{
"abstract": "OBJECTIVE\nFew data are available concerning the clinical outcome of abiraterone acetate treatment in patients with metastatic castration-resistant prostate cancer (mCRPC) in terms of the duration of androgen deprivation therapy (ADT) before diagnosis of CRPC. We investigated the clinical efficacy of a... | [
{
"companynumb": "KR-JNJFOC-20160814712",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ABIRATERONE ACETATE"
},
"drugadditional": "3",
... |
{
"abstract": "We present the case of a 56-year-old black woman with rheumatoid arthritis who developed worsening fatigue, fever, weight loss, and a vesiculobullous skin eruption while being treated with certolizumab pegol for her arthritis. Microscopic findings confirmed the diagnosis of a neutrophilic dermatosis.",... | [
{
"companynumb": "US-UCBSA-2015032974",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CERTOLIZUMAB PEGOL"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nThe causality assessment of drug-induced liver injury (DILI) remains a challenge and eagerly awaits the development of reliable hepatotoxicity biomarkers. None of the different available algorithms used for the causality assessment of DILI has been universally accepted as the gold standard. ... | [
{
"companynumb": "IN-SUN PHARMACEUTICAL INDUSTRIES LTD-2017R1-157893",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "NAPROXEN"
},
"drugad... |
{
"abstract": "Fibrosing interstitial lung diseases (ILDs) are associated with poor survival and an increased risk of developing lung cancer (LC). Patient and LC characteristics, therapeutic possibilities and survival in this rare patient population are not well established.\n\n\n\nFibrosing ILD patients treated at t... | [
{
"companynumb": "HU-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2020-BI-024917",
"fulfillexpeditecriteria": "1",
"occurcountry": "HU",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "NINTEDANIB"
},
"... |
{
"abstract": "Heparin induced thrombocytopenia (HIT) is a rare, but potentially life-threatening complication of heparin therapy. In patients with HIT, alternative means of anticoagulation are necessary. The authors present an infant with HIT who required anticoagulation during cardiopulmonary bypass for tricuspid v... | [
{
"companynumb": "US-PFIZER INC-2016109035",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ARGATROBAN"
},
"drugadditional": null,
... |
{
"abstract": "There is no known effective therapy for patients with coronavirus disease 2019 (COVID-19). Initial reports suggesting the potential benefit of hydroxychloroquine/azithromycin (HY/AZ) have resulted in massive adoption of this combination worldwide. However, while the true efficacy of this regimen is unk... | [
{
"companynumb": "US-TEVA-2020-US-1829859",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HYDROXYCHLOROQUINE"
},
"drugadditional": null,
... |
{
"abstract": "The pilot Phase IIb VIKING study suggested that dolutegravir (DTG), an HIV integrase inhibitor (INI), is efficacious in INI-resistant patients at the 50 mg twice-daily dose. However, DTG response was most reduced in subjects carrying resistance-associated mutations at position G140 and Q148. These muta... | [
{
"companynumb": "IT-GILEAD-2019-0403848",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "EMTRICITABINE\\TENOFOVIR DISOPROXIL FUMARATE"
},
... |
{
"abstract": "OBJECTIVE\nThis study investigated whether gastric hyperplastic polyps (GHPs) shrink after discontinuation of proton pump inhibitor (PPI) alone.\n\n\nBACKGROUND\nLong-term use of PPIs has been reported to increase the incidence of GHPs, which sometimes bleed and cause anemia. We experienced a patient w... | [
{
"companynumb": "JP-MYLANLABS-2022M1028078",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "OMEPRAZOLE"
},
"drugadditional": "1",
... |
{
"abstract": "Osteomyelitis is a rare initial presentation of HIV. We report a case of a 25-year-old, apparently well man presenting with a traumatic, pathological fracture of the right radius. He had a 2-week history of low-grade fever, swelling and purulent discharge of the radial aspect of his right forearm. Oste... | [
{
"companynumb": "PH-SLATE RUN PHARMACEUTICALS-20PH000336",
"fulfillexpeditecriteria": "1",
"occurcountry": "PH",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PIPERACILLIN SODIUM\\TAZOBACTAM SODIUM"
}... |
{
"abstract": "BACKGROUND\nThere is limited information concerning the overall epidemiology of invasive fungal disease (IFD) in children. The aim of this study was to clarify the clinical features of IFD in a tertiary pediatric care hospital.\n\n\nMETHODS\nPatients diagnosed with proven or probable IFD at our hospita... | [
{
"companynumb": "JP-PFIZER INC-2020087879",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUCONAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "We report a case of epidermodysplasia verruciformis (EV)-like lesions in a patient with graft-versus-host disease after peripheral blood stem cell transplantation from his HLA-matched brother. The patient presented with a diffuse papular eruption that was clinically consistent with graft-versus-host di... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2022-01088",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"druga... |
