article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "Adrenocortical carcinoma (ACC) is a rare malignancy with a poor prognosis. While mitotane is the only agent approved for ACC, clinical data are scarce, especially in the Asian population. We reviewed 10 patients with ACC who received mitotane as a single agent or in combination with other agents in our... | [
{
"companynumb": "JP-HRARD-2021000590",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "MITOTANE"
},
"drugadditional": null,
"dr... |
{
"abstract": "BACKGROUND\nEnterococcus gallinarum meningitis (EGM) is rarely found in normal adults and even rarer in children. To our knowledge, EGM in neonate has not been reported previously.\nHere we reported the first case of EGM in neonate. Prolonged fever was the only manifestation for the case after admissio... | [
{
"companynumb": "CN-AXELLIA-001434",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"drugadditional": null,
"dru... |
{
"abstract": "BACKGROUND\nNUT midline carcinoma (NMC) is a rare, highly lethal malignancy that results from a chromosome translocation and mostly arises in the midline organs. To date, no treatment has been established. Most patients receive combinations of chemotherapy regimens and radiation, and occasionally subse... | [
{
"companynumb": "IT-PFIZER INC-2017280547",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "Over the past twenty years, psychotropic drug abuse by young people, especially by teenagers, has received special attention. Here, we present the case of baclofen overdose in a 16-year-old male who recreationally, and probably recurrently, self-administered baclofen. In addition, a review of other cas... | [
{
"companynumb": "FR-OXFORD PHARMACEUTICALS, LLC-2110645",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BACLOFEN"
},
"drugadditional": "... |
{
"abstract": "Hepatic arterial aortic conduits can be used as an alternative means of revascularizing the donor liver when the native recipient hepatic artery (HA) cannot be used. Cytomegalovirus (CMV) is a common Herpesviridae infection in patients who have undergone solid organ transplants. It can be asymptomatic ... | [
{
"companynumb": "GB-ASTELLAS-2019US026137",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
... |
{
"abstract": "A pharmacodynamics (PD) and immunogenicity study was conducted to investigate biosimilarity of Pelmeg®, a pegfilgrastim biosimilar to EU-authorized Neulasta®. The multiple-dose, randomized, double-blind, two-sequence, and three-period cross-over study comprised 96 healthy male subjects, receiving Pelme... | [
{
"companynumb": "DE-AMGEN-DEUSP2019135726",
"fulfillexpeditecriteria": "2",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PEGFILGRASTIM"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nGraft-versus-host disease (GVHD) is a serious complication in allogeneic transplantation. The first-line treatment is high doses of corticosteroids. In the absence of response to corticosteroids, several immunosuppressive drugs can be used, but they entail an elevated risk of severe infecti... | [
{
"companynumb": "NVSC2020CL290939",
"fulfillexpeditecriteria": "1",
"occurcountry": "CL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nIntravenous (IV) tissue plasminogen activator (tPA) infusion combined with transcranial low-frequency ultrasound waves targeted on the occluded arterial segment (sonothrombolysis) can increase recanalization in large artery-acute ischemic stroke (LA-AIS).\n\n\nOBJECTIVE\nTo evaluate the ben... | [
{
"companynumb": "IN-ROCHE-1896382",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "BACKGROUND\nThe DYNC1H1 gene encodes the heavy chain of cytoplasmic dynein 1, a core structure of the cytoplasmic dynein complex. Dominant DYNC1H1 mutations are implicated in Charcot-Marie-Tooth disease, axonal, type 20, spinal muscular atrophy, lower extremity-predominant 1, and autosomal dominant men... | [
{
"companynumb": "JP-UCBSA-2021060665",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "3",
... |
{
"abstract": "We present the case of a subscapular abscess that was drained via a posterolateral approach to the scapula. Complete evacuation of the abscess was achieved, and the incisions healed without difficulty. There were no immediate postoperative complications from this approach.\n\n\n\nTo our knowledge, a po... | [
{
"companynumb": "US-DRREDDYS-USA/USA/18/0098915",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMOXICILLIN"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nIn China, inappropriate therapies with nucleos(t)ide analogues (NA) have induced hepatitis B virus resistance, combination therapy with nucleoside and nucleotide (ComTNsNt) failure, or multi-drug resistant mutations. However, the efficacy of combination therapy with entecavir plus tenofovir ... | [
{
"companynumb": "CN-CIPLA LTD.-2015CN08280",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ADEFOVIR"
},
"drugadditional": null,
... |
{
"abstract": "Most of the daily work of forensic toxicologists deals with fatal cases resulting from overdoses of licit and illicit drugs. However, another reason for fatalities in patients suffering from epilepsy can be undetectable or subtherapeutic levels of antiepileptic drugs. Some studies have shown a correlat... | [
{
"companynumb": "DE-MYLANLABS-2018M1020344",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VALPROIC ACID"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nPrecision medicine is based on molecular and genotypic patient characterization to define specific target treatment. BRAF mutation is an oncogenic driver, and the Cancer Genome Atlas has identified BRAF mutations in different cancer types. Tumor type agnostic therapy is based on targeting g... | [
{
