article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "We present here the case of a 62-year-old man, who was referred to the emergency department with fever and cough for 3 days. He underwent liver transplantation 4 years earlier due to HCV and NASH-related cirrhosis with hepatocellular carcinoma. At admission he was in reduced general conditions. Nasopha... | [
{
"companynumb": "CH-ACCORD-188574",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": "3",
... |
{
"abstract": "Bisphosphonate use has been associated with atypical pathologic fracture and slowed bone turnover. We present a case of a bisphosphonate-associated peri-implant atypical femur fracture following use of a recon nail for treatment of a prior bisphosphonate-associated atypical femur fracture.",
"affilia... | [
{
"companynumb": "US-AMGEN-USASP2019212885",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
... |
{
"abstract": "Intrauterine exposure to baclofen can lead to syndrome of withdrawal during the first days of the newborn. We report the case of a full-term baby exposed to baclofen during pregnancy. The mother was treated with baclofen 10 mg 4 times daily. Blood samples were collected from the mother before entering ... | [
{
"companynumb": "FR-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-337893",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BACLOFEN"
},
"drugad... |
{
"abstract": "The treatment of tuberculosis (TB) requires long-term multiple drug use. Hyperuricemia is frequently reported in adults, but there are few data for the pediatric population. This study aimed to review drug-related side effects in pediatric patients that received treatment for TB. Patients with active T... | [
{
"companynumb": "TR-SUN PHARMACEUTICAL INDUSTRIES LTD-2016R1-111640",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PYRAZINAMIDE"
},
"dr... |
{
"abstract": "Describe the multiple symptoms of irritable bowel syndrome (IBS) and their impact on quality of life. Use a staged strategy for the diagnostic evaluation of IBS based on history and physical examination, including Rome IV criteria. Individualize treatment for IBS based on an evolving understanding of p... | [
{
"companynumb": null,
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "3",
"activesubstance": {
"activesubstancename": "POLYETHYLENE GLYCOL 3350\\POTASSIUM CHLORIDE\\SODIUM BICARBONATE\\SODIUM CHLORIDE"
... |
{
"abstract": "Clozapine is the antipsychotic of choice for treatment-resistant schizophrenia; however, rigorous monitoring is required to prevent or detect adverse drug events that contribute to morbidity and mortality. In addition to the Food and Drug Administration (FDA) boxed safety warnings specific to clozapine... | [
{
"companynumb": "US-TEVA-776695USA",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BENZTROPINE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "This case describes a 46-year-old male recipient of a kidney-pancreas transplant who is Jehovah's Witness. Early in the postoperative period, he was found to have splenic vein thrombosis requiring heparin infusion. Two days later, he developed severe symptomatic anemia (hemoglobin <6 g/dL). Standard me... | [
{
"companynumb": "US-WEST-WARD PHARMACEUTICALS CORP.-US-H14001-17-02943",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
... |
{
"abstract": "Immune checkpoint inhibitors have opened a new era in treating advanced malignancies, resulting in a rapid increase in utilization, given the remarkable clinical outcomes. The incidence of immune-related adverse events increased due to the immunologic effects of these therapeutic agents. However, immun... | [
{
"companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-079560",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IPILIMUMAB"
},
"drugadd... |
{
"abstract": "Diphenhydramine (DPH), an H1-antihistamine, is identified during postmortem toxicological analyses on a relatively rare but still regular basis. This study examines suicidal intoxications with DPH by analyzing blood and gastric content concentration levels. Twenty cases of DPH intoxications within a 10... | [
{
"companynumb": "DE-ACTAVIS-2014-14414",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DIPHENHYDRAMINE"
},
"drugadditional": null,
... |
{
"abstract": "We present a 24-year-old female with trauma to her right eye. The patient was prescribed topical Tobramicin-dexamethasone eye drops but the pharmacy dispensed diclofenac diethyl amine ointment. The patient presented to the emergency room with lid edema, conjunctival injection and a corneal epithelial d... | [
{
"companynumb": "SA-DEXPHARM-20170305",
"fulfillexpeditecriteria": "1",
"occurcountry": "SA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DICLOFENAC"
},
"drugadditional": null,
... |
{
