article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "Pregnancy is associated with venous thromboembolism. Occasionally, thrombus can become entrapped across a patent foramen ovale, with risk of systemic embolism. This report presents a case of a pregnant woman who had thrombus in transit diagnosed by echocardiography, which was successfully removed by su... | [
{
"companynumb": "US-TEVA-2019-US-1046748",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "Kluyvera ascorbata is a gram-negative, catalase-positive, oxidase-negative, aerobic fermentative bacterium with flagella. This organism colonizes in the human body and its pathogenicity is extremely low; few clinical cases of K. ascorbata infection have been reported.\nWe report on a patient who experi... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2019RR-201109",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"druga... |
{
"abstract": "SGLT-2 inhibitors are known to increase hematocrit. We present two cases with marked asymptomatic erythrocytosis developing after taking SGLT-2 inhibitors. No other predisposing or causative factor was found and SGLT-2 inhibitor drug was the most likely cause in both cases. Both patients underwent phle... | [
{
"companynumb": "IN-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2020-BI-021110",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "EMPAGLIFLOZIN"
},
... |
{
"abstract": "Statins are one of the most commonly prescribed drugs in New Zealand, with 525 772 or 16.5% of the adult New Zealand population prescribed a statin between June 2013 and July 2014. While generally well-tolerated, statins are known to cause a range of muscle-related side effects, ranging from myalgia to... | [
{
"companynumb": "NZ-TEVA-808986ROM",
"fulfillexpeditecriteria": "1",
"occurcountry": "NZ",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SIMVASTATIN"
},
"drugadditional": "3",
"dru... |
{
"abstract": "Hypercalcaemia is associated with a number of symptoms that appear in of various parts of body systems. Renal dysfunction or cardiovascular abnormalities present only a part of the multidirectional action of the disturbed calcium balance. It is important for every diagnosis to know the cause of this co... | [
{
"companynumb": "PL-SUN PHARMACEUTICAL INDUSTRIES LTD-2019R1-229055",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LITHIUM"
},
"drugadd... |
{
"abstract": "BACKGROUND\nStrategies to prevent postnatal mother-to-child transmission of HIV-1 in Africa, including infant prophylaxis, have never been assessed past 6 months of breastfeeding, despite breastfeeding being recommended up to 12 months after birth. We aimed to compare the efficacy and safety of infant ... | [
{
"companynumb": "FR-CIPLA LTD.-2016FR01619",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LAMIVUDINE"
},
"drugadditional": null,
... |
{
"abstract": "Our aim was to describe the clinical profile of patients presenting sustained ventricular arrhythmias after sacubitril/valsartan (SV) initiation. All cases of sustained ventricular arrhythmias in patients receiving SV were consecutively recorded in two centers. Nineteen patients had sustained ventricul... | [
{
"companynumb": "ES-UNICHEM PHARMACEUTICALS (USA) INC-UCM201907-000258",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "VALSARTAN"
},
"dr... |
{
"abstract": "Hepatitis C virus (HCV) infection is a common susceptibility factor for porphyria cutanea tarda (PCT). Experience on HCV treatment in patients with PCT is limited. Recently, HCV treatment has improved with direct-acting antivirals (DAA). We review our experience on HCV treatment in patients with PCT wi... | [
{
"companynumb": "US-CONCORDIA PHARMACEUTICALS INC.-GSH201709-005442",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RIBAVIRIN"
},
"druga... |
{
"abstract": "Acute myeloid leukemia following organ transplantation (PT-AML) is a rare event with only a few published cases in the literature. We present three patients who developed AML (FAB M1, M5, M4) after renal, double lung or liver transplantation. Molecular analysis detected a t(9;11) in one patient and doc... | [
{
"companynumb": "AT-MYLANLABS-2018M1053061",
"fulfillexpeditecriteria": "1",
"occurcountry": "AT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "NORFLOXACIN"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nWe examined whether augmentation with olanzapine would be superior to switching to olanzapine among early non-responders (ENRs) to risperidone, and whether augmentation with risperidone would be superior to switching to risperidone among ENRs to olanzapine. We performed a rater-blinded, rand... | [
{
"companynumb": "JP-JNJFOC-20140920269",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RISPERIDONE"
},
"drugadditional": null,
... |
{
"abstract": "Autoimmune hemorrhaphilia due to anti-factor XIII (FXIII) antibodies (AH13) is a life-threatening disease associated with high risk of surgical bleeding. Since AH13 occurs mainly in the elderly, patients of AH13 tend to be complicated with other life-threatening diseases that may require surgical proce... | [
{
"companynumb": "PHHY2016JP037463",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FACTOR XIII CONCENTRATE (HUMAN)"
},
"drugadditional": ... |
{
"abstract": "Visceral leishmaniasis is an endemic in the southwestern region of Saudi Arabia, with a low incidence rate. Clinical presentations of visceral leishmaniasis include recurrent fever, substantial weight loss, hepatosplenomegaly and anemia. However, the clinical features may not be easily evident owing to... | [
{
"companynumb": "SA-ACCORD-110630",
"fulfillexpeditecriteria": "1",
"occurcountry": "SA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nComplete encasement of the inferior vena cava by retroperitoneal tumors is rare. Although replacement of the vena cava has been considered for various conditions in adults, it is rarely used in children except for challenging resections and as a last chance approach - often aiming more at d... | [