"companynumb": "IT-TEVA-2021-IT-1960998",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nPasteurella is a Gram-negative coccobacillus that causes a wide spectrum of diseases in humans and is commonly transmitted from cat and dog bites. An increasing number of cats and dogs are kept as pets in American households which increases the risk of pet-related infections.\n\n\nMETHODS\n... | [
{
"companynumb": "PHHY2016US064860",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"drugadditional": null,
"drug... |
{
"abstract": "Rhodococcus equi is an aerobic facultative intracellular organism that is known to infect cells of the macrophage-monocyte lineage. It is a common veterinary pathogen; however, the incidence of this infection in humans has risen and it has been recognised as an emerging opportunistic pathogen among the... | [
{
"companynumb": "US-MYLANLABS-2015M1039680",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FLUDARABINE PHOSPHATE"
},
"drugadditional": ... |
{
"abstract": "Timolol Maleate (also called Timolol) is a nonselective beta-adrenergic blocker and a class II antiarrhythmic drug, which is used to treat intraocular hypertension. It has been reported to cause systemic side effects especially in elderly patients with other comorbidities. These side effects are due to... | [
{
"companynumb": "GB-BAUSCH-BL-2016-009025",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ENALAPRIL MALEATE"
},
"drugadditional": null,... |
{
"abstract": "Methylphenidate, a stimulant, is prescribed commonly in the treatment of attention deficit hyperactivity disorder (ADHD) in children and adults. Methylphenidate is generally considered a safe medication, however, some rare adverse effects, such as psychotic symptoms, may occur with its therapeutic or h... | [
{
"companynumb": "IR-SUN PHARMACEUTICAL INDUSTRIES LTD-2018R1-184473",
"fulfillexpeditecriteria": "1",
"occurcountry": "IR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHYLPHENIDATE"
},
... |
{
"abstract": "METHODS\nA 71-year-old female accidentally received thiothixene (Navane), an antipsychotic, instead of her anti-hypertensive medication amlodipine (Norvasc) for 3 months. She sustained physical and psychological harm including ambulatory dysfunction, tremors, mood swings, and personality changes. Despi... | [
{
"companynumb": "US-PFIZER INC-2016438407",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CITALOPRAM HYDROBROMIDE"
},
"drugadditional":... |
{
"abstract": "Dose-intensified treatment strategies for Hodgkin lymphoma (HL) have demonstrated improvements in cure but may increase risk for acute and long-term toxicities, particularly in children. The Children's Oncology Group assessed the feasibility of a dose-intensive regimen, BEACOPP (bleomycin, etoposide, d... | [
{
"companynumb": "US-MYLANLABS-2017M1012688",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BLEOMYCIN SULFATE"
},
"drugadditional": null,... |
{
"abstract": "A 55-year-old man with several comorbidities including idiopathic interstitial pneumonia under long-term corticosteroid therapy, longstanding myocardial infarction, chronic heart failure, paroxysmal atrial fibrillation, gastro-esophageal reflux disease, constipation, and history of paralytic ileus, was... | [
{
"companynumb": "JP-MYLANLABS-2017M1007871",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": "3",
... |
{
"abstract": "Tenofovir disoproxil fumarate (TDF) is widely recommended for treatment of chronic hepatitis B virus (HBV) infection because it is safe, affordable and has a high genetic barrier to resistance. TDF resistance associated mutations (RAMs) have been reported, but data are limited, particularly for Africa.... | [
{
"companynumb": "GB-VIIV HEALTHCARE LIMITED-GB2020GSK135918",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TENOFOVIR DISOPROXIL"
},
"dr... |
{
"abstract": "Methotrexate (MTX) is the primary pharmaceutical agent that is used for management of disorders arising from trophoblastic tissue. Its widespread international use is mostly attributable to its noninvasive, safe, and effective characteristics as a treatment option for ectopic pregnancy (EP) and gestati... | [
{
"companynumb": "US-AZURITY PHARMACEUTICALS, INC.-2021AZY00116",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadd... |
{
"abstract": "Rhabdomyolysis is a potentially life-threatening clinical syndrome characterized by the breakdown of skeletal muscle cells and release of creatine kinase (CK), lactate dehydrogenase (LDH), and myoglobin into the plasma and interstitial space. Rhabdomyolysis can occur due to a variety of causes and acut... | [
{
"companynumb": "IN-MLMSERVICE-20211022-3181002-1",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LORAZEPAM"
},
"drugadditional": "3",
... |
{
"abstract": "We describe a case of internal trapping including the vasa vasorum for a thrombosed giant rapidly growing posterior cerebral artery aneurysm and performing a detailed analysis. A 48-year-old woman was followed up in our hospital for a thrombosed large posterior cerebral artery aneurysm located in the P... | [
{
"companynumb": "JP-GUERBET-JP-20200209",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ETHIODIZED OIL"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nIsolated distal deep venous thrombosis (IDDVT) is traditionally associated with less severe clinical sequelae, with ongoing debate on multiple aspects of its management. Despite numerous studies evaluating its acute management, there remains a paucity of data evaluating long-term complicati... | [
{
"companynumb": "AU-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-31312BI",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DABIGATRAN ETEXILATE MESYLATE"
... |
{
