article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "Upgaze or sustained elevation of the eyes, is an alteration of ocular motility initially described in hypoxic coma. We report a 65-year-old woman admitted with hypotension and alteration of sensorium due to the ingestion of 9.5 g of Bupropion. She presented two seizures of short duration, without epile... | [
{
"companynumb": "CL-ALVOGEN-2018-ALVOGEN-097298",
"fulfillexpeditecriteria": "1",
"occurcountry": "CL",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BUPROPION"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo describe the clinical course and surgical outcome of a patient with full-thickness macular hole recurrence after aflibercept injections for wet age-related macular degeneration.\n\n\nMETHODS\nCase report with spectral domain optical coherence tomography retinal imaging.\n\n\nRESULTS\nAn 8... | [
{
"companynumb": "CA-SA-2020SA138606",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AFLIBERCEPT"
},
"drugadditional": "3",
"dr... |
{
"abstract": "We aimed to investigate the role of FDG-PET/CT in monitoring of response and immune-related adverse events (irAEs) following first-line combination-immune checkpoint inhibitor (combination-ICI) therapy for advanced melanoma.\n\n\n\nWe retrospectively reviewed outcomes in patients who had (1) first-line... | [
{
"companynumb": "AU-BRISTOL-MYERS SQUIBB COMPANY-BMS-2020-106991",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IPILIMUMAB"
},
"drugadd... |
{
"abstract": "Twenty-two middle-aged women with severe osteoporosis were treated for 2 years with either 0.5 mg of synthetic human calcitonin subcutaneously three times per week combined with 0.5 micrograms of calcitriol and 0.5 g of calcium per day orally or calcium only. The treatment with calcitonin plus calcitri... | [
{
"companynumb": "SE-VALIDUS PHARMACEUTICALS LLC-SE-2019VAL000529",
"fulfillexpeditecriteria": "1",
"occurcountry": "SE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CALCITRIOL"
},
"drugadd... |
{
"abstract": "Fever occurs frequently early after pancreas transplant, however, the exact cause is often undetermined. Limited data are available on pancreas recipients experiencing unexplained, noninfectious fever. This study aims to characterize unexplained fever (UF) in pancreas recipients and its effect on patie... | [
{
"companynumb": "PHHY2018US081748",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "3",
... |
{
"abstract": "Iron overload is inevitably related to chronic kidney disease (CKD) treatment. Haemochromatosis leads to multiorgan damage and is associated with increased mortality. Primary haemochromatosis is the most common autosomal recessive disease in white populations. In most cases, the classic form of heredit... | [
{
"companynumb": "PL-ACCORD-228477",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": "3",
... |
{
"abstract": "Thyroid cancer is the most common endocrine cancer, with an increasing incidence around the world in the last three decades. The increased risk of secondary cancer is associated with a genetic predisposition or radioactive iodine used in the treatment.\n\n\n\nA 65-year old male patient was operated on ... | [
{
"companynumb": "TR-JUBILANT PHARMA LTD-2018TR001383",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "SODIUM IODIDE I-131"
},
"drugadditi... |
{
"abstract": "Spontaneous reossification of the sellar floor after transsphenoidal surgery has been rarely reported. Strontium ranelate, a divalent strontium salt, has been shown to increase bone formation, increasing osteoblast activity. We describe an unusual case of a young patient with Cushing's disease who was ... | [
{
"companynumb": "UY-CIPLA LTD.-2018UY06952",
"fulfillexpeditecriteria": "1",
"occurcountry": "UY",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PAMIDRONATE DISODIUM"
},
"drugadditional": nu... |
{
"abstract": "A 65-year-old man with metastatic melanoma was started on immunotherapy, switched to alternative targeted therapy and developed disseminated intravascular coagulation. This case underscores the complexity of interpreting and managing side effects of novel therapies in cancer care, identification of pro... | [
{
"companynumb": "PHHY2017US013623",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "TRAMETINIB"
},
"drugadditional": null,
"drug... |
{
"abstract": "We present a patient with catecholaminergic polymorphic ventricular tachycardia who failed maximal antiarrhythmic drug therapy and bilateral sympathetic denervation, who presented with syncope and recurrent ventricular tachycardia for 11 min refractory to 21 shocks. She underwent cardiac transplantatio... | [
{
"companynumb": "US-MYLANLABS-2020M1092872",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PROPRANOLOL HYDROCHLORIDE"
},
"drugadditional... |
{
"abstract": "Sulfhemoglobinemia is a rare condition in which a sulfur atom oxidizes the heme moiety in hemoglobin, making the hemoglobin incapable of carrying oxygen and leading to hypoxia and cyanosis. This condition has been described in patients taking sulfur medications or who have cultured hydrogen sulfide pro... | [
{
"companynumb": "US-PFIZER INC-2017151635",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CEFDINIR"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nMirtazapine is a tetracyclic antidepressant that enhances both noradrenergic and serotonergic transmission. The most common cause of papilledema is increased intracranial pressure due to brain tumor. Also it may occur as a result of idiopathic intracranial hypertension (IIH, pseudo tumor ce... | [
{
"companynumb": "TR-LUPIN PHARMACEUTICALS INC.-2016-02799",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SERTRALINE HYDROCHLORIDE"
},
"... |
{
