article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "OBJECTIVE\nTo investigate the association between tobacco smoking and disease activity, treatment adherence and treatment responses in patients with AS treated with their first tumour necrosis factor-alpha inhibitor (TNFi) therapy in routine care.\n\n\nMETHODS\nObservational cohort study based on the D... | [
{
"companynumb": "DK-JNJFOC-20160712077",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "GOLIMUMAB"
},
"drugadditional": null,
"... |
{
"abstract": ": This case report describes a patient with opioid use disorder who developed cardiac toxicity secondary to non-medical use of loperamide. At recommended doses, loperamide remains in the periphery to treat diarrhea. At high doses, loperamide causes central nervous system (CNS) opioid agonism. Complicat... | [
{
"companynumb": "US-JNJFOC-20181201825",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LOPERAMIDE HYDROCHLORIDE"
},
"drugadditional": "1... |
{
"abstract": "Cyclin-dependent kinase (CDK) 4/6 inhibitors represent a new class of targeted therapy options for the treatment of estrogen receptor-positive (ER+) human epidermal growth factor 2-negative (HER2-) metastatic breast cancer. There are currently no published prospective data on the safety of use of radia... | [
{
"companynumb": "US-PFIZER INC-2019142498",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PALBOCICLIB"
},
"drugadditional": "1",
... |
{
"abstract": "The USA is currently facing a serious opioid misuse epidemic that started with increased prescribing of oxycodone and the inclusion of pain as a fifth vital sign, and eventually resulted in massive overdose mortality. In Europe, including the Netherlands, the medical use of opioids (mainly oxycodone) h... | [
{
"companynumb": "NL-JNJFOC-20191027628",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MORPHINE"
},
"drugadditional": "3",
"dr... |
{
"abstract": "Mycobacterium haemophilum is a fastidious nontuberculosis Mycobacterium that must be considered in the differential diagnosis of infections in immunocompromised patients. Mycobacterium haemophilum typically is a pathogen of the cutaneous or subcutaneous tissue and also presents as septic arthritis, ost... | [
{
"companynumb": "IR-BAUSCH-BL-2018-036070",
"fulfillexpeditecriteria": "1",
"occurcountry": "IR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LOSARTAN"
},
"drugadditional": "3",
... |
{
"abstract": "Coronavirus disease 2019 (COVID-19), which began in China, caused a global pandemic. Few studies have shown the benefit of hydroxychloroquine (HY) ± azithromycin (AZ) for treating COVID-19. Concerns of QT prolongation and increased risks of torsade's de pointes (TdP) with this combination have been rai... | [
{
"companynumb": "US-NOVARTISPH-NVSC2021US280568",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROXYCHLOROQUINE SULFATE"
},
"drugaddi... |
{
"abstract": "BACKGROUND\nPneumomediastinum is a rare complication of COVID-19 pneumonia, which may or may not be associated with invasive ventilatory support. Therefore, the report and findings associated with its evolution can be of great contribution in the management of this unknown disease.\n\n\nMETHODS\nHere, ... | [
{
"companynumb": "BR-LUPIN PHARMACEUTICALS INC.-2021-20991",
"fulfillexpeditecriteria": "2",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "AZITHROMYCIN"
},
"drugaddition... |
{
"abstract": "Electron microscopy (EM), real-time polymerase chain reaction (PCR) and conventional PCR were used to identify viruses associated with infection in 2 transplantation patients. An autologous haematopoietic stem cell, liver and renal transplant recipient was found to be positive for simian virus 40 (SV40... | [
{
"companynumb": "PHHY2019IR228277",
"fulfillexpeditecriteria": "1",
"occurcountry": "IR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": "3",
... |
{
"abstract": "A 65 year old patient who was exposed to topical bovine thrombin during cardiac surgery developed markedly prolonged clotting times and a severe bleeding diathesis. Mixing studies with normal plasma failed to correct the clotting times. Platelet transfusions, immunosuppressive and immunomodulatory ther... | [
{
"companynumb": "US-PFIZER INC-2019005504",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "THROMBIN"
},
"drugadditional": "3",
... |
{
"abstract": "Therapy-related myeloid neoplasms (tMN) are serious late effects of the treatment of cancer with poor response to conventional treatment. Azacitidine (AZA) has been used to treat patients with tMN but current data are retrospective. We present here 47 tMN patients prospectively enrolled as a specific c... | [
{
"companynumb": "US-CELGENE-USA-2015121861",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ENTINOSTAT"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nCalciphylaxis in a nondialysis patient is a rare condition and is characterized by calcific deposition in tissue. We present a case of calciphylaxis in a nondialysis patient who was diagnosed by clinical presentation and skin biopsy and was treated with sodium thiosulfate with improvement o... | [
{
"companynumb": "US-ZYDUS-018957",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "3",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
"druga... |
{
"abstract": "OBJECTIVE\nMethotrexate (MTX) is the first-line disease-modifying antirheumatic drug in rheumatoid arthritis (RA). However, this anchor may cause some side effects that may range from nausea to mortality. The clinical features of MTX toxicity are under-researched. In this study, we aimed to find out th... | [
{
"companynumb": "TR-ACCORD-071721",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "OMEPRAZOLE"
},
"drugadditional": null,
"dru... |
{
