article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "Olanzapine is an antipsychotic medication linked to the development, or exacerbation of, type 2 diabetes mellitus. This report describes 3 patients being treated with olanzapine who died suddenly and unexpectedly with hyperglycemic ketoacidosis. All had olanzapine concentrations within the therapeutic ... | [
{
"companynumb": "US-MACLEODS PHARMACEUTICALS US LTD-MAC2022034407",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OLANZAPINE"
},
"drugad... |
{
"abstract": "Sarcoidosis is a systemic granulomatous inflammatory disease that can involve almost any organ system in the human body. It most frequently presents with pulmonary infiltrates, hilar lymphadenopathy, and skin lesions. Clinical and subclinical involvement of other organ systems is not uncommon. However,... | [
{
"companynumb": "NVSC2019US033038",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": "3",
"druga... |
{
"abstract": "Skin-tunnelled catheters have become an accepted method for establishing long-term central venous access in patients undergoing treatment for malignancies. They allow administration of continuous infusions of cytotoxic drugs, supplementation of fluids and blood products, total parenteral nutrition and ... | [
{
"companynumb": "GB-BAUSCH-BL-2019-065172",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "RIFAMPIN"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nPatients with juvenile myoclonic epilepsy (JME) may be resistant or show adverse effects to valproate. We present a multicenter, prospective, long-term, open-label study evaluating the efficacy and safety of levetiracetam in JME.\n\n\nMETHODS\nPatients with newly diagnosed (10) or resistant/... | [
{
"companynumb": "IT-UCBSA-2020000035",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND Treatment with DAAs before deceased donor liver transplantation has been shown to be an effective strategy to prevent post-transplant HCV recurrence, with a 95% cure-rate among individuals who achieve undetectable HCV VL for ≥30 days pre- transplant. This strategy has not been evaluated in L... | [
{
"companynumb": "US-009507513-1702USA008143",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SOFOSBUVIR"
},
"drugadditional": "3",
... |
{
"abstract": "Aripiprazole, due to its partial agonist activity at the D2 receptors, is often recommended as the drug of choice in patients who develop antipsychotic-induced hyperprolactinemia. We report a case of a female patient who developed hyperprolactinemia while on treatment with aripiprazole. This partial D2... | [
{
"companynumb": "IN-WATSON-2015-01169",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VALPROIC ACID"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo report a case of systemic irinotecan toxicity following regional transarterial chemoembolization with drug-eluting beads loaded with irinotecan (DEBIRI-TACE) in a patient later found to have a homozygous mutation for UGT1A1*28.\n\n\nMETHODS\nAn 80-year-old woman presented with a cecal col... | [
{
"companynumb": "US-CIPLA LTD.-2015US00403",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ENOXAPARIN"
},
"drugadditional": null,
... |
{
"abstract": "We report an unusual case of pulmonary aspergillosis in a patient with AIDS and we demonstrated the drug-drug interactions between voriconazole, darunavir/ritonavir and tenofovir/emtricitabine. The combination darunavir-ritonavir-voriconazole should be avoided.",
"affiliations": "Infectious Diseases ... | [
{
"companynumb": "FR-CIPLA LTD.-2015FR06450",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RITONAVIR"
},
"drugadditional": null,
... |
{
"abstract": "Oxaliplatin-based chemotherapy is widely used to treat advanced colorectal cancer (CRC). Sinusoidal obstruction syndrome (SOS) due to oxaliplatin is a serious type of chemotherapy-associated liver injury (CALI) in CRC patients. SOS is thought to be caused by the sinusoidal endothelial cell damage, whic... | [
{
"companynumb": "JP-AMGEN-JPNCT2016034424",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "The extravasation of cytotoxic agents into subcutaneous tissue is a serious complication of chemotherapy. Unfortunately, if such extravasation occurs into the pleural space, limited data is available to guide appropriate management. We present the first report in the literature of video-assisted thorac... | [
{
"companynumb": "AU-ALVOGEN-2017-ALVOGEN-092878",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": ... |
{
"abstract": "A 40-year-old Asian female with heavily treated relapsed Hodgkin's lymphoma showed complete remission (CR) after receiving 8 cycles of brentuximab vedotin (BV) in combination with gemcitabine as 4th line treatment. The patient remained in CR at the 18-month post-treatment follow-up. She developed sever... | [
{
"companynumb": "ID-SEATTLE GENETICS-2020SGN01945",
"fulfillexpeditecriteria": "2",
"occurcountry": "ID",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "BRENTUXIMAB VEDOTIN"
},
"drugadditiona... |
{
"abstract": "BACKGROUND\nIn clinical practice, identification of a case of severe asthma exacerbation prompts initiation of corticosteroids. However, not all that wheezes is asthma.\n\n\nMETHODS\nA 61-year-old man from the Peruvian Amazon presented with progressive dyspnea, abdominal pain, and cough for the past we... | [
{
"companynumb": "US-MYLANLABS-2019M1048693",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE"
},
... |
{
"abstract": "The treatment of choice for Stenotrophomonas maltophilia is trimethoprim-sulfamethoxazole (SXT). Fluoroquinolones (FQs) have in vitro activity against S. maltophilia; however, there is limited published information on their effectiveness. The purpose of this study is to compare the effectiveness of FQs... | [