{
"companynumb": "IT-BAYER-2019-048820",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "SORAFENIB"
},
"drugadditional": null,
"d... |
{
"abstract": "Recently, 5-azacitidine has been reported to improve the survival of patients with high-risk myelodysplastic syndrome (MDS) and was approved for the treatment of MDS in Japan. We herein report a case of high-risk MDS in which the patient exhibited a hematological improvement three months after the firs... | [
{
"companynumb": "JP-CELGENE-JPN-2014101194",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PHYTONADIONE"
},
"drugadditional": null,
... |
{
"abstract": "Among over-the-counter (OTC) drugs, loperamide has recently emerged for its potential of misuse and cardiotoxicity issues. Hence, we aimed here at assessing the loperamide-related cases being reported to the EMA's EudraVigilance (EV) database.\n\n\n\nAll spontaneous EV reports relating to loperamide mi... | [
{
"companynumb": "GB-JNJFOC-20181011655",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "OMEPRAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "Autoimmune pancreatitis (AIP) is a special form of pancreatitis that responds well to glucocorticoid (GC) treatment. Relapses of AIP are common. The anti-CD20 antibody rituximab (RTX) has shown promising results in GC refractory cases, but long-term data are scarce. The study aims to determine the clin... | [
{
"companynumb": "SE-CELLTRION INC.-2022SE000720",
"fulfillexpeditecriteria": "1",
"occurcountry": "SE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "This post-marketing surveillance is to investigate the long-term safety and effectiveness of the growth hormone receptor antagonist pegvisomant, which is used in patients with acromegaly in routine clinical practice. This surveillance included all cases treated with pegvisomant during the study period ... | [
{
"companynumb": "JP-PFIZER INC-2021051849",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PEGVISOMANT"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nPatients with metastatic colorectal cancer (mCRC) previously-treated with oxaliplatin benefit significantly from the addition of aflibercept to FOLFIRI in relation to overall survival, progression-free survival and response rate.\n\n\nMETHODS\nThe results for efficacy and safety over the ti... | [
{
"companynumb": "ZA-CIPLA LTD.-2015ZA00309",
"fulfillexpeditecriteria": "1",
"occurcountry": "ZA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEUCOVORIN"
},
"drugadditional": null,
... |
{
"abstract": "Inflammatory demyelinating neuropathies have variable responses to immunomodulating therapy. Eight patients with chronic inflammatory neuropathies who were refractory to standard therapy were treated with fludarabine, a combination of fludarabine and cyclophosphamide, and in 1 case with fludarabine and... | [
{
"companynumb": "US-ROXANE LABORATORIES, INC.-2015-RO-01928RO",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drug... |
{
"abstract": "Catastrophic antiphospholipid syndrome (CAPS) survivors rarely relapse. We herein report a case of a second CAPS episode with an unusual subacute course and no microangiopathic hemolytic anemia (MAHA), a common CAPS symptom. During the first episode, the 69-year-old woman responded well to high-dose gl... | [
{
"companynumb": "JP-ROCHE-1793937",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "A 66-year-old man was diagnosed with synchronous early esophageal cancer and advanced gastric cancer. He received CDDP-based combination chemotherapy (docetaxcel, CDDP, and TS-1). During chemotherapy for gastric cancer, he suddenly developed septic shock, requiring intensive treatment with antibiotics,... | [
{
"companynumb": "JP-MYLANLABS-2016M1004881",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOCETAXEL"
},
"drugadditional": null,
... |
{
"abstract": "We present a case of non-surgically managed bilateral osteonecrosis of the external auditory canal with a history of long-term medical therapy for osteoporosis. A 79-year-old woman with severe osteoporosis and destructive osteoarthritis received >10 years of once weekly bisphosphonate therapy before sw... | [
{
"companynumb": "GB-AMGEN-GBRSP2021133894",
"fulfillexpeditecriteria": "2",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DENOSUMAB"
},
"drugadditional": "1",
... |
{
"abstract": "A twenty-three year old woman, admitted to the intensive care unit (ICU) with a diagnosis of menin- gitis and associated lower limb ischemia suffered a car- diac arrest, due to extreme hyperkalemia, following the administration of succinylcholine in order to replace an endo-tracheal tube. After prolong... | [
{
"companynumb": "GB-MYLANLABS-2017M1002612",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "SUCCINYLCHOLINE CHLORIDE"
},
"drugadditional"... |
{
"abstract": "This is the case report of a patient with right-sided, RAS and BRAF wild-type metastatic colorectal cancer, with borderline/potentially resectable liver-limited disease. Following neoadjuvant treatment with FOLFOX plus bevacizumab and radical resection, an early intra-hepatic disease relapse was observ... | [
{
"companynumb": "IT-SUN PHARMACEUTICAL INDUSTRIES LTD-2019RR-196894",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUOROURACIL"
},
"dr... |
{
"abstract": "Ribavirin is a key component of several hepatitis C virus (HCV) treatment regimens. However, its utility in combination with newer directly acting anti-viral agents regimens is unclear.\n\n\n\nTo determine the SVR rates with paritaprevir/ritonavir/ombitasvir/dasabuvir (PrOD) regimen ± ribavirin and com... | [
{
"companynumb": "US-JNJFOC-20180100029",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RIBAVIRIN"
},