"abstract": "Babesiosis is a tick-borne infectious disease, caused by an intraerythrocytic parasite of the genus Babesia. It has clinical, biological and microbiological similarities with Plasmodium related infections. In rare cases, babesiosis may be complicated by hemophagocytic lymphohistiocytosis, which occurs ... | [
{
"companynumb": "FR-NOVARTISPH-NVSC2021FR280451",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AZITHROMYCIN"
},
"drugadditional": "3",
... |
{
"abstract": "An outbreak of anticonvulsant intoxication occurred in epileptic patients in Australia during 1968-9. All affected patients studied in Brisbane were taking one brand of phenytoin. In 87% of them the blood phenytoin levels were above the therapeutic range. Reduction of phenytoin dosage relieved the into... | [
{
"companynumb": "AU-PFIZER INC-2018370952",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "PHENYTOIN SODIUM"
},
"drugadditional": "1",
... |
{
"abstract": "Non-steroidal anti-inflammatory drugs (NSAIDs) constitute a family of drugs, which taken as a group, represents one of the most frequently prescribed around the world. Thus, not surprisingly NSAIDs, along with anti-infectious agents, list on the top for causes of Drug-Induced Liver Injury (DILI). The i... | [
{
"companynumb": "AR-PFIZER INC-2016088802",
"fulfillexpeditecriteria": "1",
"occurcountry": "AR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PIROXICAM"
},
"drugadditional": null,
... |
{
"abstract": "We carried out the first matched retrospective cohort study aimed at studying the safety and efficacy of extracorporeal photopheresis (ECP) for bronchiolitis obliterans syndrome (BOS) after allogeneic hematopoietic cell transplantation (HCT). Medical records of 1325 consecutive adult patients who under... | [
{
"companynumb": "US-MALLINCKRODT-T201802256",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "METHOXSALEN"
},
"drugadditional": null,
... |
{
"abstract": "We compared the effects on lower urinary tract symptoms and bladder outlet obstruction of combination therapy with α1-blocker and 5α-reductase inhibitor or a switch to 5α-reductase inhibitor monotherapy. We determined the factors influencing changes in lower urinary tract symptoms after α1-blocker with... | [
{
"companynumb": "JP-STRIDES ARCOLAB LIMITED-2018SP001097",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "SILODOSIN"
},
"drugadditional"... |
{
"abstract": "Majocchi granuloma (MG) is a rare dermal and subcutaneous fungal infection. We report a rare case of MG on the face of a six-year-old child caused by Trichophyton mentagrophytes after long term use of topical corticosteroids and other inadequate topical medications. He was treated with griseofulvin 25 ... | [
{
"companynumb": "BR-LEO PHARMA-316800",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MOMETASONE FUROATE"
},
"drugadditional": "3",
... |
{
"abstract": "Mycobacterium paraffinicum has been newly recognized as a species. A case of symptomatic pulmonary infection caused by M. paraffinicum is described, and as far as we know, this is the first case of the organism as a human pathogen.",
"affiliations": "Department of Medicine, Emory University, Atlanta,... | [
{
"companynumb": "US-LUPIN PHARMACEUTICALS INC.-2014-01561",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AZITHROMYCIN ANHYDROUS"
},
"dr... |
{
"abstract": "BACKGROUND\nThere have been few reports of hepatitis C virus (HCV) treatment results with interferon-based regimens in indigenous populations.\n\n\nOBJECTIVE\nTo determine interferon-based treatment outcome among Alaska Native and American Indian (AN/AI) population.\n\n\nMETHODS\nIn an outcomes study o... | [
{
"companynumb": "US-ROCHE-1902353",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TELAPREVIR"
},
"drugadditional": null,
"drug... |
{
"abstract": "Most published cases of cytomegalovirus infection in pregnancy relate to congenital abnormalities in neonates infected in early pregnancy, while the mother remains asymptomatic. We describe a diagnostically challenging case of an immunosuppressed woman with scleroderma who developed deranged liver func... | [
{
"companynumb": "GB-CONCORDIA PHARMACEUTICALS INC.-E2B_00007857",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"... |
{
"abstract": "Choreoathetoid movements are quite common in cerebral palsy (CP). This is the first report of a patient with choreoathetoid CP who was successfully treated with carbamazepine. Therefore, clinicians should try carbamazepine for involuntary movements in CP patients before pursuing other procudures.",
"... | [
{
"companynumb": "US-UCBSA-2016012048",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CARBAMAZEPINE"
},
"drugadditional": null,
... |
{
"abstract": "A Fracture Liaison Service (FLS) was set up at Lille University Hospital in 2016. The purpose of this study was to assess persistence with osteoporosis treatment in patients from the FLS over a period of 1 year, and to determine predictors of discontinuation.\n\n\n\nThe study population comprised adult... | [
{
"companynumb": "FR-AMGEN-FRASP2021078121",
"fulfillexpeditecriteria": "2",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ERGOCALCIFEROL"
},
"drugadditional": null,
... |
{
"abstract": "Basal ganglia lesions showing an expansile high signal intensity on T2-weighted MRI are termed the lentiform fork sign. This specific finding is mainly observed in diabetic patients with uremic encephalopathy with metabolic acidosis, although there are also reports in patients with ketoacidosis, dialys... | [
{
"companynumb": "JP-MACLEODS PHARMACEUTICALS US LTD-MAC2021033722",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
... |
{
"abstract": "A prospective, randomised controlled trial compared the effects of two medications intended to reduce blood loss from total knee arthroplasty. Patients were randomised to one of the following three treatment groups: 10mg/kg tranexamic acid at given at induction of anaesthesia, 10 ml of fibrin spray adm... | [
{
