article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "To review pregnancy outcomes and the safety of jet ventilation use in the gravid patient undergoing surgical airway intervention.\nA multi-institutional retrospective review of medical records was performed to identify women who underwent low-frequency jet ventilation during pregnancy for surgical trea... | [
{
"companynumb": "US-TEVA-2020-US-1242227",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": null,
... |
{
"abstract": "Systemic administration of anti-programmed cell death 1 (PD-1) antibody (Ab) has achieved remarkable success in metastatic cancers. The blockade of PD-1-mediated signaling pathways sometimes cause immune-related adverse events (irAEs) due to restored anti-cancer as well as anti-self immunity. Although ... | [
{
"companynumb": "JP-MYLANLABS-2021M1057242",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "Anorexia nervosa (AN) is a severe and complex psychiatric disorder and no medication has been approved for its treatment. This case series in youth with severe, recurrent AN supports the hypothesis that dopamine receptor agonists could be helpful in supporting fear extinction during eating disorder foc... | [
{
"companynumb": "US-DRREDDYS-USA/USA/16/0080432",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FLUOXETINE HYDROCHLORIDE"
},
"drugaddit... |
{
"abstract": "The survival rate of patients with hepatocellular carcinoma and extrahepatic metastases is very poor. Sorafenib, a targeted chemotherapy agent, has been shown effective for patients with advanced hepatocellular carcinoma (HCC), but it is associated with serious side effects. In addition, although surge... | [
{
"companynumb": "KR-BAYER-2018-163840",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional": n... |
{
"abstract": "Trichodysplasia spinulosa (TS) is a rare skin disease, caused by a specific polyomavirus, occurring in immunocompromised patients. The pathophysiological mechanisms of TS are not yet fully understood. By using polymerase chain reaction and skin biopsy immunostaining we report evidence, in a paediatric ... | [
{
"companynumb": "FR-ACCORD-048498",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "2",
"druga... |
{
"abstract": "Clinicians are often presented with the scenario of what to do when one medication in a drug class has failed a therapeutic trial on a patient. We encountered a patient who developed profound resistance to glargine, aspart and regular insulin, but had a rapid and sustained response to detemir. The mech... | [
{
"companynumb": "US-SA-2017SA024220",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "INSULIN HUMAN"
},
"drugadditional": "3",
"... |
{
"abstract": "Postherpetic pruritus is an uncommon adverse sequela of Varicella zoster infection. It can present with or without prior postherpetic neuralgia. A 57-year-old woman who developed persistent postherpetic pruritus following a Varicella zoster infection, affecting the skin between her right thoracic fifth... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2020SP012569",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GABAPENTIN"
},
"drugadditional"... |
{
"abstract": "Background: Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) is a drug delivery technique with superior pharmacological properties for treating peritoneal metastasis (PM). Adding electrostatic loading (ePIPAC) as an adjunct to aerosol and artificial hydrostatic pressure improved tissue uptake i... | [
{
"companynumb": "DE-JNJFOC-20190433306",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "GEMCITABINE\\GEMCITABINE HYDROCHLORIDE"
},
"druga... |
{
"abstract": "Therapeutic plasma exchange (TPE) and continuous kidney replacement therapy (CKRT) are extracorporeal therapeutic procedures often implemented in management of patients. Critically ill patients may be afflicted with disease processes that require both TPE and CKRT. Performing TPE discontinuous with CKR... | [
{
"companynumb": "SG-ROCHE-2882323",
"fulfillexpeditecriteria": "1",
"occurcountry": "SG",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "Hypertriglyceridemia is a known cause of 2%-7% of cases of acute pancreatitis. Although there are numerous potential causes, the use of atypical antipsychotics has been linked to elevated triglycerides and pancreatitis. Here, we present the case of a 42-year-old male patient with a diagnosis of schizoa... | [
{
"companynumb": "US-DRREDDYS-USA/USA/14/0042122",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "QUETIAPINE FUMARATE"
},
"drugadditional"... |
{
"abstract": "We report the case of a 59-year-old woman with stage IV erythrodermic mycosis fungoides (MF) and large cell transformation who, despite failing multiple previous treatments, achieved complete remission through a combination of pralatrexate and romidepsin followed by allogeneic hematopoietic stem cell t... | [
{
"companynumb": "AU-MYLANLABS-2022M1019834",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nHuman pythiosis is a life-threatening disease for which no standard treatment protocols with proven efficacy exist. We present the results of our institutional pythiosis treatment protocol, composed of surgery, antifungal agents, iron chelator (only vascular cases) and immunotherapy.\n\n\nME... | [
{
"companynumb": "TH-CIPLA LTD.-2015TH01121",
"fulfillexpeditecriteria": "1",
"occurcountry": "TH",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ITRACONAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "Fever is a common complication of endoscopic variceal obturation (EVO) therapy for gastric variceal bleeding. However, fungemia related to EVO therapy has not yet been reported. Herein, we report two cases of post-EVO fungemia in cirrhotic patients who underwent therapeutic EVO for gastric variceal ble... | [