"drugadditional": "3",
"d... |
{
"abstract": "BACKGROUND\nInfective endocarditis in intravenous drug abusers is caused mainly by Staphylococcus species and usually affects the right heart valves.\n\n\nMETHODS\nWe report the case of a 37-years-old intravenous drug abuser, who was diagnosed with infective endocarditis of the mitral and aortic valve.... | [
{
"companynumb": "GR-FRESENIUS KABI-FK201702424",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "GENTAMICIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nCerebral venous sinus thrombosis associated with protein S deficiency is rare in adolescent patients and has high disability and fatality.Patient concerns: A 15-year-old male student presented in the hospital with sudden headache, nausea, and vomiting and was diagnosed with protein S defici... | [
{
"companynumb": "CN-B.Braun Medical Inc.-2123162",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "MANNITOL"
},
"drugadditional": null,
... |
{
"abstract": "A 59-year-old woman was hospitalized in June 2012 for Stage IV bilateral breast cancer, axillary lymph-node metastasis, metastatic lung tumor, metastatic bone tumor, right carcinomatous pleuritis, and right-eye choroidal metastasis. Treatment for improvement of symptoms included steroids, continuous su... | [
{
"companynumb": "JP-MYLANLABS-2016M1004885",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CAPECITABINE"
},
"drugadditional": null,
... |
{
"abstract": "This report describes a case of fatal haemolytic uraemic syndrome (HUS) developing in a child with acute lymphoblastic leukaemia (ALL) during induction chemotherapy. The aetiology in this case is uncertain but it may have resulted from treatment with L-asparaginase or vincristine. The possibility of HU... | [
{
"companynumb": "GB-PFIZER INC-2018425163",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ASPARAGINASE"
},
"drugadditional": "3",
... |
{
"abstract": "A 40-year-old woman presented to a local clinic with abdominal distension. She was referred to our hospital for suspected ovarian cancer. Computed tomography (CT) and magnetic resonance imaging (MRI) revealed an ovarian tumor with mural nodules, ascites, pleural effusion, and peritoneal dissemination. ... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2016RR-117402",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"dru... |
{
"abstract": "BACKGROUND\nTwenty-five patients with Niemann Pick disease type C (age range: 7 months to 44 years) were enrolled in an Italian independent multicenter trial and treated with miglustat for periods from 48 to 96 months.\n\n\nMETHODS\nBased on the age at onset of neurological manifestations patients' phe... | [
{
"companynumb": "IT-ACTELION-A-CH2012-68177",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "MIGLUSTAT"
},
"drugadditional": null,
... |
{
"abstract": "The association of disulfiram-like reaction with concomitant use of metronidazole and alcohol has been reported in the literature; however, alcohol containing oral liquids may not always be identified as a culprit. A case of a 14-year-old patient who experienced a possible disulfiram-like interaction w... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2020SP008127",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"drugaddition... |
{
"abstract": "BACKGROUND Kounis syndrome is a hypersensitive coronary disorder triggered by drugs, food, and environmental factors. A 38-year-old male patient with acetaminophen-induced type 1 Kounis syndrome is described. The purpose of this paper is to show that Kounis syndrome is a serious condition that may be l... | [
{
"companynumb": "VN-B.Braun Medical Inc.-2123105",
"fulfillexpeditecriteria": "1",
"occurcountry": "VN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": nu... |
{
"abstract": "We describe a case of severe erythrocytosis caused by testosterone replacement therapy in a 66-year-old man affected with hypogonadotropic hypogonadism (HH) determining osteoporosis, resolved by switching to restoration therapy with clomiphene citrate. The patient complained fatigue, loss of libido and... | [
{
"companynumb": "IT-SA-2018SA036393",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CLOMIPHENE"
},
"drugadditional": null,
"dr... |
{
"abstract": "The global outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has had an enormous impact on the world. Owing to limited data available, it remains unclear to what extent liver transplant recipients should be considered at a higher risk of severe disease. We describe a moderate cou... | [
{
"companynumb": "DK-ALKEM LABORATORIES LIMITED-DK-ALKEM-2020-07990",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
... |
{
"abstract": "Leprechaunism was first recognized in 1954 and is characterized by severe intrauterine and postnatal growth retardation, failure to thrive, lipoatrophy, dysmorphic features (globular eyes, large ears, and micrognathia), hirsutism and acanthosis nigricans. The presented infant, a 30 day-old boy, had mul... | [
{
"companynumb": "TR-SA-2021SA135183",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "INSULIN GLARGINE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nLeptomeningeal carcinomatosis (LMC) is a rare complication of gastric cancer. Case 1. A 57-year-old female was diagnosed with gastric cancer and underwent distal gastrectomy with D2 lymph node dissection. Two years later, the patient suffered from para-aortic lymph node metastases and provi... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2016R1-110106",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOCETAXEL"
},
"druga... |
{
"abstract": "Direct-acting antiviral therapy for hepatitis C virus (HCV) infection is safe and effective, but there are little data among people who have recently injected drugs. This study evaluated the efficacy, and safety of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin for chronic HCV ... | [