"companynumb": "GB-JNJFOC-20190502740",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FIBRINOGEN HUMAN\\THROMBIN HUMAN"
},
"drugadditio... |
{
"abstract": "BACKGROUND\nDifferentiation syndrome (DS) is a life-threatening complication that may be seen in patients with acute promyelocytic leukaemia undergoing induction therapy with all-trans retinoic acid or arsenic trioxide. It can lead to severe inflammatory response syndrome and shock if adequate measures... | [
{
"companynumb": "IN-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-299158",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"d... |
{
"abstract": "OBJECTIVE\nThe aims of the present study, conducted in two regions of Italy, Calabria and Piedmont, were to assess the use of inappropriate drugs according to the Beers Criteria and to study the possible drug-drug interactions.\n\n\nMETHODS\nData were obtained retrospectively from 972 residential care ... | [
{
"companynumb": "IT-MYLANLABS-2021M1052537",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DIAZEPAM"
},
"drugadditional": "3",
... |
{
"abstract": "The paper describes three case reports of changes in sexual behavior patterns in male patients who use stimulants (amphetamine and mephedrone). Two of them demonstrate that the consumption of stimulants may lead to hypersexuality and excessive masturbation. Case report three shows that mephedrone use r... | [
{
"companynumb": "RU-BION-008786",
"fulfillexpeditecriteria": "1",
"occurcountry": "RU",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "AMPHETAMINE SULFATE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nIn resource-constrained settings where biologic agents are not widely available, there are limited therapeutic options for patients with rheumatoid arthritis (RA) refractory to other synthetic disease modifying antirheumatic (DMARD) therapies. The aim of this study is to evaluate the effect... | [
{
"companynumb": "ZA-ACCORD-045224",
"fulfillexpeditecriteria": "1",
"occurcountry": "ZA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEFLUNOMIDE"
},
"drugadditional": null,
"dru... |
{
"abstract": "BACKGROUND\nHereditary angioedema (HAE) is an autosomal dominant hereditary disorder characterized by episodic swelling of many body regions (especially throat and abdomen), potentially triggered by medication. No data are available for HAE in patients with cancer assigned to standard chemotherapy. The... | [
{
"companynumb": "IT-FRESENIUS KABI-FK201601777",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FLUOROURACIL"
},
"drugadditional": null,... |
{
"abstract": "One of the side-effects of ketamine abuse is genito-urinary damage. This report describes a case of a former ketamine user who presented with urinary symptoms associated with ketamine years after stopping consumption. This was a 26-year-old male with a history of ketamine abuse. He started treatment fo... | [
{
"companynumb": "ES-ENDO PHARMACEUTICALS INC-2017-005364",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "KETAMINE HYDROCHLORIDE"
},
"dru... |
{
"abstract": "We report a case of an 11-year-old female with Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) overlap, most likely triggered by sulfamethoxazole-trimethoprim, who was treated with the combination of methylprednisolone, cyclosporine, and etanercept. Her condition stabilized and her skin... | [
{
"companynumb": "CA-TEVA-2019-CA-1004341",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM"
},
"drugadditio... |
{
"abstract": "Background Available outcomes data for anticoagulation therapy in adults with congenital heart disease ( CHD ) provide assessment of global risk of this therapy for CHD patients (a heterogeneous population), but the risk of complications for the different CHD diagnoses is unknown. The purpose of the st... | [
{
"companynumb": "US-TEVA-2020-US-1815207",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "WARFARIN"
},
"drugadditional": "3",
"... |
{
"abstract": "Although previously associated with secondary adrenal insufficiency and other autoimmune diseases, eosinophilic esophagitis has not been described in patients with primary adrenal insufficiency. In this case series, we describe three patients with eosinophilic esophagitis and primary adrenal insufficie... | [
{
"companynumb": "US-TEVA-2021-US-1935977",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROCORTISONE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nCutaneous metastases occur in 0.6-10.4% of all patients with underlying malignancy. Among them, the site of origin remains unknown in 4.4-14.5% of all cases.\n\n\nMETHODS\nThe authors describe a 68-year-old man with widespread skin and soft tissue metastases appearing as the first and domin... | [
{
"companynumb": "SK-SUN PHARMACEUTICAL INDUSTRIES LTD-2018RR-172194",
"fulfillexpeditecriteria": "1",
"occurcountry": "SK",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GEMCITABINE\\GEMCITABINE HYDROCHLORIDE"
... |
{
"abstract": "Severe hepatotoxicity in people with human immunodeficiency virus (HIV) receiving efavirenz (EFV) has been reported. We assessed the incidence and risk factors of hepatotoxicity in women of childbearing age initiating EFV-containing regimens.\n\n\n\nIn the Promoting Maternal and Infant Survival Everywh... | [
{
"companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-050670",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "EFAVIRENZ"
},
"drugaddi... |
{
"abstract": "Intra-arterial chemotherapy (IAC), delivered directly to the globe via the internal carotid artery is now an established treatment for retinoblastoma. We report a case of anterior segment ischaemia following treatment with multiple intra-arterial chemotherapy (IAC) infusions.\nA 5 month old female pres... | [
{
"companynumb": "GB-FRESENIUS KABI-FK202003389",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "TOPOTECAN HYDROCHLORIDE"
