article dict | reports listlengths 1 3.97k |
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{
"abstract": "We report a case of a male patient of 52 years old with a 3 months history of pushing, tenesmus, hematochezia, pain while defecating, lost of 18 kg of weight, fever, fecaloid and purulent discharge through an perianal hole. During the colonoscopy procedure, we found many ulcers in the ascending, transv... | [
{
"companynumb": "PHHY2017PE028387",
"fulfillexpeditecriteria": "1",
"occurcountry": "PE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DICLOFENAC"
},
"drugadditional": "3",
"druga... |
{
"abstract": "BACKGROUND\nThere is insufficient information in the literature on the comparative efficacy and tolerability of methotrexate (MTX) and methylprednisolone (MP) in patients with pulmonary sarcoidosis in assessing primary outcomes and the relapse rate.\n\n\nOBJECTIVE\nThe aim of our study was to evaluate ... | [
{
"companynumb": "UA-PFIZER INC-202101016202",
"fulfillexpeditecriteria": "1",
"occurcountry": "UA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": nul... |
{
"abstract": "Leflunomide is an immunosuppressive agent commercialized for treatment of rheumatoid arthritis. Because of its immunosuppressive and possible antiviral properties, leflunomide has been evaluated in some case series of BKVAN with favorable results, mostly in adult patients. Leflunomide targeted levels a... | [
{
"companynumb": "FR-PBT-000045",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "1",
... |
{
"abstract": "Childhood primary angiitis of the central nervous system (cPACNS) is a rare inflammatory disease of brain vessels. The small vessel subtype is diagnosed on brain biopsy and often presents with cognitive and behavioral changes, headaches, and seizures. However, there are few reported cases of super-refr... | [
{
"companynumb": "CA-PFIZER INC-2020394447",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MIDAZOLAM"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nStatus Epilepticus is the most common non-traumatic neurologic emergency in childhood. Current algorithms prioritize the use of benzodiazepines as first line treatment followed by Levetiracetam or Valproic Acid, possibly Fosphenytoin and eventually high dose Propofol and intubation.\n\n\nME... | [
{
"companynumb": "US-ALVOGEN-2021-ALVOGEN-117844",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LORAZEPAM"
},
"drugadditional": "3",
... |
{
"abstract": "The objective of this study was to determine a safe and effective dose of granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells in patients with advanced heart failure and to determine its effects on the cytokine profile. Patients with advanced heart failure (n = 6) and imp... | [
{
"companynumb": "PHHY2018US135964",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "GRANULOCYTE COLONY-STIMULATING FACTOR NOS"
},
"drugadd... |
{
"abstract": "Background and Aim: The vast majority of the 2.7 million individuals in the United States who are currently infected with hepatitis C virus (HCV) were born between 1945 and 1965. The median age of these patients in this particular generation at the time of this writing was 55 years. In the general popu... | [
{
"companynumb": "US-009507513-1706USA005019",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "UNSPECIFIED INGREDIENT"
},
"drugadditional":... |
{
"abstract": "A 19-year-old man presented with unilateral sudden onset vision loss following an intra-articular triamcinolone injection in the right temporomandibular joint. At fundus examination emboli of triamcinolone were visible in multiple retinal arteries. Choroidal ischaemia and occlusion of the central retin... | [
{
"companynumb": "PHHY2017IN155935",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TRIAMCINOLONE"
},
"drugadditional": "3",
"dr... |
{
"abstract": "The occurrence of seizures during pregnancy is really a challenging situation which risks the health of both mothers and fetuses. However, new onset epilepsy is unpredictable in pregnancy, and its clinic feature is barely known. This study aimed to explore the clinical characteristics and pregnancy out... | [
{
"companynumb": "CN-UCBSA-2019032785",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nThe anaplastic lymphoma kinase (ALK) gene fusion rearrangement is a potent oncogene, accounting for 2-7% of lung adenocarcinomas, with higher incidence (17-20%) in non-smokers. ALK-positive tumors are sensitive to ALK tyrosine kinase inhibitors (TKIs), thus ALK-positive non-small-cell lung ... | [
{
"companynumb": "HU-MYLANLABS-2020M1098480",
"fulfillexpeditecriteria": "1",
"occurcountry": "HU",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CRIZOTINIB"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nSystemic adverse effects of intravenous antivascular endothelial growth factor (VEGF) therapy include: hypertension, proteinuria, renal failure, and thrombotic microangiopathy. Intravitreal therapy with these agents is generally believed to be safe.\n\n\nMETHODS\nWe report 2 cases of renal ... | [
{
"companynumb": "US-REGENERON PHARMACEUTICALS, INC.-2014-19746",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RANIBIZUMAB"
},
"drugaddi... |
{
"abstract": "Objectives: To compare the efficacy of cyclosporin A (CsA) alone and CsA combined with recombined human thrombopoietin (rhTPO) in patients with non-severe aplastic anemia (NSAA) . Methods: Data from 83 patients with NSAA between August 2014 and February 2019 were collected retrospectively. The study po... | [
{
"companynumb": "NVSC2020CN264488",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "Most pregnancy-related sacral stress fractures occur after delivery. This case aims to emphasise that stress fractures can occur before delivery, and since excessive weight gain is a risk factor, pregnant women should avoid gaining excess weight, especially during quarantine. This patient, who gained 2... | [