{
"companynumb": "KR-MICRO LABS LIMITED-ML2021-01047",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVOFLOXACIN"
},
"drugadditional": "... |
{
"abstract": "OBJECTIVE\nA probable case of drug reaction with eosinophilia and systemic symptoms (DRESS) associated with consecutive use of three medications for seizure control is reported.\n\n\nCONCLUSIONS\nA 36-year-old woman was treated at a community hospital for a mild fever (37.9°C) and diffuse raised maculo... | [
{
"companynumb": "US-ACTAVIS-2014-09868",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DIVALPROEX SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "Accidental foreign body aspiration can cause severe damage to the airway and threaten the patient's life. This situation requires multidisciplinary and systematic approach from the medical and surgical team, in order to achieve complete resolution maintaining airway permeability.\nThis is a 49 y/o man ... | [
{
"companynumb": "CO-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2020-BI-033433",
"fulfillexpeditecriteria": "1",
"occurcountry": "CO",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IPRATROPIUM BROMIDE"
},
... |
{
"abstract": "Pretherapy assessment has a crucial role in the management of advanced oropharyngeal carcinoma. The case report represents an example of how translational research may help to optimize the therapeutic options and to choose a well-shaped therapy adapted to the tumor and the patient.",
"affiliations": ... | [
{
"companynumb": "IT-TEVA-2018-IT-861110",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "A 21-year-old G3P2011 Caucasian woman at 27 weeks' gestation presented with fetal tachyarrhythmia between 240 and 270 beats per minute. Fetal supraventricular tachycardia, abdominal ascites, pleural effusion and pericardial effusion indicated hydrops fetalis. Management with digoxin and flecainide conv... | [
{
"companynumb": "US-VISTAPHARM, INC.-VER202011-001983",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DIGOXIN"
},
"drugadditional": null... |
{
"abstract": "Currently, nivolumab (an anti-programmed cell death-1 receptor monoclonal antibody) is available for many types of advanced cancers in Japan. However, there have been few detailed case reports about endocrine-related adverse events of this therapy. Here, we report a patient with metastatic renal cell c... | [
{
"companynumb": "JP-PFIZER INC-2017405935",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ATORVASTATIN"
},
"drugadditional": null,
... |
{
"abstract": "A 57-year-old woman with frequent respiratory infections was initially diagnosed with IgG subclass deficiency based on low levels of IgG subclasses 2 and 3. Three years later, she progressed to having IgA deficiency as well. With a normal total IgG level, she does not meet criteria for common variable ... | [
{
"companynumb": "US-IGSA-SR10005167",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CIPROFLOXACIN HYDROCHLORIDE"
},
"drugadditional": n... |
{
"abstract": "We present the first detailed report of acneiform eruptions in patients on CTLA-4 inhibitor therapy. Acneiform eruptions commonly occur (up to 75-100%) as a cutaneous adverse event associated with EGFR inhibition; however, acneiform eruptions have not been highly reported as a cutaneous adverse event a... | [
{
"companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2020-028002",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IPILIMUMAB"
},
"drugadd... |
{
"abstract": "Multifocal atrial tachycardia has certain electrocardiographic similarities to atrial fibrillation. The mechanism of atrial fibrillation is heterogenous but in some cases may arise from a single ectopic driver with fibrillatory conduction to the rest of the atria. This has led to the speculation that m... | [
{
"companynumb": "US-AMGEN-USASP2020100370",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "IVABRADINE"
},
"drugadditional": "1",
... |
{
"abstract": "Tardive tremor (TT) is an underrecognized manifestation of tardive syndrome (TS). In our experience, TT is a rather common manifestation of TS, especially in a setting of treatment with aripiprazole, and is a frequent cause of referrals for the evaluation of idiopathic Parkinson disease. There are repo... | [
{
"companynumb": "US-BAUSCH-BL-2021-002616",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TETRABENAZINE"
},
"drugadditional": "1",
... |
{
"abstract": "OBJECTIVE\nExtra-corporeal shock wave lithotripsy (ESWL) can be considered in difficult common bile duct stones (DCBDS), with a success rate greater than 90% but data on stone recurrence after ESWL are limited. We performed a retrospective analysis to evaluate long-term outcomes in patients who underwe... | [
{
"companynumb": "IT-MYLANLABS-2018M1002090",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "URSODIOL"
},
"drugadditional": "3",
... |
{
"abstract": "Refeeding syndrome is diagnosed based on the onset of multiple laboratory abnormalities (most commonly hypophosphatemia) and clinical signs in the setting of nutrition rehabilitation of malnourished patients. Because definitions are not uniform, a broad differential diagnosis should always include rena... | [
{
"companynumb": "US-BAYER-2019-026208",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "OMEPRAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo compare the efficacy and tolerance of adjuvant chemotherapy and radiotherapy delivered in sequential (chemotherapy followed by radiation) versus \"sandwich\" fashion (chemotherapy, interval radiation, and remaining chemotherapy) after surgery in patients with FIGO stage III uterine endome... | [
{
"companynumb": "PHHY2015US018163",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LETROZOLE"