},
"drugadditio... |
{
"abstract": "We sought to evaluate the use of propofol (2,6-diisopropylphenol) for ED procedural sedation, particularly when administered in a routine fashion for a variety of indications.\n\n\nMETHODS\nThis was a prospective observational study conducted in an urban teaching ED. Propofol was administered by handhe... | [
{
"companynumb": "US-PFIZER INC-2019342332",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MORPHINE SULFATE"
},
"drugadditional": "3",
... |
{
"abstract": "Massachusetts state agencies received reports of 37 adverse events (AEs) involving cataract surgery from 2011 to 2015. Fifteen were anesthesia related, including 5 wrong eye blocks, 3 cases of hemodynamic instability, 2 retrobulbar hematoma/hemorrhages, and 5 globe perforations resulting in permanent l... | [
{
"companynumb": "US-PFIZER INC-2018424628",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FENTANYL CITRATE"
},
"drugadditional": null,
... |
{
"abstract": "Lipoprotein(a) [Lp(a)] is acknowledged to be an independent atherothrombotic risk factor. Although genetic studies have highlighted the causal relationship between coronary disease and Lp(a), it is uncertain which strategies maximize the therapeutic benefit of patients with high Lp(a) levels. We report... | [
{
"companynumb": "RU-LUPIN PHARMACEUTICALS INC.-2016-00069",
"fulfillexpeditecriteria": "2",
"occurcountry": "RU",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CLOPIDOGREL BISULFATE"
},
"dr... |
{
"abstract": "Cytomegalovirus (CMV) is the most common viral infection affecting the posttransplantation course of organ recipients. However, CMV involvement of the prostate even in immunocompromised hosts is rare. We describe the first case in the heart transplant literature of a 59-year-old heart recipient with CM... | [
{
"companynumb": "US-ROCHE-1920709",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "3",
"druga... |
{
"abstract": "OBJECTIVE\nThe purpose of this study was to understand patient treatment patterns, outcomes, and healthcare resource use in cases of metastatic and/or locally recurrent, unresectable gastric cancer (MGC) in South Korea.\n\n\nMETHODS\nThirty physicians reviewed charts of eligible patients to collect de-... | [
{
"companynumb": "US-ROCHE-1973221",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUOROURACIL"
},
"drugadditional": "3",
"dru... |
{
"abstract": "Diabetic ulcers are at risk of becoming chronic and infected, as diabetics have hampered vascular structures, limiting oxygen and nutrient supply. These wounds can lead to pain, malodor, functional problems, and amputation. The current rise in antibiotic resistance demands for complementary therapies. ... | [
{
"companynumb": "MY-B.BRAUN MEDICAL INC.-2107718",
"fulfillexpeditecriteria": "1",
"occurcountry": "MY",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"drugadditional": nu... |
{
"abstract": "Even though no increased recurrence rate seems to be reported in patients with brain tumors receiving recombinant human growth hormone (rhGH) replacement, in some patients multiple risk factors could put at higher risk for recurrence. In such cases, the decision to start rhGH therapy should be very cau... | [
{
"companynumb": "IT-ROCHE-1685555",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "SOMATROPIN"
},
"drugadditional": null,
"dru... |
{
"abstract": "A 63-year-old woman on flecainide, furosemide, and triamterene-hydrochlorothiazide presented with weakness and diarrhoea. She had profound hyponatraemia, hypokalaemia and a pre-renal acute kidney injury (AKI). Her ECG showed a regular wide complex tachycardia concerning for monomorphic ventricular tach... | [
{
"companynumb": "US-TEVA-2021-US-1869968",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DILTIAZEM"
},
"drugadditional": null,
... |
{
"abstract": "We present a case of neuroleptic malignant syndrome (NMS) in a 46-year-old white female from a state psychiatric hospital who also tested positive for coronavirus-2019 (COVID-19) (severe acute respiratory syndrome coronavirus, SARS-CoV-2) infection after re-introduction of her home antipsychotics medic... | [
{
"companynumb": "US-ACCORD-222361",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ESCITALOPRAM OXALATE"
},
"drugadditional": null,
... |
{
"abstract": "The objective was to summarize pregnancy and fetal/postnatal outcomes following maternal perampanel exposure using preclinical and clinical data, and to use physiologically based pharmacokinetic (PBPK) modeling to improve understanding of perampanel pharmacokinetics (PK) during pregnancy.\n\n\n\nPrecli... | [
{
"companynumb": "US-UCBSA-2021012783",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nStatins have recently been reported to cause a rare autoimmune inflammatory and/or necrotic myopathy that begins or persists after drug cessation.\n\n\nMETHODS\nWe report on 26 patients seen at a neuromuscular centre between 2005 and 2011 who demonstrated muscle weakness/myalgias and creati... | [
{
"companynumb": "US-MYLANLABS-2015M1039676",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ATORVASTATIN"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo investigate the clinical characteristics of intraocular lymphoma and to evaluate two protocols of intravitreal methotrexate injection.\n\n\nMETHODS\nA retrospective chart review was conducted of newly-diagnosed intraocular lymphoma patients between January 2013 and January 2018 at Nationa... | [
{
"companynumb": "TW-PFIZER INC-202200044680",
"fulfillexpeditecriteria": "1",
"occurcountry": "TW",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": "3",
... |
{
"abstract": "A 57-year-old woman presented with swelling and thickening of the skin of the lower extremities. Three months prior to presentation, patient had MRI with gadolinium as part of an evaluation for suspected pancreatic malignancy. Creatinine levels at the time of gadolinium exposure were 0.9-1.2 mg/dL, wit... | [