{
"companynumb": "TR-LUPIN PHARMACEUTICALS INC.-2021-14627",
"fulfillexpeditecriteria": "2",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditio... |
{
"abstract": "We compared three fludarabine-based regimens for systemic sclerosis patients with a high-risk cardiac phenotype that according to EBMT criteria would be a contraindication for a high-dose cyclophosphamide (200 mg/kg) transplant regimen. All three regimens included fludarabine, ATG, and cyclophosphamide... | [
{
"companynumb": "NVSC2020US195047",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": "3",
... |
{
"abstract": "Boerhaave's syndrome is an uncommon syndrome characterized by spontaneous rupture of the oesophagus with a high mortality rate. While excessive alcohol intake and binge-eating are the classic precipitants of this syndrome, medication-induced vomiting causing Booerhave's is quite uncommon. Traditionally... | [
{
"companynumb": "NG-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-298441",
"fulfillexpeditecriteria": "1",
"occurcountry": "NG",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PENTAZOCINE"
},
"dru... |
{
"abstract": "The highest postmortem metformin concentrations are recorded utilizing a sensitive and specific analytical procedure. The peripheral blood metformin concentration was 240 mg/L, the liver concentration was 240 mg/kg and the gastric concentration was 1,700 mg. Additionally, an antemortem blood sample col... | [
{
"companynumb": "US-RANBAXY-2013US-72990",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CLONAZEPAM"
},
"drugadditional": null,
... |
{
"abstract": "Nasopharyngeal carcinoma (NPC), an uncommon malignancy in Western Countries and Radiotherapy, remains an effective treatment. Its side effects are classified as either immediate or late; postradiation necrosis is as an important late side effect with a strong impact on the prognosis in patients with NP... | [
{
"companynumb": "CH-TEVA-2019-CH-1153180",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PACLITAXEL"
},
"drugadditional": null,
... |
{
"abstract": "To examine methylphenidate extended-release chewable tablets (MPH ERCT) dose patterns, attention-deficit/hyperactivity disorder (ADHD) symptom scores, and safety during the 6-week, open-label (OL) dose-optimization period of a phase 3, laboratory classroom study.\n\n\n\nBoys and girls (6-12 years) diag... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2021-03828",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPHENIDATE HYDROCHLORIDE"
... |
{
"abstract": "Bullous pemphigoid (BP) is an autoimmune disorder which is usually chronic, with blistering that predominantly affects the skin and occasionally the mucosa, and which includes several different types. One of them is a very rare dyshidrosiform type which is localized on the hands and feet with small or ... | [
{
"companynumb": "HR-SAOL THERAPEUTICS-2019SAO00405",
"fulfillexpeditecriteria": "1",
"occurcountry": "HR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "WARFARIN"
},
"drugadditional": null,... |
{
"abstract": "OBJECTIVE\nTo compare the efficacy of dolutegravir plus lamivudine dual therapy (DT) with that of dolutegravir plus two NRTIs triple therapy (TT) as switch strategies.\n\n\nMETHODS\nA multicentre cohort of HIV-positive, HBsAg-negative patients with viral suppression (HIV-RNA ≤50 copies/mL) switching to... | [
{
"companynumb": "IT-ViiV Healthcare Limited-IT2021GSK255665",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOLUTEGRAVIR"
},
"drugadditi... |
{
"abstract": "We sought to determine the rate of incident neutropenia and identify potential clinical factors associated with incident neutropenia among patients treated with long courses of ceftaroline.\n\n\n\nWe retrospectively identified adult patients who received ceftaroline for ≥7 days consecutively at two lar... | [
{
"companynumb": "US-FRI-1000087647",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DOXYCYCLINE"
},
"drugadditional": null,
"d... |
{
"abstract": "Prototheca is a genus of achlorophyllic algae present ubiquitously in the environment. Human infections are rare affecting immunocompromised individuals. We report a case of fatal algaemia caused by Prototheca zopfii in a patient who underwent liver transplant. Tissue diagnosis is mandatory for diagnos... | [
{
"companynumb": "IN-MYLANLABS-2019M1005109",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "Objective Rectal lymphoid follicular aphthous (LFA) lesions are related to ulcerative colitis (UC) and can be initial lesions of UC. We investigated the clinical course and prognosis of rectal LFA lesions. Methods This is a retrospective analysis of the clinical records at a single center. Patients Thi... | [
{
"companynumb": "JP-MYLANLABS-2019M1046568",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MESALAMINE"
},
"drugadditional": "4",
... |
{
"abstract": "To analyze whether magnesium has a neuroprotective effect during episodes that indicate a critical brain perfusion after aneurysmal subarachnoid hemorrhage (SAH).\n107 patients with aSAH were randomized to continuously receive intravenous magnesium sulfate with target serum levels of 2.0 - 2.5 mmol/l (... | [
{
"companynumb": "DE-PENTEC HEALTH-2018PEN00053",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "MAGNESIUM SULFATE"
},
"drugadditional": "... |
{
"abstract": "Wernick's Encephalopathy (WE) is an acute neuropsychiatric syndrome caused by thiamine deficiency post hematopoietic stem cell transplant (HSCT). WE is associated with high mortality and morbidity rates, but due to its rare occurrence, it is rarely considered in patients submitted to this procedure. Co... | [
