article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "We report the case of a young female lung transplant recipient with difficult-to-treat cytomegalovirus (CMV) disease. While treatment with intravenous (IV) ganciclovir failed due to antiviral drug resistance, a trial with foscarnet resulted in severe side effects. In addition, the patient received IV C... | [
{
"companynumb": "DE-BAUSCH-BL-2014-007060",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "GANCICLOVIR"
},
"drugadditional": null,
... |
{
"abstract": "Left ventricular assist devices (LVAD) are a currently established destination and bridge therapy until cardiac transplantation; hence, this patient population continues to increase. Here, we present the first report of abdominal aortic cross-clamping (ACC) in a LVAD patient undergoing emergency aneury... | [
{
"companynumb": "JP-WATSON-2016-01114",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "WARFARIN"
},
"drugadditional": null,
"dr... |
{
"abstract": "Combined BRAF and MEK inhibition is one of the first-line treatment strategies for patients with advanced BRAF-mutant melanoma. Sarcoid-like reactions (SLRs) have occasionally been described with melanoma systemic treatments such as immunotherapy or the BRAF inhibitor vemurafenib, but very few cases ha... | [
{
"companynumb": "FR-BAYER-2021-183685",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SORAFENIB"
},
"drugadditional": "3",
"dr... |
{
"abstract": "Allergic reactions against GH are rare, and usually represented by the hypersensitivity type I (IgE-mediated). This type of reaction can be treated by desensitization. In this case report, we present a patient showing an allergic reaction soon after starting GH therapy mediated by immune complex (hyper... | [
{
"companynumb": "BR-PFIZER INC-2019137863",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LEVOTHYROXINE SODIUM"
},
"drugadditional": nu... |
{
"abstract": "Chronic granulomatous disease is a primary immunodeficiency caused by mutations in any one of the five components of the NADPH oxidase in phagocytic leucocytes. This causes impaired microbial killing, which leads to severe life-threatening bacterial and fungal infections. Currently, allogenic hematopoi... | [
{
"companynumb": "ES-ASTELLAS-2018US030778",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "INTERFERON GAMMA"
},
"drugadditional": null,
... |
{
"abstract": "Ischemic stroke is a very rare complication but classic ovarian hyperstimulation. We report the cases of three young women aged 35, 37 and 27 years. All three were victims of ischemic formed by proximal occlusion of the middle cerebral artery secondary to ovarian hyperstimulation. The first and the thi... | [
{
"companynumb": "FR-ROCHE-1541418",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"drugadditional": null,
"drug... |
{
"abstract": "BACKGROUND\nInflammatory bowel disease (IBD) is a lifelong, chronic inflammatory condition of the gastrointestinal tract. IBD morbidity rate in Europe has been steadily growing for the last six decades. Women with IBD are often diagnosed during the childbearing years, which makes the influence of the d... | [
{
"companynumb": "PL-ALLERGAN-1948655US",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MESALAMINE"
},
"drugadditional": "3",
"... |
{
"abstract": "BACKGROUND\nThe burden of HIV/AIDS is ever increasing, affecting populations all over the world. Along with the disease, its effects and consequences on bone health are also on a rise. A commonly used drug in managing HIV, \"Tenofovir\" has been shown to affect bone health, specifically on prolonged us... | [
{
"companynumb": "IN-GILEAD-2020-0495952",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "EFAVIRENZ"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo study the characteristics and prevention and treatment strategies of massive hemorrhage caused by fungal infections after donation-after-cardiac-death (DCD) kidney transplantation.\n\n\nMETHODS\nA total of 91 cases of DCD kidney transplantation between August 25, 2013 and June 30, 2015 in... | [
{
"companynumb": "CN-PFIZER INC-2017006418",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUCONAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nTo report a case of ischemic optic neuropathy caused by medication for benign prostatic hyperplasia (BPH).\n\n\nMETHODS\nThe medical record of a patient who experienced gradual visual loss during the BPH medication was retrospectively reviewed.\n\n\nMETHODS\nA 60-year-old man who had uveitic... | [
{
"companynumb": "KR-ALKEM LABORATORIES LIMITED-KR-ALKEM-2020-01610",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "FINASTERIDE"
},
"drug... |
{
"abstract": "The very strong relationship between suicide, depressive disorders, and substance use disorders is well recognized. Certain pain syndromes are significantly associated with suicide, irrespective of co-occurring medical or psychiatric diagnosis. Chronic pain, depression, substance use disorders, and sui... | [
{
"companynumb": "US-ACTAVIS-2014-23116",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "OXYCODONE HYDROCHLORIDE"
},
"drugadditional": nul... |
{
"abstract": "Bilateral tubal pregnancy is very rare and occurs in only 1 out of every 200,000 spontaneous pregnancies. In this case, a 29-year-old woman with a history of primary infertility underwent treatment with human menopausal gonadotropin (hMG)-human chorionic gonadotropin (hCG), and became pregnant. A gesta... | [
{
"companynumb": "JP-US-EMD SERONO, INC.-7316800",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CLOMIPHENE CITRATE"
},
"drugadditional"... |
{