"abstract": "Acute liver failure is characterized by encephalopathy and disruption of hepatic function, often requiring liver transplantation to prevent fatal consequences. We present a 33-year-old man with recurrent lymphoma presenting with acute liver failure, which was initially thought to be from drug-induced l... | [
{
"companynumb": "US-RECORDATI RARE DISEASES INC.-US-R13005-18-00146",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "GEMCITABINE"
},
"dr... |
{
"abstract": "We report a case of hypersensitivity pneumonitis (HP) in a young person secondary to vaping. He presented with a putative diagnosis of asthma and required extracorporeal membrane oxygenationbecause of intractable respiratory failure. He developed a critical illness and steroid myopathy and required pro... | [
{
"companynumb": "GB-TEVA-2021-GB-1874509",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROCORTISONE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nThe purpose of this study was to determine whether, in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the reduction in cardiac mortality in those taking bivalirudin compared with unfractionated heparin plus a glyc... | [
{
"companynumb": "US-JNJFOC-20140117290",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ABCIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nDrug-Resistant Tuberculosis (DR-TB) patients for whom a WHO recommended regimen along with Bedaquiline (BDQ) cannot be prescribed, Delamanid (DLM) was added along with other drugs to provide a \"Salvage Regimen\". The experience of the Institute in respect of early efficacy and safety of bo... | [
{
"companynumb": "IN-JNJFOC-20190339684",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LINEZOLID"
},
"drugadditional": null,
"... |
{
"abstract": "Graft-versus-host disease (GvHD) remains a major cause of transplant-related mortality. Interleukin-2 (IL-2) plus sirolimus (SIR) synergistically reduces acute GvHD in rodents and promotes regulatory T cells. This phase II trial tested the hypothesis that IL-2 would facilitate STAT5 phosphorylation in ... | [
{
"companynumb": "US-ASTELLAS-2017US003160",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SIROLIMUS"
},
"drugadditional": "3",
... |
{
"abstract": "This is case report and review of the literature focused on generic substitutions of cyclosporine and its consequences. The pharmacokinetics and pharmacodynamics of the generic substitutions are clear different than the parent compound Sandimmune and can lead to different outcomes, as was the case in t... | [
{
"companynumb": "US-APOTEX-2016AP015131",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AZATHIOPRINE"
},
"drugadditional": "3",
... |
{
"abstract": "An 84-year-old Japanese woman suffering from rheumatoid arthritis (RA), who had been treated with methotrexate (MTX) for 15 years, was admitted to our hospital for generalised lymphadenopathy, thrombocytopenia, anaemia, elevated aminotransferases, and elevated CRP levels. Pathological findings of cervi... | [
{
"companynumb": "JP-ACCORD-193087",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": "1",
"dru... |
{
"abstract": "Immune thrombocytopenia (ITP) is an acquired disease characterized by thrombocytopenia secondary to autoantibodies against platelets. Here, we report the clinical characteristics of coronavirus disease 2019 (COVID-19)-induced ITP cases.\n\n\n\nWe retrospectively reviewed 3255 COVID-19 patients. COVID-1... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2022SP000775",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugaddition... |
{
"abstract": "OBJECTIVE\nChemoimmunotherapy with cyclophosphamide, doxorubicin, vincristine, prednisolone, and rituximab (R-CHOP) is the standard of care for patients with diffuse large B-cell lymphoma (DLBCL). However, management of elderly patients is challenging as critical comorbidities often account for increas... | [
{
"companynumb": "DE-TEVA-496973GER",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"drugadditional": null,
"dr... |
{
"abstract": "Takotsubo syndrome (TTS) is an acute and transient heart failure syndrome due to reversible myocardial dysfunction characterized by a wide spectrum of possible clinical scenarios. About one-fifth of TTS patients experience adverse in-hospital events. Thromboembolic complications, especially stroke, hav... | [
{
"companynumb": "IT-VALIDUS PHARMACEUTICALS LLC-IT-2021VAL001208",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditi... |
{
"abstract": "The antipsychotic drug quetiapine is widely used, and increasingly prescribed off-label. Furthermore, quetiapine use has been linked to increased mortality rates, most likely due to a range of cardiovascular and metabolic adverse effects. This makes quetiapine a relevant substance in forensic toxicolog... | [
{
"companynumb": "NO-ALKEM LABORATORIES LIMITED-NO-ALKEM-2020-06662",
"fulfillexpeditecriteria": "1",
"occurcountry": "NO",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "OLANZAPINE"
},
"druga... |
{
"abstract": "Emberger syndrome with underlying guanine-adenine-thymine-adenine 2 (GATA2) mutation is a rare disorder and very few successful nonmyeloablative allogeneic hematopoietic stem cell transplants (HSCTs) have been reported. We report a case of Emberger syndrome with GATA2 mutation in a 9-year-old girl who ... | [
{
"companynumb": "IN-ASTELLAS-2017US051710",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "AZITHROMYCIN ANHYDROUS"
},
"drugadditional": n... |
{
"abstract": "Drug-induced severe cutaneous adverse reactions (SCARs) include acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS), and epidermal necrolysis (Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis). The identification of the causal drug is cruc... | [
{