{
"companynumb": "BR-FRESENIUS KABI-FK201900096",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SODIUM CHLORIDE"
},
"drugadditional": "3"... |
{
"abstract": "Carbamazepine and oxcarbazepine are used for behavioral disorders following organic diseases. After severe acquired brain injury, patients may develop frontal symptoms. In our neurological rehabilitation routine, oxcarbazepine is used for better safety over carbamazepine, although its efficacy is not c... | [
{
"companynumb": "IT-NOVARTISPH-NVSC2022IT024945",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "OXCARBAZEPINE"
},
"drugadditional": "1",... |
{
"abstract": "Cerebral vasculitis is a serious complication of bacterial meningitis that can cause significant morbidity and mortality due to stroke. Currently, there are no treatment guidelines or safety and efficacy studies on the management of cerebral vasculitis in this context. Herein, we report a case of a pre... | [
{
"companynumb": "CA-BAUSCH-BL-2021-024245",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CEFTRIAXONE"
},
"drugadditional": null,
... |
{
"abstract": "Organising pneumonia (OP) in rheumatoid arthritis (RA) may be part of pulmonary manifestation (disease related) or disease-modifying antirheumatic drugs (DMARDs) related. We report a case series of RA patients with DMARDs related OP. A 65-year-old woman developed OP 3 weeks after initiation of methotre... | [
{
"companynumb": "MY-PFIZER INC-2021058854",
"fulfillexpeditecriteria": "1",
"occurcountry": "MY",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nIn children, paracetamol overdose due to deliberate self-poisoning, accidental exposure or medication errors can lead to paediatric acute liver failure and death. In Australia and New Zealand, the nature of ingestion and outcomes of paracetamol-associated paediatric acute liver failure have... | [
{
"companynumb": "PHHY2015NZ005903",
"fulfillexpeditecriteria": "1",
"occurcountry": "NZ",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": null,
"d... |
{
"abstract": "A 63-year-old man with pharyngeal cancer had been prescribed pilocarpine hydrochloride for xerostomia after concomitant chemoradiotherapy. After 6 months of taking pilocarpine hydrochloride, he was referred to our hospital due to gradually developing renal insufficiency. The patient underwent detailed ... | [
{
"companynumb": "NVSC2020JP001520",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PILOCARPINE HYDROCHLORIDE"
},
"drugadditional": "1",
... |
{
"abstract": "Purpose: Multiple myeloma is an insidious haematological malignancy characterised by monoclonal proliferation of plasma cells in the bone marrow. Extramedullary plasmacytoma is a rare manifestation of multiple myeloma and usually occurs in the upper respiratory tract. Orbital involvement is particularl... | [
{
"companynumb": "PHHY2019AU165141",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ZOLEDRONIC ACID"
},
"drugadditional": "3",
"... |
{
"abstract": "Case 1 was a 70-year-old man, and case 2 was a 65-year-old woman. Both were diagnosed with type 2 advanced HER2-positive gastric cancer. Capecitabine, cisplatin, and trastuzumab (HXP therapy) were administered to both patients. However, both patients developed peritonitis caused by gastric cancer perfo... | [
{
"companynumb": "JP-MYLANLABS-2017M1005947",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": "1",
... |
{
"abstract": "The present study reported a case of portopulmonary hypertension (POPH) that was secondary to underlying liver cirrhosis in a 58-year-old woman, who was successfully treated with low-dose tolvaptan. The patient had suffered from refractory peripheral edema and electrolyte abnormalities, including sever... | [
{
"companynumb": "JP-TEVA-735077ISR",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "BOSENTAN"
},
"drugadditional": "1",
"drugad... |
{
"abstract": "Enoxaparin sodium is a heparin of low molecular weight with antithrombotic properties that acts by inhibiting factor Xa. We present a 59-year-old woman who developed heparin-related bullous hemorrhagic dermatosis, at sites distant from the injections, one month after starting treatment with enoxaparin.... | [
{
"companynumb": "PHHY2014ES146842",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "ENOXAPARIN SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "Gummy formulations are widely available with estimated 65% marketed for children. Currently, there are few studies describing children ingesting gummy formulated medications. The aim of this study was to quantify and identify the type of ingestions due to gummy formulated medications, evaluate their cl... | [
{
"companynumb": "US-HETERO-HET2021US01613",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VITAMINS"
},
"drugadditional": "3",
... |
{
"abstract": "Fungal pathogens can be the source of serious and sometimes fatal infections following organ transplantation. To the best of our knowledge, we present the first case of cutaneous blastomycosis in a renal allograft recipient in India, a country outside the known endemic regions. This case, with the very... | [
{
"companynumb": "PHHY2015IN116734",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
"drug... |
{
"abstract": "Severe thrombocytopenia with impairment of the activity of platelets and impairment of blood clotting occurs in dengue hemorrhagic fever (DHF). Continuation of dual antiplatelet therapy in such patients can result in life-threatening hemorrhages. On the other hand, withholding of antiplatelets in a pat... | [
{
"companynumb": "LK-GENUS_LIFESCIENCES-USA-POI0580202000208",
"fulfillexpeditecriteria": "1",
"occurcountry": "LK",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CLOPIDOGREL BISULFATE"
},
"... |
{