{
"abstract": "The article deals with the dynamics of echocardioscopy indices during 1.5 years in a patient who underwent an acute myocardial infarction (MI). Two months after the MI left ventricular (LV) end-diastolic size and LV volume were 61 mm and 190 ml, respectively; LV ejection fraction (EF) was 42%. At the b... | [
{
"companynumb": "RU-TEVA-2019-RU-1043636",
"fulfillexpeditecriteria": "1",
"occurcountry": "RU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BISOPROLOL"
},
"drugadditional": "3",
... |
{
"abstract": "Radial artery occlusion (RAO) is a known complication of transradial catheterization for cardiac procedures. The transradial approach has decreased bleeding complications compared with the transfemoral approach, but risks provoking hand ischemia. We present a case of a 29-year-old peripartum woman with... | [
{
"companynumb": "NVSC2020US240534",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ENOXAPARIN"
},
"drugadditional": null,
"drug... |
{
"abstract": "Status epilepticus, refractory status epilepticus, and super-refractory status epilepticus can be life-threatening conditions. This article presents an overview of the three conditions and discusses their management and outcomes.\n\n\n\nStatus epilepticus was previously defined as lasting for 30 minute... | [
{
"companynumb": "US-UCBSA-2019002893",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "3",
... |
{
"abstract": "Neonatal liver failure (NLF) is a rare diagnosis but carries with it significant risks of mortality and morbidity. Common etiologies for NLF include metabolic causes, gestational alloimmune liver disease (GALD or neonatal hemochromatosis), and viral infections. We report a case of liver failure in a pr... | [
{
"companynumb": "US-OCTA-LIT18918US",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FLUOXETINE HYDROCHLORIDE"
},
"drugadditional": null... |
{
"abstract": "BACKGROUND\nTreatment choices are limited, when deciding how to manage thyrotoxicosis and moderate to severe Graves ophthalmopathy (GO) with suspected optic nerve damage in patients with elevated liver transaminase levels. The situation become even more complicated, if methimazole induced hepatotoxicit... | [
{
"companynumb": "LT-MYLANLABS-2017M1069276",
"fulfillexpeditecriteria": "1",
"occurcountry": "LT",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "METHIMAZOLE"
},
"drugadditional": "1",
... |
{
"abstract": "OBJECTIVE\nRhabdomyolysis (RM) is potentially lethal syndrome, but there are no enough published data on its frequency and characteristics in acute poisonings. The aim of this study was to determine the causes and severity of RM in acute poisonings.\n\n\nMETHODS\nPatients hospital charts were retrospec... | [
{
"companynumb": "PHHY2014RS161383",
"fulfillexpeditecriteria": "1",
"occurcountry": "RS",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARBAMAZEPINE"
},
"drugadditional": null,
"d... |
{
"abstract": "OBJECTIVE\nFactors predicting poor outcome in patients with the reversible cerebral vasoconstriction syndrome (RCVS) have not been identified.\n\n\nMETHODS\nIn this single-center retrospective study, we analyzed the clinical, brain imaging, and angiography data in 162 patients with RCVS. Univariable an... | [
{
"companynumb": "US-PFIZER INC-2017047174",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "HYDROCORTISONE"
},
"drugadditional": "1",
... |
{
"abstract": "Postoperative vision loss (POVL) is a devastating complication and has been reported after complex spine procedures. Anterior ischemic optic neuropathy and posterior optic neuropathy are the 2 most common causes of POVL. Bilateral occipital lobe seizures causing complete blindness are rare and have not... | [
{
"companynumb": "US-ACCORD-056335",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "LORAZEPAM"
},
"drugadditional": null,
"druga... |
{
"abstract": "Acute onset of neurological symptoms in a pregnant female is a rare medical emergency. We report a case of a 38-year-old female who presented with a stroke secondary to carotid artery dissection. Our case illustrates the need to consider vascular imaging before administering thrombolytic therapy in per... | [
{
"companynumb": "US-ROCHE-1598603",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"drugadditional": null,
"drug... |
{
"abstract": "Introduction: Safety and tolerability of medications are key variables to inform treatment choice for patients with bipolar disorder (BD). This review focuses on the overall tolerability and safety profile of aripiprazole when used for its bipolar disorder indications, which include acute treatment of ... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2019-05088",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"dru... |
{
"abstract": "Anaphylaxis during pregnancy is rare but life threatening to both mother and fetus. The anaesthetist may be unexpectedly faced with an obstructing airway, severe bronchospasm and cardiac arrest requiring perimortem caesarean delivery to relieve aortocaval compression. We present a case of anaphylaxis-i... | [
{
"companynumb": "PHHY2015AU158389",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LIDOCAINE"
},
"drugadditional": null,
"druga... |
{