{
"companynumb": "US-JNJFOC-20140101415",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVOFLOXACIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nArginine starvation depletes the micronutrients required for DNA synthesis and interferes with both thymidylate synthetase activity and DNA repair pathways in preclinical models of hepatocellular carcinoma (HCC). Pegylated arginine deiminase (ADI-PEG 20), an arginine degrader, potentiates t... | [
{
"companynumb": "NVSC2021US190558",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": null,
"dru... |
{
"abstract": "Tyrosine kinase inhibitors, represented by sunitinib, sorafenib, axitinib and pazopanib, are emerging molecules harbouring antitumoural efficacy in multiple neoplasia. We report the case of a 51-year-old woman with right thoracic sarcoma who developed fatal heart failure on pazopanib. The patient had n... | [
{
"companynumb": "PHHY2015BE130399",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PAZOPANIB"
},
"drugadditional": null,
"drug... |
{
"abstract": "BACKGROUND\nThe present report describes a case of sepsis due to Erysipelothrix rhusiopathiae in a patient with B-cell chronic lymphocytic leukemia with no animal exposure, associated with concomitant bronchopneumonia due to Pseudomonas aeruginosa and Escherichia coli.\n\n\nMETHODS\nA 54-year-old Cauca... | [
{
"companynumb": "RO-SA-2015SA054648",
"fulfillexpeditecriteria": "1",
"occurcountry": "RO",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": null,
"dru... |
{
"abstract": "Several studies have shown that adding rituximab to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) or reducing the interval between chemotherapy cycles from 3 weeks to 2 weeks improves survival in patients with diffuse large B-cell lymphoma (DLBCL). These studies prompted our group (GO... | [
{
"companynumb": "ES-AMGEN-ESPSP2020025506",
"fulfillexpeditecriteria": "2",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "Exudative pericarditis is found in 30-50% of the patients with rheumatoid arthritis (RA), particularly in later stages of the disease. Most cases present with no or few symptoms. We report a case of a 68 year-old male with a history of mild RA who developed exudative pericarditis leading to recurrent c... | [
{
"companynumb": "PHHY2019PL148930",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
"drug... |
{
"abstract": "Tuberculosis (TB) is a common disease worldwide affecting more than 2 billion people, including latent, pulmonary, and extrapulmonary TB. The presentation of disseminated TB is variable and dependent on the organs affected. Therefore, making the diagnosis and providing appropriate treatment can be dela... | [
{
"companynumb": "US-IPCA LABORATORIES LIMITED-IPC201603-000333",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROXYCHLOROQUINE SULFATE"
},
... |
{
"abstract": "OBJECTIVE\nTo assess if the use of a dose-dense regimen of chemotherapy can improve the prognosis in patients with primary gastric diffuse large B-cell lymphoma in early stages (I-II) but associated with worse prognostic factors.\n\n\nMETHODS\nOne hundred and eight consecutive patients with primary gas... | [
{
"companynumb": "MX-JNJFOC-20190937290",
"fulfillexpeditecriteria": "1",
"occurcountry": "MX",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional": "... |
{
"abstract": "The patient was a 66-year-old woman with left breast cancer who underwent left segmental mastectomy with sentinel lymph node biopsy. The histopathological diagnosis was estrogen receptor-positive (ER+), progesterone receptor-positive( PgR+), human epidermal growth factor receptor-2-equivocal( HER2()2+)... | [
{
"companynumb": "JP-PFIZER INC-2018183820",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOCETAXEL"
},
"drugadditional": "3",
... |
{
"abstract": "Adult-onset Still's Disease (AOSD) is a systemic inflammatory disorder characterized by high fever, skin rashes, and joint pains, and is extremely rare in patients over 80 years of age. An 88-year-old woman was admitted with high fever lasting for > 2 weeks and arthritis of the right knee and bilateral... | [
{
"companynumb": "JP-BAUSCH-BL-2020-013326",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "1",
... |
{
"abstract": "Restless legs syndrome (RLS) is a common sleep-related movement disorder characterized by an urge to move the legs during inactivity, especially at evening-night. RLS is highly prevalent in patients with kidney failure and have an impact on quality of life, mood, sleep quality and overall on compliance... | [
{
"companynumb": "CH-BoehringerIngelheim-2022-BI-150524",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "PRAMIPEXOLE"
},
"drugadditional":... |
{
"abstract": "Dual antiplatelet therapy with aspirin plus thienopyridines has become the standard treatment of patients undergoing coronary stenting. Clopidogrel has mostly replaced the use of ticlopidine due to its more favourable adverse event profile. However, also the use of clopidogrel is not without side effec... | [
{
"companynumb": "IT-ACTAVIS-2011-14203",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CLOPIDOGREL BISULFATE"
},
"drugadditional": "1",
... |
{
"abstract": "To analyze the toxicities and dose-volume histogram parameters of external-beam and magnetic resonance imaging-based intracavitary brachytherapy in cervical cancer patients.\n\n\n\nAcute and late toxicities were assessed in 135 patients divided into four groups: group 1, grade 0; group 2, grades 1-4; g... | [
{