"abstract": "Procalcitonin (PCT), a marker of the inflammatory response during infections, can be elevated by diabetic ketoacidosis (DKA). A male patient in his 50s with diabetic nephropathy on hemodialysis presented with vomiting and a reduced level of consciousness and was diagnosed with DKA. His PCT level was ma... | [
{
"companynumb": "JP-NOVOPROD-855576",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "INSULIN ASPART"
},
"drugadditional": "4",
... |
{
"abstract": "Early severe preeclampsia with changes consistent with the Hemolysis elevated liver enzymes low platelet count (HELLP) variant and severe fetal growth restriction rarely resolves prior to delivery. Established clinical disease is preceded by endothelial dysfunction and inflammation. Endothelial activat... | [
{
"companynumb": "NZ-MYLANLABS-2016M1018156",
"fulfillexpeditecriteria": "1",
"occurcountry": "NZ",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METHYLDOPA"
},
"drugadditional": null,
... |
{
"abstract": "Aspergillus fumigatus can cause a variety of pulmonary syndromes including allergic bronchopulmonary aspergillosis (ABPA), chronic pulmonary aspergillosis and invasive pulmonary aspergillosis (IPA). Occurrence of IPA and ABPA in the same patient is rare as the risk factors for ABPA and IPA are differen... | [
{
"companynumb": "IN-MYLANLABS-2015M1043021",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": null... |
{
"abstract": "In an effort to maintain high primary response rates against multiple myeloma and without serious toxicity, we assessed 3 different bortezomib combinations in small numbers of patients, with combinations that included cyclophosphamide and lenalidomide in modest doses and for short courses. Remissions o... | [
{
"companynumb": "US-JNJFOC-20130111702",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"drugadditional": null,
... |
{
"abstract": "We experienced rocuronium-induced anaphylaxis in a 62-year-old man who was scheduled for laparoscopic ileocecal excision for cecal cancer under general anes- thesia. The patient did not have a preoperative history and examinations suggestive of heart disease, or pre- disposing factors for myocardial in... | [
{
"companynumb": "JP-MYLANLABS-2019M1010764",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "REMIFENTANIL"
},
"drugadditional": null,
... |
{
"abstract": "A 46-year-old man with a history of paranoid schizophrenia was admitted with a recurrence of psychotic symptoms. Improvement was noted after the initiation of clozapine. After 2 weeks of clozapine therapy, chest pressure and abnormal cardiac biomarkers (in the presence of a normal coronary angiogram) r... | [
{
"companynumb": "PHHY2015US052244",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CLOZAPINE"
},
"drugadditional": null,
"druga... |
{
"abstract": "BACKGROUND Acute intermittent porphyria is an inherited disease caused by a defect in heme biosynthesis, with accumulation of neurotoxic metabolites leading to acute neurovisceral symptoms. Some patients develop long-term neurological and renal damage after the acute episodes, many of them requiring he... | [
{
"companynumb": "BR-NUVO PHARMACEUTICALS INC-2107242",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PHENYTOIN"
},
"drugadditional": "1"... |
{
"abstract": "BACKGROUND\nAripiprazole is a third generation antipsychotic approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia. Aripiprazole is available as oral and long-acting injectable (LAI) depot formulations, with a unique mechanism of action comprising partial D2 and serot... | [
{
"companynumb": "US-OTSUKA-2020_026401",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "Data regarding ceftaroline use for meticillin-resistant Staphylococcus aureus bacteraemia (MRSAB) are lacking. Here we review the outcomes of 31 patients with MRSAB treated with ceftaroline, including 9 patients with endocarditis. Clinical success was observed in 23 patients (74.2%). Adverse events ass... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2017SP003872",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"drugadditional... |
{
"abstract": "Myasthenia gravis (MG), a neuromuscular junction autoimmune disease, sometimes complicates second malignancies; however, T-cell lymphoproliferative disorders have rarely been reported. A 55-year-old man, who received oral tacrolimus and prednisolone for MG for 16 years after thymectomy, presented with ... | [
{
"companynumb": "JP-ACCORD-062548",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "1",
"druga... |
{
"abstract": "Patients with chronic kidney disease (CKD) are commonly at high risk of tuberculosis (TB). Conversely, TB rarely causes tubulointerstitial nephritis. A 75-year-old Japanese man who was undergoing periodic follow-ups for CKD stage G3aA3 with membranous nephropathy was diagnosed with acute kidney injury ... | [
{
"companynumb": "JP-DSJP-DSJ-2022-106788",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OLMESARTAN MEDOXOMIL"
},
"drugadditional": "3",... |
{
"abstract": "BACKGROUND\nMinocycline-induced pigmentation of bone (black bone) is well described in tooth-bearing intra-oral bone, but is less known in periarticular bone in patients who have undergone total joint arthroplasty. On a retrospective basis, we investigated the short-term clinico-radiological results of... | [
{
"companynumb": "FR-ALKEM LABORATORIES LIMITED-FR-ALKEM-2019-01345",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MINOCYCLINE\\MINOCYCLINE HYDROCHLORIDE"
... |
{
"abstract": "OBJECTIVE\nTo expand the adverse events associated with metronidazole to include nonconvulsive status epilepticus (NCSE).\n\n\nMETHODS\nObservational single case report of a rare association.\n\n\nMETHODS\nHospitalized lung transplant recipient treated with metronidazole for prevention of infection.\n\... | [