"abstract": "This case report highlights the potentially serious side effects of hyoscine and how a seemingly innocuous patch may confound patients and doctors alike. It demonstrates how easy it is to miss an obvious diagnosis when in fact a thorough medical history including an exhaustive drug history can easily p... | [
{
"companynumb": "GB-MLMSERVICE-20211006-3152075-1?",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SIMVASTATIN"
},
"drugadditional": "1"... |
{
"abstract": "The main manifestation of acute interstitial nephritis (AIN) due to immune checkpoint inhibitors is acute kidney injury. We report here a biopsy-proven AIN revealed by tubular acidosis. This case highlights that immune checkpoint inhibitor prescribers must be aware of electrolytic disorders since tubul... | [
{
"companynumb": "FR-009507513-2004FRA000625",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "NIVOLUMAB"
},
"drugadditional": "1",
... |
{
"abstract": "Histoplasmosis is the most common endemic mycosis in the United States. Symptomatic gastrointestinal histoplasmosis is a rare entity. We report a case of isolated intestinal histoplasmosis that manifested as severe lower gastrointestinal bleeding in a renal transplant patient. The patient developed hem... | [
{
"companynumb": "US-MYLANLABS-2018M1039261",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND Intravascular large B-cell lymphoma (IVLBCL) is a rare type of extranodal large B-cell lymphoma characterized by involvement of lymphoma cells in the lumina of small blood vessels in various organs. Although many studies have claimed that timely diagnosis and early initiation of chemotherapy... | [
{
"companynumb": "JP-BAUSCH-BL-2019-018608",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nDermatomyositis is an idiopathic inflammatory myopathy with specific cutaneous manifestations, which is closely associated with malignancy. However, the exact mechanism remains elusive. Even less is known about dermatomyositis with hepatocellular carcinoma (HCC).\nWe reported a case of derm... | [
{
"companynumb": "PHHY2018CN098297",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
"dr... |
{
"abstract": "Complete R0 resection of gastrointestinal stromal tumors (GIST) of the stomach without signs of metastasis is highly reported, and the techniques for tumor resection have been evolving. Previously, laparoscopy was suggested to be safe only for GIST tumors < 2 cm. More recent reports demonstrate safety ... | [
{
"companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2020-062031",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "WARFARIN SODIUM"
},
"dr... |
{
"abstract": "Patients treated with clozapine show autonomic dysregulation and cardiac repolarisation changes. As clozapine crosses the placenta, it could have an impact on the fetus heart rate. We reported a case of reduction of the fetal heart rate variability in a patient treated with clozapine during her pregnan... | [
{
"companynumb": "FR-MYLANLABS-2015M1022209",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLOZAPINE"
},
"drugadditional": null,
... |
{
"abstract": "Mutations in the kinase domain (KD) of BCR-ABL are the leading cause of acquired imatinib resistance. In some cases, identical mutations were detected at relapse and in pretherapeutic specimens, consistent with selection of resistant clones in the presence of drug. However, the incidence of KD mutation... | [
{
"companynumb": "DE-MYLANLABS-2019M1057733",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "IMATINIB MESYLATE"
},
"drugadditional": null,... |
{
"abstract": "Previous studies examining seizures in patients with 22q11.2 deletion syndrome (22q11.2DS) have focused primarily on children and adolescents. In this study we investigated the prevalence and characteristics of seizures and epilepsy in an adult 22q11.2DS population.\n\n\n\nThe medical records of 202 ad... | [
{
"companynumb": "CA-TEVA-798412USA",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUPENTIXOL"
},
"drugadditional": "3",
"dru... |
{
"abstract": "OBJECTIVE\nThe treatment paradigm in newly diagnosed multiple myeloma (NDMM) is evolving toward individualized, risk-directed, and longer duration of therapy (DOT). The objective of this study was to describe treatment patterns and outcomes in non-transplant NDMM in four European countries.\n\n\nMETHOD... | [
{
"companynumb": "US-AMGEN-USASP2020143355",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CARFILZOMIB"
},
"drugadditional": null,
... |
{
"abstract": "Pharmacologic modulation to open the KATP channels with diazoxide is useful in treating hyperinsulinemia. Diazoxide is being used more often in neonates with hyperinsulinemic hypoglycemia. This report highlights a case of severe pulmonary hypertension (PH) with re-opening of ductus arteriosus in an ext... | [