"abstract": "Although factor Xa inhibitors have become a popular choice for chronic oral anticoagulation, effective drug reversal remains difficult due to a lack of specific antidote. Currently, 4-factor prothrombin complex concentrate (4F-PCC) is considered the treatment of choice for factor Xa inhibitor-related m... | [
{
"companynumb": "US-JNJFOC-20180639040",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RIVAROXABAN"
},
"drugadditional": "3",
... |
{
"abstract": "The authors report a case of left ventricular perforation and cardiac tamponade in a patient undergoing endovascular aortic and mesenteric stent grafting. During the procedure, the anesthetist noticed a sudden increase in central venous pressure and a decrease in blood pressure. Cardiac tamponade was s... | [
{
"companynumb": "AT-FRESENIUS KABI-FK201704426",
"fulfillexpeditecriteria": "1",
"occurcountry": "AT",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "NOREPINEPHRINE"
},
"drugadditional": nul... |
{
"abstract": "Heterotopic pregnancy is defined as the simultaneous presence of 2 or more pregnancies at different implantation sites, most commonly one intrauterine and one ectopic. Triplet heterotopic pregnancy refers to the presence of specifically 3 concurrent gestations with at least 1 being abnormally implanted... | [
{
"companynumb": "US-009507513-1810USA013170",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CHORIOGONADOTROPIN ALFA"
},
"drugadditional"... |
{
"abstract": "Recent increases in the rate of drug overdose-related deaths, the emergence of potent opioids such as carfentanil, and media reports of incidents have raised concerns about the potential for work-related exposure to a variety of illicit drugs among law enforcement officers (LEOs), other emergency respo... | [
{
"companynumb": "US-JNJFOC-20200713971",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "COCAINE"
},
"drugadditional": null,
"dr... |
{
"abstract": "OBJECTIVE\nCalcium sensing receptor (CaSR) is expressed, among others also in testis. Cinacalcet binds to the CaSR, increases sensitivity of CaSR to serum calcium and is used in the treatment of secondary hyperparathyroidism (sHPT) in chronic hemodialysis patients (HDP). In most of male HDP, serum test... | [
{
"companynumb": "PL-AMGEN-POLSP2016081268",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CALCIUM CARBONATE"
},
"drugadditional": null,... |
{
"abstract": "Subarachnoid hemorrhage is a medical emergency. Berry aneurysm rupture is the second most common cause following trauma. Diagnosis is often challenging. Neurogenic heart syndrome often complicates subarachnoid hemorrhage. A concomitant pheochromocytoma can be deadly causing sudden cardiac arrhythmia. H... | [
{
"companynumb": "US-PFIZER INC-2019299174",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "NALOXONE HYDROCHLORIDE"
},
"drugadditional": n... |
{
"abstract": "Isavuconazole (ISA) is an attractive candidate for primary mold-active prophylaxis in high-risk patients with hematologic malignancies or hematopoietic cell transplant (HCT) recipients. However, data supporting the use of ISA for primary prophylaxis in these patients are lacking.\n\n\n\nWe conducted a ... | [
{
"companynumb": "US-TEVA-2020-US-1236921",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUDARABINE PHOSPHATE"
},
"drugadditional": "3"... |
{
"abstract": "Vancomycin-variable enterococcus (VVE) is an emerging pathogen. VVE isolates initially appear phenotypically susceptible to vancomycin but possesses the vanA gene and can develop in vitro and in vivo resistance to vancomycin. We report a case of VVE bacteremia and describe how VVE poses diagnostic and ... | [
{
"companynumb": "CA-WATSON-2016-02232",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND Bladder stones are rare in pregnancy, and can be associated with adverse outcomes such as recurrent urinary tract infection and obstruction of labor. Management of bladder stones discovered in pregnancy has traditionally been done via open techniques such as cystolithotomy or with percutaneo... | [
{
"companynumb": "US-TEVA-2019-US-1043715",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CEPHALEXIN"
},
"drugadditional": null,
... |
{
"abstract": "The authors describe a rare case of \"concealed\" congenital Long QT Syndrome (LQTS) Type 3 in a patient with treatment resistant schizophrenia and no known personal or family history of cardiac disease. The patient in this Case Report had a hidden genetic condition revealed only following the essentia... | [
{
"companynumb": "US-MYLANLABS-2018M1006831",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "OLANZAPINE"
},
"drugadditional": null,
... |
{
"abstract": "Heart transplantation in patients with Marfan syndrome is challenging and raises concerns with regards to the haemodynamic and immunosuppressive-induced effects on the inherently fragile aorta. Most aortic events following transplantation reported so far in the literature occurred in patients with pre-... | [
{
"companynumb": "BE-TEVA-631080ISR",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": null,
... |
{
"abstract": "HER2 gene amplifications and activating mutations in the HER2 receptor tyrosine kinase are present in 4% of metastatic colorectal cancers (mCRCs). HER2-targeted therapy is not standard of care, although preclinical and clinical data suggest that patients with HER2 amplifications and/or HER2-activating ... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2018US-166859",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BEVACIZUMAB"
},
"dru... |
{
"abstract": "BACKGROUND\nRapid inactivation of dabigatran by its specific inhibitor idarucizamab allows intravenous thrombolysis (IVT) in patients suffering ischemic stroke while being treated with dabigatran. Only limited data of this approach is available and numerous questions regarding efficacy/safety remain to... | [
{
