article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "A 74-year-old man with advanced colon cancer was admitted to our hospital with jaundice and ascites. Four weeks before admission, he had started treatment with regorafenib because other chemotherapies had failed. Blood tests showed a characteristic increase in his serum lactate dehydrogenase level, whi... | [
{
"companynumb": "JP-ACTAVIS-2016-11212",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CAPECITABINE"
},
"drugadditional": null,
... |
{
"abstract": "As peripheral blood has surpassed bone marrow as a predominant source of stem cells for transplantation, use of the cytokine granulocyte colony-stimulating factor (G-CSF) to mobilize peripheral blood stem cells (PBSCs) is increasing. Issues regarding potential genotoxic effects of even short-term, low-... | [
{
"companynumb": "US-AMGEN-USASP2021027214",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FILGRASTIM"
},
"drugadditional": null,
... |
{
"abstract": "Cancer antigen (CA)-125 influences progression, metastasis, and outcomes in pancreatic cancer. This phase I/II trial (NCT01959672) evaluated the safety, efficacy, and immunologic correlates of chemoimmunotherapy (CIT) with oregovomab (anti-CA-125), followed by stereotactic body radiotherapy (SBRT) with... | [
{
"companynumb": "US-PFIZER INC-2019414052",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PACLITAXEL"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nTo report a case of severe neutropenia caused by valproic acid (VPA).\n\n\nMETHODS\nA 56-year-old white woman with an infectious brain abscess causing tonic-clonic seizure activity was treated with VPA. She developed severe neutropenia after 2 days of VPA therapy. The absolute neutrophil cou... | [
{
"companynumb": "TN-ORCHID HEALTHCARE-2052903",
"fulfillexpeditecriteria": "1",
"occurcountry": "TN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CHLORPROMAZINE"
},
"drugadditional": "3",
... |
{
"abstract": "The aim of this study is to evaluate the effect of levetiracetam treatment during pregnancy on fetus.. The pregnant women with epilepsy (PWWE) who were exposed to levetiracetam treatment during pregnancy in the form of monotherapy or polytherapy were retrospectively evaluated. They were compared with t... | [
{
"companynumb": "TR-UCBSA-2018035660",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FOLIC ACID"
},
"drugadditional": "3",
"dr... |
{
"abstract": "Opioids have, at most, small benefits for non-cancer pain in the medium and long-term but there is good evidence that they cause harm. The current study describes the characteristics and clinical status of people taking regular opioids in Great Britain and determines whether use is associated with mort... | [
{
"companynumb": "GB-JNJFOC-20200506379",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OXYCODONE"
},
"drugadditional": "3",
"d... |
{
"abstract": "Individuals living with schizophrenia are affected by cardiometabolic, endocrine, and motor adverse effects of current antipsychotic medications. Lumateperone is a serotonin, dopamine, and glutamate modulator with the potential to treat schizophrenia with few adverse effects.\n\n\n\nTo examine the effi... | [
{
"companynumb": "US-OTSUKA-2020_013790",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BREXPIPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "NS and related RAS/MAPK pathway (RASopathy) disorders are the leading genetic cause of HCM presenting in infancy. HCM is a major cause of morbidity and mortality in children with Noonan spectrum disorders, especially in the first year of life. Previously, there have been only isolated reports of heart ... | [
{
"companynumb": "PHHY2019US155043",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AZATHIOPRINE"
},
"drugadditional": null,
"dr... |
{
"abstract": "BACKGROUND\nClostridium difficile ribotype 027 has become increasingly prevalent in European countries. The clinical picture varies from self-limiting diarrhea to pseudomembranous colitis with toxic megacolon and ultimately death. Use of antibiotics is the principal risk factor; others include comorbid... | [
{
"companynumb": "DK-RANBAXY-2013R1-70798",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CEFUROXIME"
},
"drugadditional": null,
... |
{
"abstract": "Capecitabine is a chemotherapeutic agent used in the treatment of metastatic colon cancer and metastatic breast cancer. It is metabolized into fluorouracil (5-FU) in the liver; hence, its mechanism of action is similar to that of 5-FU. Cardiac toxicity, although rarely seen, may be of concern in some p... | [
{
"companynumb": "TR-BAUSCH-BL-2016-011797",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LEUCOVORIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nThe antiretroviral (ARV) pregnancy registry, an international voluntary registry, provides information on teratogenicity and non-defect adverse pregnancy outcomes.\n\n\nMETHODS\nWe analyzed ARV pregnancy registry prospective singleton pregnancies, estimating frequencies of and risk for nond... | [
{
"companynumb": "US-CIPLA LTD.-2016US10234",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ABACAVIR"
},
"drugadditional": "3",
... |
{
"abstract": "Aim of the study was to measure and correlate citalopram concentrations in maternal blood, amniotic fluid and umbilical cord blood to account for the distribution of the drug between these three compartments.\n\n\n\nConcentrations of citalopram were measured in twelve mother infant pairs at the time of... | [
{
"companynumb": "DE-ALLERGAN-1730035US",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "INSULIN NOS"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nParacoccidioidomycosis (PCM) is a systemic mycosis of chronic presentation more frequent in adults, which may lead to disseminated severe and lethal forms involving the lungs, skin, lymph nodes, spleen, liver, and lymphoid organs of the digestive tract. Common in Latin America, it is rare i... | [