"abstract": "BACKGROUND\nLithium use causes goiter by increasing serum thyroid-stimulating hormone levels through the inhibition of thyroid hormone release. However, there are no reports of poorly differentiated thyroid carcinoma resulting from lithium-induced goiter. Herein, we report the case of a patient with sc... | [
{
"companynumb": "KR-UNIQUE PHARMACEUTICAL LABORATORIES, A DIV. OF JBCPL-2021UNI000052",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LITHIUM CARBONATE"
... |
{
"abstract": "BACKGROUND\nTo compare the efficacy and tolerability of dapagliflozin with those of sitagliptin and metformin in patients with type 2 diabetes who have never received glucose-lowering agents.\n\n\nMETHODS\nIn this randomized, 12-week, open-label, active-controlled trial, 32 patients were randomly assig... | [
{
"companynumb": "JP-ALKEM LABORATORIES LIMITED-JP-ALKEM-2021-06813",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
... |
{
"abstract": "OBJECTIVE\nTo describe the clinical, neuroimaging, immunologic, and virologic characteristics of JC virus-associated granule cell neuronopathy (JCV GCN) in a natalizumab-treated patient with multiple sclerosis (MS) who developed immune reconstitution inflammatory syndrome (IRIS) after natalizumab withd... | [
{
"companynumb": "US-BAYER-2015-012528",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "INTERFERON BETA-1B"
},
"drugadditional": null,
... |
{
"abstract": "Incorrectly prescribed medications can have serious implications, especially in young children. Safe practice recommendations include listing patients' age, weight, and date of birth on prescriptions, verifying discharge orders, and involving pharmacists in reconciliation.",
"affiliations": null,
"... | [
{
"companynumb": "US-UCBSA-2016040737",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "1",
... |
{
"abstract": "OBJECTIVE\nTo define the maximum tolerated dose (MTD) and assess the feasibility of intravenous (IV) docetaxel, intraperitoneal (IP) carboplatin and IP paclitaxel in women with stage II-IV untreated ovarian, fallopian tube or primary peritoneal carcinoma.\n\n\nMETHODS\nPatients received docetaxel (55-7... | [
{
"companynumb": "US-CIPLA LTD.-2016US08360",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PACLITAXEL"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nKikuchi-Fujimoto disease is a rare, idiopathic and generally self-limiting cause of lymphadenitis of unknow etiology with a low recurrence rate. The typical clinical signs are cervical lymphadenopathy, fever, and symptoms of respiratory infection, and less frequently chills, night sweats, a... | [
{
"companynumb": "IT-HIKMA PHARMACEUTICALS USA INC.-IT-H14001-18-07177",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
... |
{
"abstract": "BACKGROUND\nThymic epithelial tumors (TET) are the most common tumors of the anterior mediastinum. Patients with advanced/metastatic disease are usually treated with palliative chemotherapy (CT). Unfortunately, even though various palliative CT regimens have been used for long time, there is a real sca... | [
{
"companynumb": "IN-JNJFOC-20190221883",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional": n... |
{
"abstract": "Lymphocytic colitis is a common cause of chronic, nonbloody diarrhea. However, the effects of treatment are unclear and randomized placebo-controlled trials were requested in a Cochrane review. We performed a randomized, placebo-controlled, multicenter study to evaluate budesonide and mesalazine as ind... | [
{
"companynumb": "DE-TAKEDA-2021TUS030597",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MESALAMINE"
},
"drugadditional": "3",
... |
{
"abstract": "In this article, we document a conclusive case of nebivolol-induced hyperkalemia\nfor the first time in the known medical literature. Hyperkalemia is associated with serious conditions\nsuch as cardiac arrhythmias and sudden cardiac death. Nebivolol was not known to cause hyperkalemia,\nand this event ... | [
{
"companynumb": "HR-TEVA-773240ROM",
"fulfillexpeditecriteria": "1",
"occurcountry": "HR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "NEBIVOLOL"
},
"drugadditional": "1",
"druga... |
{
"abstract": "The transforming growth factor-β superfamily signaling pathway is thought to be involved in the pathogenesis of pulmonary arteriovenous malformation (PAVM). However, the association between bone morphogenetic protein receptor type 2 (BMPR2) gene mutations and PAVM remains unclear. We present a case of ... | [
{
"companynumb": "JP-PFIZER INC-2014191798",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "AMBRISENTAN"
},
"drugadditional": null,
... |
{
"abstract": "A 62-year-old Asian British female presented with increasing tiredness. She had multiple co-morbidities and was prescribed steroid inhalers for asthma. She had also received short courses of oral prednisolone for acute asthma exacerbations in the last 2 years. Unfortunately, the frequency and dose of s... | [
{
"companynumb": "GB-MYLANLABS-2020M1018452",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CIMETIDINE"
},
"drugadditional": null,
... |
{
"abstract": "Saprochaete capitata is an arthroconidial yeast, found principally in the environment, even if it belongs also to the normal microbial flora that colonize human subjects. This yeast is increasingly associated with invasive infections in hematological patients, in particular in those affected by acute l... | [