"companynumb": "SI-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-060809",
"fulfillexpeditecriteria": "1",
"occurcountry": "SI",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DABIGATRAN ETEXILATE MESYLATE"
... |
{
"abstract": "The synthetic opioid methadone hydrochloride has a low molecular weight of 346 D, a high volume of distribution (4 - 7 L/kg), and is lipophilic. It is used as an analgesic and for the maintenance treatment of opiate dependence. In drug addicts, methadone is frequently involved in mixed intoxications th... | [
{
"companynumb": "DE-MYLANLABS-2017M1046613",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CLONAZEPAM"
},
"drugadditional": null,
... |
{
"abstract": "We investigated the role of maternal environmental factors in the aetiology of congenital heart disease (CHD). A population-based case-control study (242 CHD cases, 966 controls) was conducted using an iPad questionnaire for mother with linkage to maternity and first trimester prescription records. Ris... | [
{
"companynumb": "GB-NANJING KING-FRIEND BIOCHEMICAL PHARMACEUTICAL CO. LTD.-2020NKF00005",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ENOXAPARIN SODIUM"
... |
{
"abstract": "BACKGROUND\nBradycardia is a common vital sign encountered in the emergency department. These patients are often hemodynamically stable and require no emergent intervention. On occasion, bradycardia can cause hemodynamic instability, and there are established treatment pathways involving atropine, iono... | [
{
"companynumb": "US-VALIDUS PHARMACEUTICALS LLC-US-2019VAL000579",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METOPROLOL TARTRATE"
},
... |
{
"abstract": "Neuroleptic malignant syndrome (NMS) can be caused by various drugs. We report a case of a 60-year-old woman who presented with high-grade fever, muscular rigidity, tachycardia, tachypnoea and altered sensorium along with seizures. She had been taking olanzapine for the past 2 years for psychosis. For ... | [
{
"companynumb": "IN-VISTAPHARM, INC.-VER201712-001354",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "VALPROIC ACID"
},
"drugadditional"... |
{
"abstract": "Objective The standard anti-tuberculosis (TB) regimen occasionally causes acute kidney injury (AKI). The major etiology is rifampicin-induced acute interstitial nephritis. However, the standard management of AKI induced by anti-TB drugs has yet to be established. Methods We retrospectively reviewed pat... | [
{
"companynumb": "PHHY2019JP076770",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ISONIAZID"
},
"drugadditional": "1",
"drugad... |
{
"abstract": "A detailed understanding of the hemostatic process and the pathogenesis of thrombosis provides the basis for the development of more selective and potentially more efficient antithrombotic agents. These may allow to tailor antithrombotic treatment strategies for specific disease entities according to r... | [
{
"companynumb": "US-ROCHE-1344137",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ENALAPRIL"
},
"drugadditional": null,
"drug... |
{
"abstract": "Central nervous damage related to intra-arterial infusion chemotherapy (IAC) for head and neck cancer reported to date are cerebral infarction, transient ischemic attack, and neuropathy. There have been no reports of cerebral hemorrhage as an IAC-related complication for head and neck cancer. Authors r... | [
{
"companynumb": "JP-ACCORD-205689",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DOCETAXEL"
},
"drugadditional": "1",
"drugad... |
{
"abstract": "BACKGROUND\nThe development of complement inhibitors has greatly improved the outcome of patients with atypical hemolytic uremic syndrome (aHUS), making kidney transplantation a more feasible option. Although prophylactic eculizumab therapy may prevent recurrent disease after transplantation, its neces... | [
{
"companynumb": "NL-ALKEM LABORATORIES LIMITED-NL-ALKEM-2017-01304",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
... |
{
"abstract": "Everolimus is an mTOR (the mammalian target of rapamycin) inhibitor, which is used for the treatment of advanced renal cell carcinoma. Life-threatening hemorrhages are extremely rare adverse effect of everolimus. We herein report a successfully treated case of severe everolimus-related gastrointestinal... | [
{
"companynumb": "PHHY2019JP098564",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "EVEROLIMUS"
},
"drugadditional": "1",
"druga... |
{
"abstract": "This report details the successful use of bilateral lung transplantation for the management of severe postoperative bleomycin-associated lung injury. This case highlights that the extremely favorable prognosis of advanced testicular germ cell tumors after systemic chemotherapy (>90% cure rate) should n... | [
{
"companynumb": "US-FRESENIUS KABI-FK201706181",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": null,
... |
{
"abstract": "A man with dilated cardiomyopathy presented with decompensated heart failure and marked eosinophilia. After extensive clinical and laboratory evaluation for hypereosinophilic syndrome, including a myocardial biopsy, it was determined by means of rechallenge (second dobutamine infusion) that the patient... | [
{
"companynumb": "US-drreddys-LIT/USA/22/0148273",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DOBUTAMINE HYDROCHLORIDE"
},
"drugaddit... |
{
"abstract": "Rhodococcus equi is an animal pathogen that causes infrequent but challenging infections in immunocompromised individuals, few of which have been described in solid organ transplant recipients. Common clinical presentations include indolent cough, fever, and dyspnea, with necrotizing pneumonia and cavi... | [
{
"companynumb": "US-DRREDDYS-USA/USA/15/0053538",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
... |
{