{
"companynumb": "AU-KADMON PHARMACEUTICALS, LLC-KAD201811-000782",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RIBAVIRIN"
},
"drugaddi... |
{
"abstract": "Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune disorder caused by antibody to aquaporin-4 (AQP4). NMOSD can infrequently present as a complication of posterior reversible encephalopathy syndrome (PRES). Moreover, few cases of NMOSD patients with brain hemorrhage have been reported. We ... | [
{
"companynumb": "JP-PFIZER INC-2019077166",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE SODIUM SUCCINATE"
},
"druga... |
{
"abstract": "Introduction: T cell checkpoint inhibitors targeting Programmed cell Death protein-1 (PD-1) have emerged as novel immunotherapy agents showing remarkable efficacy in head and neck squamous cell carcinoma (HNSCC). Despite important clinical benefits, they are associated with side effects that occur as a... | [
{
"companynumb": "GR-009507513-2111GRC008229",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PEMBROLIZUMAB"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nPharmacokinetically guided (PK-guided) versus body surface area-based 5-fluorouracil (5-FU) dosing results in higher response rates and better tolerability. A paucity of data exists on PK-guided 5-FU dosing in the community setting.\n\n\nMETHODS\nSeventy colorectal cancer patients, from one... | [
{
"companynumb": "US-ROCHE-1500039",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEUCOVORIN CALCIUM"
},
"drugadditional": null,
... |
{
"abstract": "This series of columns has 3 main goals: (1) to explain class warnings as used by the United States Food and Drug Administration, (2) to increase awareness of movement disorders that may occur in patients treated with antipsychotic medications, and (3) to understand why clinicians should refrain from i... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2019-05428",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RISPERIDONE"
},
"drug... |
{
"abstract": "An 87-year-old woman not known to have either a lymphoma or leukemia developed a left multinodular, fish-flesh superior epibulbar and forniceal mass. A biopsy disclosed a blastic tumor with scattered multinucleated immature megakaryoblasts. Immunophenotyping of bone marrow cells revealed strong positiv... | [
{
"companynumb": "US-CELGENEUS-USA-20190201894",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AZACITIDINE"
},
"drugadditional": null,
... |
{
"abstract": "Hypersensitivity myocarditis is a rare but serious adverse effect of clozapine, a commonly used psychiatric drug. We report the case of sudden cardiac death from clozapine-induced hypersensitivity myocarditis diagnosed at autopsy. A 54-year-old Caucasian male on clozapine therapy for bipolar disorder p... | [
{
"companynumb": "US-ACCORD-048807",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CLOZAPINE"
},
"drugadditional": null,
"druga... |
{
"abstract": "BACKGROUND\nThis phase 1 trial utilising a Bayesian continual reassessment method evaluated bortezomib and sunitinib to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended doses of the combination.\n\n\nMETHODS\nPatients with advanced solid organ malignancies wer... | [
{
"companynumb": "US-TAKEDA-2018MPI006587",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BORTEZOMIB"
},
"drugadditional": "3",
... |
{
"abstract": "Treatment of intractable Pneumocystis jirovecii pneumonia (PCP) patients with primaquine (PQ) in combination with clindamycin (CLDM) was conducted by the Research Group on Chemotherapy of Tropical Diseases (RG-CTD), as a kind of compassionate use. Primaquine was not nationally licensed at the time but ... | [
{
"companynumb": "JP-TEVA-2021-JP-1949959",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLINDAMYCIN"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nProgressive multifocal leukoencephalopathy (PML) is a severe complication of natalizumab (NTZ) treatment in multiple sclerosis (MS) patients. Based on the analysis of cryopreserved cells, several reports have showed that CD62L+ CD4+ T-cells percentage drops before PML onset.\n\n\nOBJECTIVE\... | [
{
"companynumb": "FR-BIOGEN-2017BI00430503",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "NATALIZUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Three spontaneous reports of patients in whom a relationship between hypertrichosis and inhaled corticosteroids (ICS) was suspected, were reported to Lareb, The Netherlands Pharmacovigilance Center. We sought evidence for and against a causal relationship between hypertrichosis and ICS in children. The... | [
{
"companynumb": "NL-MYLANLABS-V-DE-2007-1108",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "FLUTICASONE"
},
"drugadditional": "1",
... |
{
"abstract": "Although uveitis is reported as a rare adverse event (AE) associated with dabrafenib/trametinib therapy or nivolumab, the occurrence of severe uveitis is extremely rare. We describe two cases of Vogt-Koyanagi-Harada (VKH)-like uveitis developing after the sequential administration of nivolumab and dabr... | [
{
"companynumb": "PHHY2018JP034715",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "NIVOLUMAB"
},
"drugadditional": "1",
"drugad... |
{
"abstract": "Exercise-induced purpura, which has also been called \"golfer's purpura,\" is a phenomenon that has been rarely reported in the pediatric literature. This is the first case series in which this benign vasculopathy, which is most often associated with warm weather and high-impact activity, is described.... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2019SP004190",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "TRIAMCINOLONE ACETONIDE"
},
"d... |
{