"abstract": "We present a case of an 85-year-old woman diagnosed with uncomplicated pyelonephritis, who was treated with intravenous ceftriaxone. Her chronic medications were phenprocoumon, diltiazem and bisoprolol. During the infectious phase, the patient presented tachycardia - despite high-dose beta-blocker trea... | [
{
"companynumb": "CH-B.BRAUN MEDICAL INC.-2083602",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PHENPROCOUMON"
},
"drugadditional": nu... |
{
"abstract": "We present a fatal case of persistent neonatal candidemia by Candida parapsilosis following omphalocele, without other anomalies. Despite an encouraging initial prognosis, after surgical correction and closure of the abdominal wall the case became difficult to treat, as in addition to the exposure of t... | [
{
"companynumb": "BR-FLAMINGO-001121",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "AMIKACIN"
},
"drugadditional": null,
"drug... |
{
"abstract": "Post-transplant lymphoproliferative disease is a recognized complication following solid organ transplantation. This is usually a B cell disease and frequently associated with Epstein Barr virus infection, although T cell PTLD can occur. T cell PTLD is usually a monomorphic, lymphomatous disease associ... | [
{
"companynumb": "GB-ACCORD-194388",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "1",
"druga... |
{
"abstract": "Chronic lymphocytic leukemia (CLL) is frequently complicated by secondary autoimmune cytopenias (AICs). Ibrutinib is an irreversible inhibitor of Bruton's tyrosine kinase approved for the treatment of relapsed CLL and CLL with del(17p). The effect of ibrutinib treatment on the incidence of AIC is curre... | [
{
"companynumb": "PHHY2016US038952",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "IBRUTINIB"
},
"drugadditional": null,
"druga... |
{
"abstract": "BACKGROUND\nAutologous chondrocyte implantation (ACI) has been shown to provide adequate durability, pain relief, and improved long-term functional outcomes in the average patient, but proof of its efficacy in individuals with greater than average physical demands is scarce. Further knowledge is requir... | [
{
"companynumb": "US-VERICEL CORPORATION-VCEL-2017-000684",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "AUTOLOGOUS CULTURED CHONDROCYTES"
},
... |
{
"abstract": "BACKGROUND\nTibolone is a synthetic steroid, used with increasing frequency to treat symptoms of menopause, including patients with solid-organ transplants who are taking concurrent immune suppression. To the best of our knowledge, there are no reported drug interactions between tibolone and tacrolimus... | [
{
"companynumb": "PHHY2018AU012481",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "3",
... |
{
"abstract": "For women on maintenance dialysis, pregnancy is still uncommon. The outcome of such pregnancies has improved in recent case series. Here, we report in detail the treatment of five successful pregnancies in dialysis patients from our centre. The present case series also includes the first successful pre... | [
{
"companynumb": "FR-MYLANLABS-2014M1006926",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "CYSTEAMINE BITARTRATE"
},
"drugadditional": n... |
{
"abstract": "BACKGROUND\nPeterborough has one of the highest rates of tuberculosis in the East of England; ∼40% of TB treated locally is extra-pulmonary.\n\n\nOBJECTIVE\nAll adults diagnosed with abdominal tuberculosis (ATB) between January 2008 and September 2011 in Peterborough Hospitals were retrospectively eval... | [
{
"companynumb": "PHHY2015GB001845",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ISONIAZID"
},
"drugadditional": null,
"druga... |
{
"abstract": "BACKGROUND\nHeatstroke is a life-threatening condition defined by failure of heat load dissipation, resulting in a core temperature higher than 40 °C (104 °F) associated with neurological dysfunction. Topiramate may cause anhidrosis, potentially resulting in heatstroke, as reported especially in childr... | [
{
"companynumb": "CH-ACCORD-040149",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ALLOPURINOL"
},
"drugadditional": null,
"dr... |
{
"abstract": "Generalized pustular psoriasis of pregnancy (GPPP) is a rare and severe condition that may impair the health of the mother and fetus. Effective treatment is essential, as treatment options for GPPP are limited due to concerns about unfavorable pregnancy outcomes. We report the case of a 22-year-old wom... | [
{
"companynumb": "TR-CELLTRION INC.-2021TR006568",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional":... |
{
"abstract": "A 70-year-old woman with an 11-year history of indeterminate inflammatory bowel disease developed rapidly progressive glomerulonephritis (RPGN) 3 months after the initiation of infliximab therapy. A renal biopsy showed Congo red-positive homogenous deposits in the mesangial area, glomerular capillary w... | [
{
"companynumb": "JP-PFIZER INC-2019075790",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": "1",
... |
{
"abstract": "Most patients who could be cured of sickle cell disease (SCD) with stem cell transplantation do not have a matched sibling donor. Successful use of alternative donors, including mismatched family members, could provide a donor for almost all patients with SCD. The use of a reduced-intensity conditionin... | [
{
"companynumb": "US-ADIENNEP-2018AD000025",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "THIOTEPA"
},
"drugadditional": null,
... |
{
"abstract": "High-risk neuroblastoma is characterised by poor long-term survival, especially for very high-risk (VHR) patients (poor response of metastases after induction therapy). We report the results of an intensified high-dose chemotherapy (HDC) strategy to improve the prognosis of VHR patients. This strategy ... | [
{
"companynumb": "FR-MYLANLABS-2017M1034510",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BUSULFAN"
},
"drugadditional": "3",