"abstract": "Clonidine, an alpha-2-adrenergic agonist, may have a clinically relevant analgesic action but also a hypotensive action, when administered spinally.\n\n\nOBJECTIVE\nTo evaluate the analgesic and circulatory effects of low-dose intrathecal clonidine co-administered with hyperbaric bupivacaine in septuag... | [
{
"companynumb": "IN-MYLANLABS-2016M1033733",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "BUPIVACAINE"
},
"drugadditional": null,
... |
{
"abstract": "A four-year-old girl on maintenance therapy for acute lymphoblastic leukemia (ALL) complained of a headache and low back pain on the day she received her 21st intrathecal methotrexate (it-MTX) administration, and the next day experienced numbness and pain in her foot. This numbness gradually spread to ... | [
{
"companynumb": "JP-MYLANLABS-2015M1012774",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,
... |
{
"abstract": "Dyskeratosis congenita (DC) is a rare inherited disorder characterized by reticular skin pigmentation, oral cavity leukoplakia, and nail dystrophy. Bone marrow failure in DC can only be cured by allogeneic hematopoietic stem cell transplantation (HSCT). After a nonmyeloablative, matched unrelated donor... | [
{
"companynumb": "PHHY2015DE007690",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": null,
"dr... |
{
"abstract": "Tyrosinemia type 1 is a hereditary disorder with liver, kidney and nervous system involvement. Neurological crises can occur in tyrosinemic patients without treatment or when treatment stops. Here we report three children that developed diaphragmatic paralysis after discontinuation of nitisinone. In pa... | [
{
"companynumb": "IR-BIOVITRUM-2017IR0895",
"fulfillexpeditecriteria": "1",
"occurcountry": "IR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "NITISINONE"
},
"drugadditional": "1",
... |
{
"abstract": "Introduction: Paliperidone palmitate treatment of schizophrenia or schizoaffective disorder is effective and well tolerated, but there is almost no data on its safety during pregnancy. Case report: An analysis is made of the safety and tolerability of paliperidone palmitate treatment throughout the ges... | [
{
"companynumb": "ES-SUN PHARMACEUTICAL INDUSTRIES LTD-2017RR-139404",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LORAZEPAM"
},
"druga... |
{
"abstract": "OBJECTIVE\nTo report a case of recalcitrant Prototheca spp. keratitis and endophthalmitis in a patient with Stevens-Johnson syndrome (SJS) and Boston type 1 keratoprosthesis (B1 KPro).\n\n\nMETHODS\nCase report.\n\n\nRESULTS\nA 67-year-old female with a history of SJS with chronic severe ocular surface... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2016SP014433",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drug... |
{
"abstract": "Citalopram is one of the selective serotonin re-uptake inhibitors (SSRIs) most commonly prescribed for depression and many affective disorders. Abrupt cessation of this medication has been associated with dizziness, nausea, myalgias, anxiety and irritability. It is unclear whether blood pressure can be... | [
{
"companynumb": "US-DRREDDYS-USA/USA/13/0027790",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CITALOPRAM HYDROBROMIDE"
},
"drugadditi... |
{
"abstract": "BACKGROUND\nPaclitaxel has significant single agent activity in urothelial cancer. The 130 nm albumin bound paclitaxel (nab-paclitaxel, ABI-007) delivers more paclitaxel to tumor than conventional paclitaxel without cremophor related toxicities. We assessed the efficacy of nab-paclitaxel in combination... | [
{
"companynumb": "US-CIPLA LTD.-2014US00145",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PACLITAXEL"
},
"drugadditional": "3",
... |
{
"abstract": "A 34-year-old man with allergic asthma died an (instantaneous) sudden cardiac death as a result of multiple myocardial infarcts. These occurred in the absence of coronary atherosclerosis. The major mechanism by which the infarcts occurred was recurrent coronary artery spasm. The latter can occur sponta... | [
{
"companynumb": "US-PFIZER INC-2016384258",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PROPRANOLOL HYDROCHLORIDE"
},
"drugadditional... |
{
"abstract": "BACKGROUND\nPolypoidal choroidal vasculopathy (PCV) consists of polyps that potentially cause massive subretinal hemorrhage and their branching vascular network (BVN) of feeder vessels. Although conventional indocyanine green angiography (IA) has shown anti-vascular endothelial growth factor (VEGF) age... | [
{
"companynumb": "JP-ROCHE-2221918",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RANIBIZUMAB"
},
"drugadditional": "1",
"drug... |
{
"abstract": "Computed tomography (CT) is the most reliable method to evaluate the progression of COVID-19 pneumonitis. However, in a pandemic, transportation of critically ill invasively ventilated patients to radiology facilities is challenging, especially for those on extracorporeal membrane oxygenation (ECMO). N... | [
{
"companynumb": "JP-COVIS PHARMA GMBH-2021COV23903",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "REMDESIVIR"
},
"drugadditional": nul... |
{
"abstract": "BACKGROUND\nMyeloid sarcoma (MS) is a tumor secondary to myeloid leukemia that consists of immature granulocytes with or without mature granulocytes and is a rare extramedullary manifestation of acute myeloid leukemia (AML).\n\n\nMETHODS\nWe report a case of a 34-year-old woman diagnosed with AML-M4 wh... | [
{
"companynumb": "CN-NATCO PHARMA LIMITED-2120935",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "AZACITIDINE"
},
"drugadditional": null... |
{
"abstract": "We report our experience using the double-carbapenem combination as salvage therapy for patients with untreatable infections caused by KPC-2- producing Klebsiella pneumoniae. A total of 27 patients in two institutions in Athens, Greece suffering from complicated urinary tract infections (16) with or wi... | [