{
"companynumb": "IT-MYLANLABS-2022M1002014",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PIPERACILLIN SODIUM\\TAZOBACTAM SODIUM"
},
"d... |
{
"abstract": "Choriocarcinoma presents usually as persistent trophoblastic disease, with prognosis worsening with duration from antecedent pregnancy. We present a unique case of a woman with choriocarcinoma who presented in the third trimester of pregnancy with eclampsia. She was managed with magnesium sulphate and ... | [
{
"companynumb": "IN-PFIZER INC-2016557170",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VINCRISTINE SULFATE"
},
"drugadditional": "3",... |
{
"abstract": "Chromosomal abnormalities in Ph-negative metaphases from patients with chronic myeloid leukemia (CML) treated with imatinib have been described in some cases. Trisomy 8 is the most frequent, but monosomy 7 has also been described. However, the association of these chromosomal alterations with myelodysp... | [
{
"companynumb": "ES-MYLANLABS-2018M1048433",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "GRANULOCYTE COLONY-STIMULATING FACTOR NOS"
},
... |
{
"abstract": "BACKGROUND\nBrugada pattern on electrocardiography (ECG) can manifest as type 1 (coved pattern) and type 2 (saddleback pattern). Brugada syndrome represents an ECG with Brugada pattern in a patient with symptoms or clinical factors, including syncope, cardiac arrest, ventricular dysrhythmias, and famil... | [
{
"companynumb": "US-PFIZER INC-2019080411",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "EPINEPHRINE"
},
"drugadditional": "3",
... |
{
"abstract": "Toxic epidermal necrolysis (TEN) is severe cutaneous hypersensitivity reaction characterized by necrosis of the epidermis and detachment of the epidermis and dermis that usually occurs as an idiosyncratic reaction to certain drugs. We report the case of a patient admitted to our Intensive Care Unit aft... | [
{
"companynumb": "HR-FRESENIUS KABI-FK201705102",
"fulfillexpeditecriteria": "1",
"occurcountry": "HR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"drugadditional": null,
... |
{
"abstract": "A woman in her thirties was found dead on a bed. Considerable amounts of \"aroma liquid\" and \"bath salt\" products and hypnotic drug tablets were scattered beside the bed. Autopsy showed pulmonary congestion and edema. Gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectr... | [
{
"companynumb": "JP-WATSON-2015-22373",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FLUNITRAZEPAM"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nConcerns about an inhibitory effect of proton pump inhibitors (PPIs) on clopidogrel metabolism have been raised. Because the pharmacological effect of clopidogrel is dependent on genetically determined activity of the hepatic cytochrome P450 isoenzymes system, it is important to examine the... | [
{
"companynumb": "JP-ALKEM LABORATORIES LIMITED-JP-ALKEM-2018-04219",
"fulfillexpeditecriteria": "2",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RABEPRAZOLE"
},
"drug... |
{
"abstract": "Varicella live attenuated vaccine led to a significant reduction in morbidity and mortality from varicella zoster disease. Vaccine adverse effects are mostly mild. Immunosuppression is the main risk factor for severe varicella. Risk factors for disease following vaccination are less studied. We report ... | [
{
"companynumb": "IL-TEVA-2021-IL-1946868",
"fulfillexpeditecriteria": "1",
"occurcountry": "IL",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CEFTRIAXONE"
},
"drugadditional": null,
... |
{
"abstract": "The combination of bendamustine, bortezomib and dexamethasone (BBD) was evaluated as a first-line therapy for multiple myeloma. The original treatment regimen of bendamustine 80 mg/m2 , days 1, 4; bortezomib 1·3 mg/m2 , days 1, 4, 8, 11; dexamethasone 40 mg, days 1, 2, 3, 4 on a 28-day cycle (up to 8 c... | [
{
"companynumb": "US-TEVA-743985ACC",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "BORTEZOMIB"
},
"drugadditional": null,
"dru... |
{
"abstract": "BACKGROUND\nAutism spectrum disorder (ASD) is a neurodevelopmental condition characterized by deficits in social communication and interaction and restricted, repetitive behaviors. The unmet medical need in ASD is considerable since there is no approved pharmacotherapy for the treatment of these defici... | [
{
"companynumb": "US-OTSUKA-2020_009723",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nBuprenorphine is a semisynthetic opioid with both agonist and antagonist activity at the opioid receptor. Currently, buprenorphine is commonly available in sublingual preparations combined with naloxone (e.g., Suboxone®, Subutex®). There has been increased use of buprenorphine derivatives in... | [
{
"companynumb": "CA-RECKITT BENCKISER PHARMACEUTICAL, INC-RB-69924-2014",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "OXYCODONE"
},
"d... |
{
"abstract": "This paper reports the case of an 88-year-old male with a history of chronic abdominal aortic aneurysm admitted to the emergency department with resting chest pain consistent with angina. Beta-blockade therapy triggered a cardiogenic shock, which motivated an urgent computed tomography scan and echocar... | [