{
"companynumb": "BR-PFIZER INC-2014179020",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "Bipolar disorder is associated with a high risk of suicide attempts and suicide deaths. The suicide mortality of people with bipolar disorder is approximately 25 times higher than the general population. No approved pharmacological strategies for suicidal thoughts and attempts in bipolar disorder have ... | [
{
"companynumb": "PL-ALEMBIC PHARMACUETICALS LIMITED-2019SCAL000586",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "OLANZAPINE"
},
"druga... |
{
"abstract": "Early neonatal meningitis with non-fermenting Gram negative bacilli (NFGNB) is rare, and whenever it occurrs, inanimate environment is usually implicated as the source. The authors report a case of neonatal meningitis and sepsis with Chryseobacterium indologenes, a rare non fermenting Gram negative bac... | [
{
"companynumb": "IN-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-295809",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CIPROFLOXACIN"
},
"d... |
{
"abstract": "Gemcitabine (Gemzar) is the only chemotherapeutic agent approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced pancreatic cancer. Thromboembolism requiring anticoagulation is a common paraneoplastic complication in these patients. We report a case of patient with pancreat... | [
{
"companynumb": "US-PFIZER INC-2019357324",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CAPECITABINE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nPatients with moderate to severe psoriasis may not respond adequately to single systemic agent and may require combination systemic therapy.\n\n\nOBJECTIVE\nTo evaluate the prevalence, indications, and response to combination systemic therapy with ustekinumab for psoriasis in a tertiary ref... | [
{
"companynumb": "US-APOTEX-2015AP010270",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": null,
... |
{
"abstract": "The usual age range of acute lymphoblastic malignancies (acute lymphoblastic leukemia and advanced-stage lymphoblastic lymphoma) includes teenagers and young adults (<22 years of age) and coincides with the age of fertility. Concurrence of acute lymphoblastic malignancy with pregnancy is therefore most... | [
{
"companynumb": "US-APOTEX-2017AP018796",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DAUNORUBICIN"
},
"drugadditional": null,
... |
{
"abstract": "Reactivation of hepatitis B virus (HBV) is a serious complication of immunosuppressive therapy and cytotoxic chemotherapy. The optimal duration of HBV-DNA monitoring for at-risk patients depends on the clinical features of reactivation, especially the range of potency from therapies to reactivation. We... | [
{
"companynumb": "JP-JNJFOC-20170126796",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "VINCRISTINE"
},
"drugadditional": null,
... |
{
"abstract": "Bisphosphonate-related osteonecrosis of the jaw (BRONJ) is a well-characterized oral complication of systemic therapy with bisphosphonates. Pseudoepitheliomatous hyperplasia was observed in some of the lesions. Because podoplanin expression has been linked to malignant lesions of the oral mucosa, we ai... | [
{
"companynumb": "PHHY2015DE001375",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ZOLEDRONIC ACID"
},
"drugadditional": null,
... |
{
"abstract": "A 27-year-old male patient presented with a maculopapular eruption on the flexural areas and buttocks after using oral ketoconazole. The patient was diagnosed with drug-induced baboon syndrome based on his history, which included prior sensitivity to topical ketoconazole, a physical examination, and hi... | [
{
"companynumb": "PHHY2014TR165288",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "KETOCONAZOLE"
},
"drugadditional": null,
"dr... |
{
"abstract": "The use of pharmacogenomics has become more prevalent over the past several years in treating many disease states. Several cytochrome P450 enzymes play a role in the metabolism of many pain medications including opioids and antidepressants. Noncytochrome P450 enzymes such as methylenetetrahydrofolate r... | [
{
"companynumb": "US-TEVA-2018-US-872990",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DULOXETINE"
},
"drugadditional": "3",
... |
{
"abstract": "Cholestatic liver disease has long been associated with childhood rickets, secondary to impaired absorption of fat-soluble vitamin D. Elevated serum levels of fibroblast growth factor 23 (FGF23), secondary to genetic defects or tumor-induced osteomalacia, causes hypophosphatemic rickets in childhood. W... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2017SP001384",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": null,
"drugadditional": null,
"drugadministrationroute": null,
... |
{
"abstract": "Recommendations on lithium dosing around delivery vary, with several guidelines suggesting that lithium should be discontinued prior to delivery. We aimed to evaluate the validity of these recommendations by investigating 1) maternal lithium blood level changes following delivery, and 2) the associatio... | [
{
"companynumb": "US-ALEMBIC PHARMACUETICALS LIMITED-2020SCAL000307",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LITHIUM CARBONATE"
},
... |
{
"abstract": "BACKGROUND\nSystemic sclerosis is a complex disorder that requires systematic screening. Our objective is to report the European Scleroderma Trials and Research group centre affiliation and its impact in our clinical practice.\n\n\nMETHODS\nThe European Scleroderma Trials and Research group affiliation... | [
{
"companynumb": "PT-ACTELION-A-CH2018-175219",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BOSENTAN"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nValproate is a first-line antiepileptic agent and is also used in the treatment of bipolar disorder and migraine. It is a known human teratogen. The objective of the study was to evaluate the teratogenic risk of valproate.\n\n\nMETHODS\nAll callers who contacted the Israeli Teratology Infor... | [