{
"companynumb": "BR-ACCORD-031353",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
"drug... |
{
"abstract": "This study examines the effects of the tyrosine hydroxylase inhibitor L1-79, a racemic formulation of α-methylparatyrosine, in patients with autism spectrum disorder (ASD) in a prospective case series. The l-isomer formulation of α-methylparatyrosine, metyrosine, is approved for the management of patie... | [
{
"companynumb": "US-OTSUKA-2020_002099",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "Occupational exposure to certain substances would cause cancer. Herein, we report on a case of a 58-year-old former orthoprostethist who died from a lung adenocarcinoma. He had a 3 pack-year history of smoking and a single exposure to asbestos during his professional career. Between 1979 and 2010, he u... | [
{
"companynumb": "FR-MLMSERVICE-20171020-0933365-1",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": "4",... |
{
"abstract": "Only two cases of deliberate self-poisoning with metformin have been described in the literature. We report the management of three cases, all of which presented with severe lactic acidosis. Two cases had a fatal outcome. The options for treatment and previous cases reported in the literature are revie... | [
{
"companynumb": "GB-BAUSCH-BL-2018-023752",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
"drugadditional": ... |
{
"abstract": "OBJECTIVE\nTo evaluate whether adverse event reports to the US Food and Drug Administration on incidents of ketoacidosis from use of sodium glucose cotransport inhibitors (SGLT2 inhibitors) provide insight into ways this new class of drugs is being prescribed with other antihyperglycemic agents; to exa... | [
{
"companynumb": "US-JNJFOC-20170710042",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CANAGLIFLOZIN"
},
"drugadditional": "3",
... |
{
"abstract": "Aggressive fibromatosis, also known as desmoid-type fibromatosis (DTF) or desmoid tumor, is an uncommon locally invasive tumor. Because of its low incidence and variable behavior, DTF is often first seen by physicians who are not familiar with it, and recent advances in understanding this disease have ... | [
{
"companynumb": "PHHY2017US183461",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "OBJECTIVE\nWe investigated the safety and pharmacokinetics of a recombinant human monoclonal antibody to vascular endothelial growth factor (rhuMAb VEGF) in patients with cancer.\n\n\nMETHODS\nCohorts of patients with metastatic cancer having failed prior therapy entered a phase I trial of rhuMAb VEGF ... | [
{
"companynumb": "CH-ROCHE-2833735",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ATEZOLIZUMAB"
},
"drugadditional": "1",
"dru... |
{
"abstract": "OBJECTIVE\nThis study examines safety, efficacy, and pharmacokinetics of chemoembolization with loadable microspheres ≤100 μm for hepatocellular carcinoma.\n\n\nMETHODS\nA pilot safety study was performed in 19 patients with size and dose escalation and then 52 patients were enrolled prospectively and ... | [
{
"companynumb": "GR-JNJFOC-20160913515",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional": "... |
{
"abstract": "To compare the risk of community-acquired pneumonia (CAP) requiring hospitalization in spondyloarthritis (SpA) and non-specific back pain (NSBP), and to identify the risk factors for CAP in SpA.\nA total of 2984 patients with SpA from 11 rheumatology centers and 2526 patients with NSBP from orthopedic ... | [
{
"companynumb": "HK-JNJFOC-20210431481",
"fulfillexpeditecriteria": "1",
"occurcountry": "HK",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GOLIMUMAB"
},
"drugadditional": "3",
"d... |
{
"abstract": "Amiodarone is a class 3 antiarrhythmic drug which may be associated with thyroid dysfunction. Amiodarone-induced thyrotoxicosis (AIT) is classified as type 1 (AIT 1; which may develop in the presence of latent autoimmune hyperthyroid condition) or type 2 (AIT 2; which develops in an apparently normal t... | [
{
"companynumb": "GB-TEVA-2021-GB-1966429",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "4",
... |
{
"abstract": "The development of cardiovascular disease appears in subjects with several cardiovascular risk factors. However, other agents could be related to the appearance of cardiovascular disease, like chemotherapy drugs. We present a 63 years-old man with very high cardiovascular risk and chronic myeloid leuke... | [
{
"companynumb": "NVSC2019ES005237",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ATORVASTATIN"
},
"drugadditional": "3",
"dru... |
{
"abstract": "AIHA is a rare and serious complication of solid organ transplantation. Herein, we report four cases of warm or mixed AIHA in pediatric patients following combined liver, small bowel and pancreas transplant. The hemolysis was refractory to multiple treatment modalities including steroids, rituximab, IV... | [
{
"companynumb": "US-MYLANLABS-2015M1002830",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
... |
{
"abstract": "H2 receptor antagonists are commonly employed to manage gastro-esophageal reflux and peptic ulcer diseases with a very low incidence of side effects. Herein, we report an extremely rare incidence of famotidine-induced acute confusion in a patient with end-stage renal failure. We also discuss the pharma... | [
{
"companynumb": "HK-TEVA-824235ROM",
"fulfillexpeditecriteria": "1",
"occurcountry": "HK",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CALCIUM CARBONATE"
},
"drugadditional": "3",
... |
{