"abstract": "Pregnancy registries for women with epilepsy (WWE) are arising all over the world. The aim of this work was to assess the risk factors of pregnancy losses and major birth defects (MBDs) of WWE through the Egyptian Registry of Anti-seizure medications and Pregnancy system.\n\n\n\nAn observational prospe... | [
{
"companynumb": "EG-CHEPLA-2022000076",
"fulfillexpeditecriteria": "1",
"occurcountry": "EG",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CLONAZEPAM"
},
"drugadditional": null,
... |
{
"abstract": "Although hydroxyurea is proven effective in treatment of sickle cell anemia (SCA) and is widely prescribed in high-income countries, due to questions about feasibility of treating large numbers of patients in resource-limited health systems, its use is limited in sub-Saharan Africa (SSA), where most ch... | [
{
"companynumb": "US-TEVA-2018-US-983278",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROXYUREA"
},
"drugadditional": "3",
... |
{
"abstract": "Ralstonia species are Gram-negative bacilli that have increasingly been recognized as emerging nosocomial pathogens, particularly in immunocompromised hosts. Ralstonia pickettii is the most clinically important pathogen from the Ralstonia genus. Nosocomial outbreaks of Ralstonia pickettii infections br... | [
{
"companynumb": "PK-PFIZER INC-202100923372",
"fulfillexpeditecriteria": "1",
"occurcountry": "PK",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MEROPENEM"
},
"drugadditional": null,
... |
{
"abstract": "Combining anti-GD2 (disialoganglioside) mAb with GM-CSF, IL2, and isotretinoin is now FDA-approved for high-risk neuroblastoma minimal residual disease (MRD) therapy. The humanized anti-GD2 antibody conjugated to IL2 (hu14.18-IL2) has clinical activity in neuroblastoma and is more effective in neurobla... | [
{
"companynumb": "US-MYLANLABS-2019M1119054",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR"
},
... |
{
"abstract": "Background and Aims: The drug resistance of hepatitis B virus (HBV) originates from mutations within HBV reverse transcriptase (RT) region during the prolonged antiviral therapy. So far, the characteristics of how these mutations distribute and evolve in the process of therapy have not been clarified y... | [
{
"companynumb": "CN-GLAXOSMITHKLINE-CN2020GSK225294",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LAMIVUDINE"
},
"drugadditional": "3"... |
{
"abstract": "BACKGROUND\nImmunoglobulin E-mediated allergy to drugs and substances used during general anaesthesia as well as non-allergic drug hypersensitivity reactions may account for anaesthesia-induced anaphylaxis. As IgE-mediated anaphylaxis is a potentially life-threatening reaction, identification of the cu... | [
{
"companynumb": "DE-FRESENIUS KABI-FK201601055",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CISATRACURIUM"
},
"drugadditional": null... |
{
"abstract": "Three patients who developed renal papillary necrosis while receiving long-term, high-dose aspirin therapy for juvenile rheumatoid arthritis are presented. It appears that aspirin alone or aspirin in combination with other drugs is the causative agent. The incidence and biologic significance of renal p... | [
{
"companynumb": "US-JNJFOC-20131003180",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": null,
... |
{
"abstract": "Lipomas are the third most common benign tumor of the gastrointestinal (GI) tract, typically occurring in the colon or small intestine. Less than 100 cases of symptomatic duodenal lipomas have been reported. Symptoms include non-specific upper GI complaints of heartburn, fullness, or abdominal pain. Th... | [
{
"companynumb": "US-BAYER-2021A252408",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "POLYETHYLENE GLYCOL 3350"
},
"drugadditional": nu... |
{
"abstract": "Breast carcinoma with osteoclastic giant cells (OGCs) is a rare entity characterized by an admixture of giant cells and malignant epithelial cells within an inflammatory and vascular stroma. Denosumab is a monoclonal antibody that targets the pathway for osteoclast formation and activation, indicated f... | [
{
"companynumb": "IL-AMGEN-ISRSP2018054279",
"fulfillexpeditecriteria": "1",
"occurcountry": "IL",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DENOSUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Pseudoaneurysm formation around the ankle area is a very rare complication of an anatomic region that is highly exposed to trauma. A review of the published medical data revealed the rarity of the condition. Pseudoaneurysms of the perforating branch of the peroneal artery account for only 8 in the publ... | [
{
"companynumb": "GR-IPCA LABORATORIES LIMITED-IPC201611-000987",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "DALTEPARIN"
},
"drugaddit... |
{
"abstract": "In the present study, we aimed to clarify features of carcinomatous cirrhosis from breast cancer presenting as refractory transudate ascites and acute liver failure. In our systematic literature review, we identified 26 studies and 31 cases including our case of this rare condition. Our patient was a 4... | [
{
"companynumb": "JP-PFIZER INC-202100930501",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PACLITAXEL"
},
"drugadditional": "3",
... |
{
"abstract": "Primary peritoneal serous carcinoma (PPSC) is a rare malignancy of the peritoneum. Clinically and histopathologically, PPSC is similar to serous ovarian papillary carcinoma. Brain metastases (BM) from PPSC are exceedingly rare. We report here a new case of BM two years after complete remission from a P... | [
{
"companynumb": "TN-SUN PHARMACEUTICAL INDUSTRIES LTD-2017RR-159825",
"fulfillexpeditecriteria": "1",
"occurcountry": "TN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PACLITAXEL"
},
"drug... |
{
"abstract": "Spinal anesthesia (SA) is being increasingly used in infants to avoid the potential negative neurocognitive effects of general anesthesia (GA). However, SA has been reported to provide a relatively short duration of surgical anesthesia.\n\n\n\nWe retrospectively reviewed SA cases for surgical procedure... | [