},
"drugadditional": null,
"drug... |
{
"abstract": "The authors report on the death of two women who were married to the same man one after the other. Exhumation and toxicological investigation of the first wife, who had died 7 years before, did not produce any conclusive evidence of homicide. With regard to the circumstances of death of the second wife... | [
{
"companynumb": "DE-ACTAVIS-2014-23696",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PROMETHAZINE HYDROCHLORIDE"
},
"drugadditional":... |
{
"abstract": "A 39-year man with primary steroid resistant focal segmental glomerulosclerosis (FSGS) was treated with mycophenolate mofetil and ACE-inhibitors. After six months a different therapeutics approach was mandatory due to the worsening of renal function and the relapse of proteinuria at the nephrotic range... | [
{
"companynumb": "IT-MYLANLABS-2020M1004620",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "RAMIPRIL"
},
"drugadditional": null,
... |
{
"abstract": "The CFTR potentiator ivacaftor is responsible for significant clinical improvements among a subset of patients with cystic fibrosis. Because it is a substrate of the cytochrome P450 system, specifically CYP3A4/5, ivacaftor is subject to significant drug-drug interactions, including due to commonly used... | [
{
"companynumb": "US-LANNETT COMPANY, INC.-US-2018LAN000557",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IVACAFTOR"
},
"drugadditional... |
{
"abstract": "This study sought to evaluate the long-term risk of developing heart failure (HF) in patients receiving trastuzumab therapy.\n\n\n\nTrastuzumab has improved the prognosis in patients with HER2-positive breast cancer, but it can induce left ventricular dysfunction with reduced ejection fraction or HF du... | [
{
"companynumb": "DK-ROCHE-2275860",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TRASTUZUMAB"
},
"drugadditional": "3",
"drug... |
{
"abstract": "OBJECTIVE\nTo describe a case of exacerbated mania potentially related to an interaction between lopinavir/ritonavir and valproic acid (VPA) and propose a mechanism of action for this interaction.\n\n\nMETHODS\nA 30-year-old man with bipolar disorder and HIV initiated treatment with lopinavir/ritonavir... | [
{
"companynumb": "CA-ABBVIE-06P-087-0325384-00",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "3",
"activesubstance": {
"activesubstancename": "DIVALPROEX SODIUM"
},
"drugadditional": nu... |
{
"abstract": "BACKGROUND\nGemella bergeri is one of the nine species of the genus Gemella and is relatively difficult to identify. We herein describe the first case of septic shock due to a Gemella bergeri coinfection with Eikenella corrodens.\n\n\nMETHODS\nA 44-year-old Asian man with a medical history of IgG4-rela... | [
{
"companynumb": "JP-MYLANLABS-2018M1088188",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "DOBUTAMINE\\DOBUTAMINE HYDROCHLORIDE"
},
"dru... |
{
"abstract": "Dermatomyositis is a rare immune-related adverse event caused by immune checkpoint inhibitors. We herein report a 75-year-old Japanese man with small-cell lung carcinoma who developed dermatomyositis after the administration of atezolizumab. He developed rashes on day 13 and myalgia and motor weakness ... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-314329",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"dru... |
{
"abstract": "Although osteonecrosis of the jaw is a well-known adverse reaction of bisphosphonates (BPs), random cases of oral mucosal ulceration after per os administration of BP-aledronate have been attributed to prolonged mucosal irritation. This report, for the first time, describes the mucosal ulceration relat... | [
{
"companynumb": "GR-CIPLA LTD.-2012GR00338",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUVOXAMINE"
},
"drugadditional": "3",
... |
{
"abstract": "Disclosure of medical errors and adverse outcomes is expected by regulatory agencies and society as a whole. Disclosure should occur in a systematic way that ensures honesty and transparency regarding the care that has been provided. It is often appropriate to seek professional help from Clinical Risk ... | [
{
"companynumb": "US-FRESENIUS KABI-FK201914161",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MAGNESIUM SULFATE"
},
"drugadditional": n... |
{
"abstract": "Systemic lupus erythematosus is a chronic autoimmune disease characterized by the production of autoantibodies resulting in tissue injury across multiple organs; up to 50% of patients develop neurologic involvement, collectively referred to as neuropsychiatric systemic lupus erythematosus. The cases in... | [
{
"companynumb": "US-TEVA-2019-US-1019716",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "The role of allogeneic hematopoietic stem cell transplantation (HSCT) for infants with acute lymphoblastic leukemia (ALL) and KMT2A gene rearrangement (KMT2A-r) is controversial in terms of both its efficacy and potential for acute and late toxicities. In Japanese Pediatric Leukemia/Lymphoma Study Grou... | [
{
"companynumb": "JP-OTSUKA-2021_034759",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BUSULFAN"
},
"drugadditional": "3",
"dr... |
{
"abstract": "BACKGROUND\nMedication resistant temporal lobe epilepsy occurs in a small population of patients with fragile X syndrome. We present the case of a 24-year-old man with medically refractory temporal lobe epilepsy and fragile X syndrome who underwent left anterior temporal lobectomy resulting in cessatio... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2015US-96155",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LAMOTRIGINE"
},
"drug... |
{