"abstract": "Stevens-Johnson syndrome/toxic epidermal necrolysis overlap is an acute hypersensitivity reaction that compromises the integrity of mucous membranes and cutaneous tissue. While the pathophysiology of this syndrome has not been fully elucidated, it is commonly associated with the medication use and carr... | [
{
"companynumb": "US-DRREDDYS-USA/USA/14/0042124",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PROCHLORPERAZINE"
},
"drugadditional": ... |
{
"abstract": "Epilepsy is one of the most common neurological disorders requiring continuous treatment during pregnancy. In Saudi Arabia, there is only one publication that studied the outcome of pregnancies in women with epilepsy, published in 1999. The aim of the study is to determine the major congenital malforma... | [
{
"companynumb": "SA-GLAXOSMITHKLINE-SA2020GSK102920",
"fulfillexpeditecriteria": "1",
"occurcountry": "SA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LAMOTRIGINE"
},
"drugadditional": nu... |
{
"abstract": "OBJECTIVE\nTo compare procedure duration, complications, and acceptability of dilation and evacuation (D&E) with and without feticide by intra-cardiac potassium chloride (KCL) injection.\n\n\nMETHODS\nWe evaluated outcomes with D&E at 18-24 weeks of gestation in the 6 months before and 6 months after r... | [
{
"companynumb": "US-PHARMACEUTICS INTERNATIONAL, INC. (PII)-2018PII000023",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "POTASSIUM CHLORIDE"
},
... |
{
"abstract": "With the aging of the hepatitis C virus (HCV)-infected patient cohort and the availability of highly effective and tolerable treatment regimens, an increasing number of elderly patients are now eligible for HCV therapy. This study investigated clinical and epidemiologic characteristics of elderly HCV-i... | [
{
"companynumb": "DE-KADMON PHARMACEUTICALS, LLC-KAD201809-000603",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "RIBAVIRIN"
},
"drugaddi... |
{
"abstract": "Bronchiolitis obliterans syndrome (BOS) is the term used for the progressive obliteration of small airways before the patient has had a confirmatory lung biopsy. It is also recognized as a transplant-related complication. There have been no reports of BOS during initial standard chemotherapy.\nA 50-yea... | [
{
"companynumb": "JP-MYLANLABS-2019M1129018",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nAmyloid infiltration of endocrine glands has been reported, mostly in the thyroid, pancreas, adrenals, and testes, but affected patients do not frequently exhibit overt endocrine insufficiency. Here we report the case of a patient with complete anterior hypopituitarism probably due to a kno... | [
{
"companynumb": "BE-ASTELLAS-2018US031678",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": null,... |
{
"abstract": "Broken heart syndrome, more commonly known as Takotsubo cardiomyopathy (TCM), is an acute cardiac condition. It is characterized by regional cardiac wall motion abnormalities triggered by physical or emotional stress or administration of catecholamines such as epinephrine. The initial clinical presenta... | [
{
"companynumb": "GB-AMNEAL PHARMACEUTICALS-2019-AMRX-01994",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "EPINEPHRINE"
},
"drugaddition... |
{
"abstract": "Introduction.Exophiala dermatitidisis a relatively common environmental black yeast with worldwide distribution and is a rare cause of fungal infection, mostly in patients with certain predisposing factors. Due to the rarity of the infection, little is known about the specific predisposing factors, way... | [
{
"companynumb": "SK-009507513-1707SVK008259",
"fulfillexpeditecriteria": "1",
"occurcountry": "SK",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "POSACONAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "Venous limb gangrene (VLG) can occur in cancer patients, but the clinical picture and pathogenesis remain uncertain. We identified 10 patients with metastatic cancer (7 pathologically proven) who developed severe venous limb ischemia (phlegmasia/VLG) after initiating treatment of deep-vein thrombosis (... | [
{
"companynumb": "CA-MYLANLABS-2015M1028629",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DALTEPARIN SODIUM"
},
"drugadditional": null... |
{
"abstract": "Biologic immune modulators such as ipilimumab have demonstrated the efficacy against metastatic melanoma. We present a recent case of a 52-year-old male who initially developed mild colitis following the initiation of ipilimumab treatment for metastatic melanoma. Despite initial improvement with immedi... | [
{
"companynumb": "US-JNJFOC-20150208939",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nOctreotide reduces splanchnic blood flow and is effective in controlling gastrointestinal bleeding (GIB) caused by portal hypertension. Monthly long-acting octreotide (OCT-LAR) with an efficacy and safety profile similar to subcutaneous daily administration presents an attractive option for ... | [
{
"companynumb": "GB-MYLANLABS-2015M1004667",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OCTREOTIDE"
},
"drugadditional": null,
... |
{
"abstract": "Polyomavirus nephropathy is characterized histopathologically by evidence of viral replication and acute tubular injury with interstitial inflammation, tubulitis, and intranuclear inclusions. Polyomavirus nephropathy typically develops in the kidney transplant as a combination of the unique nature of t... | [
{
"companynumb": "US-ACCORD-047379",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "3",
"druga... |
{
"abstract": "We describe a case of immune thrombocytopenic purpura (ITP) occurring 15 days after the first dose of a 4-dose rabies vaccination series. ITP is thought to be an immune-mediated process triggered by an infection or toxin. There is little evidence in the literature beyond case reports of an association ... | [
{