{
"companynumb": "GR-PFIZER INC-2017094476",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MEROPENEM"
},
"drugadditional": "3",
... |
{
"abstract": "We report a case of bilateral atypical femoral fractures that occurred in a patient who had been taking bisphosphonate long-term. A 36-year-old premenopausal female diagnosed with systemic lupus erythematosus and dermatomyositis had been treated with glucocorticoid and alendronate (5 mg/day) to prevent... | [
{
"companynumb": "JP-WATSON-2016-00990",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "WARFARIN"
},
"drugadditional": null,
"d... |
{
"abstract": "The effect of chemotherapeutic agents on concomitant colorectal adenomas in patients with advanced colorectal cancer is not clear. We report a case of an enlarged rectal adenoma while achieving a clinical complete response with chemotherapy for an advanced rectal adenocarcinoma. A 78-year-old man was r... | [
{
"companynumb": "JP-PFIZER INC-2020285249",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IRINOTECAN HYDROCHLORIDE"
},
"drugadditional":... |
{
"abstract": "We report a case of a patient who had been on long time valproic acid for treatment of bipolar affective disorder. While being an inpatient, serology ammonia level testing revealed a very high ammonia level despite being asymptomatic. Dual therapy of carnitine and lactulose was provided to the patient ... | [
{
"companynumb": "US-CATALENT PHARMA SOLUTIONS-CAT-000058-2016",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "VALPROIC ACID"
},
"drugadd... |
{
"abstract": "Intracranial germ cell tumors (GCT) account for less than 5% of all central nervous system tumors in children in Western countries. Approximately 40% are nongerminomatous GCT (NGGCT). Despite correct treatment, 16% to 47% of the patients will relapse. There are no standard approaches in case of recurre... | [
{
"companynumb": "ES-ACCORD-162460",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "Prolonged QT syndrome precipitates cardiac arrhythmias such as torsades de pointes (TdP) resulting in cardiogenic syncope or sudden death. We report a case of prolonged QT syndrome caused by donepezil which resulted in a fall and hip fracture. In this case female sex, advanced age and diuretic use may ... | [
{
"companynumb": "GB-ALEMBIC PHARMACUETICALS LIMITED-2019SCAL000099",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DONEPEZIL HYDROCHLORIDE"
},
... |
{
"abstract": "A 53-year-old Asian woman was treated with hydroxychloroquine and chloroquine for lupus erythematosus. Within a few years, she noticed circle-shaped shadows in her central vision. Upon examination, the patient's visual acuity was 20 / 25 in both eyes. Humphrey visual field (HVF) testing revealed a cent... | [
{
"companynumb": "KR-CONCORDIA PHARMACEUTICALS INC.-GSH201702-001022",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CHLOROQUINE"
},
"dru... |
{
"abstract": "Keloidal morphea is a rare variant of scleroderma, which often can be clinically confused with keloid or scar formation. We report a 34-year-old woman with a medical history of asthma and Raynaud's phenomenon, presented for the evaluation and management of multiple erythematous hyperpigmented annular p... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2020R1-241735",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM"
... |
{
"abstract": "Despite fluoropyrimidines (FPs) constituting the main component of the chemotherapy combination protocols in 50% of chemotherapies for solid tumour treatments, incidence data for FP-related toxicity are poorly documented in real life. This study evaluated the number of patients receiving FP-based chemo... | [
{
"companynumb": "FR-TEVA-2019-FR-1156653",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "Objective Analyze the demographics, clinical characteristics, efficacy and safety of natalizumab treatment in Brazilian patients with multiple sclerosis (MS) followed up for at least 12 months, in two tertiary MS care centers in São Paulo.Method We evaluated the effect of natalizumab treatment on annua... | [
{
"companynumb": "BR-BIOGEN-2013BI030031",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE SODIUM SUCCINATE"
},
"drugad... |
{
"abstract": "We herein report the clinical course of a patient who had a good neurological outcome despite severe anemia, high serum lactate levels, and a long period of time from cardiac arrest (CA) to extracorporeal cardio-pulmonary resuscitation (ECPR) establishment. During the period of resuscitation, the tissu... | [
{
"companynumb": "JP-INTERNATIONAL MEDICATION SYSTEMS, LIMITED-2031483",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "EPINEPHRINE"
},
"... |
{
"abstract": "Adverse effects associated with synthetic cannabinoid use include agitation, psychosis, seizures and cardiovascular effects, all which may result in a lethal outcome. We report the collection of data from 25 medical examiner and coroner cases where the presence of synthetic cannabinoids was analyticall... | [
{
"companynumb": "US-APOTEX-2017AP013830",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "THEOBROMINE"
},
"drugadditional": null,
... |
{
"abstract": "Improved survival achieved by HIV-infected patients has complicated their medical care, as increasing numbers of comorbidities have led to polypharmacy and a higher risk of drug-drug interactions. Here, evidence is provided that weight-loss drugs should be used with caution in HIV-infected patients tre... | [
{
"companynumb": "IT-JNJFOC-20180916970",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ESTRADIOL"
},
"drugadditional": null,
"... |
{