{
"companynumb": "US-BRACCO-2017US04685",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "GADOBENATE DIMEGLUMINE"
},
"drugadditional": null... |
{
"abstract": "BACKGROUND\nAlthough several consolidation strategies to prolong treatment-free survival (TFS) in chronic lymphocytic leukaemia have been investigated, most have proven either ineffective or toxic. Ofatumumab is a human type I anti-CD20 antibody approved by the US Food and Drug Administration as mainte... | [
{
"companynumb": "US-PFIZER INC-2018115350",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "OFATUMUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Lamotrigine is an important anticonvulsant drug. Its use, however, has been limited by the risk of potentially life-threatening dermatological reactions, such as a drug reaction with eosinophilia and systemic symptoms (DRESS). Here, we report the case of a 7-year-6-month-old girl with a history of epil... | [
{
"companynumb": "TW-GLAXOSMITHKLINE-TW2021GSK265991",
"fulfillexpeditecriteria": "1",
"occurcountry": "TW",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LAMOTRIGINE"
},
"drugadditional": "1... |
{
"abstract": "We report a very high factor V inhibitor affecting the measurement of all coagulation factors besides fibrinogen, all these factors being dramatically decreased. This inhibitor could be linked to antibiotic use. The patient died of massive hemorrhage before a plasma exchange could be initiated.",
"af... | [
{
"companynumb": "FR-PFIZER INC-2019238946",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CLINDAMYCIN HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "OBJECTIVE\nTo investigate the clinical and macular spectral-domain optical coherence tomography (SD-OCT) findings after intravitreal ranibizumab treatment for type 1 retinopathy of prematurity (ROP).\n\n\nMETHODS\nEighteen eyes of 10 premature infants with type 1 ROP were retrospectively studied. All e... | [
{
"companynumb": "TR-ROCHE-1684161",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "RANIBIZUMAB"
},
"drugadditional": null,
"dr... |
{
"abstract": "There have been increasing reports of food-borne zoonotic transmission of hepatitis E virus (HEV) genotype 3, which causes chronic infections in immunosuppressed patients. We performed phylogenetic analyses of the HEV sequence (partial and full-length) from 1 patient from the Middle East who underwent ... | [
{
"companynumb": "SG-CONCORDIA PHARMACEUTICALS INC.-GSH201808-003118",
"fulfillexpeditecriteria": "1",
"occurcountry": "SG",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "EZETIMIBE"
},
"druga... |
{
"abstract": "Tissue plasminogen activator (t-PA) is an effective therapy for acute ischemic stroke, but some patients still have poor clinical outcome. In this study, we investigated clinical characteristics of stroke patients and determined predictors for poor clinical outcome in response to t-PA treatment.\n\n\n\... | [
{
"companynumb": "CN-ROCHE-2515638",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "We report a 21-year-old young male with Lemierre's syndrome presented as tonsillitis and Fusobacterium septicemia with respiratory failure and required intensive care. Lemierre's syndrome is the septic embolic complication of recent pharyngeal illness. Fusobacterium spp. accounts for the majority of ca... | [
{
"companynumb": "HK-ALKEM LABORATORIES LIMITED-HK-ALKEM-2018-01699",
"fulfillexpeditecriteria": "2",
"occurcountry": "HK",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CEFUROXIME AXETIL"
},
... |
{
"abstract": "OBJECTIVE\nTo study the efficacy and incidence of treatment-related side effects of mycophenolate mofetil (MMF) therapy in patients with noninfectious inflammatory eye diseases.\n\n\nMETHODS\nRetrospective cohort study of 27 Chilean patients treated for noninfectious inflammatory eye diseases using MMF... | [
{
"companynumb": "CL-JUBILANT CADISTA PHARMACEUTICALS-2016JUB00073",
"fulfillexpeditecriteria": "1",
"occurcountry": "CL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
... |
{
"abstract": "Use of an anticoagulant after transcatheter aortic valve replacement (TAVR) has been increasing in practice after noted leaflet thrombosis on dual antiplatelet therapy. As the use of anticoagulation increases so does the number of poor warfarin candidates or warfarin intolerant patients. While direct o... | [
{
"companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2020-023546",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "WARFARIN SODIUM"
},
"dr... |
{
"abstract": "Disulfiram has been widely used for over six decades in the treatment of alcohol dependence, as an aversive therapeutic agent. Despite having very few side effects when taken without concurrent alcohol consumption, some of these may underlie serious clinical complications. Epileptic seizure induction i... | [
{
"companynumb": "PT-ENDO PHARMACEUTICALS INC-2021-002571",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "OXAZEPAM"
},
"drugadditional":... |
{
"abstract": "OBJECTIVE\nPrimary: to investigate Italian rheumatology practice regarding latent tubercular infection (LTBI) detection and tuberculosis (TB) prevention in patients requiring anti-tumor necrosis factor (anti-TNF) therapy. Secondary: to assess the overall number of TB cases over 10 years and their distr... | [
{
"companynumb": "IT-UCBSA-2016038735",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CERTOLIZUMAB PEGOL"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nOral mucositis is a common complication of cancer therapy. Animal models suggest that curcumin may prevent oral mucositis. To date, no clinical studies have been reported.\n\n\nOBJECTIVE\nThe primary aim of this pilot study was to assess the tolerability of a curcumin mouthwash. The seconda... | [
{