... |
{
"abstract": "Autoimmune retinopathy (AIR) is an immune-mediated retinopathy, resulting from an immunologic process caused by the aberrant recognition of retinal antigens as autoantigens. The diagnosis of AIR involves the detection of antiretinal antibodies with concurrent clinical and electrophysiological evidence ... | [
{
"companynumb": "CONCORDIA PHARMACEUTICALS INC.-CO-OR-KR-2016-007",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"dru... |
{
"abstract": "Recently, medical examiners reported two cases of a 21-year-old male and 24-year-old male with high amounts of morphine in their blood at autopsy. It was suspected that the decedents ingested lethal amounts of morphine from home-brewed poppy seed tea. No studies to date have investigated opium alkaloid... | [
{
"companynumb": "US-PFIZER INC-2017437176",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "THEBAINE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nThe clinical response of rituximab (RTX) is related to the degree of B cell depletion, although other circulating lymphocytes may be affected. We investigated the changes in lymphocyte sub-populations in rheumatoid arthritis (RA) patients treated with RTX and their relationship with the ther... | [
{
"companynumb": "IT-ROCHE-1937621",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "The Canadian Cancer Trials Group study HN.6 is the largest randomized clinical trial to date comparing the concurrent administration of anti-epidermal growth factor receptor (EGFR) monoclonal antibodies with radiotherapy (RT) to standard chemoradiotherapy in locoregionally advanced squamous cell carcin... | [
{
"companynumb": "CA-AMGEN-CANSP2019067158",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PANITUMUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Emergence of extensively drug-resistant (XDR) bacteria has forced clinicians to use off-label antimicrobial agents such as tigecycline. We present our experience on salvage use of tigecycline for the treatment of infections caused by XDR Gram-negative bacteria in critically ill children and review publ... | [
{
"companynumb": "GR-PFIZER INC-2017265842",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "AMIKACIN"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo evaluate the efficacy and safety of gemcitabine plus cisplatin in Japanese patients with unresectable gallbladder cancer (GBC).\n\n\nMETHODS\nChemo-naïve patients with histologically proven unresectable GBC were enrolled in this study. The patients received gemcitabine (1000 mg/m2) and ci... | [
{
"companynumb": "JP-CIPLA LTD.-2018JP02588",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "GEMCITABINE\\GEMCITABINE HYDROCHLORIDE"
},
"d... |
{
"abstract": "Cutaneous delayed reactions to antihypertensive drugs have been described in a limited number of case reports but the mechanisms remain mostly unknown. We report the case of a 60-year-old female patient with a 3-week history of an itchy erythematous maculopapular eruption. Although the patient was poly... | [
{
"companynumb": "PT-TEVA-2019-PT-1115421",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVOTHYROXINE"
},
"drugadditional": "3",
... |
{
"abstract": "There is a higher incidence of acute cellular rejection (ACR) in small bowel transplantation (SBT) compared with transplantation of other solid organs. Although there are reports on the use of infliximab to successfully treat ACR refractory to other treatments, there are no reports, to our knowledge, r... | [
{
"companynumb": "US-ACTAVIS-2016-14241",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MESALAMINE"
},
"drugadditional": null,
... |
{
"abstract": "With the advent of more aggressive cytotoxic chemotherapy regimens, the incidence of ocular toxicity due to these drugs is also on the rise. We report a case of Presumed Chemotherapy-Induced optic neuropathy and maculopathy secondary to treatment with cytarabine and daunorubicin for Acute Myeloid Leuka... | [
{
"companynumb": "IN-FRESENIUS KABI-FK201710628",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CYTARABINE"
},
"drugadditional": null,
... |
{
"abstract": "N-butyl cyanoacrylate (NBCA) has been used to embolise brain arteriovenous malformations (AVMs) for over 30 years. It is a mixed with lipiodol in varying proportions. We report a 22-year-old male with intraventricular hemorrhage from a ruptured intranidal AVM aneurysm in the left temporal lobe. The int... | [
{
"companynumb": "JP-GUERBET-JP-20190125",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ENBUCRILATE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nAccording to the results of the international study Relapsed AML 2001/01 response was better after re-induction with L-DNR/FLAG (liposomal daunorubicin, fludarabine, cytarabine, G-CSF) compared to FLAG only but survival rate was not improved. However, the findings might be group-specific.\n... | [
{
"companynumb": "DE-SA-2015SA081109",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FLUDARABINE PHOSPHATE"
},
"drugadditional": null,
... |
{
"abstract": "Although quantitative PCR (qPCR) has been explored for chimerism monitoring after allogeneic stem cell transplantation (SCT), evidence regarding its clinical utility compared with standard short tandem repeat (STR) is still limited. We retrospectively studied commercial qPCR and STR chimerism with resp... | [
{
"companynumb": "PHHY2017DE126299",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": null,
"dr... |
{
"abstract": "BACKGROUND\nPosterior reversible encephalopathy syndrome (PRES) is a reversible neurological condition presenting with seizures and visual disturbances and diagnosed on magnetic resonance imaging (MRI). Little is understood about its pathogenesis, particularly in children, but it is thought to be relat... | [