"companynumb": "BE-SEBELA IRELAND LIMITED-2017SEB00325",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "REPAGLINIDE"
},
"drugadditional"... |
{
"abstract": "Although males and females gain comparable weight when prescribed second-generation antipsychotics (SGAs), males may be uniquely vulnerable to an array of endocrinological, inflammatory, and psychosocial adverse drug effects. This opinion piece reviews work in each of these three areas for considerati... | [
{
"companynumb": "US-OTSUKA-2021_024596",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "We report a case of a 52-year-old man with drug-resistant temporal lobe epilepsy, with post-ictal violent aggressive behaviors. Postictal violent outbursts would occur 3-4 times per year following clusters of seizures or generalized tonic-clonic convulsions. The violent outbursts were traumatizing for ... | [
{
"companynumb": "CA-MYLANLABS-2019M1126138",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CLOBAZAM"
},
"drugadditional": null,
... |
{
"abstract": "Takotsubo cardiomyopathy (TTC) is a rare but life-threatening condition that is still not completely understood. Characterised by rapidly reversible ventricular dysfunction without any prior coronary artery disease, it can imitate a myocardial infarction and lead to death if not managed appropriately. ... | [
{
"companynumb": "AU-MYLANLABS-2021M1018051",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FENTANYL"
},
"drugadditional": null,
... |
{
"abstract": "Graft-vs-host disease, characteristically a major complication of allogenic hematopoietic stem cell transplantation, is rare after solid organ transplantation. We report a 50-year-old man who presented with abdominal pain, vomiting, and diarrhea shortly after bilateral lung transplantation. Colonoscopy... | [
{
"companynumb": "NVSC2020US056062",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": "3",
"druga... |
{
"abstract": "Severe congenital neutropenia is a rare disease, and autosomal dominantly inherited ELANE mutation is the most frequently observed genetic defect in the registries from North America and Western Europe. However, in eastern countries where consanguineous marriages are common, autosomal recessive forms m... | [
{
"companynumb": "TR-AMGEN-TURSP2019151574",
"fulfillexpeditecriteria": "2",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FILGRASTIM"
},
"drugadditional": null,
... |
{
"abstract": "Neuromyelitis optica spectrum disorders (NMOSD) are important evolving entities, which have reached much attention in the recent years. NMOSD are characterized by inflammatory lesions in the optic nerves, spinal cord, and central parts of the brain, as well as an autoimmune process directed against aqu... | [
{
"companynumb": "CN-ALKEM LABORATORIES LIMITED-CN-ALKEM-2018-07722",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IMMUNE GLOBULIN NOS"
},
... |
{
"abstract": "A suicide bomb blast in 2013 at a distant city of Pakistan killed 84 and wounded more than 150 people. Some patients were transferred to our tertiary care hospital because of extreme load on medical services there. This patient arrived at the Aga Khan Hospital, 2 days after the bomb blast injury and un... | [
{
"companynumb": "PK-ROCHE-1941473",
"fulfillexpeditecriteria": "1",
"occurcountry": "PK",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "EPINEPHRINE"
},
"drugadditional": null,
"dr... |
{
"abstract": "A 65-year-old male patient with metastatic CCRCC developed steroid-dependent, grade 3 AIN secondary to nivolumab weeks after its initiation that resulted in 3 hospitalizations with acute renal failure. The patient was started on MM and his AIN was successfully controlled after a 2-year period of follow... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-293403",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FUROSEMIDE"
},
"drug... |
{
"abstract": "We conducted a phase I/II multicenter trial using 6 cycles of brentuximab vedotin (BV) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for treatment of patients with CD30-positive (+) B-cell lymphomas. Thirty-one patients were evaluable for toxicity and 29 for effic... | [
{
"companynumb": "US-MYLANLABS-2021M1059125",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
... |
{
"abstract": "There is a pressing need for better pharmacological treatment strategies for psychiatric disorders as current treatment often results in partial symptom remission and unwanted side effects. A point of entry may be the glutamatergic system since glutamatergic dysregulation contributes to multiple psychi... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2019-07744",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RILUZOLE"
},
"drugadd... |
{
"abstract": "Background: Afatinib has shown good efficacy in patients harboring uncommon EGFR mutations, but the incidence of afatinib-induced interstitial pneumonia should be alert as its rapid progression. Here, we report two cases of interstitial pneumonia during afatinib treatment. Case presentation: The first ... | [
{
"companynumb": "CN-BoehringerIngelheim-2021-BI-136682",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AFATINIB"
},
"drugadditional": "1... |
{
"abstract": "BACKGROUND\nAssessment of the metabolic safety of second-generation antipsychotics (SGAs) is mandatory in pregnant women, where the occurrence of metabolic complications and, especially, gestational diabetes mellitus (GDM) may severely impact on pregnancy and fetal outcomes.\n\n\nMETHODS\nThe aim of th... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2019-03421",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "QUETIAPINE FUMARATE"
},
... |
{