"companynumb": "US-JNJFOC-20130603072",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"drugadditional": null,
... |
{
"abstract": "Hepatitis C (HCV) remains the single most common etiology of end-stage liver disease leading to simultaneous liver/kidney transplant (SLKT) and has worse post-transplant survival compared to non-HCV patients. We aim to assess the effectiveness and tolerance of the all-oral direct-acting antiviral (DAA)... | [
{
"companynumb": "US-BAUSCH-BL-2018-011294",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "RIBAVIRIN"
},
"drugadditional": null,
... |
{
"abstract": "HIV-associated lymphomas (HALs) have high rates of latent infection by gammaherpesviruses (GHVs). We hypothesized that proteasome inhibition would induce lytic activation of GHVs and inhibit HIV infectivity via preservation of cytidine deaminase APOBEC3G, improving lymphoma control. We tested this onco... | [
{
"companynumb": "US-TAKEDA-2019MPI000099",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": "3",
... |
{
"abstract": "We conducted a phase I-II study of transplantation conditioning with clofarabine-melphalan-alemtuzumab for patients with advanced hematologic malignancies. Ten patients were accrued to the phase I portion, which utilized an accelerated titration design. No dose-limiting toxicity was observed, and clofa... | [
{
"companynumb": "US-SA-2014SA124582",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "MELPHALAN"
},
"drugadditional": null,
"dr... |
{
"abstract": "The purpose of this study is to describe the effects and complications of photodynamic therapy (PDT) on Chinese patients with circumscribed choroidal hemangioma (CCH). In this retrospective study, 22 CCH patients who underwent PDT performed 15 min after the injection of intravenous verteporfin (6 mg/m2... | [
{
"companynumb": "CN-BAUSCH-BL-2018-035642",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VERTEPORFIN"
},
"drugadditional": "3",
... |
{
"abstract": "Although prognosis in patients with localized osteosarcoma has been dramatically improved by the introduction of multiple chemotherapy agents known as combination chemotherapy, there is growing concern about the development of secondary malignant neoplasms. We report the case of a 13-year-old girl in w... | [
{
"companynumb": "JP-FRESENIUS KABI-FK201706053",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,... |
{
"abstract": "BACKGROUND\nAlthough FOLFIRINOX (5-Fluorouracil + leucovorin + irinotecan + oxaliplatin) is now the standard of care for patients (pts) with metastatic pancreatic cancer (PC) based on the 2011 study by Conroy et al. which demonstrated improved median overall survival (mOS), pts > 75 yrs old were exclud... | [
{
"companynumb": "NVSC2020US207587",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": "3",
"drug... |
{
"abstract": "It has been hypothesized that silent hypoxemia is the cause of rapid progressive respiratory failure with severe hypoxia that occurs in some COVID-19 patients without warning.\nA 60-year-old male presented cough without any breathing difficulty. Vital signs showed blood pressure 130/75 mmHg, pulse 84x/... | [
{
"companynumb": "ID-PFIZER INC-2021841902",
"fulfillexpeditecriteria": "1",
"occurcountry": "ID",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "AZITHROMYCIN ANHYDROUS"
},
"drugadditional": n... |
{
"abstract": "RET rearrangements are observed in 1-2% of non-small-cell lung cancer (NSCLC) patients and result in the constitutive activation of downstream pathways normally implied in cell proliferation, growth, differentiation and survival. In NSCLC patients, RET rearrangements have been associated with a history... | [
{
"companynumb": "PT-Accord-256636",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": null,
"dru... |
{
"abstract": "A 42-year-old man with a history of childhood asthma presented with a 2-week history of watery diarrhoea and marked peripheral eosinophilia in the setting of recent use of cephalexin. His colonoscopy revealed patchy colitis. Biopsies were consistent with eosinophilic colitis. Two months later he receiv... | [
{
"companynumb": "AU-ALKEM-001075",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CEPHALEXIN"
},
"drugadditional": null,
"druga... |
{
"abstract": "Double-expressor diffuse large B-cell lymphoma (DLBCL) with 17p deletion is an aggressive and refractory disease. Immune checkpoint blockade and epigenetic drugs have been widely used, but the efficacy of different combined applications varied. We report a case with \"double-expressor\" DLBCL treated w... | [
{
"companynumb": "CN-ROCHE-2993827",
"fulfillexpeditecriteria": "1",
"occurcountry": null,
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "DRESS syndrome (drug reaction with eosinophilia and systemic symptoms) is an adverse life-threatening drug reaction characterized by a polymorphous rash associated with fever, lymphadenopathy and multiorgan involvement with eosinophilia. We present the case of an immunocompetent man with DRESS syndrome... | [
{
"companynumb": "ES-MYLANLABS-2017M1003872",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CARBAMAZEPINE"
},
"drugadditional": "1",
... |
{
"abstract": "A 69-year-old man complained of abdominal pain and appetite loss. Advanced gastric cancer with bilateral adrenal metastases( stage Ⅳ)was revealed via an examination. XP(cisplatin and capecitabine)chemotherapy was administered. As a result, the tumor was reduced prominently, and his symptoms disappeared... | [
{
"companynumb": "JP-ROCHE-1613781",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CAPECITABINE"
},
"drugadditional": null,
"d... |
{
"abstract": "Phendimetrazine is an anorectic agent which recently has been detected in three medical examiner's cases. In one instance death was attributed to this drug. Methods of detecting and identifying this drug in urine and blood are discussed. In the one instance where death was attributed to this substance,... | [