"companynumb": "KR-BAUSCH-BL-2017-004120",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nThe Calvert formula was derived from the study among patients with glomerular filtration rates (GFRs) of 33-135 ml/min, and it remains unclear whether the formula can be used to calculate optimal and safe dosages of carboplatin in patients with severe renal insufficiency. We evaluated the ut... | [
{
"companynumb": "JP-CIPLA LTD.-2015JP03884",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "GEMCITABINE\\GEMCITABINE HYDROCHLORIDE"
},
"d... |
{
"abstract": "The coronavirus disease 2019 (COVID-19) vaccination frequently leads to minor side-effects, that may be more intense after the second dose, but more serious side effects have been reported. We report a case of a 24-year-old man who presented to the hospital with acute substernal chest pain, 4 days afte... | [
{
"companynumb": "US-ORGANON-O2201USA002152",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LOSARTAN POTASSIUM"
},
"drugadditional": "4",... |
{
"abstract": "A 31-year-old hypertensive woman was admitted to hospital with palpitations. Her hypertension was treated with bendroflumethiazide, which had been increased from 2.5 to 5 mg daily by her general practitioner about 18 months prior to her admission. She was also on ramipril 10 mg once daily. There were n... | [
{
"companynumb": "GB-LUPIN PHARMACEUTICALS INC.-2015-00647",
"fulfillexpeditecriteria": "2",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "BENDROFLUMETHIAZIDE"
},
"drug... |
{
"abstract": "Salvage regimens containing mitoxantrone have been successfully used for the treatment of primary induction failure or relapsed acute myeloid leukemia. However, the combination of cyclophosphamide with mitoxantrone and cytarabine (MAC) has never been assessed in these patients. A total of 91 patients, ... | [
{
"companynumb": "CN-BAXTER-2016BAX001755",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MITOXANTRONE HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "Neurotoxicity and cognitive effects of low-dose methotrexate for rheumatologic disease have often been described, but the neuropsychiatric effects of low-dose methotrexate for cutaneous disease have been underreported in the dermatology literature. We describe two children who experienced mood changes ... | [
{
"companynumb": "US-WEST-WARD PHARMACEUTICALS CORP.-US-H14001-18-03021",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
... |
{
"abstract": "This study aimed to examine the use of therapeutic plasma exchange (TPE) as adjunctive therapy in neonatal septic shock.\n\n\n\nThis retrospective cohort study was performed on a convenience sample of neonates in a quaternary children's hospital between January 2018 and February 2019.\n\n\n\nWe identif... | [
{
"companynumb": "US-MYLANLABS-2020M1068972",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CIDOFOVIR"
},
"drugadditional": null,
... |
{
"abstract": "Gilteritinib is primarily metabolized via cytochrome P450 (CYP). Therefore, concomitant administration of strong CYP3A4 inducers or inhibitors is not recommended. We evaluated the incidence of gilteritinib-related adverse events (AEs) in 47 patients who received gilteritinib with or without antifungal ... | [
{
"companynumb": "US-ASTELLAS-2021US020996",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GILTERITINIB"
},
"drugadditional": "3",
... |
{
"abstract": "Osimertinib is a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) used both as the first-line treatment of EGFR-mutated non-small cell lung cancer patients and in second-line after T790M-positive disease progression to first- or second-generation TKIs. Unfortunatel... | [
{
"companynumb": "2021A747929",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "OSIMERTINIB"
},
"drugadditional": null,
"drugadmi... |
{
"abstract": "We report a rare case of squamous cell carcinoma (SCC) of the nasal cavity arising in a patient with granulomatosis with polyangiitis (GPA). The patient was a 35-year-old man who had been diagnosed 15 years earlier with GPA and treated medically for sinonasal, pulmonary, and renal involvement. He prese... | [
{
"companynumb": "US-WEST-WARD PHARMACEUTICALS CORP.-US-H14001-18-02328",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
... |
{
"abstract": "Fusarium spp. cause a broad spectrum of infection and are relatively resistant to most antifungal agents, leading to unfavorable prognosis, especially in immunocompromised patients. Several reports have shown synergism among amphotericin B, voriconazole (VRC), terbinafine (TRB), and other antifungal ag... | [
{
"companynumb": "JP-TEVA-558449ISR",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VORICONAZOLE"
},
"drugadditional": null,
"d... |
{
"abstract": "Background: Heparin-induced thrombocytopenia (HIT) is a rare autoimmune reaction that involves a decrease in platelet count following heparin exposure and can be associated with life-threatening thrombosis. Because of their prolonged heparin exposure, patients undergoing cardiac surgery are at risk of ... | [
{
"companynumb": "US-HIKMA PHARMACEUTICALS USA INC.-US-H14001-21-55027",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
... |
{
"abstract": "We present a case of suspected linezolid toxicity in a 34-year-old man with sickle cell disease and line-related vancomycin-resistant enterococcal bacteremia and tricuspid valve endocarditis. The patient developed sudden-onset hypoglycemia, lactic acidosis, and acute pancreatitis 11 days after initiati... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2022-01052",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LINEZOLID"
},
"drugad... |
{
"abstract": "The purpose of our paper is to present a case of a rare complication of posterior lumbar surgery. Our patient presented for elective lumbar decompression, which was complicated by durotomy. She then developed sudden headache and right eye pain once upright on postoperative day 2. Then on postoperative ... | [