{
"companynumb": "NVSC2020ES059854",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": "3",
"drugadmi... |
{
"abstract": "Bortezomib- and lenalidomide-containing regimens are well-established therapies in multiple myeloma (MM). However, despite their extensive use, head-to-head comparisons have never been performed. Therefore, we compared bortezomib and lenalidomide in fixed-duration therapies. In this open-label, phase I... | [
{
"companynumb": "IT-TAKEDA-2020TUS001935",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": "3",
... |
{
"abstract": "3 chronic paranoid schizophrenic men, aged 29, 30 and 37 years, respectively, developed retrograde ejaculation, a rare side-effect of clozapine. It disappeared after the dose was lowered in 1 of the patients and after stopping the drug in the other 2. On rechallenging with the drug, retrograde ejaculat... | [
{
"companynumb": "PHHY2014IL081617",
"fulfillexpeditecriteria": "1",
"occurcountry": "IL",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "CLOZAPINE"
},
"drugadditional": null,
"druga... |
{
"abstract": "A 20-year-old man underwent an outpatient general anesthetic procedure with sevoflurane for the correction of a bilateral gynecomastia. The patient had been first exposed to sevoflurane two years before, without any complication. He presented an overweight with a body mass index (BMI) of 31.4 kg/m2 and... | [
{
"companynumb": "BE-ABBVIE-21K-013-4052070-00",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ATRACURIUM BESYLATE"
},
"drugadditional": ... |
{
"abstract": "Von Willebrand disease (VWD) is the most common bleeding disorder and reportedly affects 1:1,000 of the world's population. There are three subtypes of VWD characterized by a quantitative defect (types 1 and 3 VWD) or a qualitative defect (type 2 VWD). Type 1 VWD results in a partial deficiency of von ... | [
{
"companynumb": "US-TEVA-2022-US-2018990",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "WARFARIN"
},
"drugadditional": "3",
"... |
{
"abstract": "The incidence of central nervous system (CNS) metastases in patients with anaplastic lymphoma kinase (ALK) fusion gene-positive (ALK+) non-small cell lung cancer (NSCLC) is high, ranging from approximately 20%-70%. Although ALK inhibitors (ALKis) are generally effective for CNS metastases in patients w... | [
{
"companynumb": "JP-TAKEDA-2021TUS030704",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BRIGATINIB"
},
"drugadditional": "3",
... |
{
"abstract": "Bisphosphonates have been associated with a serious adverse reaction known as bisphosphonate-related osteonecrosis of the jaws (BRONJ). The aim of this study was to describe its clinical characteristics in patients with dental implants who were taking bisphosphonates orally. We made a retrospective mul... | [
{
"companynumb": "ES-APOTEX-2015AP007340",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALENDRONATE SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "Second-generation antipsychotics have well-known metabolic side effects such as hyperlipidaemia and hyperglycaemia. A middle-aged man presented with epigastric and flank pain associated with nausea, and was noted to have elevated triglycerides (3590 mg/dL or 40.53 mmol/L), lipase and glucose. Haematolo... | [
{
"companynumb": "TW-ALKEM LABORATORIES LIMITED-TW-ALKEM-2018-02973",
"fulfillexpeditecriteria": "1",
"occurcountry": "TW",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "VALPROIC ACID"
},
"d... |
{
"abstract": "Anti-glomerular basement membrane (anti-GBM) disease is characterized by circulating IgG glomerular basement membrane antibodies and is clinically expressed as a rapidly progressive crescentic glomerulonephritis (GN), with 30-60% of patients also developing pulmonary hemorrhage. Classically, the renal ... | [
{
"companynumb": "CA-TEVA-2019-CA-1019711",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": "3",
... |
{
"abstract": "The aim of the study is to report the rare association of two complications of long-term treatment of osteoporosis with bisphosphonates in the same Caucasian elderly patient. A female patient of Italian descent, age 87 years, consulted in February 2013. She had a history of osteoporosis and had taken a... | [
{
"companynumb": "AR-CIPLA LTD.-2017IT04085",
"fulfillexpeditecriteria": "1",
"occurcountry": "AR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALENDRONATE SODIUM"
},
"drugadditional": "3",... |
{
"abstract": "Severe agitation is a common symptom in pediatric cases of anti-N-methyl-D-aspartate receptor (anti-NMDAR) encephalitis-an autoimmune encephalitis with prominent neuropsychiatric symptoms. Agitation is a major barrier to treatment of the underlying disease process and increases patients' risk of harmin... | [
{
"companynumb": "US-DRREDDYS-USA/USA/17/0090516",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DIPHENHYDRAMINE"
},
"drugadditional": n... |
{
"abstract": "Psoriasis is a chronic immune-mediated inflammatory condition that affects 2-3% of the population. Apremilast was FDA-approved in March 2014 for the treatment of psoriatic arthritis and in September 2014 for the treatment of moderate to severe plaque psoriasis. Apremilast appears to have lower efficacy... | [