{
"companynumb": "ZA-ROCHE-2523618",
"fulfillexpeditecriteria": "1",
"occurcountry": "ZA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "POTASSIUM"
},
"drugadditional": null,
"drug... |
{
"abstract": "To present a case of colopathy related to the use of diclofenac in a patient with a positive immunochemical faecal occult blood test (iFOBT) and to discuss the influence of nonsteroidal anti-inflammatory drugs (NSAIDs) on iFOBT specificity.\n\n\n\nA colonoscopy in a 56-year-old female presenting with a... | [
{
"companynumb": "ME-MYLANLABS-2018M1017030",
"fulfillexpeditecriteria": "1",
"occurcountry": "ME",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DICLOFENAC"
},
"drugadditional": "3",
... |
{
"abstract": "Two girls, 15- and 17-year-old, were consecutively and involuntarily admitted to the local child and adolescent psychiatric hospital with severe first onset psychosis. Due to refractory agitation, ongoing psychosis and insomnia, catatonic features, autonomic instability and the need for one-on-one guid... | [
{
"companynumb": "NL-MYLAN-2014M1002570",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HALOPERIDOL"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nRapid treatment of agitation in the emergency department (ED) is critical to avoid injury to patients and providers. Treatment with intramuscular antipsychotics is often utilized, but there is a paucity of comparative effectiveness evidence available.\n\n\nOBJECTIVE\nThe purpose of this inv... | [
{
"companynumb": "US-JNJFOC-20190523326",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HALOPERIDOL DECANOATE"
},
"drugadditional": "3",
... |
{
"abstract": "PEPDar compared the tolerability and safety of ritonavir-boosted darunavir (DRV/r)-based post-exposure prophylaxis (PEP) with the tolerability and safety of standard of care (SOC). The primary endpoint was the early discontinuation rate among the per-protocol population.\n\n\n\nPEPDar was an open-label... | [
{
"companynumb": "DE-CIPLA LTD.-2016DE05745",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RITONAVIR"
},
"drugadditional": null,
... |
{
"abstract": "35 yr old steroid dependent lady with Pulmonary TB underwent debridement of epidural abscess & posterior stabilization for paraparesis. With histopathology and cultures showing Aspergillus fumigatus, voricanozole was started. By the fourth week, she developed persistent fever, and altered mental status... | [
{
"companynumb": "IN-SA-2017SA015194",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ETHAMBUTOL HYDROCHLORIDE"
},
"drugadditional": null... |
{
"abstract": "Acute liver failure (ALF) is a dramatic, highly unpredictable clinical syndrome defined by the sudden onset of coagulopathy and encephalopathy. Acetaminophen overdose, the leading cause of ALF in the United States, has a 66% chance of recovery with early N-acetylcysteine treatment and supportive care. ... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2017-01165",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"dr... |
{
"abstract": "BACKGROUND\nIn this study, we aimed to review spontaneous rectus sheath hematoma (RSH) and the results of endovascular therapy in patients presenting with a rare acute abdomen.\n\n\nMETHODS\nWe evaluated the patients with RSH because of acute abdominal pain and applied endovascular embolization treatme... | [
{
"companynumb": "TR-SA-2020SA079768",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "Three cases of major bleeding associated with thromboprophylactic unfractionated heparin (UFH) therapy in underweight neurocritically ill patients are reported.\n\n\n\nThree underweight patients (body mass index of <18.5 kg/m2) were treated in the intensive care unit with major bleeds associated with U... | [
{
"companynumb": "US-FRESENIUS KABI-FK202009474",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PROTAMINE SULFATE"
},
"drugadditional": n... |
{
"abstract": "Presenting a case of acute theophylline and salbutamol overdose with distributive shock. Twenty one years old lady presented with history of consumption of 3 gram of theophylline and 40 mg of salbutamol. On admission she had altered sensorium with the systolic blood pressure of 60 mmHg, unrecordable di... | [
{
"companynumb": "IN-MYLANLABS-2021M1011245",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "EPINEPHRINE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nKN012 is a proposed biosimilar candidate for the reference drug denosumab, with the brand name Prolia®. This study explored the tolerance, variability, and pharmacokinetics (PK) of denosumab and its biosimilar in healthy Chinese subjects.\n\n\nMETHODS\nA randomized, double-blind, parallel, ... | [
{
"companynumb": "CN-AMGEN-CHNSP2020205350",
"fulfillexpeditecriteria": "2",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "DENOSUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Changes in imaging findings and hormone levels before and after pheochromocytoma rupture, as well as detailed histopathology of resected tumors, have rarely been reported. A 52-year-old woman developed hypertension and diabetes mellitus in 2014, but despite treatment with antihypertensive and hypoglyce... | [
{
"companynumb": "JP-MYLANLABS-2019M1016309",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VALSARTAN"
},
"drugadditional": "3",
... |
{
"abstract": "Triple-negative breast cancer is associated with early recurrence and low survival rates. Several trials investigate the safety of a more conservative approach of axillary treatment in clinically T1-2N0 breast cancer. Triple-negative breast cancer comprises only 15 % of newly diagnosed breast cancers, ... | [
{
"companynumb": "NL-JNJFOC-20170407512",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": null,