"companynumb": "US-TEVA-601503USA",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "RABIES VACCINE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nThis study was undertaken to evaluate the long-term efficacy, retention, and tolerability of add-on brivaracetam (BRV) in clinical practice.\n\n\nMETHODS\nA multicenter, retrospective cohort study recruited all patients who initiated BRV between February and November 2016, with observation u... | [
{
"companynumb": "DE-UCBSA-2021049264",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "BRIVARACETAM"
},
"drugadditional": null,
... |
{
"abstract": "Although everolimus potentially improves long-term heart transplantation (HTx) outcomes, its early postoperative safety profile had raised concerns and needs optimization.\n\n\n\nThis 6-month, open-label, multicenter randomized trial was designed to compare the cumulative incidence of a primary composi... | [
{
"companynumb": "IT-ROCHE-2100609",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "EVEROLIMUS"
},
"drugadditional": "3",
"druga... |
{
"abstract": "OBJECTIVE\nAcute antibody-mediated rejection is an important cause of acute and chronic kidney allograft dysfunction and graft loss. The purpose of the present study was to evaluate our experience using plasmapheresis and intravenous immunoglobulin in treating patients who had acute antibody-mediated r... | [
{
"companynumb": "PHHY2014TH094388",
"fulfillexpeditecriteria": "1",
"occurcountry": "TH",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
"dr... |
{
"abstract": "Fungemia is classically caused by a single species and the detection of more than one species in blood samples is uncommon. We report four cases of mixed fungemia (MF) diagnosed in the parasitology-mycology laboratory of Farhat-Hached hospital in Sousse, Tunisia. The MF episodes occurred in two neonate... | [
{
"companynumb": "TN-SUN PHARMACEUTICAL INDUSTRIES LTD-2015RR-099951",
"fulfillexpeditecriteria": "1",
"occurcountry": "TN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"drug... |
{
"abstract": "BACKGROUND\nAutologous dendritic cell (DC) vaccines can induce tumor-specific T cells, but their effect can be counteracted by immunosuppressive mechanisms. Cisplatin has shown immunomodulatory effects in vivo which may enhance efficacy of DC vaccination.\n\n\nMETHODS\nThis is a prospective, randomized... | [
{
"companynumb": "NL-HQ SPECIALTY-NL-2020INT000027",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "INVESTIGATIONAL PRODUCT"
},
"drugaddit... |
{
"abstract": "OBJECTIVE\nMethotrexate (MTX) is a disease modifying anti-rheumatic drug commonly used to treat children with Juvenile Idiopathic Arthritis (JIA). Unfortunately, half of children taking MTX will experience MTX intolerance, which includes distressing gastrointestinal and behavioural symptoms associated ... | [
{
"companynumb": "CA-TEVA-2020-CA-1796961",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,
... |
{
"abstract": "A 32 year-old male presented with a pulsatile facial mass with palpable thrill and audible bruit. Imaging revealed a very large diffuse left-sided facial arteriovenous malformation with extensive bilateral supply, as well as a previously ligated left external carotid artery. Endovascular treatment was ... | [
{
"companynumb": "CA-FRESENIUS KABI-FK201704192",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "BLEOMYCIN SULFATE"
},
"drugadditional": ... |
{
"abstract": "At the end of 2018, South Africa updated its all-oral regimen, to include bedaquiline (BDQ) and 2 months of linezolid (LZD) for all patients initiating the shorter 9-12 months regimen for rifampicin-resistant tuberculosis (RR-TB). We assessed a group of patients in rural KwaZulu-Natal for safety and ef... | [
{
"companynumb": "ZA-TEVA-2022-ZA-2007085",
"fulfillexpeditecriteria": "1",
"occurcountry": "ZA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LINEZOLID"
},
"drugadditional": "3",
... |
{
"abstract": "Immune-related adverse events (IrAEs) of immune checkpoint inhibitors (ICIs) can be serious and unpredictable. We examine the incidence rate and risk factors for IrAEs in an Asian cohort of nonsmall cell lung cancer (NSCLC) patients treated with immunotherapy. Between June 2014 and August 2020, we retr... | [
{
"companynumb": "SG-ROCHE-2939982",
"fulfillexpeditecriteria": "1",
"occurcountry": "SG",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ATEZOLIZUMAB"
},
"drugadditional": "3",
"dru... |
{
"abstract": "BACKGROUND\nWe report what we believe to be the first case of a child affected by two rare vascular diseases complicated by kidney failure and successfully treated by kidney transplantation.\n\n\nMETHODS\nA 3-year-old Caucasian girl with fibromuscular dysplasia and infantile myofibromatosis presented w... | [
{
"companynumb": "PHHY2015BE165760",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "NADROPARIN"
},
"drugadditional": null,
"drug... |
{
"abstract": "BACKGROUND\nCurrent chemotherapy regimens for adults with acute lymphoblastic leukemia (ALL) result in high rates of complete remission (CR), but relapses are still frequent.\n\n\nMETHODS\nIn this retrospective single-center study, we evaluated the results of the Hyper-CVAD (fractionated cyclophosphami... | [
{
"companynumb": "BR-BAXTER-2015BAX050619",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,
... |
{
"abstract": "Stenotrophomonas maltophilia is an aerobic, glucose non- fermentative, gram negative bacillus, which is being increasingly recognized as a cause of serious infections such as bacteraemia, urinary tract infections, respiratory tract infections, skin and soft tissue infections, endocarditis, meningitis a... | [
{
"companynumb": "IN-PFIZER INC-2021812016",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMIKACIN"
},
"drugadditional": "3",
... |
{