{
"companynumb": "IL-VISTAPHARM, INC.-VER202001-000151",
"fulfillexpeditecriteria": "1",
"occurcountry": "IL",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "VALPROIC ACID"
},
"drugadditional"... |
{
"abstract": "Pentoxifylline is an agent that improves red blood cell deformability (known as a hemorrheologic effect) and reduces blood viscosity. Here, we present a case of a patient with hemolytic anemia after continuous-flow left ventricular assist device (CF-LVAD) implantation that was successfully treated with... | [
{
"companynumb": "PHHY2014US160285",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": null,
"drugadm... |
{
"abstract": "The XEN implant is a small hydrophilic stent designed to be implanted permanently for the treatment of glaucoma. As with other bleb-forming surgical procedures, needling is part of postoperative care. We describe 3 cases of XEN fracture of the subconjunctival portion that occurred during the needling p... | [
{
"companynumb": "IT-BAUSCH-BL-2020-000922",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE\\TOBRAMYCIN"
},
"drugadditional"... |
{
"abstract": ": The development of neutralizing antibodies is a rare complication of von Willebrand disease treatment. In major surgical procedures for severe forms of the disease, the recognition of ineffective therapy and alternative treatment protocols are lifesaving. We report the case of a 6-year-old girl with ... | [
{
"companynumb": "SI-BEH-2019109742",
"fulfillexpeditecriteria": "1",
"occurcountry": "SI",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX"
}... |
{
"abstract": "Clozapine has been associated with various adverse effects at both subtherapeutic and standard doses. These adverse effects are most commonly seen during the initiation of therapy in treatment-naïve patients. However, reports of intoxication in patients with long-term use of clozapine are yet to be doc... | [
{
"companynumb": "US-ACCORD-237527",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "HALOPERIDOL"
},
"drugadditional": null,
"dr... |
{
"abstract": "To report the induction of anti-Ma2 antibody-associated paraneoplastic neurologic syndrome (Ma2-PNS) in 6 patients after treatment with immune checkpoint inhibitors (ICIs). We also analyzed (1) patient clinical features compared with a cohort of 44 patients who developed Ma2-PNS without receiving ICI t... | [
{
"companynumb": "FR-SHIRE-FR202013667",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "HUMAN IMMUNOGLOBULIN G"
},
"drugadditional": null,... |
{
"abstract": "We report on a case of a 59-year-old female patient with atrial fibrillation who received edoxaban. She withdrew edoxaban before tooth extraction. She was brought to our emergency department due to acute onset of left-side weakness. Under the impression of acute ischemic stroke, edoxaban was replaced w... | [
{
"companynumb": "TW-DSJP-DSJ-2021-100355",
"fulfillexpeditecriteria": "1",
"occurcountry": "TW",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "EDOXABAN TOSYLATE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nAlthough mitral valve repair is the preferred treatment for mitral regurgitation in neonates and infants, mitral valve replacement (MVR) is sometimes necessary.\n\n\nMETHODS\nFrom 1999 through 2013, 18 patients younger than 1 year underwent MVR with the smallest (16 mm) commercially availab... | [
{
"companynumb": "JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-23824GD",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "WARFARIN"
},
"d... |
{
"abstract": "The present case report described a 61-year-old female patient who was diagnosed as Meige syndrome with double eyelid spasm, anxiety and insomnia. After she was treated with psychoactive drugs, it was found that clonazepam tablets in the benzodiazepine class and dopamine antagonist olanzapine tablets a... | [
{
"companynumb": "CN-ACCORD-053183",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MELITRACEN"
},
"drugadditional": "1",
"druga... |
{
"abstract": "Septic arthritis of the pubic symphysis is a rare but serious entity which can be difficult to distinguish from common pregnancy-related problems. The following highlights the risk factors and clinical features of this uncommon condition and describes its diagnosis and management. The patient is a 26-y... | [
{
"companynumb": "US-SLATE RUN PHARMACEUTICALS-20US000334",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CEFEPIME HYDROCHLORIDE"
},
"dru... |
{
"abstract": "BACKGROUND\nRuptured abdominal aortic aneurysm (AAA) is a highly lethal condition which requires rapid identification and treatment to improve the chance of survival. Computed tomography is the diagnostic modality of choice for ruptured AAA though it is time-consuming and often requires movement of the... | [
{
"companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2020-044927",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "WARFARIN SODIUM"
},
"dr... |
{
"abstract": "Pharmacogenomics (PGx) is a powerful tool that can predict increased risks of adverse effects and sub-therapeutic response to medications. This article establishes the core principles necessary for a primary care provider to meaningfully and prudently use PGx testing. Key topics include in which patien... | [
{
"companynumb": "US-OTSUKA-2020_000570",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "This article presents a case of suicide by intoxication with various pharmaceuticals, particularly anticonvulsants, combined with the fungicide captan. A cause of death could not be ascertained at autopsy. However, systematic toxicological analysis (STA) including a screening via solid-phase microextra... | [