{
"companynumb": "US-TEVA-2019-US-1102837",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DIAZOXIDE"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nIn 2012, the American Society of Clinical Oncology issued a guideline urging health care professionals to \"routinely use an obese patient's actual body weight, rather than an ideal body weight or other estimate, to calculate the appropriate dose of nearly all chemotherapy drugs. \" This gu... | [
{
"companynumb": "US-TEVA-586038USA",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": null,
"drug... |
{
"abstract": "The aim of this study was to develop a consensus guideline by certified experts of the Japanese Society of Clinical Neuropsychopharmacology on the psychopharmacological treatment for bipolar disorders I and II (BP-I and BP-II), in order to fill the gap in the literature and provide more concrete guidan... | [
{
"companynumb": "US-OTSUKA-2021_007596",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nHaemolytic uraemic syndrome is a rarely seen in adults often leading to critical illness. This case highlights how difficult it can be to establish a diagnosis and treat when a patient presents with bloody diarrhoea.\n\n\nMETHODS\nA 17-year-old Iraqi man presented to the emergency departmen... | [
{
"companynumb": "GB-SA-2019SA299957",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "HYDROCORTISONE"
},
"drugadditional": null,
... |
{
"abstract": "A 69-year-old woman presented with arterial hypotension, pulmonary oedema and a severely depressed left ventricular ejection fraction (LVEF) of 25% only 3 days after having received her first treatment for colorectal cancer with 5-fluorouracil (5-FU)-based therapy. The ECG demonstrated widespread ST-se... | [
{
"companynumb": "DK-FRESENIUS KABI-FK201604846",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "FLUOROURACIL"
},
"drugadditional": "1",
... |
{
"abstract": "OBJECTIVE\nEpidermal growth factor receptor (EGFR) tyrosine kinase inhibitors are key drugs in the treatment of non-small cell lung cancer (NSCLC) harboring EGFR activating mutations. We assessed the efficacy and safety of one EGFR tyrosine kinase inhibitor, erlotinib, in elderly Japanese patients with... | [
{
"companynumb": "JP-ASTELLAS-2016US034415",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ERLOTINIB"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nSpindle cell carcinoma (SPCC) of the lung is a subset of sarcomatoid carcinoma. Its clinical features are unclear because of its rarity. Here, we report an autopsy case of SPCC and review CT findings and chemotherapeutic regimens based on previous reports of this disease. To our knowledge, ... | [
{
"companynumb": "JP-CIPLA LTD.-2015JP08858",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PEMETREXED"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nPrimary central nervous system lymphoma (PCNSL) is an aggressive lymphoma confined to the CNS. Although the pathogenesis of PCNSL in immunocompetent individuals remains unclear, there have been several case studies demonstrating the \"sentinel\" inflammatory lesions months before the manife... | [
{
"companynumb": "PHHY2016CA009452",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
"dru... |
{
"abstract": "Here we report a fatal case of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) due to methimazole use in a 64-year-old woman. She was initially hospitalized for abdominal pain and possible colitis, and subsequently developed hematuria, renal failure, and hemoptysis. The serologic... | [
{
"companynumb": "US-PFIZER INC-2019187981",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHIMAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo investigate potential fluctuations in prostate cancer antigen 3 (PCA 3) scores in castration-resistant prostate cancer (CRPC) patients treated with docetaxel and investigate the assay as a potential prognostic factor.\n\n\nMETHODS\nThis was a prospective observational cohort study. Inclus... | [
{
"companynumb": "GB-TEVA-616148ISR",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "DOCETAXEL"
},
"drugadditional": null,
"drug... |
{
"abstract": "It is expected that the number of long-term breast cancer survivors will increase owing to the improvements in chemotherapy and irradiation, while the risk of double cancers, including secondary malignancy, may become an issue. There are many unclear points in the treatment policy with regard to when a... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2021RR-310830",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "IMATINIB"
},
"drugad... |
{
"abstract": "The coronavirus disease 2019 (COVID-19) has swept the world, posing a serious threat to people's lives and health. Several cases of COVID-19 infection in renal transplant recipients (RTRs) have been reported, but the treatment and prognosis have not been fully elucidated. We followed-up with RTRs infec... | [