{
"companynumb": "US-AMGEN-USASP2017144250",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ETANERCEPT"
},
"drugadditional": null,
... |
{
"abstract": "Acute Respiratory Distress Syndrome (ARDS) was first recognized during the 1960s. It is a distinct type of hypoxemic respiratory failure characterized by acute abnormality of both lungs. Extracorporeal membrane oxygenation (ECMO) is being increasingly used for patients with severe ARDS refractory to ot... | [
{
"companynumb": "US-MYLANLABS-2018M1018477",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "NALOXONE"
},
"drugadditional": null,
... |
{
"abstract": "Peristomal pyoderma gangrenosum (PPG) is an under-recognised and difficult condition to treat. We describe a case series using a novel topical combination therapy that promotes wound healing and allows for adhesion of the stoma appliance. A crushed oral prednisolone tablet mixed with Stomahesive Protec... | [
{
"companynumb": "AU-MYLANLABS-2019M1112294",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MINOCYCLINE HYDROCHLORIDE"
},
"drugadditional... |
{
"abstract": "Chronic granulomatous disease (CGD) is a rare congenital disorder in which phagocytes cannot generate superoxide (O(2)(-)) and other microbicidal oxidants due to mutations in one of the five components of the O(2)(-)-generating NADPH oxidase complex. The most common form is caused by mutations in CYBB ... | [
{
"companynumb": "PHHY2014FR158460",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": null,
"drugadditional": null,
"drugadministrationroute": null,
"drugauthorizationn... |
{
"abstract": "Psychosis is common in Parkinson's disease-related disorders and is associated with significant morbidity. Pimavanserin is a newly approved treatment for Parkinson's disease psychosis, but real-world experience with pimavanserin has been limited by small sample sizes and limited assessment of longitudi... | [
{
"companynumb": "US-ACADIA PHARMACEUTICALS INC.-ACA-2019-012738",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PIMAVANSERIN"
},
"drugad... |
{
"abstract": "OBJECTIVE\nNo standard salvage chemotherapy has been identified for metastatic pancreatic adenocarcinoma (mPA), and there is an urgent need for active agents against this disease. This phase II trial explored the activity of trabectedin in mPA progressing after gemcitabine-based first-line chemotherapy... | [
{
"companynumb": "IT-CIPLA LTD.-2015IT09828",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "TRABECTEDIN"
},
"drugadditional": null,
... |
{
"abstract": "The presence of KMT2A/AFF1 rearrangement in B-lymphoblastic leukemia (B-ALL) is an independent poor prognostic factor and has been associated with higher rate of treatment failure and higher risk of linage switch under therapy. Blinatumomab has shown promising therapeutic results in refractory or relap... | [
{
"companynumb": "US-AMGEN-USASP2020002278",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BLINATUMOMAB"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nTo report a case of posterior ciliary artery occlusion after posterior subtenon injection.\n\n\nMETHODS\nClinical examination and fundus fluorescein angiography was performed to confirm diagnosis. A 49-year-old female who was on treatment for bilateral chronic sclerokeratouveitis was given p... | [
{
"companynumb": "IN-G+W LABS-GW2017IN000140",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TRIAMCINOLONE ACETONIDE"
},
"drugadditional"... |
{
"abstract": "BACKGROUND\nThere are numerous reports of successful pregnancies following kidney transplantation. However, little information is available regarding the management and evolution of multiple pregnancies in a kidney-transplanted woman.\n\n\nMETHODS\nWe report the case of successful consecutive spontaneo... | [
{
"companynumb": "PHHY2019BR221273",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "UNSPECIFIED INGREDIENT"
},
"drugadditional": null,
... |
{
"abstract": "We observed a severe case of cerebral toxoplasmosis in a 22-year-old woman diagnosed with dermatomyositis in 2016 in Venezuela, and treated with rituximab and azathioprine. The patient met clinical and microbiological criteria. Treatment with pyrimethamine and sulfadiazine was initiated, and the patien... | [
{
"companynumb": "ES-SEBELA IRELAND LIMITED-2020SEB00093",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "HYDROXYCHLOROQUINE"
},
"drugadd... |
{
"abstract": "We report a case of a 63-year-old man who developed diabetic ketoacidosis (DKA) associated with canagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor. He presented acutely unwell with a silent myocardial infarction, diverticulitis and DKA with a minimally raised blood glucose level. Stand... | [
{
"companynumb": "GB-JNJFOC-20181234075",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
"drugadditional": nul... |
{
"abstract": "BACKGROUND\nAntipsychotics have been used for more than 50 years in the treatment of schizophrenia and many other psychiatric disorders. Prolactin levels usually increase in patients treated with risperidone. Aripiprazole, which has a unique effect as an antipsychotic, is a D2 receptor partial agonist.... | [
{
"companynumb": "IR-CIPLA LTD.-2015IR02748",