"abstract": "Multiple myeloma is the second most common hematological malignancy. Ixazomib is the first oral proteasome inhibitor approved in the United States for the management of multiple myeloma who have received at least one prior treatment. The availability of oral chemotherapeutic agents for the management o... | [
{
"companynumb": "US-MYLANLABS-2021M1030401",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "We report a 21-year-old male patient with dentatorubral-pallidoluysian atrophy (DRPLA) showing progressive myoclonus epilepsy (PME), who responded to levetiracetam (LEV) at an initial dose of 1,000 mg/day. The patient developed epilepsy at the age of 10 years, and also showed intellectual regression. V... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2015R1-104341",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "CLONAZEPAM"
},
"drug... |
{
"abstract": "Bullous pemphigoid is an autoimmune cutaneous blistering disorder, the exact pathogenesis of which is still not fully elucidated. Drug-induced bullous pemphigoid eruptions are rare but have been reported earlier with the use of frusemide, psoralens, ibuprofen, galantamine hydrobromide, ACE inhibitors l... | [
{
"companynumb": "IN-SUN PHARMACEUTICAL INDUSTRIES LTD-2015R1-109323",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"d... |
{
"abstract": "OBJECTIVE\nThis study was performed to evaluate the radiological features of and therapeutic responses to pulmonary disease caused by nontuberculous mycobacteria (NTM) in the setting of biological therapy for rheumatoid arthritis (RA).\n\n\nMETHODS\nWe conducted a retrospective chart review of 13 patie... | [
{
"companynumb": "JP-PFIZER INC-202200320684",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nIdiopathic nephrotic syndrome (INS) necessitates administration of corticosteroids or corticoid-sparing agents in 60% of the cases for prolonged periods resulting in serious adverse effects.\n\n\nMETHODS\nTo avoid these complications, we investigated the efficacy and safety of mycophenolate... | [
{
"companynumb": "DE-MYLANLABS-2018M1020481",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "... |
{
"abstract": "A 2-year-old male presented to hospital with a 5-day history of vomiting and pyrexia. He was initially treated with non-steroidal medication as an anti-pyretic. Initial investigations demonstrated a raised urea and creatinine and he was treated with intravenous fluids. Within 24 h he became anuric with... | [
{
"companynumb": "GB-STRIDES ARCOLAB LIMITED-2016SP016310",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IBUPROFEN"
},
"drugadditional":... |
{
"abstract": "Painful diabetic neuropathy is a common, difficult-to-manage complication of diabetes. We report two case of intractable painful diabetic neuropathy which occurred after the rapid lowering of blood sugar level. Although pregabalin, antidepressants, opioid analgetics and various nerve block did not impr... | [
{
"companynumb": "JP-MYLANLABS-2015M1017078",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "GABAPENTIN"
},
"drugadditional": null,
... |
{
"abstract": "Anti-glomerular basement membrane disease (anti-GBM) is a well-documented, small vessel vasculitis that is classically associated with glomerulonephritis and alveolitis [1]. However, regardless of clinical process, not every patient will present with a constellation of classically associated symptoms. ... | [
{
"companynumb": "US-HIKMA PHARMACEUTICALS USA INC.-US-H14001-21-01809",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"d... |
{
"abstract": "We report a 66-year-old male who developed diabetic ketoacidosis (DKA) and necrosis of the small intestine due to non-occlusive mesenteric ischemia (NOMI), 3 months after starting quetiapine treatment. He was transferred to our hospital and diagnosed as diabetic for the first time, associated with DKA.... | [
{
"companynumb": "JP-ACCORD-138424",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "TIAPRIDE"
},
"drugadditional": null,
"druga... |
{
"abstract": "Although the use of endocrine therapy in combination with intravenous chemotherapy has not been standardized, the combination of fulvestrant and chemotherapy may be promising. A 62-year-old woman came to our hospital's outpatient clinic with extensive ascites. Approximately 10 years earlier, she had un... | [
{
"companynumb": "JP-CIPLA LTD.-2016JP06490",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ANASTROZOLE"
},
"drugadditional": null,
... |
{
"abstract": "Statins are a group of frequently-prescribed drugs with proven cardiovascular risk-benefit. The most common adverse effects include weakness and myalgias. However, prescribers need to be aware of a less common complication, statin-associated necrotizing myopathy, which can occur at any time during the ... | [
{
"companynumb": "US-CPL-002112",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GEMFIBROZIL"
},
"drugadditional": "3",
"drugadm... |
{
"abstract": "In human immunodeficiency virus (HIV)-positive adults, low CD4 cell counts despite fully suppressed HIV-1 RNA on antiretroviral therapy (ART) have been associated with increased risk of morbidity and mortality. We assessed the prevalence and outcomes of poor immune response (PIR) in children receiving ... | [
{
"companynumb": "GB-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2020-BI-021422",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": null,
"drugadditional": null,
"drugadministrationrout... |
{
"abstract": "The objective of this study was to evaluate the effectiveness and impact of once- versus twice-daily dosing of risperidone and olanzapine on clinical outcomes in patients with schizophrenia. Data from phase 1 of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study... | [
{
"companynumb": "CA-JNJFOC-20150406129",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RISPERIDONE"