{
"companynumb": "DE-DRREDDYS-GER/GER/19/0106627",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LAMOTRIGINE"
},
"drugadditional": null,
... |
{
"abstract": "Phaeohyphomycosis is a chronic infectious disease caused by dematiaceous fungi. It is characterized by the presence of pigmented septate mycelia within tissues. In the case of superficial infection, the lesion(s) chronically evolve(s) toward painless pseudo-tumor(s) of the soft parts. We report herein ... | [
{
"companynumb": "FR-ASTELLAS-2020US021944",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "1",
... |
{
"abstract": "Adenosine is frequently administered to convert the rhythm of patients with paroxysmal supraventricular tachycardia to sinus rhythm. Adverse reactions are common after its administration, but these have been short-lived because adenosine has a half-life of less than 10 seconds. This report describes a ... | [
{
"companynumb": "US-PFIZER INC-2020472070",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ADENOSINE PHOSPHATE"
},
"drugadditional": "3",... |
{
"abstract": "Parathyroid carcinoma is an extremely rare endocrine malignancy that accounts for less than 1% of cases of primary hyperparathyroidism. We report a 44-year-old woman who presented with fatigue and diffuse bone pain. Laboratory findings revealed highly elevated serum calcium and parathyroid hormone (PTH... | [
{
"companynumb": "GR-CIPLA LTD.-2018GR06950",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TEMOZOLOMIDE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo report a case of hepatitis, rhabdomyolysis and multi-organ failure resulting from the use of statins.\n\n\nMETHODS\nA 70 year old Caucasian woman was admitted with general malaise, myalgia and jaundice. She was being treated with a statin for aortic stenosis, the dose of which had been in... | [
{
"companynumb": "GB-PFIZER INC-2011160809",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ATORVASTATIN CALCIUM"
},
"drugadditional": nul... |
{
"abstract": "OBJECTIVE\nIrinotecan-induced severe toxicities are possibly related to UGT1A1*6 and *28 genotypes. However, the correlation between UGT1A1 polymorphisms and the risk of toxicities induced by low-dose irinotecan plus platinum combination therapy still remains controversial. This prospective observation... | [
{
"companynumb": "JP-CIPLA LTD.-2016JP01681",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "The Japanese guidelines for the treatment of gastric cancer recommend nivolumab as third-line chemotherapy for metastatic gastric adenocarcinoma. We report a case in which long-term control of metastatic gastric adenocarcinoma was achieved with nivolumab after pseudoprogression. A man in his late 70s w... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2022RR-332236",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"dru... |
{
"abstract": "New-onset psoriasis in patients receiving tumor necrosis factor inhibitors is well recognized in children and adults. We describe three children who underwent cardiac transplantation and developed an analogous form of paradoxic eczema occurring 2-48 months after starting systemic tacrolimus, a drug wid... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2018-00572",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"druga... |
{
"abstract": "A 66-YEAR-OLD female requiring cardiac surgery had persisting anti-platelet factor 4 (PF4)/heparin antibodies (HIT-abs) 8 years after heparin-induced thrombocytopenia (HIT). In 2010, she developed thrombotic thrombocytopenic purpura (TTP) (ADAMTS-13 <5%, inhibitor at 1.0 BU/mL), which was treated succe... | [
{
"companynumb": "CH-TEVA-2019-CH-1129234",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CANGRELOR"
},
"drugadditional": null,
... |
{
"abstract": "A safe, simple, effective, and pan-genotypic regimen to treat hepatitis C virus (HCV) infection in patients coinfected with human immunodeficiency virus type 1 (HIV-1) remains a medical need. We assessed the efficacy and safety of the NS5B polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatas... | [
{
"companynumb": "US-MYLANLABS-2017M1054005",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "ATAZANAVIR\\RITONAVIR"
},
"drugadditional": n... |
{
"abstract": "In the context of palliative medicine, spinal cord compression occurs in around 5% of patients with cancer. Ten per cent of patients with spinal metastases are affected; the commonest causes are breast, prostate, lung cancer and multiple myeloma. We describe a rare cause of spinal cord compression in a... | [
{
"companynumb": "GB-FRESENIUS KABI-FK201503161",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": null,... |
{
"abstract": "High-dose chemotherapy with autologous hematopoietic stem cell transplantation improves event-free survival in patients with high-risk neuroblastoma. However, in heavily pretreated patients, poor marrow function can be an obstacle in the successful proceeding of therapy. Priming with plerixafor plus fi... | [
{
"companynumb": "PL-TEVA-2021-PL-1874492",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"drugadditional": "3",
... |
{
"abstract": "An 11-month-old girl presented with dermatitis, boggy arthritis, and keratitis shortly after her hospitalization for bacterial pneumonia. A skin biopsy and genetic testing led to a diagnosis of Blau syndrome. Her symptoms persisted despite a stepwise increase in immune-modulating therapies. Her ocular ... | [
{
"companynumb": "NVSC2020CA229129",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": "3",
"dr... |
{