"abstract": "Tandem vertebral ostial disease with acute intracranial vertebrobasilar occlusion with contralateral vertebral occlusion or hypoplasia presents a unique challenge to the interventionalist.\nThe authors queried a prospectively maintained institutional endovascular database from August 2013 to June 2018 ... | [
{
"companynumb": "US-009507513-2003USA007527",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "EPTIFIBATIDE"
},
"drugadditional": null,
... |
{
"abstract": "Chronic rejection (CR) remains a challenging complication after liver transplantation. Everolimus, which is a mammalian target of rapamycin inhibitor, has an anti-fibrosis effect. We report here the effect of everolimus on CR. Case 1 was a 7-year-old girl who underwent living donor liver transplantatio... | [
{
"companynumb": "PHHY2018JP138096",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "3",
"druga... |
{
"abstract": "A 72-year-old man developed dipeptidyl peptidase-4 inhibitor-associated bullous pemphigoid (BP) during treatment for type 2 diabetes mellitus and was administered prednisolone (PSL, 0.5 mg/kg). Despite PSL treatment at a daily dose of 19 mg/day, purpura appeared on his bilateral forearms 3 months later... | [
{
"companynumb": "JP-MYLANLABS-2020M1073991",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMPHOTERICIN B"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nCombination of chemotherapy with a tyrosine-kinase inhibitor is effective in the treatment of Philadelphia chromosome-positive acute lymphoblastic leukaemia. Ponatinib is a more potent BCR-ABL1 inhibitor than all other tyrosine-kinase inhibitors and selectively suppresses the resistant T315... | [
{
"companynumb": "US-JNJFOC-20151112444",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,
... |
{
"abstract": "Heparin-induced thrombocytopenia (HIT) and thrombosis affect a small minority of patients exposed to heparin. However, given the high proportion of patients who receive heparin during hospitalization, clinicians should be mindful to keep it on their differential. This case involves a 56-year-old woman ... | [
{
"companynumb": "NVSC2019US021577",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MEROPENEM"
},
"drugadditional": null,
"druga... |
{
"abstract": "Authors would like to demonstrate the beneficial effect of myo-inositol supplementation in a pregnant woman with insulin-dependent type 2 diabetes mellitus and polycystic ovary syndrome. Insulin and metformin treatment could not achieve normalization of glucose homeostasis for 3 years, and hypoglycemic... | [
{
"companynumb": "HU-CIPLA LTD.-2017HU07424",
"fulfillexpeditecriteria": "1",
"occurcountry": "HU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FOLIC ACID"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nPI3K/AKT pathway alterations are frequent in hormone receptor-positive (HR+) breast cancers. IPATunity130 Cohort B investigated ipatasertib-paclitaxel in PI3K pathway-mutant HR+ unresectable locally advanced/metastatic breast cancer (aBC).\n\n\nMETHODS\nCohort B of the randomized, double-bli... | [
{
"companynumb": "GB-PFIZER INC-202101772508",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PACLITAXEL"
},
"drugadditional": "3",
... |
{
"abstract": "I report a case of multiple organ failure (acute kidney injury, interstitial pneumonitis and liver dysfunction) associated with combined androgen blockade(CAB) with bicalutamide and leuprorelin acetate for prostate cancer that was successfully managed by prompt hemodialysis and withdrawal of medication... | [
{
"companynumb": "JP-TOLMAR, INC.-20JP019975",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEUPROLIDE ACETATE"
},
"drugadditional": "1"... |
{
"abstract": "Neoadjuvant radiotherapy with or without chemotherapy decreases the risk of local recurrence after surgery for rectal cancer. Emerging data suggest that diabetic patients on metformin may have improved cancer outcome after radiotherapy. A single institutional pilot study was performed to determine if m... | [
{
"companynumb": "CA-ALKEM LABORATORIES LIMITED-CA-ALKEM-2021-05967",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
... |
{
"abstract": "BACKGROUND Adalimumab is a biological anti-tumor necrosis factor (TNF) agent which induces and maintains remission in patients with moderate-to-severe Crohn disease (CD). An adverse effect of its use is reactivation of latent infections, such as tuberculosis (TB). TB is caused by Mycobacterium tubercul... | [
{
"companynumb": "BR-PFIZER INC-202101366520",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ADALIMUMAB"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nDevelopment of polyneuropathy (PNP) under treatment for tuberculosis (TB), including isoniazid (INH), is a highly relevant adverse drug effect. The NAT2 acetylation status is a predictor of potential toxic effects of INH. The question as to whether individual risk stratification by genotypi... | [
{
"companynumb": "PHHY2015DE100755",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ISONIAZID"
},
"drugadditional": null,
"druga... |
{
"abstract": "BACKGROUND\nTo perform a comparative effectiveness analyses between enzalutamide and abiraterone acetate in both the pre-docetaxel and post-docetaxel settings based on published phase III randomized trials.\n\n\nMETHODS\nThe primary measure of efficacy was the posterior probability that enzalutamide ou... | [
{
"companynumb": "SG-JNJFOC-20180921600",
"fulfillexpeditecriteria": "1",
"occurcountry": "SG",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ABIRATERONE ACETATE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nClenbuterol is a β2-agonist approved in the United States for veterinary use in nonfood animals. Clenbuterol use is emerging among bodybuilders and fitness enthusiasts attracted to the hypertrophic and lipolytic effects.\n\n\nMETHODS\nThis was a retrospective chart review of clenbuterol exp... | [
{