"abstract": "BACKGROUND Rheumatoid arthritis tenosynovitis is difficult to discriminate from non-tuberculous tenosynovitis on the basis of radiological and pathological findings. CASE REPORT A 74-year-old woman with a 4-year history of rheumatoid arthritis was referred to our hospital to undergo treatment for uncon... | [
{
"companynumb": "PHHY2018JP049061",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": "1",
"dru... |
{
"abstract": "Bisphosphonates are widely used to prevent osteoporotic fractures. Long-term use has resulted in unexpected subtrochanteric fractures in some elderly patients. We report a patient on long-term alendronate therapy who sustained fractures of the ulna and tibia sequentially over a 7-month period, without ... | [
{
"companynumb": "SG-MYLANLABS-2016M1013984",
"fulfillexpeditecriteria": "1",
"occurcountry": "SG",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ALENDRONATE SODIUM"
},
"drugadditional": null... |
{
"abstract": "Risperidone, an atypical antipsychotic drug, is one of the most frequently used atypical neuroleptic drugs for the treatment of symptoms of behavioral disorders seen in autism. Although various cardiovascular side effects have been reported with risperidone, to our knowledge, it has not yet been report... | [
{
"companynumb": "TR-PRINSTON PHARMACEUTICAL INC.-2016PRN00027",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RISPERIDONE"
},
"drugaddit... |
{
"abstract": "OBJECTIVE\nMedications are a major cause of acute pancreatitis; however, little is known about their influence in children. Our primary aims were to identify common comorbidities and concomitant pancreatitis etiologies in children with drug-associated pancreatitis. Our secondary aims were to identify t... | [
{
"companynumb": "US-JNJFOC-20161012815",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": "3",
... |
{
"abstract": "Drug- and toxin-induced rhabdomyolysis is a nonspecific clinical syndrome resulting from the release of skeletal muscle cell contents into the plasma and urine. Antihistamine drugs are the active ingredients in a number of over-the-counter preparations and are frequently ingested in suicide attempts. W... | [
{
"companynumb": "US-SA-2020SA362459",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DIPHENHYDRAMINE"
},
"drugadditional": null,
... |
{
"abstract": "Reactivation of hepatitis B virus (HBV) infection may occur in adult T-cell leukemia-lymphoma (ATL) patients with resolved HBV infection who receive monotherapy with the anti-CC chemokine receptor 4 monoclonal antibody, mogamulizumab. However, there is little evidence regarding the incidence and charac... | [
{
"companynumb": "JP-JNJFOC-20150902604",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VINDESINE"
},
"drugadditional": null,
"... |
{
"abstract": "Hypersensitivity reactions to intravenous antibiotics are common in cystic fibrosis (CF). As well as causing immediate morbidity, the need for future avoidance of the causative antibiotic can have a long-term negative impact on CF management. This paper reviews the epidemiology and clinical presentatio... | [
{
"companynumb": "GB-ACS-001210",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CEFOXITIN SODIUM"
},
"drugadditional": "1",
"dr... |
{
"abstract": "BACKGROUND\nHistoplasmosis is an endemic mycosis with most cases of clinical illness reported in North and Central America. Rarely, patients develop progressive disseminated histoplasmosis with extrapulmonary manifestations. These infections are fatal if not appropriately treated.\n\n\nMETHODS\nWe repo... | [
{
"companynumb": "US-ROXANE LABORATORIES, INC.-2014-RO-01625RO",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LEVOFLOXACIN"
},
"drugadd... |
{
"abstract": "BACKGROUND\nChronic pulmonary aspergillosis (CPA) is a fungal disease with high mortality and morbidity. Guidelines suggest treatment with azoles as first-line therapy. However, patients often develop treatment intolerance or increasingly azole resistance.\n\n\nOBJECTIVE\nThis retrospective review asse... | [
{
"companynumb": "GB-PFIZER INC-2020138720",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VORICONAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nTo assess unlicensed and off-label drug use in a tertiary care paediatric hospital in Canada on a single day.\n\n\nMETHODS\nA cross-sectional study in a tertiary care paediatric hospital was conducted on one randomly selected day. Active prescriptions for children <18 years of age were analy... | [
{
"companynumb": "CA-JNJFOC-20160421403",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nMonoclonal antibodies (MAbs) targeting epidermal growth factor receptor (EGFR) are effective in treatment of metastatic colorectal cancer (mCRC). Cetuximab, a chimeric MAb targets EGFR. Even with premedication, cetuximab can cause a hypersensitivity reaction (HSR). In case of severe HSR, fu... | [
{
"companynumb": "US-PFIZER INC-2019259503",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IRINOTECAN HYDROCHLORIDE"
},
"drugadditional":... |
{
"abstract": "BACKGROUND\nLittle is known about drug hypersensitivity reactions from antituberculosis drugs.\n\n\nOBJECTIVE\nTo determine the frequency, risk factors, and characteristics of immediate-type hypersensitivity reactions from first-line antituberculosis drugs and to evaluate the usefulness of a readminist... | [
{
"companynumb": "TR-LUPIN PHARMACEUTICALS INC.-2015-03104",
"fulfillexpeditecriteria": "2",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ISONIAZID"
},
"drugadditional... |
{
"abstract": "We present 2 cases of early-onset Alzheimer's disease due to a novel N135Y mutation in PSEN1. The proband presented with memory and other cognitive symptoms at age 32. Detailed clinical characterization revealed initial deficits in memory with associated dysarthria, progressing to involve executive dys... | [