"abstract": "We report 9 cases of exit-site infection and continuous ambulatory peritoneal dialysis peritonitis associated with atypical mycobacteria. All patients had been using topical gentamicin cream as prophylaxis for exit-site infection before the onset of these infections. Gentamicin cream is postulated to b... | [
{
"companynumb": "HK-WATSON-2014-15388",
"fulfillexpeditecriteria": "1",
"occurcountry": "HK",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GENTAMICIN"
},
"drugadditional": null,
"... |
{
"abstract": "OBJECTIVE\nTo describe a case of iatrogenic Cushing's syndrome (ICS) following a triamcinolone injection for subscapular bursitis in an HIV-positive patient receiving an antiretroviral regimen that included ritonavir boosted-atazanavir.\n\n\nMETHODS\nUniversity outpatient HIV clinic.\n\n\nMETHODS\nA 60... | [
{
"companynumb": "PHHY2015US036368",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "EMTRICITABINE\\TENOFOVIR DISOPROXIL FUMARATE"
},
"drug... |
{
"abstract": "A 71-year-old male, a renal allograft recipient, presented to us with a history of fever and right palm swelling. He had a history of fever 7 years back when he was treated with antitubercular treatment (ATT). Three years back, he was diagnosed to have gout and he was started on allopurinol. He develop... | [
{
"companynumb": "IN-ACCORD-061885",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": null,
"d... |
{
"abstract": "Triple-hit lymphoma is a highly aggressive B-cell lymphoma. We report a case of triple-hit lymphoma transformed from systemic follicular lymphoma (FL) after 9-year remission and presented primarily as an isolated orbital mass without systemic symptoms or lymphadenopathy.\nA 58-year-old female presented... | [
{
"companynumb": "US-ACCORD-100051",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": null,
"druga... |
{
"abstract": "OBJECTIVE\nWomen with a history of bipolar disorder or postpartum psychosis are at extremely high risk of relapse postpartum. Although lithium prophylaxis has demonstrated efficacy in reducing postpartum relapse, the timing of prophylaxis remains controversial given the balance of risks and benefits fo... | [
{
"companynumb": "NL-MYLANLABS-2015M1036896",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LITHIUM"
},
"drugadditional": null,
... |
{
"abstract": "We describe an immunodeficient adult with Ogilvie's syndrome preceding a disseminated papulovesicular skin rash in whom varicella-zoster virus infection was demonstrated by PCR assay in cutaneous and colonic biopsy specimens. In view of the significant morbidity and mortality that this condition carrie... | [
{
"companynumb": "ES-PFIZER INC-2014207085",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE SODIUM SUCCINATE"
},
"druga... |
{
"abstract": "A man in his 40s was brought to the accident and emergency department in an acute psychotic state, 3 weeks after the European Union referendum results in the UK were declared. His mental health had deteriorated rapidly following the announcement of the results, with significant concerns about Brexit. H... | [
{
"companynumb": "GB-DRREDDYS-USA/UKI/19/0116273",
"fulfillexpeditecriteria": "2",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "OLANZAPINE"
},
"drugadditional": "1",
... |
{
"abstract": "This report highlights azathioprine-induced severe myelosuppression in the patient with NUDT15 minor variant. This case report is particularly instructive because several typical symptoms are the clues to this critical adverse drug reaction.",
"affiliations": "Division of Hepatology Department of Int... | [
{
"companynumb": "JP-SEBELA IRELAND LIMITED-2022SEB00013",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AZATHIOPRINE"
},
"drugadditional... |
{
"abstract": "We describe a rare case of desmoplastic infantile ganglioglioma that appears to have transformed into a glioblastoma multiforme tumor in a 5-year-old girl. The patient was initially treated with total removal of the tumor, without subsequent radiation therapy or chemotherapy. She was in good health for... | [
{
"companynumb": "US-009507513-1905USA002789",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TEMOZOLOMIDE"
},
"drugadditional": null,
... |
{
"abstract": "Fixed drug eruption (FDE) is a type of cutaneous drug reaction that occurs at the same sites upon re-exposure to specific medications. Herein we discuss the case of a 23-year-old man with a FDE to fluconazole.",
"affiliations": "USC Keck School of Medicine.",
"authors": "Lai|Olivia|O|;Hsu|Sylvia|S|... | [
{
"companynumb": "GB-CLARIS PHARMASERVICES-1057831",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "FLUCONAZOLE"
},
"drugadditional": "1",... |
{
"abstract": "BACKGROUND\nThe MAGIC/UK Medical Research Council (MRC) trial set the standard of care for treatment of resectable gastric and junctional adenocarcinoma, demonstrating that perioperative chemotherapy with epirubicin, cisplatin and 5-fluorouracil (ECF) confers a survival benefit over surgery alone. The ... | [
{
"companynumb": "IE-ROCHE-1355554",
"fulfillexpeditecriteria": "1",
"occurcountry": "IE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": null,
"dr... |
{
"abstract": "OBJECTIVE\nWe present this case to emphasize the importance of early diagnosis and treatment of an acute severe hypercalcemic syndrome due to primary hyperparathyroidism as a consequence of an undiagnosed adenoma of the parathyroid gland.\n\n\nMETHODS\nA 50-year-old man presented at another hospital wi... | [
{
"companynumb": "BE-MYLANLABS-2020M1079367",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FUROSEMIDE"
},
"drugadditional": "3",
... |
{
"abstract": "Myeloablative conditioning is a well-established procedure that precedes hematopoietic stem cell transplantation (HSCT), particularly in pediatric patients. In the period directly following transplantation, several factors may contribute to complications that lead to the activation or damage of endothe... | [