{
"companynumb": "US-APOTEX-2017AP023906",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AMITRIPTYLINE"
},
"drugadditional": "1",
... |
{
"abstract": "Developing treatment options have resulted in prolonged admission and increased bacterial and fungal nosocomial infections as well as improved survival in neonatal intensive care unit. Invasive fungal infections in newborns are associated with significant morbidity and mortality and can cause endorgan ... | [
{
"companynumb": "TR-STRIDES ARCOLAB LIMITED-2018SP005953",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "GENTAMICIN"
},
"drugadditional... |
{
"abstract": "Combined checkpoint inhibition therapy targeting the programmed cell death 1 (PD-L1) and cytotoxic T-lymphocyte associated protein 4 pathways has been a successful approach in the treatment of metastatic melanoma, leading to its investigation in the treatment of head and neck squamous cell carcinoma (H... | [
{
"companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2020-081927",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "IPILIMUMAB"
},
"drugadd... |
{
"abstract": "BACKGROUND\nSelf-medication, including both the use of over-the-counter (OTC) drugs and the use of formerly prescribed drugs taken without a current physician's recommendation, is a public health concern; however, little data exist regarding the actual risk.\n\n\nOBJECTIVE\nWe aimed to analyse self-med... | [
{
"companynumb": "DE-JNJFOC-20181211498",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IBUPROFEN"
},
"drugadditional": "3",
"d... |
{
"abstract": "Since 1993, eight new antiepileptic drugs (AEDs) have become available in the United States for the treatment of epilepsy: felbamate, gabapentin, lamotrigine, topiramate, tiagabine, levetiracetam, oxcarbazepine, and zonisamide. Of the older AEDs, six continue to be widely used: phenobarbital, phenytoin... | [
{
"companynumb": "US-PFIZER INC-2020295038",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PHENYTOIN SODIUM"
},
"drugadditional": "3",
... |
{
"abstract": "We present a patient with prednisone-induced spinal epidural lipomatosis (SEL) and relatively acute neurologic deterioration followed by rapid recovery after surgical decompression. SEL is a rare disease characterized by hypertrophy of epidural fat, most commonly associated with exogenous steroid use. ... | [
{
"companynumb": "PHHY2015US102327",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
"drug... |
{
"abstract": "Super-refractory status epilepticus is a life-threatening condition. Resistance to benzodiazepine and barbiturate treatment for this disorder is thought to be due to internalization of synaptic γ-aminobutyric acid (GABA)A receptors, and withdrawal of benzodiazepines and barbiturates during treatment of... | [
{
"companynumb": "US-UCBSA-2015000737",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": null,
... |
{
"abstract": "It was suggested that D, L-Methadone might improve the clinical course of glioma patients. Owing to massive press coverage, patients demand the prescription of D, L-Methadone, but regarding its adjunctive use in glioma therapy there is no standard medication plan. Furthermore, it is not known which sid... | [
{
"companynumb": "DE-ALKEM LABORATORIES LIMITED-DE-ALKEM-2021-00832",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHADONE HYDROCHLORIDE"
},
... |
{
"abstract": "BACKGROUND\nRenal disease associated with paraproteinemias is classically predicated upon pathologic paraprotein deposition in the kidney. However, growing evidence suggests that paraproteins may be able to systemically activate complement or neutrophils to drive renal damage. This may provide an alter... | [
{
"companynumb": "US-BAUSCH-BL-2018-001587",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nThe interpretation of acetaminophen concentrations obtained prior to 4 hours after an acute, single overdose remains unclear. Patient care decisions in the Emergency Department could be accelerated if such concentrations could reliably exclude the need for treatment.\n\n\nOBJECTIVE\nTo dete... | [
{
"companynumb": "CA-JNJFOC-20170116153",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALCOHOL"
},
"drugadditional": "3",
"dru... |
{
"abstract": "Limited data are currently available regarding the course of COVID-19 in lung and solid organ transplant recipients. We hereby present four cases of SARS-CoV-2 pneumonia in lung transplant recipients from our center, set in Milan, Italy. We reduced immunosuppressive regimen in all these patients, typic... | [
{
"companynumb": "IT-ACCORD-186549",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AZATHIOPRINE"
},
"drugadditional": null,
"dr... |
{
"abstract": "Super-refractory status epilepticus (SRSE) is defined as status epilepticus that continues 24 h or more after the onset of anesthesia, and includes those cases in which epilepsy is recurrent upon treatment reduction. We describe the presentation and successful management of a male patient with SRSE usi... | [
{
"companynumb": "KZ-MYLANLABS-2015M1005075",
"fulfillexpeditecriteria": "1",
"occurcountry": "KZ",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VALPROATE SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo assess clinical and B cell biomarkers to predict relapse after rituximab in antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) using retreatment on clinical relapse strategy.\n\n\nMETHODS\n35 patients with AAV received treatment with 2×1000 mg rituximab, repeated on cl... | [
{
"companynumb": "GB-ROCHE-1642460",
"fulfillexpeditecriteria": "1",
"occurcountry": null,