{
"companynumb": "CN-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-309022",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drug... |
{
"abstract": "BACKGROUND\nAs a result of increased resistance to antibiotics, Helicobacter pylori eradication rates using standard triple therapy have been declining.\n\n\nOBJECTIVE\nTo validate the efficacy and tolerability of a concomitant regimen as a first-line treatment for H. pylori infection.\n\n\nMETHODS\nA ... | [
{
"companynumb": "KR-BAXTER-2015BAX047672",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "3",
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "Gemcitabine and erlotinib have shown a survival benefit in the first-line setting in metastatic pancreatic cancer (mPC). The aim of this study was to assess whether combining capecitabine (C) with gemcitabine + erlotinib (GE) was safe and effective versus GE in patients with mPC.\n\n\n\nPreviously untr... | [
{
"companynumb": "ES-PFIZER INC-2019494489",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "GEMCITABINE HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "BACKGROUND\nThe hemodynamic state of the posterior dominant vasogenic edema in posterior reversible encephalopathy syndrome (PRES) is controversial. The aim of this retrospective study was to examine the contribution of epileptic ictal hyperperfusion in patients with PRES using combined magnetic resona... | [
{
"companynumb": "JP-UCBSA-2016011048",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "3",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": null,
... |
{
"abstract": "Pseudocirrhosis is an infrequently reported clinico-radiologic complication that primarily occurs in a subset of patients with a history of breast carcinoma metastatic to the liver that has been treated with systemic chemotherapy, particularly capecitabine, gemcitabine, trastuzumab, and/or paclitaxel. ... | [
{
"companynumb": "US-CORDEN PHARMA LATINA S.P.A.-US-2018COR000040",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugad... |
{
"abstract": "Cardiotoxicity related to antineoplastic agents is a rising and growing issue, therefore early recognition and prompt management can impact on the overall prognosis of cancer patients. We report the case of a 70-year-old woman without cardiovascular risk factors, with a medical history of non-Hodgkin l... | [
{
"companynumb": "IT-SUN PHARMACEUTICAL INDUSTRIES LTD-2019RR-198048",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"dru... |
{
"abstract": "In recent years, the use of valproic acid (VPA) as a mood-stabilizing agent has continuously increased. Although VPA usually is well tolerated, its use in combination with other psychotropic compounds might bear an elevated risk of adverse reactions. Here, we present the case of a 42-year-old male suff... | [
{
"companynumb": "DE-VISTAPHARM, INC.-VER201803-000462",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "FLUPENTIXOL"
},
"drugadditional": ... |
{
"abstract": "Denosumab is an antiresorptive drug targeting RANK ligand, currently licensed for postmenopausal and male osteoporosis, bone loss associated with hormone ablation in men with prostate cancer and with systemic glucocorticoid treatment, and also used in oncology for the treatment of bone metastases and u... | [
{
"companynumb": "US-ALLERGAN-2002656US",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CALCIUM"
},
"drugadditional": null,
"d... |
{
"abstract": "OBJECTIVE\nTo describe a case of neovascular glaucoma from cytomegalovirus (CMV) retinitis in a human immunodeficiency virus-negative patient with immunosuppression after stem-cell transplant for multiple myeloma.\n\n\nMETHODS\nRetrospective case report.\n\n\nRESULTS\nA 71-year-old man on monthly infus... | [
{
"companynumb": "US-JNJFOC-20201253502",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": "3",
... |
{
"abstract": "We report on a case of a female patient who had serious side effects from treatment with clozapine and chlorpromazine and the appeared to have a withdrawal reaction from cessation of clozapine. During the treatment process she was misdiagnosed as having malignant syndrome. This case highlights the impo... | [
{
"companynumb": "CN-ACCORD-053357",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "TRIHEXYPHENIDYL"
},
"drugadditional": null,
... |
{
"abstract": "Infants undergoing cardiac surgery are at risk for bleeding and massive transfusion due to an immature coagulation system, complex surgeries, and cardiopulmonary bypass (CPB) effects. Hemodilution from CPB promotes an acquired hypofibrinogenemia that results in impaired fibrin formation, inadequate clo... | [
{