},
"drugadditional": null,
... |
{
"abstract": "A woman was found unresponsive with an empty bottle of Cogentin(®) prescribed to another. Admitted to an area hospital, her condition steadily declined until death 29 h after admission. Following toxicological screening on hospital (admission) whole blood, the only significant compound detected was ben... | [
{
"companynumb": "US-UPSHER-SMITH LABORATORIES, INC.-14003673",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "BENZTROPINE MESYLATE"
},
"... |
{
"abstract": "Acute promyelocytic leukemia differentiation syndrome (APL DS) is a common and severe complication seen in patients with APL treated with all-trans retinoic acid (ATRA) and/or arsenic trioxide (ATO). The presenting symptoms of APL DS are diverse, and rare symptoms are easy to be misdiagnosed. Therefore... | [
{
"companynumb": "CN-ZO SKIN HEALTH-2021ZOS00016",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TRETINOIN"
},
"drugadditional": "1",
... |
{
"abstract": "Flibanserin is a medication recently approved by the FDA for treatment of generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Its mechanism of action is not fully understood but is thought to modulate serotonin receptors and increase levels of norepinephrine and dopamine. While... | [
{
"companynumb": "US-BAUSCH-BL-2017-026832",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FLIBANSERIN"
},
"drugadditional": null,
... |
{
"abstract": "Philadelphia positive ALL (Ph + ALL) is an aggressive leukemia associated with lower remission rates and poor survival. Current treatment approach for Ph + ALL is chemotherapy along with TKI and CNS directed therapy followed by Allogeneic stem cell transplantation (Allo-SCT). To analyze outcome of Ph +... | [
{
"companynumb": "PHHY2019IN099970",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DASATINIB"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "OBJECTIVE\nDue to reduction of immune-suppressive drugs, patients with rheumatic diseases can experience an increase in disease activity during pregnancy. In such cases, TNF-inhibitors may be prescribed. However, monoclonal antibodies with the Fc moiety are actively transported across the placenta, res... | [
{
"companynumb": "CH-CONCORDIA PHARMACEUTICALS INC.-CO-PL-CH-2015-421",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CERTOLIZUMAB PEGOL"
},
... |
{
"abstract": "Posterior reversible encephalopathy syndrome, previously known as Reversible posterior leukoencephalopathy syndrome, is a clinical-radiological condition characterized by headache, altered mental functioning, seizures and visual alterations, with the magnetic resonance imaging showing cerebral edema, p... | [
{
"companynumb": "ES-ROXANE LABORATORIES, INC.-2016-RO-00246RO",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drug... |
{
"abstract": "Intravenous acetylcysteine is the treatment of choice for paracetamol poisoning. A previous UK study in 2001 found that 39% of measured acetylcysteine infusion concentrations differed by >20% from anticipated concentrations. In 2012, the UK Commission on Human Medicines made recommendations for the man... | [
{
"companynumb": "GB-JNJFOC-20170122018",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nIn the ALIAS (Albumin in Acute Stroke) Part 2 Multicenter Trial, 85% of subjects received standard-of-care intravenous tissue plasminogen activator, and 21% received some form of endovascular thrombolysis. The overall rate of symptomatic intracranial hemorrhage was within the expected range... | [
{
"companynumb": "US-BAXTER-2015BAX034405",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "SODIUM CHLORIDE"
},
"drugadditional": null,
... |
{
"abstract": "Introduction: The panorama of drug-induced ototoxicity has widened in the last decades; moreover, post-marketing data are necessary to gain a better insight on ototoxic adverse drug reactions (ADRs). The aim of this study was to perform an analysis of ADR reports describing drug-induced ototoxicity fro... | [
{
"companynumb": "IT-JNJFOC-20191034818",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": "3",
"... |
{
"abstract": "Neurological complications are common after liver transplantation, as they affect up to one-third of the transplanted patients and are associated with significant morbidity. The introduction of calcineurin inhibitors, cyclosporine A and tacrolimus, in immunosuppressive regimens significantly improved t... | [
{
"companynumb": "IT-MYLANLABS-2020M1033427",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "... |
{
"abstract": "To educate healthcare providers on Cryptococcus neoformans as a novel cause of glottic webs especially in an immunocompromised patient and discuss recurrence of the glottic web. This case also emphasizes the importance of a comprehensive patient evaluation in cases such as this, as laryngeal involvemen... | [
{
"companynumb": "US-ASTELLAS-2021US004427",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "3",
... |
{
"abstract": "Despite increasing reports of human infection, data about the optimal care of Phaeoacremonium infections are missing. We report a case of an infection due to Phaeoacremonium parasiticum and Paraconiothyrium cyclothyrioides, initially localized to skin and soft tissue, in a kidney transplant patient. De... | [
{
"companynumb": "FR-ACCORD-030650",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
"drug... |
{
"abstract": "A majority of patients with hypertension fail to achieve blood pressure (BP) control despite treatment with commonly prescribed drugs. This randomized, double-blind phase III trial assessed the superiority of sacubitril/valsartan 200 mg (97/103 mg) to continued olmesartan 20 mg in reducing ambulatory s... | [