{
"companynumb": "US-UCBSA-2017002755",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": null,
... |
{
"abstract": "Possible dulaglutide-induced cholecystitis, with successful resumption of dulaglutide after cholecystectomy, is discussed.\n\n\n\nA 72-year-old White man was started on dulaglutide for outpatient management of type 2 diabetes, in addition to his existing antihyperglycemic regimen of metformin, glipizid... | [
{
"companynumb": "US-ALS-000419",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
"drugadditional": "3",
... |
{
"abstract": "Anti-tumor necrosis factor (anti-TNF) is an effective biological agent for the treatment of moderate-to-severe active ulcerative colitis (UC) refractory to conventional therapy. On the other hand, anti-TNF therapy is strongly associated with a potential risk of tuberculosis (TB). Active TB is a critica... | [
{
"companynumb": "KR-JNJFOC-20191001952",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "MESALAMINE"
},
"drugadditional": null,
... |
{
"abstract": "Abiraterone acetate (AA) gives a significant improvement in survival for patients with metastatic castration-resistant prostate cancer (mCRPC) before and after chemotherapy and has a favorable effect on patients' health-related quality of life and pain. Only a few studies have investigated patient-repo... | [
{
"companynumb": "IT-JNJFOC-20171012364",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nBrimonidine tartrate is an alpha-2 agonist used for glaucoma treatment. It can lead to serious poisoning symptoms when misused by children.\n\n\nMETHODS\nIn this case report, 3 months-old male patient with severe central nervous system depression and respiratory arrest as a result of acciden... | [
{
"companynumb": "TR-INDOCO-000018",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BRIMONIDINE TARTRATE"
},
"drugadditional": "3",
... |
{
"abstract": "The aesthetic use of botulinum toxins is widely accepted in routine treatment of glabellar lines.\n\n\n\nTo strengthen existing efficacy and safety data, and examine subject satisfaction concerning abobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines.\n\n\n\nA 150-day prospective, ... | [
{
"companynumb": "US-IPSEN BIOPHARMACEUTICALS, INC.-2019-16200",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ABOBOTULINUMTOXINA"
},
"dr... |
{
"abstract": "BACKGROUND\nPaediatric prolactinomas are rare. The aim of this study was to investigate the clinical features and outcome of paediatric patients with prolactinomas.\n\n\nMETHODS\nIn this single-centre retrospective analysis, clinical, biochemical, and radiological features of all paediatric patients wi... | [
{
"companynumb": "DE-MYLANLABS-2018M1075567",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CABERGOLINE"
},
"drugadditional": "3",
... |
{
"abstract": "In this secondary analysis of the Glyburide Advantage in Malignant Edema and Stroke (GAMES-RP) Trial, we report the effect of IV glyburide on adjudicated, edema-related endpoints.\n\n\n\nBlinded adjudicators assigned designations for hemorrhagic transformation, neurologic deterioration, malignant edema... | [
{
"companynumb": "US-IMPAX LABORATORIES, LLC-2018-IPXL-04486",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "GLYBURIDE"
},
"drugadditiona... |
{
"abstract": "Granulomatosis with polyangiitis (GPA, also known as Wegener's granulomatosis) is a type of systematic vasculitis that primarily involves the lung and kidney. Diffuse alveolar hemorrhage (DAH) and associated acute respiratory failure are uncommon but devastating complications of GPA. Experience in usin... | [
{
"companynumb": "US-PFIZER INC-2021178269",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nPyometra is an uncommon but serious condition that is generally diagnosed in postmenopausal women. It rarely occurs in premenopausal patients, particularly adolescents.\n\n\nMETHODS\nA 16-year-old girl with multiple comorbidities including severe intellectual disability, neurogenic bladder,... | [
{
"companynumb": "US-PFIZER INC-2020323129",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MEDROXYPROGESTERONE ACETATE"
},
"drugadditiona... |
{
"abstract": "Background and study aims Endoscopic biliary sphincterotomy (EBS) related-bleeding is a common adverse event related to endoscopic retrograde cholangiopancreatography (ERCP). Traditionally, endoscopic modalities such as epinephrine injection, cauterization, and balloon tamponade have been used for man... | [
{
"companynumb": "US-BAYER-2021-192568",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": null,
"dr... |
{
"abstract": "OBJECTIVE\nTo assess the efficacy/safety of tofacitinib in adult patients with active ankylosing spondylitis (AS).\n\n\nMETHODS\nThis phase III, randomised, double-blind, placebo-controlled study enrolled patients aged ≥18 years diagnosed with active AS, meeting the modified New York criteria, with cen... | [
{
"companynumb": "RU-PFIZER INC-2019056635",
"fulfillexpeditecriteria": "1",
"occurcountry": "RU",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TOFACITINIB CITRATE"
},
"drugadditional": "1",... |
{
"abstract": "Leiomyosarcomas of the lower extremity are extremely rare disorders and account for 10-15% of limb soft tissue sarcomas. These tumours have poor prognosis and even in early stages, patients persist at high risk for local and distant relapse; consequently, the treatment of advanced leiomyosarcoma of the... | [
{
"companynumb": "PT-SUN PHARMACEUTICAL INDUSTRIES LTD-2020R1-252781",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"dru... |
{
"abstract": "OBJECTIVE\nThe objective of this study was to compare the outcomes of patients undergoing ultrasound-accelerated thrombolysis (USAT) and standard catheter-directed thrombolysis (CDT) for the treatment of acute pulmonary embolism (PE).\n\n\nMETHODS\nThe records of all patients in our institution having ... | [