... |
{
"abstract": "Chimeric antigen receptor T-cell (CAR-T) therapies are increasingly used to treat relapsed B-cell lymphomas and acute lymphoblastic leukemia. Considering the frequency of cytokine release syndrome and CAR-T-related encephalopathy syndrome (CRS/CRES) after CAR-T administration, strategies enabling timel... | [
{
"companynumb": "NVSC2020CH222542",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TISAGENLECLEUCEL"
},
"drugadditional": null,
... |
{
"abstract": "FOLFIRINOX has been shown to significantly increase both overall survival (OS) and progression-free survival (PFS) in metastatic pancreas cancer. There is limited data regarding the treatment of locally advanced pancreatic cancer. We present a retrospective study of patients with both locally advanced ... | [
{
"companynumb": "CA-FRESENIUS KABI-FK201502249",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "IRINOTECAN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nBoth gemcitabine and docetaxel have been associated with pulmonary toxicity when used as single agents. We report a study in which three of five cases developed pulmonary toxicity (which proved fatal in one case) when these drugs were used in combination to treat metastatic transitional cel... | [
{
"companynumb": "GB-PFIZER INC-2017205242",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOCETAXEL"
},
"drugadditional": "3",
... |
{
"abstract": "A 45 year-old-man was admitted to our hospital because of discomfort in his left scrotum. He had a left testicular tumor. We performed high orchiectomy and pathological findings revealed testicular cancer. He was treated with bleomycin, etoposide and cisplatin. Computed tomography showed a new mass in ... | [
{
"companynumb": "JP-FRESENIUS KABI-FK201706573",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "Coupled plasma filtration and adsorption (CPFA) is a detoxification system that combines a plasma adsorption circuit and a continuous renal replacement therapy circuit. Its main application is for sepsis and septic shock with or without acute renal failure. Several recent studies have suggested that CP... | [
{
"companynumb": "IT-PFIZER INC-2018130598",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AMIODARONE HYDROCHLORIDE"
},
"drugadditional":... |
{
"abstract": "BACKGROUND\nAlemtuzumab has been demonstrated to reduce the risks of relapse and accumulation of sustained disability in Multiple Sclerosis (MS) patients compared to β-interferon. It acts against CD52, leading primarily to lymphopenia. Recent data have shown that mild neutropenia is observed in 16% of ... | [
{
"companynumb": "GR-SA-2018SA309616",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "ALEMTUZUMAB"
},
"drugadditional": null,
"d... |
{
"abstract": "Tumor necrosis factor alpha inhibitors (TNFi) are basilar treatments in a number of inflammatory rheumatic conditions and autoimmune phenomena such as de novo neuroinflammatory events were already described in these populations under TNFi. We conducted a single-center retrospective study in a cohort of... | [
{
"companynumb": "PT-NOVARTISPH-NVSC2021PT291494",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ADALIMUMAB"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nThe treatment of metastatic colorectal cancer (mCRC) relies of chemotherapy. The efficacy of the standard FOLFIRI-therapy could be improved by a modification of the regimen by splitting the dose of irinotecan on day 1 and day 3 in the FOLFIRI3 regimen.\n\n\nOBJECTIVE\nTo determine safety an... | [
{
"companynumb": "FR-ROCHE-2693702",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IRINOTECAN"
},
"drugadditional": "3",
"druga... |
{
"abstract": "BACKGROUND\nDermatologic toxicities from targeted agents such as panitumumab can interfere with cancer treatment.\n\n\nOBJECTIVE\nWe sought to evaluate the rash assessment and management in a consecutive patient cohort who received panitumumab for colorectal cancer treatment.\n\n\nMETHODS\nThis was a r... | [
{
"companynumb": "CA-AMGEN-CANSP2014056096",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PANITUMUMAB"
},
"drugadditional": null,
... |
{
"abstract": "We analyzed 661 adult patients who underwent single-unit (n = 226) or double-unit (n = 435) unrelated cord blood transplantation (UCBT) following a reduced-intensity conditioning (RIC) consisting of low-dose total body irradiation (TBI), cyclophosphamide, and fludarabine (Cy/Flu/TBI200). Eighty-two pat... | [
{
"companynumb": "FR-SA-2015SA137118",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FLUDARABINE PHOSPHATE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo raise awareness of the potentially adverse consequences of postpartum cerebral vasoconstriction, which is typically considered benign and self-limiting, by describing 4 fulminantly fatal cases.\n\n\nMETHODS\nRetrospective case series.\n\n\nMETHODS\nTertiary referral center.\n\n\nMETHODS\n... | [
{
"companynumb": "CH-ALKEM LABORATORIES LIMITED-CH-ALKEM-2022-01110",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "NIMODIPINE"
},
"druga... |
{
"abstract": "We described a case of a 54-year-old male who presented with dizziness and dyspnea due to cardiac metastasis of leiomyosarcoma. Cardiac metastasis of leiomyosarcoma caused both bradyarrhythmia and tachyarrhythmia in the patient. He was treated with implantation of a permanent pacemaker for management o... | [
{
"companynumb": "PHHY2016KR061797",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "AMIODARONE"
},
"drugadditional": null,
"dru... |
{
"abstract": "Opioid rotation is a practice used when patients with chronic pain have insufficient analgesia, experience unwanted opioid-related adverse reactions, or other pharmacologic challenges with their current opioid. Methadone is an opioid with unique pharmacological properties, which render it clinically di... | [