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "BACKGROUND\nDrug-induced liver injury (DILI) is the leading cause of acute liver injury (ALI), market withdrawal of a drug, and rejection of applications for marketing licenses. The incidence of DILI is very low, with a value between 1 and 19 per 100,000 patient years. All antidepressants may induce DI... | [
{
"companynumb": "CN-PFIZER INC-202200040789",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "VENLAFAXINE HYDROCHLORIDE"
},
"drugadditiona... |
{
"abstract": "OBJECTIVE\nWe evaluated the tolerability and cardiac safety of docetaxel, cyclophosphamide, and trastuzumab (TCyH) for the treatment of early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer and compared to the standard trastuzumab-based chemotherapy regimens doxorubicin wit... | [
{
"companynumb": "US-MYLANLABS-2015M1002011",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nIn recent years, proton pump inhibitors (PPIs) have been investigated at high-dose to modulate tumour microenvironment acidification thus restoring chemotherapeutic sensitivity. Moreover, several clinical data supports the role of cytotoxic drugs at low-dose continuously delivered as antica... | [
{
"companynumb": "IT-MYLANLABS-2017M1003818",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "IRINOTECAN"
},
"drugadditional": null,
... |
{
"abstract": "Portomesenteric venous thrombosis is a rare complication reported in only a few cases involving laparoscopic bariatric surgery. We report a case of a 44-year-old woman who presented 14 days after recent laparoscopic sleeve gastrectomy with the chief complaint of abdominal pain and associated nausea. Ab... | [
{
"companynumb": "US-FRESENIUS KABI-FK201804432",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": "1",... |
{
"abstract": "This 52-week, randomized, open-label study evaluated long-term safety/tolerability of fixed-dose combination azilsartan medoxomil/chlorthalidone (AZL-M/CLD) vs fixed-dose combination olmesartan medoxomil/hydrochlorothiazide (OLM/HCTZ) in patients with essential hypertension (stage 2; clinic systolic bl... | [
{
"companynumb": "US-PRINSTON PHARMACEUTICAL INC.-2017PRN00506",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROCHLOROTHIAZIDE\\OLMESARTAN MEDOXOMIL"
... |
{
"abstract": "Intrathecal baclofen (ITB) is a reversible treatment that reduces muscle tone to ameliorate spasticity and dystonia in patients with cerebral palsy (CP). The resulting decrease in energy expenditure allows patients to gain much-needed weight, albeit temporarily. Modern techniques require sufficient abd... | [
{
"companynumb": "PHHY2014GB154262",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CHLORAL HYDRATE"
},
"drugadditional": null,
... |
{
"abstract": "Atraumatic trismus can be one of the presentations of medication-induced acute dystonia, particularly by antipsychotics and less commonly antidepressants. A case of an unusual emergency presentation of atraumatic trismus on initiation of duloxetine is reported. The patient was a 40-year-old woman exper... | [
{
"companynumb": "GB-LUPIN PHARMACEUTICALS INC.-2021-03779",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DULOXETINE"
},
"drugadditional... |
{
"abstract": "A healthy teenage Japanese girl was admitted to our hospital after experiencing out-of-hospital cardiac arrest. She had attempted to commit suicide by taking 4,950 mg of disopyramide and 12 mg of flunitrazepam. Mechanical cardiopulmonary support was started with percutaneous cannulation of the femoral ... | [
{
"companynumb": "JP-PFIZER INC-2016511391",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FLUNITRAZEPAM"
},
"drugadditional": null,
... |
{
"abstract": "We report the case of a 44-year-old woman with Masaoka stage IV, World Health Organization type B1 thymoma associated with pure red cell aplasia, thrombocytopenia, and myasthenia gravis, which occurred during preoperative chemotherapy with high-dose methylprednisolone. Noninvasive positive-pressure ven... | [
{
"companynumb": "JP-PFIZER INC-2015106494",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": null,... |
{
"abstract": "OBJECTIVE\nA case of profound neutropenia and agranulocytosis associated with the off-label use of ceftaroline is reported.\n\n\nCONCLUSIONS\nA 67-year-old Caucasian man arrived at the emergency room with right shoulder pain and weakness that radiated to his right chest, back, and right arm. A review o... | [
{
"companynumb": "US-FRI-1000071279",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "MONTELUKAST SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "An 82-year-old man receiving oral administration of warfarin for atrial fibrillation underwent distal gastrectomy for advanced gastric cancer. The postoperative diagnosis was pT3(SS)N2M1H1P0CY0, pStage Ⅳ,(HER2, score 3+)gastric cancer. He received chemotherapy for the treatment of multiple liver metast... | [
{
"companynumb": "JP-TEVA-2019-JP-1064140",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "GIMERACIL\\OTERACIL\\TEGAFUR"
},
"drugadditiona... |
{
"abstract": "There are limited data from prospective controlled trials regarding optimal treatment strategies in patients with primary breast diffuse large B-cell lymphoma (DLBCL). In this phase 2 study (NCT01448096), we examined the efficacy and safety of standard immunochemotherapy and central nervous system (CNS... | [
{
"companynumb": "KR-ROCHE-2662365",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VINCRISTINE"
},
"drugadditional": "3",
"drug... |
{
"abstract": "Chronic subdural hematoma (CSDH) after spinal anesthesia is a rare complication. We experienced a patient who developed CSDH after postdural puncture headache (PDPH) following combined spinal and epidural anesthesia (CSE).\nA 38-week-gestation parturient with a history of previous cesarean delivery und... | [