{
"companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-030575",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLONIDINE HYDROCHLORIDE"
}... |
{
"abstract": "OBJECTIVE\nTo assess the short term safety and tolerability of a fixed dose combination (FDC) of olmesartan, amlodipine and hydrochlorothiazide (OAH) in real-world clinical setting in India.\n\n\nMETHODS\nPhysicians were requested to provide eight weeks observational clinical event data of the patients... | [
{
"companynumb": "IN-DSJP-DSU-2015-110647",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMLODIPINE BESYLATE\\HYDROCHLOROTHIAZIDE\\OLMESARTAN MEDOXOMIL"
... |
{
"abstract": "OBJECTIVE\nWe reported the alveolar bone histology prior to dental extractions in cancer patients, who received bone-targeting agents (BTA).\n\n\nMETHODS\nFifty-four patients were included. Patients underwent extractions, and bone biopsies were taken.\n\n\nRESULTS\nExtractions were performed due to pai... | [
{
"companynumb": "GR-AMGEN-GRCSP2020042125",
"fulfillexpeditecriteria": "2",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DENOSUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Hemophagocytic lymphohistiocytosis (HLH) is a rare, hyperinflammatory syndrome characterized by clinical signs and symptoms of extreme inflammation. In adults, HLH is typically a complication of infections, autoimmune diseases, and malignancies. While the disease is often fatal, classic management of H... | [
{
"companynumb": "US-ACCORD-157512",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": null,
"druga... |
{
"abstract": "Hypercalcemia in pregnancy is an uncommon event that can cause major maternal morbidity and/or fetal or neonatal morbidity and mortality. Management is a challenge for the clinicians, especially as regards to investigations in pregnancy, surgery, and the use of cinacalcet and bisphosphonates. We presen... | [
{
"companynumb": "CA-MYLANLABS-2016M1046801",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SODIUM CHLORIDE"
},
"drugadditional": "3",
... |
{
"abstract": "A 59 year-old woman was treated with adjuvant chemotherapy for triple negative breast cancer (TNBC) stage IB. She received pegfilgrastrim as secondary prophylaxis of neutropenia. After administration of pegfilgrastrim on day 11, she was hospitalised because of carotidynia and myocarditis that improved ... | [
{
"companynumb": "ES-AMGEN-ESPSP2020114458",
"fulfillexpeditecriteria": "2",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PEGFILGRASTIM"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nTranscatheter valve replacement (TAVR) is an important therapeutic intervention for patients with aortic valve stenosis. As TAVR has become available to a broader population, there has been an increase in the number of less common, yet potentially catastrophic, complications. TAVR related i... | [
{
"companynumb": "US-LUPIN PHARMACEUTICALS INC.-2021-26333",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"drugadditio... |
{
"abstract": "An 83-year-old man under warfarin therapy presented for assessment of prolonged prothrombin time and cough. High-resolution computed tomography findings of the chest showed diffuse alveolar hemorrhage. His international normalized ratio (INR) was 11.89. He had been treated with rifampicin for a persist... | [
{
"companynumb": "JP-AKORN PHARMACEUTICALS-2019AKN00406",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "BENIDIPINE"
},
"drugadditional":... |
{
"abstract": "BACKGROUND\nThe evidence to date on the relationship between antipsychotic drugs and the risk of venous thromboembolism (VTE) is limited.\n\n\nOBJECTIVE\nOur aim was to examine the association between the use of typical and atypical antipsychotics and risk of VTE and to assess the effects of dose and d... | [
{
"companynumb": "US-JNJFOC-20141113213",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RISPERIDONE"
},
"drugadditional": null,
... |
{
"abstract": "Catatonia may be more common in children and adolescents than previously thought. A boost for the recognition of pediatric catatonia comes from changes in Diagnostic and Statistical Manual of Mental Disorders, 5th edition, facilitating the diagnosis in a wide range of pediatric and adult patients with ... | [
{
"companynumb": "US-OTSUKA-2019_008494",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "MELATONIN"
},
"drugadditional": null,
... |
{
"abstract": "A 46-year-old man who had previously undergone open surgery for renal cell carcinoma (RCC) developed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph-ALL). After the induction therapy, he achieved complete molecular remission. However, fever and bilateral buttock pain continued during ... | [
{
"companynumb": "JP-TAKEDA-2020TUS027759",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PONATINIB"
},
"drugadditional": "3",
... |
{
"abstract": "We present the case of a 37 years old patient with idiopathic pulmonary arterial hypertension (PAH). After initial treatment with calcium channel blockers (CCB), based on a positive vasoreactive response at right heart catheterization, due to disease progression, major vasodilator therapies were introd... | [
{
"companynumb": "RO-PFIZER INC-2014273189",
"fulfillexpeditecriteria": "1",
"occurcountry": "RO",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "BOSENTAN\\BOSENTAN MONOHYDRATE"
},
"drugaddit... |
{
"abstract": "Serotonin syndrome (SS) is a potentially fatal condition associated with increased serotonergic activity in the central nervous system that can be attributed to certain drugs or interactions between drugs. There are some published articles reporting this syndrome caused by the combination of fentanyl a... | [
{
"companynumb": "MX-WATSON-2015-21443",
"fulfillexpeditecriteria": "1",