{
"companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-065007",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"d... |
{
"abstract": "Proton pump inhibitors (PPIs) are proven medications of choice for gastroesophageal reflux disease (GERD), acid-related disorders, erosive esophagitis, Barrett esophagus, prevention of gastrointestinal bleeding while on nonsteroidal anti-inflammatory drugs, eosinophilic esophagitis, peptic ulcer diseas... | [
{
"companynumb": "US-APOTEX-2021AP001053",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OMEPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "Vulnerable populations are disproportionately affected by hepatitis C virus (HCV) infection and experience high rates of health disparity. There are no data on real-world experience with highly efficacious direct-acting anti-HCV treatment in this population.\n\n\n\nWe aimed to evaluate the real-world e... | [
{
"companynumb": "US-JNJFOC-20161124287",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "SIMEPREVIR"
},
"drugadditional": null,
... |
{
"abstract": "In low-income and middle-income countries, affordable direct-acting antivirals are urgently needed to treat hepatitis C virus (HCV) infection. The combination of ravidasvir, a pangenotypic non-structural protein 5A (NS5A) inhibitor, and sofosbuvir has shown efficacy and safety in patients with chronic ... | [
{
"companynumb": "MY-GILEAD-2021-0526400",
"fulfillexpeditecriteria": "1",
"occurcountry": "MY",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "SOFOSBUVIR"
},
"drugadditional": null,
... |
{
"abstract": "We present the case of a 17-year-old woman with a history of bipolar disorder, who developed a clinical syndrome manifested by fever, lymphadenopathy, skin rash, diarrhea, and acute renal failure requiring dialysis after the use of lamotrigine. Renal biopsy showed acute interstitial nephritis (AIN) wit... | [
{
"companynumb": "US-VISTAPHARM, INC.-VER202010-001891",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "VALPROIC ACID"
},
"drugadditional"... |
{
"abstract": "To improve disease control without increasing the toxicity of a reduced-intensity allogeneic hematopoietic cell transplantation (HCT) in multiple myeloma (MM), a phase I trial was performed using an antibody-radionuclide conjugate targeting CD45 (90Y-DOTA-BC8) as conditioning. 90Y-DOTA-BC8 was combined... | [
{
"companynumb": "US-PFIZER INC-2021205744",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "3... |
{
"abstract": "An 80-year-old man with autoimmune hemolytic anemia (AIHA) received immunosuppressive therapy with prednisolone (1 mg/kg). One month later, his hemoglobin level had normalized, and the prednisolone dose was tapered. The next day, he complained of acute and progressive back pain. He was admitted to our ... | [
{
"companynumb": "JP-BAUSCH-BL-2016-025164",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "All lung cancer patients with mutant epidermal growth factor receptor (EGFR) or rearranged EML4-ALK eventually develop acquired resistance to treatment. Rebiopsy may give insight into the resistance mechanisms and direct further lines of treatment. Here, we evaluate the potential interest and limitatio... | [
{
"companynumb": "FR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-35024GD",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AFATINIB"
},
"d... |
{
"abstract": "BACKGROUND\nImmune responses due to radiotherapy and immune checkpoint inhibitors potentially have synergistic effects.\n\n\nMETHODS\nHere, we report a 65-year-old Japanese woman presenting with high-grade endometrial cancer. She was diagnosed with carcinosarcoma, stage IB. A month post-surgery, lung, ... | [
{
"companynumb": "JP-MYLANLABS-2020M1069190",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nThe purpose of this study was to estimate the safety and efficacy of abciximab treatment in combination with prophylactic heparin, acetylsalicylic acid (ASA), and clopidogrel application in cases of thrombus formation complicating endovascular coil embolization in cerebral aneurysms.\n\n\nME... | [
{
"companynumb": "DE-JNJFOC-20130611731",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CLOPIDOGREL BISULFATE"
},
"drugadditional": null... |
{
"abstract": "COVID-19 is a potentially critical infectious disease. Inflammatory response and disease severity may vary according to immune system status. The aim of this case series is to investigate different presentation of COVID-19 in immunocompromised patients.\nthis is a single centre case series about 17 imm... | [
{
"companynumb": "IT-MYLANLABS-2021M1066503",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FONDAPARINUX"
},
"drugadditional": "4",
... |
{
"abstract": "Taxane-associated maculopathy is scarcely reported in the literature but should be considered as a known complication of intravenous use of the chemotherapy medication to ophthalmologists as well as primary care physicians and oncologists. We report a case of paclitaxel maculopathy in a 61-year-old fem... | [
{
"companynumb": "PHHY2013US043735",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BEVACIZUMAB"
},
"drugadditional": null,
"dru... |
{
"abstract": "BACKGROUND\nHeparin-induced bullous hemorrhagic dermatosis (HBHD) is an unusual cutaneous adverse reaction to heparin characterized by acute onset of hemorrhagic bullae.\n\n\nMETHODS\nAn exuberant case of HBHD is reported, and a revision of previously reported cases indexed on PubMed is provided. Cases... | [
{
"companynumb": "BR-NANJING KING-FRIEND BIOCHEMICAL PHARMACEUTICAL CO. LTD.-2021NKF00051",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