{
"companynumb": "US-BAUSCH-BL-2017-023014",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PHENDIMETRAZINE TARTRATE"
},
"drugadditional":... |
{
"abstract": "Anthracyclines have cardiotoxic side effects. Cardioprotective drugs such as angiotensin-converting enzyme inhibitors and beta-blockers are therefore recommended for patients with anthracycline-induced cardiomyopathy. We herein present a 54-year-old woman with recurrent metastatic breast cancer who dev... | [
{
"companynumb": "JP-TEVA-2021-JP-1906980",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "3",
"activesubstance": {
"activesubstancename": "CARVEDILOL"
},
"drugadditional": null,
... |
{
"abstract": "This case report focuses on an elderly gentleman with extensive stage small cell lung cancer (SCLC) who experienced episodes of bowel obstruction shortly after commencing first-line chemotherapy with cisplatin and etoposide. The patient had no radiological or pathological evidence of intra-abdominal ca... | [
{
"companynumb": "GB-PFIZER INC-1620535",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nAutoimmune polyglandular syndrome type 1 (APS 1) is an autosomal recessive disorder characterized by immune injury of multiple organ systems (primarily endocrine) secondary to a mutation in the autoimmune regulator (AIRE) gene. In some cases, patients develop tubulointerstitial nephritis (T... | [
{
"companynumb": "US-ASTELLAS-2016US028249",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": n... |
{
"abstract": "OBJECTIVE\nRefractory status epilepticus (RSE) is a life-threatening emergency, demonstrating, by definition, significant pharmacoresistance. We describe five cases of pediatric RSE treated with mild hypothermia.\n\n\nMETHODS\nRetrospective chart review was performed of records of children who received... | [
{
"companynumb": "US-JNJFOC-20130915208",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PROPOFOL"
},
"drugadditional": null,
"d... |
{
"abstract": "Job's syndrome or hyperimmunoglobulin E syndrome (HIES) is a rare primary immunodeficiency. Characterized by recurrent pulmonary and skin infections with elevated IgE serum level, this syndrome has been considered a risk factor for lymphoma. Although the majority of cases were diagnosed in childhood, t... | [
{
"companynumb": "ID-ROCHE-2663342",
"fulfillexpeditecriteria": "1",
"occurcountry": "ID",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": null,
"druga... |
{
"abstract": "BACKGROUND\nThe hearts of amphetamine and cocaine users demonstrate essentially the same microscopic features: hypertrophy, interstitial fibrosis, myocyte hypertrophy and intimal and medial hyperplasia. According to Karch (2016), some investigations suggest that amphetamines have properties that make u... | [
{
"companynumb": "DE-ALKEM LABORATORIES LIMITED-DE-ALKEM-2021-07604",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "AMPHETAMINE SULFATE"
},
... |
{
"abstract": "Ten patients with Stage II (four) and Stage IV (six) breast cancer were enrolled in a trial of conventional-dose induction therapy followed by high-dose therapy with autologous bone marrow support. Cyclophosphamide, methotrexate, and 5-fluorouracil were given to best response or five courses (Stage II)... | [
{
"companynumb": "US-PFIZER INC-2021101679",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "Topiramate (TOPAMAX®) is an anti-epileptic drug for which acute toxicity is infrequently reported. We present the case report of a five-year-old, otherwise healthy boy who presented to the emergency department (ED) for symptoms of acute encephalopathy. He was lethargic, having slurred speech, hallucina... | [
{
"companynumb": "US-ACCORD-223722",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TOPIRAMATE"
},
"drugadditional": "3",
"druga... |
{
"abstract": "Gaucher disease (GD) may worsen during pregnancy, leading to the discussion of continuing treatment during pregnancy. We examined fetal outcomes of pregnancies reported in the Gaucher Outcome Survey, an international GD-specific registry established in 2010. A total of 453 pregnancies were reported. Mo... | [
{
"companynumb": "US-SA-2017SA269244",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IMIGLUCERASE"
},
"drugadditional": "3",
"d... |
{
"abstract": "A 27 year old female with a complex history of congenital heart disease, cardiac surgery, heart failure, and arrhythmias was admitted for a Pseudomonas aeruginosa sternal wound infection and treated with intravenous antibiotics. After discharge and completion of an outpatient course of intravenous anti... | [
{
"companynumb": "US-RANBAXY-2013US-74864",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "CIPROFLOXACIN"
},
"drugadditional": null,
... |
{
"abstract": "X-linked inhibitor of apoptosis (XIAP) is the most potent human inhibitor of apoptosis, and is also involved in NOD2-dependent NFκB and MAPK signalling cascade activation. The absence or defective function of XIAP leads to the development of a rare and severe primary immunodeficiency known as X-linked ... | [
{
"companynumb": "NVSC2020CZ186353",
"fulfillexpeditecriteria": "1",
"occurcountry": "CZ",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nThe hormonal management of patients with androgen insensitivity can be challenging.\n\n\nMETHODS\nAn illustrative case is presented of a newborn with ambiguous genitalia who was raised female. She was diagnosed as 46,XY Disorder of Sexual Development with partial androgen insensitivity. To ... | [
{
"companynumb": "US-MYLANLABS-2015M1025757",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ETHINYL ESTRADIOL\\NORETHINDRONE"
},
"drugadd... |
{
"abstract": "Chronic subdural hematomas are a common neurosurgical presentation. They are difficult to treat, and current interventions - namely surgical evacuation - are not without complications or recurrences. Embolization of the middle meningeal artery is a promising new treatment option for this pathology. We ... | [