"companynumb": "US-MYLANLABS-2015M1010721",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LIOTHYRONINE"
},
"drugadditional": null,
... |
{
"abstract": "Visual symptoms in pregnancy are ominous. The spectrum of ocular symptoms seen in pre-eclampsia includes blurring of vision, scotoma, hemianopia and even total cortical blindness. Diplopia, though rare has also been reported in cases of pre-eclampsia and occurs due to pathological changes affecting the... | [
{
"companynumb": "IN-MYLANLABS-2017M1064148",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMLODIPINE BESYLATE"
},
"drugadditional": "3"... |
{
"abstract": "Despite over 40 years of worldwide usage, relatively few data have been published on the pharmacokinetics of cefazolin in pediatric surgical patients. The primary objectives of this study were to examine the pharmacokinetics and safety of cefazolin in children 10 to 12 years of age (inclusive) receivin... | [
{
"companynumb": "US-B. BRAUN MEDICAL INC.-1062591",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CEFAZOLIN SODIUM"
},
"drugadditional":... |
{
"abstract": "In order to replace the central venous line necessary for continuous infusion of vincristine and doxorubicin with high-dose dexamethasone (VAD) and to avoid hospitalization, we evaluated the efficacy and toxicity of oral idarubicin, vincristine and dexamethasone (VID) in patients with multiple myeloma.... | [
{
"companynumb": "DE-PFIZER INC-2018149869",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "IDARUBICIN"
},
"drugadditional": null,
... |
{
"abstract": "To assess the feasibility, safety, and efficacy of a sedation protocol using dexmedetomidine as the primary sedative in mechanically ventilated critically ill children.\n\n\n\nOpen-label, pilot, prospective, multicenter, randomized, controlled trial. The primary outcome was the proportion of sedation s... | [
{
"companynumb": "AU-HQ SPECIALTY-AU-2020INT000102",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PROPOFOL"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nSome chronic hepatitis C virus (HCV), genotype 1 infected patients treated with direct antiviral agents (DAAs) remain viremic at end of treatment (EOT+), yet go on to achieve sustained virological response 12 weeks after completion of therapy (SVR12). The incidence of EOT+/SVR in patients w... | [
{
"companynumb": "US-JNJFOC-20170122029",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "SOFOSBUVIR"
},
"drugadditional": null,
... |
{
"abstract": "Infant delirium is an under-recognized clinical entity in neonatal intensive care, and earlier identification and treatment could minimize morbidities associated with this condition. We describe a case of a 6-month-old former 32 weeks gestation infant undergoing a prolonged mechanical ventilation cours... | [
{
"companynumb": "US-LANNETT COMPANY, INC.-US-2017LAN000808",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DIAZEPAM"
},
"drugadditional"... |
{
"abstract": "Safety and tolerability of long-term treatment with the long-acting antipsychotic aripiprazole lauroxil (AL) were evaluated in patients with schizophrenia.\n\n\n\nThis was an international, multicenter, phase 3, 52-week safety study of 2 fixed doses of AL (441 mg or 882 mg intramuscular every 4 weeks).... | [
{
"companynumb": "US-AJANTA PHARMA USA INC.-2055161",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"drugadditional": nu... |
{
"abstract": "BACKGROUND\nCyanide (CN) toxicity commonly occurs during enclosed-space fires. Historically, the first step in treating CN toxicity utilized amyl nitrite and sodium nitrite to induce methemoglobinemia, which can be dangerous in this population. Hydroxocobalamin (OHCob), which binds to CN to form the no... | [
{
"companynumb": "US-TEVA-2019-US-1108523",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "SILVER SULFADIAZINE"
},
"drugadditional": null,... |
{
"abstract": "BACKGROUND\nCarbamazepine (CBZ) overdose can result in significant neurologic and cardiovascular toxicity, and is compounded by the presence of an active metabolite, carbamazepine-10,11-epoxide (CBZE). Existing publications describing continuous venovenous hemofiltration (CVVH) in CBZ overdose are limi... | [
{
"companynumb": "US-JUBILANT CADISTA PHARMACEUTICALS-2015JUB00196",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "VALPROIC ACID"
},
"dr... |
{
"abstract": "BACKGROUND\nNeuromyelitis optica spectrum disorders (NMOSD) are immune-mediated inflammatory disorders of the central nervous system involving astrocytes, B lymphocytes, anti-aquaporin 4, and such inflammatory mediators as interleukin-6. Several immunosuppressants are used in their treatment. Tocilizum... | [
{
"companynumb": "ES-CELLTRION INC.-2019ES021207",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": "3",
... |
{
"abstract": "Pediatric patients often have poor pregnancy outcomes. Systemic lupus erythematosus predominantly impacts women in their second to fourth decade of life, with childhood-onset disease being particularly aggressive. Reproductive issues are an important clinical consideration for pediatric patients with s... | [
{
"companynumb": "US-PFIZER INC-2018391378",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROXYCHLOROQUINE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nTo examine the efficacy and safety of interleukin-6 inhibition by tocilizumab (TCZ) in difficult- to-treat, real-world patients with systemic sclerosis (SSc).\n\n\nMETHODS\nTwenty-one patients (20 women; 16 diffuse cutaneous SSc; mean age: 52 ± 10 yrs; 10 with early disease [< 5 yrs]; and 11... | [
{
"companynumb": "GR-ROCHE-3099688",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "3",
... |
{