... |
{
"abstract": "Primary poor graft function (PGF) is a severe complication after allogeneic stem cell transplantation (SCT). The incidence, risk factors, and outcomes of PGF have not been well described, especially in the haploidentical SCT setting. We retrospectively reviewed patients who received haploidentical SCT ... | [
{
"companynumb": "PHHY2015CN082965",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": null,
"d... |
{
"abstract": "BACKGROUND\nConcern for postoperative complications causing airway compromise has limited widespread acceptance of ambulatory thyroid surgery. We evaluated differences in outcomes and hospital costs in those monitored for a short stay of 6 h (SS), inpatient observation of 6-23 h (IO), or inpatient admi... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-296375",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadd... |
{
"abstract": "For advanced non-small cell lung cancer anti-PD-1 treatment has become standard care in first and second line treatment in recent years. Because many of the clinical trials with anti-PD-1 drugs have only recently been completed, long term follow up data of patients treated with these agents is scarce, ... | [
{
"companynumb": "NL-BRISTOL-MYERS SQUIBB COMPANY-BMS-2020-102574",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "NIVOLUMAB"
},
"drugaddi... |
{
"abstract": "The neuroprotective action of sex hormones has been described. Data on the association between 5α-reductase inhibitor (5-ARI), a male sex hormone antagonist, and macular abnormalities are lacking to date.\n\n\n\nTo assess the association between the use of 5-ARI for treatment of benign prostate hypertr... | [
{
"companynumb": "KR-GLAXOSMITHKLINE-KR2021GSK020727",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DUTASTERIDE"
},
"drugadditional": "3... |
{
"abstract": "Granulomatosis with polyangiitis (GPA) presents with a variety of systemic findings, sometimes with ocular findings initially, but is often difficult to diagnose at an early stage. An 85-year-old male had complaints of ocular dryness and redness and was diagnosed with meibomian gland dysfunction with m... | [
{
"companynumb": "JP-TEVA-2021-JP-1944507",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "The authors report a case of probable serotonin syndrome caused by the coadministration of sertraline and oxycodone. A 34 year-old male patient experienced visual hallucinations and severe tremor after dramatically increasing his dosage of oxycodone while on stable amounts of sertraline and cyclosporin... | [
{
"companynumb": "US-MALLINCKRODT-T201305067",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FLUCONAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "There is no literature on the use of belatacept for sensitized patients or regrafts in kidney transplantation. We present our initial experience in high immunologic risk kidney transplant recipients who were converted from tacrolimus to belatacept for presumed acute calcineurin inhibitor (CNI) toxicity... | [
{
"companynumb": "PHHY2015US124111",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
"drug... |
{
"abstract": "OBJECTIVE\nTo describe a case of first episode mania and in which varenicline (Champix) or its withdrawal appears to have been the precipitating factor.\n\n\nMETHODS\nThe clinical presentation and progress are detailed and the relevant literature in relation to varenicline is provided.\n\n\nRESULTS\nTh... | [
{
"companynumb": "AU-PFIZER INC-2016059684",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "VARENICLINE TARTRATE"
},
"drugadditional": nul... |
{
"abstract": "We validated an algorithm to detect frequency errors in computerized healthcare data and estimated the incidence of these errors in an integrated healthcare system.\n\n\n\nWe applied Sentinel System analytic tools on the electronic health records of Kaiser Permanente, Northern California, January 1, 20... | [
{
"companynumb": "US-PFIZER INC-2019361961",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE SODIUM"
},
"drugadditional": "3",... |
{
"abstract": "BACKGROUND\nPosterior reversible encephalopathy syndrome (PRES) is a condition characterized by seizures, headache, visual disturbances, paresis, nausea and altered mental status. Risk factors include hypertension, eclampsia/pre-eclampsia, infection/sepsis, transplantation (allograft, bone marrow and s... | [
{
"companynumb": "IT-AMNEAL PHARMACEUTICALS-2020-AMRX-01310",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CAPECITABINE"
},
"drugadditio... |
{
"abstract": "Kawasaki disease is an acute vasculitis of childhood. Its clinical presentation is well known, and coronary artery aneurysms are classical complications. Shock and pleural or pericardiac effusion are rare presentations of the disease. In intensive care units, the disease may be mistaken for septic shoc... | [
{
"companynumb": "CH-ROCHE-2500790",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "BACKGROUND\nKrukenberg tumors are among rare cases of metastatic ovary cancers. They are presented as a solid mass which generally has bilateral and sometimes cystic components and is also known through symptoms related to the mass effect and/or hormonal imbalance. However, they may present findings be... | [
{
"companynumb": "TR-ROCHE-2972938",
"fulfillexpeditecriteria": "1",
"occurcountry": null,
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CAPECITABINE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "Carfilzomib is a newer drug approved for the treatment of relapsing and refractory multiple myeloma. It has been rarely associated with acute liver failure (ALF).\n\n\nMETHODS\nWe present a case of 58-year-old man presenting with abnormal liver function tests and subsequently diagnosed with ALF due to ... | [