{
"companynumb": "US-DSJP-DSU-2018-103880",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OLMESARTAN MEDOXOMIL"
},
"drugadditional": "3",... |
{
"abstract": "Acebutolol is a β1-selective adrenergic receptor antagonist with moderate membrane-stabilizing activity and intrinsic sympathomimetic activity; accordingly, the drug is indicated in hypertension, angina pectoris, and arrhythmia. However, acebutolol's beta-blocking properties also extend the QRS and QTc... | [
{
"companynumb": "FR-MYLANLABS-2019M1089684",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "OXAZEPAM"
},
"drugadditional": null,
... |
{
"abstract": "Spinal epidural lipomatosis (SEL) represents pathologic overgrowth of extradural adipose tissue in the spinal canal that can result in spinal cord compression. SEL has been associated with excess corticosteroids, whether from exogenous steroid use or from excess endogenous steroids. Spinal epidural lip... | [
{
"companynumb": "US-MALLINCKRODT-T201903889",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "CORTICOTROPIN"
},
"drugadditional": "1",
... |
{
"abstract": "OBJECTIVE\nWe assessed post-marketing safety of sodium-glucose co-transporter-2 inhibitors (SGLT2-Is) by analyzing adverse events (AEs) reported in international pharmacovigilance databases.\n\n\nRESULTS\nEudravigilance, WHO-Vigibase (as of Feb 25, 2017) and the FDA Adverse Event Reporting System (FAER... | [
{
"companynumb": "IT-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2017-BI-057039",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "EMPAGLIFLOZIN"
},
... |
{
"abstract": "BACKGROUND\nDrug reaction with eosinophilia and systemic symptoms (DRESS) is a rare but life-threatening adverse drug reaction. Several criteria have been established to aid the diagnosis. However, patients with DRESS remained underdiagnosis and undertreatment.\n\n\nMETHODS\nMedical records of hospital... | [
{
"companynumb": "TH-LANNETT COMPANY, INC.-TH-2017LAN000007",
"fulfillexpeditecriteria": "1",
"occurcountry": "TH",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "OMEPRAZOLE"
},
"drugadditiona... |
{
"abstract": "We present a case report of a 42 year old female, diagnosed at the age of 3 with Juvenile Dermatomyositis. The clinical course was severe and refractory to immunosuppressive therapy. Currently, she is mostly affected by severe muscle atrophy, large joint contractures, calcinosis, and a lipodystrophy as... | [
{
"companynumb": "PT-PFIZER INC-2018389910",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PAMIDRONATE DISODIUM"
},
"drugadditional": nul... |
{
"abstract": "BACKGROUND\nChildren with rheumatic diseases (cRD) receiving immunosuppressive medications (IM) are at a higher risk for acquiring potentially lethal pathogens, including Histoplasma capsulatum (histoplasmosis), a fungal infection that can lead to prolonged hospitalization, organ damage, and death. Wit... | [
{
"companynumb": "US-TEVA-2021-US-1963863",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": "1",
... |
{
"abstract": "A 63-year-old man with an extensive travel history to South East Asia presented with generalised malaise, temporal headaches and high inflammatory markers. He was treated with corticosteroids for presumed giant cell arteritis. Unsuccessful attempts to wean him from prednisolone prompted further investi... | [
{
"companynumb": "GB-TEVA-2019-GB-1019760",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "1",
... |
{
"abstract": "Growing teratoma syndrome (GTS) after adjuvant chemotherapy for ovarian germ cell tumors is uncommon, with approximately 60 cases reported in the English literature. The objective of this study was to report clinical parameters including outcomes of patients with a diagnosis of GTS after adjuvant chemo... | [
{
"companynumb": "CA-CORDEN PHARMA LATINA S.P.A.-CA-2016COR000252",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BLEOMYCIN SULFATE"
},
"... |
{
"abstract": "A 61-year-old man was implanted with a Jarvik 2000, a continuous axial flow type left ventricular assist device (LVAD), for end-stage heart failure due to dilated cardiomyopathy. One month later, his postoperative course was complicated with intractable oozing-type gastrointestinal bleeding from multip... | [
{
"companynumb": "JP-BAYER-2016-185457",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": null,
"dr... |
{
"abstract": "Observational findings demonstrating improved survival for younger adults following pediatric, as opposed to adult, acute lymphoblastic leukemia (ALL) regimens have been translated into international, prospective multicenter clinical trials testing the pediatric regimen in young adult ALL. The results ... | [
{
"companynumb": "US-FRESENIUS KABI-FK202012026",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "VINCRISTINE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nMycobacterium avium complex can be responsible for a number of different radio-clinical presentations, ranging from invasive infections to hypersensitivity pneumonitis due to repeated inhalation of antigens. The diagnosis of hypersensitivity pneumonitis is clinical, radiological, biological... | [
{
"companynumb": "FR-TEVA-2019-FR-1032545",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ZOPICLONE"
},
"drugadditional": null,
... |
{
"abstract": "Porokeratosis is a rare diagnosis in the pediatric population, and eruptive disease has been documented prior in patients with history of stem cell transplantation. Comparing various porokeratosis eruptions between patients can be difficult due to limitations in current classification and nomenclature.... | [
{
"companynumb": "US-ASTELLAS-2022US003920",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "3",
... |
{