{
"companynumb": "IT-JAZZ-2019-IT-002078",
"fulfillexpeditecriteria": "2",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DEFIBROTIDE SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "Oxaliplatin is a platinum commonly used in the treatment of metastatic colon cancer. It can cause thrombocytopenia through different mechanism. Sudden isolated drop in platelets should raise the concern for oxaliplatin immune-induced thrombocytopenia and abrupt discontinuation of the drug. Patients sho... | [
{
"companynumb": "PHHY2017US185854",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": "1",
"drug... |
{
"abstract": "Minor bleeding is the most common complication of dermatologic surgery. Topical brimonidine, 0.33%, gel has been reported for the use of hemostasis in dermatologic surgery. The safety profile and risk of systemic toxic effects when brimonidine is used topically for hemostasis is unknown.\n\n\n\nTo dete... | [
{
"companynumb": "US-GALDERMA-US17002844",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BRIMONIDINE TARTRATE"
},
"drugadditional": "3",
... |
{
"abstract": "Sodium valproate is widely used as an antiepileptic drug. It has potential side effects and its overdosage is toxic. We present a case where a sodium valproate intoxication with severe cerebral oedema was managed in the intensive care unit with hemodialysis, levocarnitine and supportive care.",
"affi... | [
{
"companynumb": "PHHY2015FI022392",
"fulfillexpeditecriteria": "1",
"occurcountry": "FI",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VALPROATE SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "Hepatitis C Virus (HCV) infections are blood-borne, generally chronic and are associated with increased morbidity and mortality. The aim of this study is to describe the results of therapies with direct-acting antiviral agents (DAAs) in healthcare personnel.\nSecondary data analysis using data from the... | [
{
"companynumb": "DE-BAUSCH-BL-2018-017051",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "RIBAVIRIN"
},
"drugadditional": null,
... |
{
"abstract": "Epstein-Barr virus-associated smooth muscle tumor (EBV-SMT) is a rare neoplasm recognized in immunocompromised patients. There are less than 30 cases of EBV-SMT reported in pediatric population following solid organ transplantation. Herein, we report a case of an 8-year-old female who was incidentally ... | [
{
"companynumb": "US-MYLANLABS-2017M1063130",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": null,
... |
{
"abstract": "A 52-year-old man underwent pneumonectomy of the left lung for previously diagnosed primary spindle cell carcinoma (pT4aN1M0, stage III B) with programmed death-ligand 1 expression (tumor proportion score ≥95%) and without epidermal growth factor receptor gene mutation and anaplastic lymphoma kinase fu... | [
{
"companynumb": "JP-009507513-2107JPN004684",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "PEMBROLIZUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Most authors believe that the optimal treatment for pulmonary hydatid cyst is surgery. Albendazole has been used as a prophylactic measure for reducing recurrence rate but there are some controversies about this strategy. Some researchers have described the increased risk of spontaneous rupture of cyst... | [
{
"companynumb": "IR-IMPAX LABORATORIES, LLC-2018-IPXL-04407",
"fulfillexpeditecriteria": "1",
"occurcountry": "IR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugaddi... |
{
"abstract": "A 40-year-old man presented to the emergency department with dyspnoea and fatigue after bupropion and popper consumption. Clinical examination was remarkable for central cyanosis not responding to supplementary oxygen. Arterial blood gas analysis showed a methaemoglobin value of 30.3%. Methaemoglobinem... | [
{
"companynumb": "PT-GLAXOSMITHKLINE-PT2019GSK060391",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VALPROIC ACID"
},
"drugadditional": ... |
{
"abstract": "Starvation ketosis outside pregnancy is rare and infrequently causes a severe acidosis. Placental production of hormones, including glucagon and human placental lactogen, leads to the insulin resistance that is seen in pregnancy, which in turn increases susceptibility to ketosis particularly in the thi... | [
{
"companynumb": "GB-BAUSCH-BL-2019-014830",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ERYTHROMYCIN"
},
"drugadditional": "3",
... |
{
"abstract": "We report an 18-year-old female individual with septic arthritis due to Mycobacterium kansasii. Three years and 6 months before arthritis, the patient underwent bone marrow transplantation and developed severe chronic graft-versus-host disease. The arthritis was refractory to medication, and she underw... | [
{
"companynumb": "JP-ACCORD-210510",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": "1",
... |
{
"abstract": "Orolingual angioedema (OLAE) is a rare adverse effect of alteplase. Previous studies have associated the occurrence of OLAE with thrombolysed patients maintained on angiotensin converting enzyme inhibitors. We report a case of a 60-year-old male presenting with hyperacute ischemic stroke developing hem... | [
{
"companynumb": "PH-ZYDUS-037043",
"fulfillexpeditecriteria": "1",
"occurcountry": "PH",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"drugadditional": null,
"drugad... |
{
"abstract": "We present the case of radiation myonecrosis of the iliopsoas muscle, identified five months after stereotactic body radiation therapy (SBRT, 21 Gy in three fractions) to a metastatic lesion in the right iliac bone of a patient with leiomyosarcoma. The patient had been treated with various chemotherape... | [
{
"companynumb": "US-ACCORD-198591",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "GEMCITABINE\\GEMCITABINE HYDROCHLORIDE"