"fulfillexpeditecriteria": "1",
"occurcountry": "IR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RISPERIDONE"
},
"drugadditional": null,
... |
{
"abstract": "Disseminated carcinomatosis of the bone marrow (DCBM) is often accompanied by disseminated intravascular coagulation (DIC) and has a poor prognosis. DCBM develops most frequently in gastric cancer and is rarely associated with intrahepatic cholangiocarcinoma. A 41-year-old man was incidentally found to... | [
{
"companynumb": "JP-PFIZER INC-202200458554",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "GEMCITABINE HYDROCHLORIDE"
},
"drugadditiona... |
{
"abstract": "Chronic recurrent multifocal osteomyelitis (CRMO) or also called chronic non-bacterial osteomyelitis (CNO) is the most common autoinflammatory bone disease. It is characterized by the presence of symptomatic and non-symptomatic bone lesions, mono or multifocal. The main sites involved are the metaphyse... | [
{
"companynumb": "IT-MYLANLABS-2022M1041692",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,
... |
{
"abstract": "A 59-year-old male patient was admitted to hospital diagnosed with moderate pneumonia associated with COVID-19. Upfront treatment with hydroxychloroquine and azithromycin was started. Due to a clinical deterioration (ARDS, circulatory shock) and greatly increased inflammation markers 6 days after admis... | [
{
"companynumb": "DE-TEVA-2021-DE-1902407",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "NOREPINEPHRINE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nThis study was to determine the efficacy of vincristine and irinotecan in children with relapsed hepatoblastoma (HB).\n\n\nMETHODS\nA total of 10 patients with relapsed HB were enrolled. Three patients were excluded. Patients received irinotecan 50 mg/m(2)/day, day 1-5 and vincristine 1.5 mg... | [
{
"companynumb": "CN-SUN PHARMACEUTICAL INDUSTRIES LTD-2016R1-112385",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "IRINOTECAN"
},
"drug... |
{
"abstract": "Gastric antral vascular ectasia (GAVE) is known to be characterized by red patches or spots in a diffuse or linear array in the antrum of the stomach. The precise etiology of GAVE remains to be elucidated. Argon plasma laser coagulation (APC) has been used to control oozing from GAVE; however, there is... | [
{
"companynumb": "JP-LANNETT COMPANY, INC.-JP-2017LAN001052",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ESOMEPRAZOLE"
},
"drugadditio... |
{
"abstract": "Atypical antipsychotic use among children and adolescents is a cause for concern secondary to metabolic adverse effects. There have been reports of weight gain, metabolic syndrome, dyslipidemia, glucose abnormalities, and decreased insulin sensitivity in children aged 4 to 19 years using atypical antip... | [
{
"companynumb": "US-JNJFOC-20160608249",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RISPERIDONE"
},
"drugadditional": null,
... |
{
"abstract": "Lafora disease (LD) clinically appears in previously healthy teenagers as progressively worsening seizures, myoclonus, dementia, and ultimately a vegetative state leading to death within a decade of its onset. Here we present a typical case of LD in which the patient survived until the age of 40. Altho... | [
{
"companynumb": "CA-TEVA-2018-CA-969311",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PHENOBARBITAL"
},
"drugadditional": null,
... |
{
"abstract": "To describe an immunosuppressed patient who developed acute-onset postoperative endophthalmitis caused by a moxifloxacin-resistant strain of Staphylococcus epidermidis after cataract surgery despite the use of intracameral moxifloxacin.\nA 76-year old woman with a history of birdshot chorioretinopathy ... | [
{
"companynumb": "PHHY2019US019052",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "Different outcomes of brucellosis in pregnancy regarding the fetus/neonate and the mother are described. Medical records of five pregnant women with brucellosis were retrospectively analyzed. Patients were treated in several departments of infectious diseases in the Republic of Macedonia between 1995 a... | [
{
"companynumb": "MK-SUN PHARMACEUTICAL INDUSTRIES LTD-2020R1-274770",
"fulfillexpeditecriteria": "1",
"occurcountry": "MK",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM"
... |
{
"abstract": "SDRIFE (symmetrical drug related intertriginous and flexural exanthem) is a benign self-limiting adverse drug reaction (ADR) primarily affecting the intertriginous, gluteal and flexural regions symmetrically in the absence of systemic involvement. It is considered to be a variant of baboon syndrome. Pa... | [
{
"companynumb": "IN-STRIDES ARCOLAB LIMITED-2020SP009176",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ITRACONAZOLE"
},
"drugadditiona... |
{
"abstract": "Monoclonal gammopathy causes several kinds of renal pathology. A rare and special form is monoclonal gammopathy-induced C3 glomerulopathy (MG-C3G). Like idiopathic C3G, MG-C3G frequently leads to end-stage renal disease. MG-C3G frequently recurs after renal transplantation, leading to graft failure in ... | [
{