{
"companynumb": "US-ZYDUS-010496",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHADONE HYDROCHLORIDE"
},
"drugadditional": null,
... |
{
"abstract": "Intradural extramedullary peripheral primitive neuroectodermal tumor (pPNET) with t(11;22) is a rare clinical finding in the pediatric population with few published cases in the literature. The authors report 3 cases of intradural primary pPNET and discuss the clinical presentation, treatment, and surv... | [
{
"companynumb": "US-PFIZER INC-202101586100",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "VINCRISTINE SULFATE"
},
"drugadditional": nu... |
{
"abstract": "Polypharmacy of elderly oncology patients and fragmented medication management are well-known risk factors for drug-drug interactions (DDIs). These interactions can occur among antineoplastic, ongoing chronic treatment(s) and chemotherapy-associated treatments, like antiemetics. Clinically relevant int... | [
{
"companynumb": "FR-MLMSERVICE-20190214-1521355-1",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "APREPITANT"
},
"drugadditional": "1",
... |
{
"abstract": "Extraintestinal infection with Clostridium difficile has been reported but remains uncommon. Treatment of this unusual complication is complex given the limitations of current therapeutic options. Here we report a novel case of recurrent extraintestinal C. difficile infection that occurred following fe... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2018SP005271",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"drugadditio... |
{
"abstract": "We report a rare case of multicentric reticulohistiocytosis (MRH) associated with liver carcinoma. A 36-year-old man who had been diagnosed as having liver carcinoma for 2 years presented with a 2-month history of multiple papulonodules on the face, ears, neck, and upper chest, accompanied by progressi... | [
{
"companynumb": "CN-VISTAPHARM, INC.-VER201706-000171",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional":... |
{
"abstract": "Metastatic testicular cancer (TC) can be cured with bleomycin, etoposide and cisplatin (BEP) chemotherapy. This comes at the price of an increased cardiovascular disease risk, not only years afterwards, but also during and shortly after chemotherapy. To prevent cardiovascular events, high-risk patients... | [
{
"companynumb": "NL-ACCORD-042370",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "Corticosteroids are widely used in total knee arthroplasty (TKA) to relieve postoperative pain and prevent postoperative nausea. The aim of this prospective, randomized controlled study was to compare the effects of intravenous and periarticular administration of corticosteroids on pain control, preven... | [
{
"companynumb": "US-AMNEAL PHARMACEUTICALS-2021-AMRX-04207",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE SODIUM PHOSPHATE"
},
... |
{
"abstract": "Second primary malignancy following multiple myeloma (MM) was reported several years ago. There are also rare reports of cases with synchronous MM and other malignancies. To our knowledge, only one case of MM following bladder cancer has been reported in the literature. Here, we report the second case ... | [
{
"companynumb": "IR-BAUSCH-BL-2016-011768",
"fulfillexpeditecriteria": "1",
"occurcountry": "IR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nBK polyomavirus infects most of the general population. However, its clinical manifestations are almost exclusively seen in immunocompromised patients, particularly in kidney and hematopoietic stem cell transplantation recipients.\n\n\nMETHODS\nA 15-y-old female suffering from common B-cell... | [
{
"companynumb": "IT-BAXTER-2016BAX012256",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "THIOTEPA"
},
"drugadditional": null,
... |
{
"abstract": "We present a 19-year-old man with a diagnosis of Ehlers-Danlos syndrome (EDS) and a delayed presentation of testicular torsion. EDS is a rare and heterogeneous condition affecting collagen synthesis and presents multiple difficulties in a surgical setting. Management of this case of testicular torsion ... | [
{
"companynumb": "IE-ALKEM LABORATORIES LIMITED-IE-ALKEM-2018-02900",
"fulfillexpeditecriteria": "1",
"occurcountry": "IE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"d... |
{
"abstract": "Kounis syndrome, which is known as allergic angina and allergic myocardial infarction today, was described as the coexistence of acute coronary syndrome with allergic reactions in 1991 by Kounis and Zavras. We report a case of a 79-year-old man with hypertension, hepatocellular carcinoma (HCC), and no ... | [
{
"companynumb": "JP-GUERBET LLC-1044499",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ETHIODIZED OIL"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nMycophenolic acid (MPA) pharmacokinetics using the mycophenolate mofetil (MMF) formulation are known to differ between patients receiving tacrolimus or cyclosporine, but only limited data exist concerning concomitant use of tacrolimus and enteric-coated mycophenolate sodium (EC-MPS).\n\n\nM... | [
{
"companynumb": "NVSC2020DE029364",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "3",
"druga... |
{
"abstract": "Thromboembolic complications commonly occur in patients with multiple myeloma (MM). The risk of such complications may be elevated by the use of immunomodulatory agents such as thalidomide and lenalidomide as initial therapy for MM. However, arterial thrombosis after treatment with bortezomib is rare. ... | [
{
"companynumb": "CN-MPIJNJ-2010-05538",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": null,
... |
{