},
"drugadditi... |
{
"abstract": "Aspiration pneumonia and extreme weight loss are risks whenever globus pharyngeus (GP) complicates major depressive disorder (MDD) in the older adult. The timely administration of electroconvulsive therapy (ECT) may reverse GP in this context. We review cases of GP in depressed older adults and describ... | [
{
"companynumb": "US-LUPIN PHARMACEUTICALS INC.-2022-07040",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FLUOXETINE HYDROCHLORIDE"
},
"... |
{
"abstract": "Vulvar cancer accounts for about 5% of cancer of female genitalia. It may initially present as benign symptoms resulting in potential delay in diagnosis. Few cases of distant metastases to skin or breast have been reported. We present the case of a 76-year-old female with possible delay in diagnosis of... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-293279",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"dru... |
{
"abstract": "OBJECTIVE\nTo highlight a problem of eating disorders in pregnancy and the need for interdisciplinary cooperation in these cases.\n\n\nMETHODS\nCase report.\n\n\nMETHODS\nDepartment of Gynecology and Obstetrics, 2nd Faculty of Medicine, University hospital Motol, Prague.\n\n\nMETHODS\nWe report the cou... | [
{
"companynumb": "CZ-MYLANLABS-2021M1063845",
"fulfillexpeditecriteria": "1",
"occurcountry": "CZ",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MIRTAZAPINE"
},
"drugadditional": null,
... |
{
"abstract": "We report a case of a 58-year-old man suffering from advanced colon cancer with liver metastases. After the sigmoidectomy and left lateral segmentectomy, mFOLFOX6+bevacizumab was initiated. The mFOLFOX6+bevacizumab therapy was performed for 15 courses, but it was stopped because of an increase in serum... | [
{
"companynumb": "JP-PFIZER INC-2017445335",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEUCOVORIN CALCIUM"
},
"drugadditional": "3",
... |
{
"abstract": "A 73-year-old woman with malignant insulinoma was treated with 100 μg/day octreotide for unresected insulinoma and liver metastases. The daily administration of the drug induced hyperglycemia after dinner in addition to existing fasting hypoglycemia possibly because this drug suppressed both insulin an... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2022R1-338149",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "OCTREOTIDE"
},
"drug... |
{
"abstract": "An ultrasound-guided thoracic paravertebral nerve block was administered for left-sided abdominal pain. Lidocaine 0.4% (9.5 mL) was injected. Spinal anesthesia developed after the injection that resolved after 3 hours. One week later, a magnetic resonance imaging scan of thoracic spine identified a lef... | [
{
"companynumb": "CN-SCILEX PHARMACEUTICALS INC.-2019SCX00060",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LIDOCAINE"
},
"drugaddition... |
{
"abstract": "Although post-transplant lymphoproliferative disorder is a classical complication encountered after kidney transplantation, its diagnosis can still be challenging and its outcome life-threatening. Most cases are related to Epstein-Barr virus (EBV) infection and occur mainly in the first year post-trans... | [
{
"companynumb": "BE-TEVA-626322ISR",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
"dru... |
{
"abstract": "Given the current climate of drug shortages in the United States, this review summarizes available comparative literature on the use of alternative immunosuppressive agents in adult solid organ transplant recipients including kidney, pancreas, liver, lung, and heart, when immediate-release tacrolimus (... | [
{
"companynumb": "ES-ALKEM LABORATORIES LIMITED-ES-ALKEM-2020-02651",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
... |
{
"abstract": "Transient reactive papulotranslucent acrokeratoderma (TRPA) is an unusual skin condition characterized by the rapid and transient development of symmetric, edematous white papules with eccrine duct prominence on the palms after exposure to water. We present the case of a 28-year-old woman diagnosed in ... | [
{
"companynumb": "PHHY2014RO158352",
"fulfillexpeditecriteria": "1",
"occurcountry": "RO",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "KETOROLAC\\KETOROLAC TROMETHAMINE"
},
"drugadditional"... |
{
"abstract": "OBJECTIVE\nThe ideal approach to complex ventral hernia repair is frequently debated. Differences in processing techniques among biologic materials may impact hernia repair outcomes. This study evaluates the outcomes of hernia repair with a terminally sterilized human acellular dermal matrix (TS-HADM) ... | [
{
"companynumb": "US-JNJFOC-20160703448",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": null,
"drugadditional": null,
"drugadministrationroute": "061",
"drugauthori... |
{
"abstract": "To report a case of bilateral choroidal effusion after laser capsulotomy.\nA healthy 85 years old white woman was referred to our hospital with a diagnosis of posterior capsule opacification in the left eye. The patient was treated with laser capsulotomy and oral acetazolamide was administered after th... | [
{
"companynumb": "IT-SUN PHARMACEUTICAL INDUSTRIES LTD-2022R1-327619",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ACETAZOLAMIDE"
},
"d... |
{
"abstract": "BACKGROUND\nAnagrelide is an established treatment option for essential thrombocythemia (ET). Cardiovascular adverse events can occur with its use including heart failure and cardiomyopathy.\n\n\nMETHODS\nA 52-year-old African American male with ET presented with chest pain, shortness of breath, and dy... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2018US-169310",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "HYDROXYUREA"
},
"dru... |
{