"abstract": "This report describes the death of a four-month-old Hispanic male which may be related to benzocaine toxicity. A toxicological evaluation revealed benzocaine at a concentration of 3.48 mg/L, and postmortem methemoglobin of 36% (normal 0.4-1.5). Methemoglobinemia is a complication of benzocaine toxicity... | [
{
"companynumb": "US-PFIZER INC-2020398765",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BENZOCAINE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nProlonged hospitalizations for sickle cell disease painful episodes are not uncommon, as analgesic options are often suboptimal.\n\n\nMETHODS\nSeven patients (15.4 ± 3.7 y, 6 females) were treated with epidural analgesia for refractory pain. The median duration of epidural catheter placemen... | [
{
"companynumb": "US-ACTAVIS-2014-22374",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "KETOROLAC\\KETOROLAC TROMETHAMINE"
},
"drugadditi... |
{
"abstract": "Introduction. Jod-Basedow Syndrome refers to a paradoxical phenomenon in which large loads of iodine can cause hyperthyroidism. It is most commonly seen in populations already at risk for thyroid disease or those with underlying kidney disease. Case Presentation. We present a case of an acutely ill 17-... | [
{
"companynumb": "US-PFIZER INC-202200010556",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHIMAZOLE"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nTardive dyskinesia (TD) is a potentially irreversible, chronic syndrome related to antipsychotic medication use characterized by hyperkinetic abnormal involuntary movements. Various studies have shown that development of TD is possible with both first- and second-generation antipsychotics. ... | [
{
"companynumb": "US-JNJFOC-20140706183",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RISPERIDONE"
},
"drugadditional": null,
... |
{
"abstract": "The new antiepileptic drug (AED) lacosamide (vimpat, \"UCB Pharma\") with a new mechanism of action was registered in Russia in 2010. The drug should be used as add-on treatment in patients over 16 years and older with non-controlled focal seizures with- or without secondary localization. The authors r... | [
{
"companynumb": "PL-AUROBINDO-AUR-APL-2020-025668",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LACOSAMIDE"
},
"drugadditional": null,... |
{
"abstract": "The ARISTOTLE study investigated apixaban, at a dose of 5 mg PO bid, for the prevention of stroke in patients with atrial fibrillation; however, it has been noted anecdotally that many patients are receiving 2.5 mg PO bid, despite being eligible for the full dosage. A recent study examining the use of ... | [
{
"companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2017-BI-005622",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DABIGATRAN ETEXILATE MESYLATE"
... |
{
"abstract": "OBJECTIVE\nThe incidence of breast cancer in China is increasing at a rate greater than the global average. For treatment of metastatic breast cancer, a phase 3 trial of 529 patients (study JHQG) found that the combination of gemcitabine, a cytotoxic nucleoside analog, and paclitaxel, a taxane, signifi... | [
{
"companynumb": "CN-CIPLA LTD.-2014CN02666",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GEMCITABINE\\GEMCITABINE HYDROCHLORIDE"
},
"d... |
{
"abstract": "In children, similar to adults, the agents that cause movement disorders are most commonly dopaminergic and antidopaminergic drugs. However, it is also known that selective serotonin reuptake inhibitors (SSRIs), which are frequently prescribed in child psychiatry practice, may rarely lead to tremor, ak... | [
{
"companynumb": "TR-ACCORD-099252",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SERTRALINE HYDROCHLORIDE"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nMisuse of gammahydroxybutrate (GHB) and its prodrugs gammabutyrolactone (GBL) and 1,4 butanediol (1,4-BD) has increased greatly since the early 1990s, particularly amongst lesbian, gay, bisexual and transgender (LGBT) individuals in recreational and sexual settings, e.g. 'chemsex'.\n\n\nOBJ... | [
{
"companynumb": "GB-ROCHE-2244593",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CHLORDIAZEPOXIDE"
},
"drugadditional": null,
... |
{
"abstract": "Infections are the primary cause of morbidity and mortality in multiple myeloma (MM) patients (pts). The aim of our retrospective analysis was to evaluate incidence and course of COVID-19 infection in a cohort of 351 MM outpatients treated with novel drugs. COVID-19 disease was detected in 50/351 pts (... | [
{
"companynumb": "CZ-AMGEN-CZESP2022059948",
"fulfillexpeditecriteria": "2",
"occurcountry": "CZ",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CARFILZOMIB"
},
"drugadditional": "4",
... |
{
"abstract": "FOLFIRINOX is a standard first-line treatment for advanced pancreatic cancer (aPC). The Gruppo Oncologico Nord Ovest (GONO) FOLFOXIRI regimen demonstrated efficacy in metastatic colorectal cancer. We aimed to evaluate activity and tolerability of FOLFOXIRI regimen in patients with aPC and to explore pu... | [
{
"companynumb": "IT-FRESENIUS KABI-FK201606544",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LEUCOVORIN CALCIUM"
},
"drugadditional":... |
{
"abstract": "Cytomegalovirus (CMV) is a major pathogen in immunocompromised population and CMV infections in immunocompromised patients cause substantial morbidity and mortality. The common clinical manifestations of CMV infection are pneumonia, hepatitis, colitis and so on, while CMV peritonitis without gut perfor... | [
{
"companynumb": "IR-ALKEM LABORATORIES LIMITED-IR-ALKEM-2020-05744",
"fulfillexpeditecriteria": "1",
"occurcountry": "IR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
... |
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