{
"companynumb": "JP-BAYER-2016-082153",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": "1",
"drug... |
{
"abstract": "Crohn's disease (CD) is an idiopathic inflammatory disease of the gastrointestinal tract and typically causes inflammation with granuloma formation. Biologic agents like infliximab (IFX) that target tumor necrosis factor alpha (TNF-α), have emerged as important medications for treating refractory CD. W... | [
{
"companynumb": "US-JNJFOC-20160425172",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo report the surgical results of goniotomy for corticosteroid-induced glaucoma and to provide evidence to support its use as initial surgical therapy.\n\n\nMETHODS\nThe medical records of 5 patients with a history of goniosurgery for steroid-induced glaucoma were reviewed. Preoperative and ... | [
{
"companynumb": "US-BAUSCH-BL-2015-030371",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PREDNISOLONE ACETATE"
},
"drugadditional": nul... |
{
"abstract": "Carpel tunnel syndrome (CTS) is a condition in which median nerve compression results in paresthesias and pain in the wrist and hand. We are going to report a rare case of topiramate-induced neuropathy which clinically resembles CTS. Discontinuation of topiramate resulted in spontaneous resolution of n... | [
{
"companynumb": "US-AUROBINDO-AUR-APL-2018-004141",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TOPIRAMATE"
},
"drugadditional": "1",
... |
{
"abstract": "Takotsubo cardiomyopathy (TC) describes a reversible left ventricular dysfunction characterized by apical ballooning and basal hyperkinesis, commonly triggered by emotional or physical distress. TC associated with an esophagogastroduodenoscopy (EGD) has rarely been reported. We report a case of TC with... | [
{
"companynumb": "US-DRREDDYS-USA/USA/19/0113831",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FENTANYL CITRATE"
},
"drugadditional": "... |
{
"abstract": "BACKGROUND\nDislocation following total hip arthroplasty is mainly caused by malposition. However, the coexistence of neuromuscular disorders is also considered a risk for dislocation due to excessive hip joint laxity. To minimize risk of dislocation, preoperative planning using combined anteversion ha... | [
{
"companynumb": "PHHY2018JP184293",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": "3",
... |
{
"abstract": "A 58-year-old man who presented with syncope, dyspnea, and hemodynamic compromise was found to have large free-floating right atrial thrombuses on echocardiogram. Decision was made to transfer the patient for emergent atriotomy. Cardiothoracic surgeons declared the patient as inoperable and recommended... | [
{
"companynumb": "IR-ROCHE-2259303",
"fulfillexpeditecriteria": "1",
"occurcountry": "IR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "Metronidazole is an antibiotic classically used against most anaerobic bacteria and protozoa. Because an intravenous form of metronidazole has recently entered the market, the use of this antibiotic is attracting renewed interest in many clinical settings in Japan. However, neurotoxicity is a major adv... | [
{
"companynumb": "JP-PAR PHARMACEUTICAL COMPANIES-2016SCPR015777",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"druga... |
{
"abstract": "OBJECTIVE\nTo identify the frequency and characteristics of eating disorders in patients with schizophrenia treated with second generation antipsychotics.\n\n\nMETHODS\nA sample included 56 patients (48 women and 8 men, mean age 28 ± 4.5 years) with schizophrenia and schizoaffective disorder. Patients ... | [
{
"companynumb": "RU-JNJFOC-20151113395",
"fulfillexpeditecriteria": "1",
"occurcountry": "RU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "QUETIAPINE"
},
"drugadditional": null,
... |
{
"abstract": "A 48-year-old woman was hospitalized because of severe thrombocytopenia, leg edema, and fever. Intravenous immunoglobulin therapy was administered, but no efficacy was obtained. Her bone marrow was dry-tap, and fibrosis was found in the biopsy specimens. A positron emission tomographic study showed FDG... | [
{
"companynumb": "JP-BAXTER-2014BAX037130",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "HUMAN IMMUNOGLOBULIN G"
},
"drugadditional": n... |
{
"abstract": "Postoperative delirium was reported to be associated with increased postoperative mortality after liver resection. Therefore, it is crucial to prevent postoperative delirium in such cases. Ramelteon, an agonist of melatonin receptor has been suggested to be useful for preventing delirium. The aim of th... | [
{
"companynumb": "JP-TAKEDA-2021TJP002067",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RAMELTEON"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nLactic acidosis often occurs in severely unwell patients presenting to Accident and Emergency. It is commonly associated with either hypoxia or decreased tissue perfusion secondary due to cardiovascular collapse or sepsis.\n\n\nMETHODS\nWe present a case of severe lactic acidosis in the pre... | [
{
"companynumb": "GB-BAUSCH-BL-2019-014033",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "ALBUTEROL"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nThe aim of the present study was to evaluate the long-term outcomes of anti-tumour necrosis factor alpha therapy in perianal Crohn's disease and identify factors predicting response to treatment.\n\n\nMETHODS\nData from hospital clinical records and coding databases were retrospectively rev... | [
{
"companynumb": "NZ-JNJFOC-20170402429",
"fulfillexpeditecriteria": "1",
"occurcountry": "NZ",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ADALIMUMAB"