{
"companynumb": "US-BAYER-2020-009400",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": null,
"dr... |
{
"abstract": "Gastrointestinal mucormycosis is a rare infection in solid organ transplant recipients. Our patient, a 79-year-old male, presented with severe dysphagia and odynophagia about 2 weeks after receiving a renal transplant. An upper gastrointestinal (UGI) endoscopy revealed esophagitis and gastric ulceratio... | [
{
"companynumb": "KR-ACCORD-125251",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": null,
... |
{
"abstract": "Patients with severe diabetic acidosis may present varying electrocardiography (ECG) abnormalities including ST-segment elevation. The authors described a case of 70-year-old type 2 diabetic woman hospitalized due to ST elevation myocardial infarction and serious metabolic disorders. According to the c... | [
{
"companynumb": "PL-MYLANLABS-2019M1062765",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo study the effect of intravitreal (IVT) ranibizumab on the retinal arteriolar diameter in patients with neovascular age-related macular degeneration (AMD).\n\n\nMETHODS\nTen eyes of 10 patients with previously untreated neovascular AMD were included. All eyes had three monthly IVT injectio... | [
{
"companynumb": "CH-ROCHE-2208295",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BENOXINATE"
},
"drugadditional": "3",
"druga... |
{
"abstract": "Fungal endophthalmitis is a rare condition often associated with poor prognosis. We present a case of postoperative acute fungal endophthalmitis caused by the yeast-like fungus Stephanoascus ciferrii (Candida ciferrii). The fungus was resistant to fluconazole, voriconazole, and amphotericin B but susce... | [
{
"companynumb": "RO-ALVOGEN-2017-ALVOGEN-093368",
"fulfillexpeditecriteria": "1",
"occurcountry": "RO",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "FLUCONAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "The renal function is a key-issue in HIV/HCV co-infected patients, nevertheless, it has not established so far whether HCV treatment with new direct acting agents could impact on estimated glomerular filtration rate (eGFR) variations. In the present work, we examined the real-life data on renal functio... | [
{
"companynumb": "IT-AUROBINDO-AUR-APL-2018-023885",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RIBAVIRIN"
},
"drugadditional": "3",
... |
{
"abstract": "Sulfasalazine is a compound of 5-aminosalicylic acid (5-ASA) and sulfapyridine joined by an azo bond. It is a widely used drug in the treatment of chronic inflammatory bowel disease. Fatal toxicity of sulfasalazine arises from its effects on the bone marrow and the resulting blood dyscrasias. Pulmonary... | [
{
"companynumb": "IE-PFIZER INC-2016227578",
"fulfillexpeditecriteria": "1",
"occurcountry": "IE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SULFASALAZINE"
},
"drugadditional": null,
... |
{
"abstract": "Severe pulmonary arterial hypertension (PAH) rarely develops in children with an atrial septal defect (ASD), even those with a large defect. We herein report the case of a 27-year-old man with a moderate-sized secundum ASD and right ventricular failure due to severe PAH, which developed in his early te... | [
{
"companynumb": "JP-ACTELION-A-CH2018-165722",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "SILDENAFIL"
},
"drugadditional": null,
... |
{
"abstract": "A female patient (47 years) who suffered from a severe episode of a recurrent depression with psychotic symptoms (F33.3) firstly underwent several unsuccessful treatments. She was then submitted to a combined treatment with 2×300 mg/day extended-release venlafaxine (VEN) and lithium (0.7 mmol/l). She r... | [
{
"companynumb": "PL-BAUSCH-BL-2019-019456",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LITHIUM"
},
"drugadditional": "3",
"... |
{
"abstract": "Oral isotretinoin is a synthetic analog of vitamin - A, reserved for cases with severe resistant acne. We hereby report a case of drug-induced vasculitis (DV) from isotretinoin exposure leading to life-threatening pulmonary-renal syndrome requiring immunosuppression and plasmapheresis. A previously hea... | [
{
"companynumb": "US-MYLANLABS-2020M1005688",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ISOTRETINOIN"
},
"drugadditional": "3",
... |
{
"abstract": "Isolated cardiac lymphomas are very rare, especially in immunocompetent patients. As a consequence, little is known about the best therapeutic management and about patients' outcomes in these cases. Diffuse large B-cell lymphoma is the most frequent subtype; anthracycline-based chemotherapy has been th... | [
{
"companynumb": "IT-PFIZER INC-2016469607",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "Adverse drug reaction (ADR) reporting rates and high-quality data within case summary reports are crucial to detect emerging safety concerns and implement regulatory action. In this study we aimed to improve the data quality and reporting rates of ADR reports in Malta through a series of national activ... | [
{
"companynumb": "MT-LUPIN PHARMACEUTICALS INC.-2022-05273",
"fulfillexpeditecriteria": "2",
"occurcountry": "MT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "NORETHINDRONE"
},
"drugadditio... |
{
"abstract": "Glucocorticoid use during pregnancy is known to increase the risk of preterm birth and preterm premature rupture of membranes (pPROM). Here, we investigated the mechanism of how glucocorticoids weaken the fetal membranes. The amnion mesenchymal layer was significantly thinner in pregnant women treated ... | [
{
"companynumb": "JP-VISTAPHARM, INC.-VER202005-001063",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional":... |
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