"companynumb": "DE-ASTELLAS-2018US027774",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BORTEZOMIB"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nSurvivors of childhood malignancies have an increased risk of developing second malignant neoplasms (SMN) due to their prior treatment and/or genetic susceptibility. A small proportion of SMNs are soft tissue sarcomas (STS), whose prognosis is generally thought to be poor, though publicatio... | [
{
"companynumb": "IT-PFIZER INC-2017238468",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "VINCRISTINE SULFATE"
},
"drugadditional": null... |
{
"abstract": "BACKGROUND\nAs higher vancomycin doses have been used in children, concern for acute kidney injury (AKI) has increased. Data describing factors associated with AKI, particularly dose-related factors, are limited.\n\n\nOBJECTIVE\nTo determine the incidence of AKI in children receiving intravenous vancom... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2015SP002687",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"drugadditional"... |
{
"abstract": "Acute pancreatitis (AP) is associated with risks of morbidity and mortality. The incidence of AP recently increased compared to that traditionally reported in the literature.\n\n\n\nThe purpose of this study was to evaluate the possible association between AP and drugs using the Japanese Adverse Drug E... | [
{
"companynumb": "JP-JNJFOC-20200136715",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BORTEZOMIB"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo report a case of severe apnea in an infant exposed to lamotrigine through breast-feeding.\n\n\nMETHODS\nA 16-day-old infant developed several mild episodes of apnea that culminated in a severe cyanotic episode requiring resuscitation. A thorough examination at the hospital gave no evidenc... | [
{
"companynumb": "NO-LUPIN PHARMACEUTICALS INC.-2014-01031",
"fulfillexpeditecriteria": "2",
"occurcountry": "NO",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LAMOTRIGINE"
},
"drugaddition... |
{
"abstract": "Pediatric cancer patients experience different psychological processes during hospitalization that may regulate the immune response and affect recovery and response to cancer treatment. In this study, we aimed to examine the feasibility of longitudinal testing of psychophysiological parameters of stres... | [
{
"companynumb": "BR-CLINIGEN GROUP PLC/ CLINIGEN HEALTHCARE LTD-BR-CLGN-18-00382",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DEXRAZOXANE HYDROCHLORIDE"... |
{
"abstract": "Immune thrombocytopenia (ITP) during pregnancy is an acquired autoimmune disease present in 1-2 of every 1000 pregnancies. Thrombopoietin (TPO)-mimetic drugs, such as eltrombopag, have been successfully used for treatment of ITP during pregnancy, but studies regarding its safety during gestation are la... | [
{
"companynumb": "PT-BAUSCH-BL-2018-021183",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "AZATHIOPRINE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo assess the causes of early death (ED) and late death (LD) in patients with systemic lupus erythematosus (SLE) and determine the features of deceased SLE patients followed-up in a single Croatian tertiary hospital center, because little if any data on causes of death (CODs) in SLE patients... | [
{
"companynumb": "HR-ROCHE-2107365",
"fulfillexpeditecriteria": "1",
"occurcountry": "HR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "3",
... |
{
"abstract": "To evaluate the prevalence of torsades de pointes and to identify risk factors associated with QTc prolongation of ≥500 milliseconds in hospitalized pediatric oncology patients. A QTc prolongation of ≥500 milliseconds is associated with higher mortality in hospitalized adults but has not been demonstra... | [
{
"companynumb": "US-DRREDDYS-USA/USA/20/0119751",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ONDANSETRON"
},
"drugadditional": "3",
... |
{
"abstract": "Antiepileptic drugs (AEDs) are widely used for the treatment of epilepsy, but they can be associated with the development of mainly delayed/non-immediate hypersensitivity reactions (HRs). Although these reactions are usually cutaneous, self-limited, and spontaneously resolve within days after drug disc... | [
{
"companynumb": "IT-GLAXOSMITHKLINE-IT2020GSK246996",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AMOXICILLIN"
},
"drugadditional": "1... |
{
"abstract": "Hemophagocytic lymphohistiocytosis (HLH) is an uncommon and life-threating condition characterized by major immune activation and massive cytokine production by mononuclear inflammatory cells, due to defects in cytotoxic lymphocyte function. It is even more unusual in renal transplant recipients, in wh... | [
{
"companynumb": "BR-SUN PHARMACEUTICAL INDUSTRIES LTD-2019R1-223592",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drug... |
{
"abstract": "OBJECTIVE\nThe case of a patient with decreased plasma efavirenz concentrations during concomitant rifabutin therapy is reported.\n\n\nCONCLUSIONS\nA 42-year-old Hispanic man newly diagnosed with acquired immune deficiency syndrome (AIDS) and coinfected with aseptic meningitis and disseminated Mycobact... | [
{
"companynumb": "US-CIPLA (EU) LIMITED-2020US00558",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RITONAVIR"
},
"drugadditional": null,... |
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