"abstract": "Drug-induced acute interstitial nephritis (AIN) is often encountered in clinical practice. Cephalexin is a first-generation cephalosporin with antimicrobial sensitivity ranging from Gram-positive to Gram-negative organisms. Cephalexin-induced AIN presenting with hypokalemic periodic paralysis (HPP) has... | [
{
"companynumb": "IN-PRAGMA PHARMACEUTICALS, LLC-2019PRG00268",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CEPHALEXIN"
},
"drugadditio... |
{
"abstract": "Idiopathic pulmonary arterial hypertension is a progressive disease with high mortality with an increasing burden of right ventricular. Right ventricular dyssynchrony was observed in idiopathic pulmonary arterial hypertension, but the association with mortality is unclear. This study aimed to investiga... | [
{
"companynumb": "CN-ACTELION-A-CH2019-199917",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BOSENTAN"
},
"drugadditional": "3",
... |
{
"abstract": "Cryptococcal meningitis is a critical illness affecting 0.2% to 5% solid-organ transplant recipients with a 40% to 50% mortality. We report the case of a 48-year-old lung transplant recipient, who, 15 months after a right lung graft, kept parakeets and developed meningitis due to Cryptococcus neoforman... | [
{
"companynumb": "FR-TEVA-2018-FR-879474",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": "3",
... |
{
"abstract": "There is preliminary evidence for prostate-specific membrane antigen (PSMA) upregulation effects of androgen receptor blockade in prostate cancer. In an attempt to find the best condition for PSMA radioligand therapy in metastatic castration-resistant prostate cancer (mCRPC) patients, we evaluated the ... | [
{
"companynumb": "DE-ASTELLAS-2020US002369",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ENZALUTAMIDE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nThe present study aimed to analyze 219 notifications of suspected adverse reactions (AR) produced by psychoactive medicaments (ARPM), notified by Brazilian psychiatrists, during a 3-month period (April 1999 up to September 2001).\n\n\nMETHODS\nA notifying card for adverse reactions possibly ... | [
{
"companynumb": "BR-PFIZER INC-2020397141",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VENLAFAXINE HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "BACKGROUND\nThere are few data relating to sirolimus overdose in the medical literature. Our objectives were to describe all cases of overdose with sirolimus reported to Swiss, German and Austrian Poisons Centres between 2002-2013.\n\n\nMETHODS\nAn observational case-series analysis was performed to de... | [
{
"companynumb": "CH-PFIZER INC-2015191656",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "SIROLIMUS"
},
"drugadditional": null,
... |
{
"abstract": "The combination of gemcitabine and docetaxel is often used to treat patients with recurrent sarcoma. Nab-paclitaxel is a taxane modified to improve drug exposure and increase intratumoral accumulation and, in combination with gemcitabine, is standard therapy for pancreatic cancer. Applying the dosages ... | [
{
"companynumb": "US-CELGENEUS-USA-20200507237",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "PACLITAXEL"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nVenous thromboembolism (VTE) - which includes deep venous thrombosis (DVT) and pulmonary embolism (PE) - has been increasingly recognized in the pediatric population. The estimated incidence is 0.07-0.14 cases per 10,000 children. Most cases are associated with two or more risk factors. Med... | [
{
"companynumb": "PT-SA-2019SA045975",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "WARFARIN SODIUM"
},
"drugadditional": "3",
... |
{
"abstract": "We report a case of a malignant lymphoma that was treated with laparoscopic resection of the pericardium. A 43-year-old woman was diagnosed with asymptomatic extrahepatic nodule by medical examination. CT, MRI, and PET-CT examination indicated a solitary fibrous tumor(SFT). Therefore, we performed lapa... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2019R1-209362",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"dr... |
{
"abstract": "Children with intellectual and developmental disabilities (IDD) are likely to receive high-risk prescribing practices, such as polypharmacy, long-term use of psychotropic medications, and overuse of antipsychotics. Behavioural interventions, such as applied behavioural analysis, are evidence-based prac... | [
{
"companynumb": "US-OTSUKA-2019_027999",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "Acetaminophen is known to be generally safe, and the occurrence of anaphylaxis due to acetaminophen has been rarely reported. We report a case of acetaminophen-induced anaphylaxis in a healthy male subject who participated in a clinical trial on the pharmacokinetics of ibandronate. The subject had not ... | [
{
"companynumb": "KR-JNJFOC-20210745966",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "IBANDRONATE SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nThyroid storm is a rare complication of Graves' disease that can carry a poor prognosis. In order to prevent major complications, thyroid storm must be quickly identified in patients and treatment must be promptly implemented. Medical treatment is usually initiated with antithyroid medicati... | [
{
"companynumb": "US-ENDO PHARMACEUTICALS INC-2015-000427",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PROPYLTHIOURACIL"
},
"drugaddit... |
{
"abstract": "We conducted a prospective evaluation of all eosinophilic drug reactions (EDRs) through the Prospective Pharmacovigilance Program from Laboratory Signals at Hospital to find out the incidence and distribution of these entities in our hospital, their causative drugs, and predictors.\n\n\n\nAll periphera... | [
{