"occurcountry": "MX",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "FENTANYL"
},
"drugadditional": null,
"dr... |
{
"abstract": "Colorectal cancer (CRC) has a propensity to metastasize to the liver, lungs and regional abdominal lymph nodes, but rarely to the bone marrow. A 60-year-old man presented to the National Hospital Organization Kyushu Cancer Center with a 4-week history of persistent lower back pain, anorexia and difficu... | [
{
"companynumb": "JP-PFIZER INC-2016478022",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CAPECITABINE"
},
"drugadditional": null,
... |
{
"abstract": "A 63-year-old woman with diabetes type II and a history of breast cancer was treated with clozapine for her refractory schizophrenia. She developed a dilated cardiomyopathy with an ejection fraction of 25%, a life-threatening event. The cause of heart failure could be multifactorial, with clozapine, fa... | [
{
"companynumb": "NL-GLENMARK PHARMACEUTICALS-2017GMK028019",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CLOZAPINE"
},
"drugadditional... |
{
"abstract": "We present data on a 10-year-old patient with drug-resistant epilepsy who was treated with methylphenidate for symptoms of attention deficit hyperactivity disorder (ADHD) that developed after she underwent surgical resection of a left frontal cortical dysplasia. . The patient's parents reported methylp... | [
{
"companynumb": "US-CIPLA LTD.-2021US07257",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LAMOTRIGINE"
},
"drugadditional": null,
... |
{
"abstract": "Preclinical studies have shown reproductive toxicity with bosutinib, but little is known about its effects during conception or pregnancy in humans.\nPregnancy cases in patients receiving bosutinib were identified from the Pfizer safety database.\nThirty-three pregnancy reports were identified. Sixteen... | [
{
"companynumb": "US-TARO-2020TAR01805",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BENDROFLUMETHIAZIDE"
},
"drugadditional": "3",
... |
{
"abstract": "This study describes the clinical presentation, treatment, and outcomes of SARS-CoV-2 infection in lung transplant recipients (LTRs). This is a multicenter, retrospective study of all adult LTRs with confirmed SARS-CoV-2 infection from March 4 until April 28, 2020 in six Spanish reference hospitals for... | [
{
"companynumb": "ES-VELOXIS PHARMACEUTICALS-2021VELES-000367",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LOPINAVIR\\RITONAVIR"
},
"d... |
{
"abstract": "Paraneoplastic syndromes associated with prostate cancer that cause visual disturbances are rare. We present the case of a 71 year old man with a history of adenocarcinoma of the prostate who developed cancer associated retinopathy concomitant with small cell transformation. This represents an unusual ... | [
{
"companynumb": "AU-PFIZER INC-2019286978",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nPatients undergoing double-balloon enteroscopy require sedatives such as midazolam; however, patient's body motion often hampers the outcome of double-balloon enteroscopy. Recently, dexmedetomidine has been used for endoscopic sedation and was reported to effectively reduce body motion. This... | [
{
"companynumb": "JP-PFIZER INC-2018435619",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEXMEDETOMIDINE HYDROCHLORIDE"
},
"drugadditio... |
{
"abstract": "Takotsubo cardiomyopathy is a cardiac syndrome characterized by transient left ventricular dysfunction. A 61-year-old woman underwent laparoscopic cholecystectomy under general anesthesia. During recovery from general anesthesia, several arrhythmias occurred without cardiac collapse following desfluran... | [
{
"companynumb": "JP-BAXTER-2015BAX046500",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DESFLURANE"
},
"drugadditional": null,
... |
{
"abstract": "A 60-year-old man had visited our hospital a few times due to vomiting since July 2008. In January 2009, because he was no longer able to eat, he was hospitalized to receive close examination. Single balloon enteroscopy revealed jejunal adenocarcinoma. After examination of the whole body, as there was ... | [
{
"companynumb": "PHHY2015JP067279",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "IRINOTECAN"
},
"drugadditional": null,
"drug... |
{
"abstract": "BACKGROUND\nThe purpose of the study is to analyse the prevalence of hepatitis B virus (HBV) infection and its incidence of reactivation among multiple myeloma (MM) patients treated in the era of novel therapy in an endemic Asian setting.\n\n\nMETHODS\nFrom 2000 to 2008, 273 patients with newly diagnos... | [
{
"companynumb": "SG-CELGENEUS-141-CTHAL-12020190",
"fulfillexpeditecriteria": "1",
"occurcountry": "SG",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadd... |
{
"abstract": "Postmortem redistribution (PMR) refers to the site- and time-related blood drug concentration variations after death. We compared central blood (cardiac and subclavian) with peripheral blood (femoral and popliteal) concentrations of diazepam, methadone, and morphine. To our knowledge, popliteal blood h... | [
{
"companynumb": "BE-ALLERGAN-1821858US",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MORPHINE SULFATE"
},
"drugadditional": null,
... |
{
"abstract": "Increased galectin-3 expression has been currently showed to be associated with poor prognosis in some hematological malignancies, such as acute myeloid leukemia, diffuse large B cell lymphoma. However, little is known about the clinical significance of galectin-3 in patients with acute promyelocytic l... | [
{
"companynumb": "CN-CHEPLA-C20170324",
"fulfillexpeditecriteria": "2",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ARSENIC TRIOXIDE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nRosai Dorfman disease (RDD) is a rare disorder that typically presents with bilateral cervical lymphadenopathy and follows a benign course.\n\n\nOBJECTIVE\nWe present a case of late-onset atypical primary cutaneous RDD that is resistant to treatment modalities described in the literature.\n... | [