},
"drugadditional": "3",
"... |
{
"abstract": "Linezolid is an oxazolidinone antimicrobial agent often used to treat multidrug-resistant Gram-positive bacterial infections. The common adverse reactions of linezolid are diarrhea, nausea, headache and bone marrow suppression, and so on. Here, we report the first case of teeth discoloration induced by... | [
{
"companynumb": "PT-ALKEM LABORATORIES LIMITED-PT-ALKEM-2020-03883",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LINEZOLID"
},
"drugad... |
{
"abstract": "Arterial and venous complications are major causes of morbidity and mortality in myeloproliferative neoplasms (MPNs). MPNs patients, frequently receive heparin. Heparin-induced thrombocytopenia (HIT) is a rare but potentially life-threatening complication resulting in a severe acquired thrombophilic co... | [
{
"companynumb": "IT-MYLANLABS-2018M1011946",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "Since its introduction >20 years ago, Azithromycin has been widely used owing to its broad spectrum and good tolerability, especially when used for <7 days. In literature, there are only very few, sporadic reports available of patients developing cholestatic hepatitis following treatment with it. The c... | [
{
"companynumb": "US-LUPIN PHARMACEUTICALS INC.-2015-02808",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "AZITHROMYCIN ANHYDROUS"
},
"d... |
{
"abstract": "The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, ... | [
{
"companynumb": "CA-PFIZER INC-2016259940",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUCONAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "Background and Study Aim Facial nerve (FN) weakness as a presenting feature in vestibular schwannoma (VS) is extremely rare. We are presenting two different cases of VS with significant facial weakness and reviewed the literature for similar cases. Methods and Results We are presenting two cases of V... | [
{
"companynumb": "DE-INGENUS PHARMACEUTICALS NJ, LLC-ING201903-000159",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLOPIDOGREL BISULFATE"
},
... |
{
"abstract": "Mydriatic drops are routinely administered to premature neonates to screen for retinopathy of prematurity. Adverse anticholinergic side effects, particularly convulsions and tachycardia have been reported in the pediatric age group following instillation of mydriatics for diagnostic fundus examination ... | [
{
"companynumb": "CA-SUN PHARMACEUTICAL INDUSTRIES LTD-2017US-132655",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OMEPRAZOLE"
},
"drug... |
{
"abstract": "Tuberous sclerosis complex (TSC) is a multisystem disease with prominent neurologic manifestations such as epilepsy, cognitive impairment and autism spectrum disorder. mTOR inhibitors have successfully been used to treat TSC-related manifestations in older children and adults. However, data on their sa... | [
{
"companynumb": "DE-LUNDBECK-DKLU3016462",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMIODARONE HYDROCHLORIDE"
},
"drugadditional": ... |
{
"abstract": "We describe a case of a woman with uncomplicated Type 2 diabetes mellitus, presenting with severe burning pains and intense redness of the legs, for which only cooling could provide relief. Although the description was classic of erythromelalgia, the lack of familiarity of the disorder caused considera... | [
{
"companynumb": "BE-MICRO LABS LIMITED-ML2021-00347",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
"drugad... |
{
"abstract": "The aim of the study was to analyse late side-effects of the antineoplastic treatment in patients with diagnosed nephroblastoma.\n\n\nMETHODS\nIn the years 1986-2002, 80 children were treated in the Gdańsk Centre, for nephroblastoma, 13 of them followed SIOP-6, 25 were treated according to SIOP-9 and t... | [
{
"companynumb": "PL-PFIZER INC-2015025653",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "EPIRUBICIN HYDROCHLORIDE"
},
"drugadditional":... |
{
"abstract": "Pulmonary reinfection by Nocardia has been rarely reported. We describe a case of pulmonary reinfection by Nocardia in an immunocompetent patient. An 82-year-old immunocompetent woman with bronchiectasis presented with exacerbation of cough. She had a history of pulmonary nocardiosis three years earlie... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2018RR-188507",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MINOCYCLINE\\MINOCYCLINE HYDROCHLORIDE"
... |
{
"abstract": "Subclinical hypothyroidism (SCH) has been associated with increased risk of adverse pregnancy outcomes in some, but not all, studies. Uncertainty remains regarding the impact of levothyroxine (LT4) therapy on improving health outcomes in pregnant women with SCH. The objective of this study was to asses... | [
{
"companynumb": "US-PROVELL PHARMACEUTICALS-2065641",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "LEVOTHYROXINE SODIUM"
},
"drugadditi... |
{
"abstract": "BACKGROUND\nChemotherapy is a standard regimen for advanced or relapsed biliary tract cancer (BTC) with a 5-year overall survival (OS) rate of approximately 5% and a median OS of less than a year. Targeted therapies and immunotherapy aimed at providing more personalized treatments for BTCs have been te... | [
{
"companynumb": "NVSC2020CN290714",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TRAMETINIB"
},
"drugadditional": "3",
"druga... |
{
"abstract": "OBJECTIVE\nUterine carcinosarcomas (UCSs) are highly aggressive, rare, biphasic tumors composed of epithelial and mesenchymal elements. Surgery remains the mainstay of treatment in early-stage disease. Adjuvant pelvic radiotherapy improves locoregional control without proven overall survival (OS) benef... | [
{