"companynumb": "ES-JNJFOC-20170205776",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "IBUPROFEN"
},
"drugadditional": null,
"... |
{
"abstract": "Bone fractures in patients with severe motor and intellectual disabilities (SMIDs) have become an important problem to be solved. These fractures may result from disuse osteoporosis. Bisphosphonate administration is generally the most established treatment for patients with osteoporosis. However, tradi... | [
{
"companynumb": "JP-JNJFOC-20170326348",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ALENDRONATE SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "Hereditary angioedema (HAE) is characterized by nonpitting, nonpruritic subcutaneous, or submucosal edema that may be accompanied by a nonpruritic serpentine erythematous rash. The swelling in this autosomal dominantly inherited disorder is mediated by uncontrolled localized bradykinin production. The... | [
{
"companynumb": "US-SHIRE-US201618204",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "HUMAN C1-ESTERASE INHIBITOR"
},
"drugadditional": ... |
{
"abstract": "A 70-year-old woman presented to our practice with profound ptosis of the left upper eyelid and notable asymmetry of the periocular area. On examination, she was noted to have significant atrophy of the periocular tissues on the left side, with lower eyelid retraction. These features were present but l... | [
{
"companynumb": "US-APOTEX-2016AP010611",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "TRAVOPROST"
},
"drugadditional": null,
... |
{
"abstract": "Catheter-directed interventions (CDIs) are increasingly performed for acute pulmonary embolism (PE) as they are presumed to provide similar therapeutic benefits to systemic thrombolysis while decreasing the dose of thrombolytic required and the associated risks. This study aimed to identify factors ass... | [
{
"companynumb": "US-ROCHE-1933302",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "Liver transplantation offers excellent long-term survival for hepatocellular carcinoma (HCC) patients who fall within established criteria. For those outside such criteria, or with high-risk pathologic features in the explant, HCC recurrence rates are higher. We conducted a multicenter phase I trial of... | [
{
"companynumb": "US-BAYER-2015-307306",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "SORAFENIB"
},
"drugadditional": null,
"... |
{
"abstract": "Although the risks of medication poisoning in children are often reported, there is a lack of studies addressing this issue. The majority of papers deal with a wide range of xenobiotics poisoning and, in particular, alcohol intoxications. All hospital admissions during three years were prospectively re... | [
{
"companynumb": "CZ-TEVA-2020-CZ-1242337",
"fulfillexpeditecriteria": "1",
"occurcountry": "CZ",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "VERAPAMIL HYDROCHLORIDE"
},
"drugadditional": n... |
{
"abstract": "Central diabetes insipidus (DI) is a rare clinical entity characterized by low circulating levels of antidiuretic hormone (ADH) presenting with polyuria and volume depletion. Pituitary surgery is the most common cause of central DI in adults. Pituitary and hypothalamic disease, particularly invasive ne... | [
{
"companynumb": "PT-BAXTER-2018BAX017168",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "VINCRISTINE SULFATE"
},
"drugadditional": null,... |
{
"abstract": "Mesenteric vein thrombosis is a rare but potentially lethal cause of abdominal pain. It is usually caused by prothrombotic states that can either be hereditary or acquired. Testosterone supplementation causes an acquired prothrombotic state by promoting erythropoeisis thus causing a secondary polycytha... | [
{
"companynumb": "US-ABBVIE-14P-163-1302206-00",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TESTOSTERONE"
},
"drugadditional": null,
... |
{
"abstract": "A patient suffered a myocardial injury as a manifestation of anaphylactic reaction to amoxicillin-clavulanic acid administration. A cardiologic study (ergometry and catheterization) showed no obstructive coronary disease and prick test to amoxicillin was positive. Anaphylaxis may cause myocardial injur... | [
{
"companynumb": "ES-AUROBINDO-AUR-APL-2021-024071",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMOXICILLIN\\CLAVULANIC ACID"
},
"drug... |
{
"abstract": "Quetiapine, an atypical antipsychotic drug, is recommended for the treatment of schizophrenia and mood disorders. In addition, given its sedative effects, a low dose of the agent is also widely used in the treatment of anxiety disorders, personality disorders, substance abuse, and sleep disturbances. I... | [
{
"companynumb": "BE-ALKEM LABORATORIES LIMITED-NL-ALKEM-2017-02059",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ZOLPIDEM TARTRATE"
},
... |
{
"abstract": "Integrase strand transfer inhibitors (InSTIs) are recommended agents in first-line combination antiretroviral therapy (cART). We examined the evolution of drug resistance mutations throughout HIV-1 pol and the effects on InSTI susceptibility and viral fitness. We performed single-genome sequencing of f... | [
{
"companynumb": "GB-GLAXOSMITHKLINE-GB2021GSK193634",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RALTEGRAVIR"
},
"drugadditional": "3... |
{
"abstract": "A three-year old child was anaesthetized by halothane. Cardiac arrest occurred soon after the injection of suxamethonium. Signs of rhabdomyolysis associated with hyperkalemia were present. The diagnosis of Duchenne muscular dystrophy was obtained afterwards.",
"affiliations": null,
"authors": "Arno... | [
{
"companynumb": "FR-ROCHE-2178497",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HALOTHANE"
},
"drugadditional": "3",
"drugad... |
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