{
"companynumb": "US-AMGEN-USASP2018094035",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CARFILZOMIB"
},
"drugadditional": "1",
... |
{
"abstract": "Despite the fact that there are individuals who have chronic HIV infection, few studies have investigated ART interruption in this setting. The aim of this study was to evaluate the ability to spontaneously control viral replication during analytical treatment interruption (ATI) in adults with chronic ... | [
{
"companynumb": "IT-MYLANLABS-2019M1119575",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LAMIVUDINE"
},
"drugadditional": null,
... |
{
"abstract": "Chemotherapy-induced radiation recall reactions are rare, commonly affecting skin but can affect internal organs. Treatments include antihistamines and topical steroids and discontinuation of therapy if severe. Rechallenge may not cause recurrence.",
"affiliations": "Northern Cancer Service Northwest... | [
{
"companynumb": "AU-AMGEN-AUSSP2021096818",
"fulfillexpeditecriteria": "2",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DOCETAXEL"
},
"drugadditional": null,
... |
{
"abstract": "Infections remain an important cause of death among hemodialysis patients. This population have a higher risk of candidemia. Candida endocarditis it´s a rare but frequently fatal complication of candidemia. A 64 year-old female presented with a purulent discharge at the insertion site of a hemodialysis... | [
{
"companynumb": "PT-TEVA-2020-PT-1510551",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALLOPURINOL"
},
"drugadditional": "3",
... |
{
"abstract": "Our case describes the serial microbiome changes in twins discordant for necrotizing enterocolitis (NEC), who shared similar intrauterine and early environmental exposures. The key findings were that the 2 neonates had distinctly different microbiome compositions from the first stool samples collected.... | [
{
"companynumb": "US-JNJFOC-20160608676",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FAMOTIDINE"
},
"drugadditional": null,
... |
{
"abstract": "We previously demonstrated a distinct hepatic microRNA (miRNA) signature (down-regulation of miRNA-23a, -150, - 200b, -503, and -663 and up-regulation of miRNA-20a) is associated with successful regeneration in auxiliary liver transplantation (ALT). This study aimed to evaluate whether the serum expres... | [
{
"companynumb": "GB-JNJFOC-20200631558",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": null,
... |
{
"abstract": "Morphine, oxycodone, and fentanyl are commonly used to control cancer pain. Because these drugs have differences in receptor affinity or pharmacokinetic parameters, changing the opioid formulation may result in an unexpected outcome, depending on the patient's condition. This study investigated whether... | [
{
"companynumb": "JP-JNJFOC-20141216115",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FENTANYL CITRATE"
},
"drugadditional": null,
... |
{
"abstract": "Neuroendocrine tumors (NETs) comprise a heterogeneous group of neoplasms. These tumors can produce a wide variety of hormones that can lead to syndromes of hormone excess, such as carcinoid syndrome. We present the case of a 47-year-old man who presented with right upper quadrant abdominal pain and eme... | [
{
"companynumb": "US-ROCHE-2032382",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CAPECITABINE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "This case demonstrates the use of a single levonorgestrel 13.5 mg intrauterine system (IUS) for contraception in a patient with uterine didelphys. IUS are contraindicated for use with Congenital Müllerian uterine anomalies, but there is very limited evidence to support this restriction.",
"affiliatio... | [
{
"companynumb": "US-BAYER-2020-248994",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LEVONORGESTREL"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nThe incidence of acyclovir-induced hypersensitivity is rare. To our knowledge, there are four published case reports of oral acyclovir desensitization in adults. Evidence-based guidelines prompt the use of acyclovir for herpes simplex virus (HSV) prophylaxis and treatment. Literature on the... | [
{
"companynumb": "US-GLENMARK PHARMACEUTICALS-2020GMK049977",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ACYCLOVIR"
},
"drugadditional... |
{
"abstract": "We report a septicemia and disseminated candidiasis due to delayed gastrointestinal mucosae repair in a patient treated with tocilizumab after anti-CD19 CAR T-cell therapy. Tocilizumab could have inhibited intestinal tissue repair and furthered bacteria translocation leading to the invasion of intestin... | [
{
"companynumb": "FR-TEVA-2021-FR-1949880",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "Autonomic modulation is being increasingly employed as a strategy to treat ventricular arrhythmias refractory to beta-blockers, antiarrhythmic drugs, and catheter-based ablation procedures. We report 6 patients with refractory ventricular tachycardia (VT) or ventricular fibrillation (VF) treated with s... | [
{
"companynumb": "US-GLENMARK PHARMACEUTICALS-2017GMK028844",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMIODARONE"
},
"drugadditiona... |
{
"abstract": "A 29-year-old man presented with scintillation scotoma. MR imaging demonstrated a diffuse lesion in right parahippocampal gyrus. He underwent a biopsy, and the diagnosis was diffuse astrocytoma. Because of enlargement and new areas of gadolinium enhancement, the tumor was resected 18 months after biops... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2015R1-106814",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TEMOZOLOMIDE"
},
"dr... |
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