"abstract": "Checkpoint blockade inhibitors have revolutionized the treatment of metastatic melanoma. Despite the success of these agents in improving the overall survival of patients with metastatic melanoma, not all patients achieve clinical benefit, leaving room for improvement. The presence of cutaneous metasta... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2017SP006186",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IMIQUIMOD"
},
"drugadditional":... |
{
"abstract": "BACKGROUND\nCondyloma acuminatum (CA) is a common sexually transmitted disease associated with human papilloma virus (HPV). CA occurring in the urethra is rare and has not been reported in male renal transplant recipients. In addition, despite immunosuppressive conditions and increased risk of HPV-rela... | [
{
"companynumb": "JP-ACCORD-090664",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "Drug-related toxicities represent an important clinical concern in chemotherapy, genetic variants could help tailoring treatment to patient. A pharmacogenetic multicentric study was performed on 508 pediatric acute lymphoblastic leukemia patients treated with AIEOP-BFM 2000 protocol: 28 variants were g... | [
{
"companynumb": "IT-JNJFOC-20170321730",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional": "... |
{
"abstract": "Urea cycle disorders (UCD) are rare diseases that usually affect neonates or young children. During decompensations, hyperammonemia is neurotoxic, leading to severe symptoms and even coma and death if not treated rapidly. The aim was to describe a cohort of patients with adult onset of UCDs in a multic... | [
{
"companynumb": "FR-AUROBINDO-AUR-APL-2022-000565",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VALPROIC ACID"
},
"drugadditional": "3... |
{
"abstract": "Reducing drug burden is a key challenge for achieving lifelong suppressive HIV therapy. Dolutegravir, with a high potency, long half-life and high genetic barrier, offers potential for monotherapy.\n\n\n\nThis observational single-centre study enrolled all patients with HIV RNA (viral load) <50 copies/... | [
{
"companynumb": "FR-VIIV HEALTHCARE LIMITED-FR2019GSK223345",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DOLUTEGRAVIR"
},
"drugadditi... |
{
"abstract": "Extremely low birth weight (ELBW) infants weighing less than 1 kilogram are at a high-risk for delayed patent ductus arteriosus (PDA) closure. Percutaneous PDA closure offers a less invasive approach when compared with surgical PDA closure, which may provide faster recovery times and less transfusion r... | [
{
"companynumb": "US-TEVA-2021-US-1993064",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "INDOMETHACIN"
},
"drugadditional": "3",
... |
{
"abstract": "We describe a case of late onset Morganella morganii sepsis in an extremely low birth weight male neonate born at 23 and 4/7 weeks gestational age to a 30-year-old primigravid mother due to preterm labor. The mother was otherwise healthy with an unremarkable prenatal course. She received steroids and a... | [
{
"companynumb": "US-LUPIN PHARMACEUTICALS INC.-2022-00001",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "AZITHROMYCIN"
},
"drugaddition... |
{
"abstract": "Azacitidine is the first-line therapeutic option for myelodysplastic syndrome (MDS). This report describes a case of MDS in a patient who developed fatal acute interstitial pneumonitis (AIP) after the first seven-day course of intravenous azacitidine (75 mg/m(2)/day) treatment. A review of previous and... | [
{
"companynumb": "JP-CELGENEUS-087-50794-14081092",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "AZACITIDINE"
},
"drugadditional": null... |
{
"abstract": "We report a rapidly progressive and fatal CD8 T-cell-mediated cerebellitis after ipilimumab (cytotoxic T-lymphocyte-associated protein 4 inhibitor) for small cell lung cancer. Clinical features and histopathology were consistent with an accelerated form of paraneoplastic cerebellar degeneration. A patc... | [
{
"companynumb": "GB-PFIZER INC-202200560114",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE SODIUM SUCCINATE"
},
"dru... |
{
"abstract": "OBJECTIVE\nThis article provides practical guidance on successful management of women with multiple sclerosis (MS) through pregnancy and the postpartum period.\n\n\nRESULTS\nRecent studies indicate that most women diagnosed with MS today can have children, breast-feed, and resume beta interferons or gl... | [
{
"companynumb": "NVSC2020US027792",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": "3",
... |
{
"abstract": "Seronegative myasthenia gravis (MG) is a generalized form of MG that is diagnosed on the basis of clinical symptoms, electrophysiological testing, and pharmacological responses, in the absence of a seropositive status for anti-acetylcholine receptor (AChR) antibodies. Generalized MG that is seronegativ... | [
{
"companynumb": "JP-BAUSCH-BL-2018-022459",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "Herein we report a previously undescribed case of treatment-emergent non-structural protein 5A (NS5A) resistance mutations, Q30H and Y93C, leading to a failure of 24-week course of sofosbuvir/ledipasvir+ribavirin therapy for the treatment of hepatitis C virus (HCV) genotype 1a in interferon-experienced... | [
{
"companynumb": "IE-BAUSCH-BL-2016-019750",
"fulfillexpeditecriteria": "1",
"occurcountry": "IE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LANSOPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nThe application of systemic isotretinoin in the treatment of cutaneous photoaging has been well investigated. In addition, well-recognized topical antiaging therapies such as superficial chemical peeling (CP) with α-hydroxy acids have been shown to be more helpful when combined with low-dos... | [
{
"companynumb": "DE-SUN PHARMACEUTICAL INDUSTRIES LTD-2016R1-111536",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ISOTRETINOIN"
},
"dr... |
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