{
"companynumb": "CA-CELGENEUS-CAN-20170609215",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nAPF530 is a novel sustained-release formulation of granisetron. In a Phase III trial, APF530 500 mg was noninferior to palonosetron 0.25 mg in preventing acute chemotherapy-induced nausea and vomiting (CINV) after moderately (MEC) or highly emetogenic chemotherapy (HEC) and delayed CINV aft... | [
{
"companynumb": "US-JNJFOC-20151017206",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VINBLASTINE"
},
"drugadditional": null,
... |
{
"abstract": "Electroconvulsive therapy (ECT) has been recognized as an effective treatment option in catatonia, and for prolonged or severe affective episodes and schizophrenia. Response rates vary from 40 to 80% in adolescents. The procedure is safe if the required precautions are undertaken. Nonetheless, ECT rema... | [
{
"companynumb": "PL-Orion Corporation ORION PHARMA-SERT2021-0013",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "SERTRALINE HYDROCHLORIDE"
},
... |
{
"abstract": "The management of Women With Epilepsy (WWE) in pregnancy is a challenge that demands balancing the risks of Major Congenital Malformation (MCM) on one hand with adequate seizure control on the other. While most studies have analysed the risks of Anti-Epileptic Drugs (AED) exposure in the first trimeste... | [
{
"companynumb": "IN-UCBSA-2018036804",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "3",
... |
{
"abstract": "We report a 72-year-old male with past medical history of stage IV squamous lung cancer treated with radiation therapy and chemotherapy with gemcitabine/carboplatin. One year later, he presented with hemoptysis treated with another session of palliative radiotherapy. Two weeks later, patient developed ... | [
{
"companynumb": "US-DRREDDYS-USA/USA/17/0094973",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GEMCITABINE\\GEMCITABINE HYDROCHLORIDE"
},
... |
{
"abstract": "We report two methods of intraoperative fetal heart rate (FHR) monitoring in cases of cerebral arteriovenous malformation surgery during pregnancy. In one case in her third trimester, cardiotocography was used. In another case in her second trimester, ultrasound sonography was used, with a transesophag... | [
{
"companynumb": "JP-MYLANLABS-2016M1047954",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PROPOFOL"
},
"drugadditional": null,
... |
{
"abstract": "Alemtuzumab is an anti-CD52 monoclonal antibody recently licensed for use in relapsing-remitting multiple sclerosis. Here, we report our experience of its use in neuromyelitis optica (NMO) spectrum disorders. A retrospective case review of patients treated with alemtuzumab in Cambridge, UK, was conduct... | [
{
"companynumb": "DE-SA-2016SA212921",
"fulfillexpeditecriteria": "2",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": "3",
... |
{
"abstract": "Hemophagocytic lymphohistiocytosis (HLH) is a rare disease that can be fatal in pregnancy. We report two cases of severe HLH that highlight etoposide use in pregnancy.\n28-year-old G2P1 with lupus presented at 18 weeks with acute hypoxic respiratory failure, hepatic dysfunction, leukopenia, thrombocyto... | [
{
"companynumb": "US-ACCORD-117527",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": null,
"d... |
{
"abstract": "We will present a 42-year-old woman with acute myeloid leukemia and pulmonary aspergillosis. She was treated with several antifungal agents, including three triazoles. Voriconazole, posaconazole, and isavuconazole all led to hepatocellular liver injury. Voriconazole administration led to a peak alanine... | [
{
"companynumb": "CH-PFIZER INC-2019291078",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "POSACONAZOLE"
},
"drugadditional": "1",
... |
{
"abstract": "In this case report, we describe a patient who has a persistent left superior vena cava (PLSVC) manifesting as a transient ischemic attack (TIA) and a remote brain abscess. PLSCV, when draining in the left atrium, is a cause of right to left shunt, and it has been related to brain abscesses and, as rep... | [
{
"companynumb": "ES-BAXTER-2018BAX009187",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "SODIUM CHLORIDE"
},
"drugadditional": null,
... |
{
"abstract": "Reversible myoclonus, tremor, and asterixis induced by high dose trimethoprim-sulfamethoxazole.\n\n\nMETHODS\nThe patient was a 66-year-old male with T9 AIS(1) C quadriplegia secondary to spinal cord compression by a tumor due to large B cell lymphoma. Subsequent to tumor resection and chemotherapy, th... | [
{
"companynumb": "US-PFIZER INC-2016051626",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "3",
... |
{
"abstract": "An 81-year-old male and a 47-year-old female experienced recurrent severe bullous dermatosis secondary to an intake of drugs and alternative medicines indicated for arthralgias. The first patient had previously presented with Stevens-Johnson/toxic epidermal necrolysis (TEN) overlap syndrome in 2007 sec... | [
{
"companynumb": "MX-GLENMARK PHARMACEUTICALS INC, USA.-2016GMK024552",
"fulfillexpeditecriteria": "1",
"occurcountry": "MX",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "NAPROXEN"
},
"druga... |
{
"abstract": "Massive splenic infarction and portal vein thrombosis (PVT) due to chronic myeloid leukemia (CML) is extremely rare. We describe 2 children who were presented with massive splenic infarction and PVT in the course of CML. Massive splenic infarction and PVT treated with splenectomy in one and with medica... | [
{
"companynumb": "PHHY2015TR000574",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROXYUREA"
},
"drugadditional": null,
"dru... |
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