"abstract": "BACKGROUND\nMinocycline-induced drug rash with eosinophilia and systemic symptoms (DRESS) may have a prolonged course, especially in African and African-American patients.\n\n\nOBJECTIVE\nTo determine if a prolonged course of minocycline-induced DRESS was associated with an accumulation of the culprit ... | [
{
"companynumb": "FR-MYLANLABS-2020M1060693",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MINOCYCLINE HYDROCHLORIDE"
},
"drugadditional... |
{
"abstract": "Panniculitis is a rare complication of BRAF inhibitor therapy that is used to treat patients with BRAF-mutated metastatic melanoma. We present a clinicopathologic review of 9 patients who developed panniculitis while on BRAF inhibitor therapy. In 13% of patients on vemurafenib, 3% of patients on dabraf... | [
{
"companynumb": "AU-GLAXOSMITHKLINE-AU2015GSK083336",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DABRAFENIB"
},
"drugadditional": nul... |
{
"abstract": "A 41-year-old female presented with a large anterior mediastinal mass adjacent to the heart. Biopsy demonstrated lymphoma. Upon administration of chemotherapy, she developed cardiogenic shock requiring a 5-day course of extracorporeal membrane oxygenation (ECMO) as a bridge through her treatment. After... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2016US-130964",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"dru... |
{
"abstract": "Salvage chemotherapy for recurrent chest wall lesions in breast cancer results in response rates of 20% to 30%. Preclinical studies showed significant disease regression could be induced in murine chest wall mammary cancers with a topical toll-like receptor (TLR)-7 agonist, imiquimod.\nTo evaluate the ... | [
{
"companynumb": "US-CELGENEUS-USA-2017019650",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PACLITAXEL"
},
"drugadditional": "3",
... |
{
"abstract": "This post hoc study assessed the evidence-base for esketamine nasal spray for management of treatment-resistant depression (TRD) using number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH).\n\n\n\nData sources were four phase III randomized, double-blind... | [
{
"companynumb": "US-OTSUKA-2020_019474",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "We examined outcomes of haploidentical hematopoietic cell transplantation (haplo-HCT) using T-cell receptor αβ+ (TCRαβ+)/CD19+-depleted grafts (TCR group, 14 patients) in children with hemoglobinopathies. Patients received a preparative regimen consisting of busulfan, thiotepa, cyclophosphamide, and an... | [
{
"companynumb": "IT-ASPEN-GLO2018IT002977",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROXYUREA"
},
"drugadditional": "3",
... |
{
"abstract": "The role of mTOR inhibitors, such as EVL, has not been established for pediatric liver transplant recipients up to now, although data from adult solid organ graft transplantation are very promising. Major complications following pediatric liver transplantation in the long-term course include chronic gr... | [
{
"companynumb": "PHHY2011DE87665",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BASILIXIMAB"
},
"drugadditional": null,
"drug... |
{
"abstract": "OBJECTIVE\nThis retrospective case series study of the effectiveness of electroconvulsive therapy (ECT) augmentation on clozapine-resistant schizophrenia was conducted by EMR review.\n\n\nMETHODS\nClozapine-resistance was defined as persistent psychotic symptoms despite at least 12 weeks of clozapine a... | [
{
"companynumb": "KR-MYLANLABS-2017M1004827",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLOZAPINE"
},
"drugadditional": "3",
... |
{
"abstract": "A 63-year-old African American man was diagnosed with prostate cancer by biopsy for elevated prostrate-specific antigen. He was initially treated with radiation and then with intermittent androgen ablation because of biochemical relapse. He continued to have rising prostrate-specific antigen and he was... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2016US-110250",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
... |
{
"abstract": "Delayed recovery/awakening/ emergence can occur under anaesthesia and is multifactorial, could be drug or non drug related. Similarly, we report a case of delayed recovery in a 68-year-old patient, for laparoscopic cholecystectomy, a known case of hypertension, bronchial asthma and hypothyroidism. Preo... | [
{
"companynumb": "PHHY2015IN095228",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "INDAPAMIDE"
},
"drugadditional": null,
"drug... |
{
"abstract": "An 81-year-old man was admitted for evaluation of progressive dyspnea over the previous 4 weeks. He initially noticed dyspnea when walking briskly, but this progressed to dyspnea after only walking several feet. He also endorsed a dry cough without hemoptysis. Review of systems revealed a history of in... | [
{
"companynumb": "US-PFIZER INC-2019371341",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "Ciprofloxacin and fluconazole combination therapy is frequently used as prophylaxis for, and treatment of, infections in patients with haematological malignancies. However, both drugs are known to prolong the heart rate-corrected QT (QTc) interval, which is a serious risk factor for torsade de pointes ... | [
{
"companynumb": "NL-MYLANLABS-2018M1003500",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CIPROFLOXACIN"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nA species of hawthorn, Crataegus mexicana (tejocote), has been marketed as a weight-loss supplement that is readily available for purchase online. While several hawthorn species have shown clinical benefit in the treatment of heart failure owing to their positive inotropic effects, little i... | [
{
"companynumb": "US-BTG-201900157",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OVINE DIGOXIN IMMUNE FAB"
},
"drugadditional": "3",
... |
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