"abstract": "Cyclophosphamide is a potent DNA alkylating agent used in chemotherapy and immunosuppression. Although an old agent, its use in the present day has expanded for cases of refractory autoimmune disease. In this report, a case of haemorrhagic myopericarditis resulting from high-dose cyclophosphamide for c... | [
{
"companynumb": "US-ROXANE LABORATORIES, INC.-2016-RO-00557RO",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"dru... |
{
"abstract": "Cytomegalovirus (CMV) reactivation is common in organ transplant recipients and can lead to significant morbidity and mortality. Cutaneous CMV findings are rarely reported in the literature and diagnosis can be delayed if not clinically recognized. We describe a case of a female patient 20 years post r... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2022SP001588",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditiona... |
{
"abstract": "Heart transplantation is an effective treatment for Chagas disease patients with severe cardiomyopathy. However, Trypanosoma cruzi reactivation is of great concern. The T. cruzi parasite is classified into six discrete typing units (DTUs identified as TcI-TcVI). It is unknown whether there is an associ... | [
{
"companynumb": "CO-SUN PHARMACEUTICAL INDUSTRIES LTD-2019R1-223473",
"fulfillexpeditecriteria": "1",
"occurcountry": "CO",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"dr... |
{
"abstract": "Epstein-Barr virus (EBV) reactivation is an unresolved medical issue after allogeneic hematopoietic stem cell transplantation (HSCT). Rituximab treatment is recommended for EBV reactivation after HSCT but the number of doses of rituximab to use is unclear. In this study, risk factors and outcomes of pa... | [
{
"companynumb": "NVSC2020US010492",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "3",
... |
{
"abstract": "The primary objective is to identify and describe the complications associated with the use of intravenous lipid emulsion (ILE) therapy as an antidote for lipophilic drug toxicity. This study is a retrospective chart review of patients treated with ILE at two academic medical centers between 2005 and 2... | [
{
"companynumb": "US-MYLANLABS-2014S1010381",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PROPRANOLOL\\PROPRANOLOL HYDROCHLORIDE"
},
"... |
{
"abstract": "To examine the incidence and severity of paracetamol poisoning in a population-based cohort in Iceland. A previous study showed a decrease in the incidence during a financial crisis in Iceland, by approximately half (16/100,000 annually). The aims of the study were to assess the incidence and nature of... | [
{
"companynumb": "IS-VISTAPHARM, INC.-VER202106-001401",
"fulfillexpeditecriteria": "1",
"occurcountry": "IS",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN\\HYDROCODONE"
},
"dr... |
{
"abstract": "A 25-year-old man who received alemtuzumab as induction therapy for a multivisceral transplant experienced delayed onset of warm autoimmune haemolytic anaemia and neutropaenia. Serological testing and bone marrow biopsy excluded alternative causes. Haemolysis was refractory to standard therapies includ... | [
{
"companynumb": "GB-TAKEDA-2021TUS032282",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HUMAN IMMUNOGLOBULIN G"
},
"drugadditional": "3... |
{
"abstract": "The tricyclic antidepressants, while older, still have their place in the treatment of depression today. They are efficacious but less selective and thus have the potential of eliciting many side effects. Anticholinergic delirium is a potential complication when using a tricyclic antidepressant or othe... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2018US-162119",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AMITRIPTYLINE"
},
"d... |
{
"abstract": "Tuberculosis (TB) is an important cause of significant morbidity and mortality, particularly in patients living with human immunodeficiency virus (HIV ) infections. The co-infection of TB and HIV coinfection is further complicated by a relatively higher frequency of extra-pulmonary TB and upsurge of dr... | [
{
"companynumb": "IN-HETERO-HET2019IN01579",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ZIDOVUDINE"
},
"drugadditional": "3",
... |
{
"abstract": "Macropolycytes are giant neutrophils found in a variety of benign and neoplastic conditions. Since megaloblastic anaemia is one of the recognised causes of macropolycytes, other blood film features of megaloblastic anaemia should be sought when they harbor hypersegmented nuclei. When they are hypolobul... | [
{
"companynumb": "FR-AMGEN-FRASP2020158420",
"fulfillexpeditecriteria": "2",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": null,
... |
{
"abstract": "Psychosis with phenytoin use has earlier been reported only in the context of Vitamin B12 or folic acid deficiency. We report a rare case of phenytoin toxicity manifesting as psychosis in the absence of Vitamin deficiency. The importance of recognition of psychosis as a harbinger of phenytoin toxicity ... | [
{
"companynumb": "IN-PFIZER INC-2016049756",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LORAZEPAM"
},
"drugadditional": null,
... |
{
"abstract": "The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch... | [
{
"companynumb": "US-DRREDDYS-USA/USA/16/0080123",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "AMLODIPINE BESYLATE"
},
"drugadditional... |
{
"abstract": "OBJECTIVE\nWe aimed to describe a case of prematurely born infant with accidental sildenafil overdose.\n\n\nMETHODS\nThis was a retrospective case report followed with chart and literature review.\n\n\nRESULTS\nA prematurely born infant with moderate bronchopulmonary dysplasia, corrected congenital hea... | [
{
"companynumb": "NL-ALKEM LABORATORIES LIMITED-NL-ALKEM-2021-04003",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SILDENAFIL"
},
"druga... |
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