"companynumb": "GB-CIPLA LTD.-2015GB07467",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "PACLITAXEL"
},
"drugadditional": null,
... |
{
"abstract": "Several studies have reported rhabdomyolysis induced by various drugs but not by the antiepileptic drug levetiracetam. We present a case of suspected levetiracetam-induced rhabdomyolysis. A 29-year-old woman was hospitalized for generalized tonic-clonic seizure and given levetiracetam for the first tim... | [
{
"companynumb": "JP-ALVOGEN-2015AL000885",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PHENYTOIN"
},
"drugadditional": null,
... |
{
"abstract": "We present a patient with an acute kidney injury thought secondary to acute interstitial nephritis as a result of vedolizumab maintenance therapy for Crohn's disease. This appears to be a rare but serious side effect in patients receiving this treatment which clinicians should consider in the event of ... | [
{
"companynumb": "GB-TAKEDA-2021TUS075945",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VEDOLIZUMAB"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nWe investigated the real-world effectiveness of interferon-free regimens for the treatment of patients with compensated cirrhosis infected with hepatitis C virus (HCV).\n\n\nMETHODS\nUsing the Irish national HCV treatment registry, the effectiveness and safety of interferon-free regimens fo... | [
{
"companynumb": "IE-KADMON PHARMACEUTICALS, LLC-KAD201703-000580",
"fulfillexpeditecriteria": "1",
"occurcountry": "IE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "RIBAVIRIN"
},
"drugaddi... |
{
"abstract": "A 65-year-old white female patient with normal baseline renal function was referred to our hospital with nonoliguric renal failure requiring hemodialysis after progressive deterioration over the previous 6 months. Her past medical history was remarkable for easy fatigability, weight loss, low-grade fev... | [
{
"companynumb": "GR-BAXTER-2020BAX019791",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": "1",
... |
{
"abstract": "We describe a fatal primary human herpesvirus 6 (HHV-6) variant A infection in a kidney transplanted adult woman. On day 20 post transplantation (TX), after rejection therapy, the patient presented an acute hemophagocytic syndrome with hepatitis and central nervous system involvement. HHV-6 IgG and IgM... | [
{
"companynumb": "BE-ROCHE-2104166",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FOSCARNET SODIUM"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nKidney transplantation (KT) is the treatment option for patients with end stage renal disease (ESRD) to prolong survival and improve quality of life. Although the use of potent immunosuppressive agents increases graft survival in kidney transplantation recipients (KTRs), it may lead to the ... | [
{
"companynumb": "KR-MYLANLABS-2017M1066112",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": "1",
... |
{
"abstract": "We report here the case of a 63-year-old man, diagnosed with rheumatoid arthritis, who presented fever, weakness, diarrhea, chest, limbs and face erythema 20 days after starting of therapy with salazopyrin; these symptoms only partially and temporarily subsided after early drug withdrawal. The subseque... | [
{
"companynumb": "IT-ALKEM LABORATORIES LIMITED-IT-ALKEM-2022-01923",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MESALAMINE"
},
"druga... |
{
"abstract": "Bullous systemic lupus erythematosus (BSLE) is a rare autoimmune subepidermal blistering disease, with few cases described in childhood. It has different clinical-pathological features. We report a case of BSLE in a 10-year-old child with systemic lupus erythematosus, treated with prednisone and hydrox... | [
{
"companynumb": "BR-CONCORDIA PHARMACEUTICALS INC.-GSH201801-000130",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drug... |
{
"abstract": "BACKGROUND\nOpioids can suppress testosterone in men, which can lead to extensive morbidity. Identifying risk factors for androgen deficiency in men using daily opioids could improve monitoring and safety.\n\n\nMETHODS\nIn a retrospective cohort study, we used Kaiser Permanente Northern California data... | [
{
"companynumb": "US-JNJFOC-20150109021",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OXYCODONE"
},
"drugadditional": "3",
"d... |
{
"abstract": "A 68-year-old man presented with type 3 advanced gastric cancer(Circ, tub2>por, HER2 score 3)in the antrum, with skip lesions in the duodenum. The tumor was cT4aN2M1(DUO)CY0, cStage IV . An XP plus trastuzumab regimen(1,000mg/m2 capecitabine[Xeloda®]twice a day on days 1-14, 80mg/m2 CDDP on day 1, 8 mg... | [
{
"companynumb": "JP-ACCORD-048401",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": null,
"druga... |
{
"abstract": "We describe the case of a young Hispanic female who presented with thyrotoxicosis with seizures and ischemic stroke. She was diagnosed with a rare vasculopathy - moyamoya syndrome. After starting antithyroid therapy, her neurologic symptoms did not improve. Acute neurosurgical intervention had relieved... | [
{
"companynumb": "US-UCBSA-2017007793",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHIMAZOLE"
},
"drugadditional": "3",
"d... |
{
"abstract": "BACKGROUND\nCardiovascular medication overdoses can be difficult to treat. Various treatment modalities are currently recommended.\n\n\nOBJECTIVE\nTo describe patient outcomes and adverse events of high-dose insulin therapy in consecutive overdose patients in cardiogenic shock after implementation of a... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2018SP009239",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CARBAMAZEPINE"
},
"drugadditio... |
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