"companynumb": "US-BEH-2019107166",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FIBRINOGEN HUMAN"
},
"drugadditional": null,
... |
{
"abstract": "The GH-receptor antagonist pegvisomant (PEG) reduces peripheral IGF-1 synthesis and is used to treat acromegaly patients resistant or intolerant to somatostatin analogues (SSA). Medical therapy is generally life-long in patients with acromegaly, since disease remission is very uncommon after SSA discon... | [
{
"companynumb": "IT-SUN PHARMACEUTICAL INDUSTRIES LTD-2019RR-202791",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "OCTREOTIDE"
},
"drug... |
{
"abstract": "Association of dysregulated calcium homeostasis and granulomatous disease is well established. There exist reports in the literature of granulomatous reactions produced by silicones associated with hypercalcemia. In this case series we report four young women that underwent methacrylate injections in g... | [
{
"companynumb": "AR-GILEAD-2014-0119121",
"fulfillexpeditecriteria": "1",
"occurcountry": "AR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TENOFOVIR DISOPROXIL FUMARATE"
},
"drugadditiona... |
{
"abstract": "Status epilepticus and encephalopathy have been reported with use of cephalosporins in patients with renal failure. We here report the case of a 79-year-old patient with normal renal function who developed subtle mental status changes during cefepime therapy for urinary tract infection. Emergent electr... | [
{
"companynumb": "SA-PFIZER INC-2012324826",
"fulfillexpeditecriteria": "1",
"occurcountry": "SA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CEFTRIAXONE"
},
"drugadditional": "1",
... |
{
"abstract": "Immune checkpoint inhibitors (ICI) have become a primary treatment modality for patients with a variety of malignancies. Given their increasing use, it is essential to be familiar with their immune-related adverse events (irAEs). Here we report a severe case of autoimmune hemolytic anemia (AIHA) associ... | [
{
"companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2020-104150",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "NIVOLUMAB"
},
"drugaddi... |
{
"abstract": "OBJECTIVE\nLevodopa-carbidopa intestinal gel infusion (LCIG) is indicated in patients with advanced levodopa-responsive Parkinson's disease (PD) for the treatment of motor fluctuations and dyskinesias unsatisfactorily managed with conventional medication. The outcome of non-motor symptoms - particularl... | [
{
"companynumb": "IT-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-43900GD",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LEVODOPA"
},
"... |
{
"abstract": "The term baby presented with respiratory distress with X-ray pictures consistent as hyaline membrane disease (HMD). Baby was ventilated and treated with surfactant. Because of the persistence of high ventilation needs with X-ray pictures consistent with HMD with a transient response to surfactant every... | [
{
"companynumb": "IN-MYLANLABS-2020M1098025",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "SILDENAFIL"
},
"drugadditional": null,
... |
{
"abstract": "A 69-year-old man underwent left atrial radiofrequency ablation for atrial fibrillation. After 10 minutes, the procedure was terminated due to pericardial tamponade secondary to perforation during mapping. Pericardiocentesis resolved the tamponade. Ablation was completed one week later, and the patient... | [
{
"companynumb": "CA-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-60210GD",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DABIGATRAN ETEXILATE MESYLATE"
... |
{
"abstract": "Body fluids and tissues in eight doxepin (Dox)-related deaths were investigated in order to prove whether the individual concentration of Dox, the concentration sum of parent drug and its active metabolite N-desmethyldoxepin (NDox) or the concentration ratio Dox/Ndox valuably contribute to making a cau... | [
{
"companynumb": "DE-BAUSCH-BL-2018-027813",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DIAZEPAM"
},
"drugadditional": null,
... |
{
"abstract": "The incidence of chronic rhinosinusitis with nasal polyps has recently increased in Japan and other East Asian countries, and this disease is called eosinophilic chronic sinusitis (ECRS) in Japan. ECRS usually occurs in adults and is frequently accompanied by refractory bronchial asthma. However, its o... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2019RR-223115",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"dr... |
{
"abstract": "This case report describes a case of fatal toxic epidermal necrolysis complicated by both vanishing bile duct syndrome and hemophagocytic lymphohistiocytosis due to Influenza B infection. Here we highlight the potential for complex morbidity secondary to underlying autoimmune hypersensitivity. Furtherm... | [
{
"companynumb": "US-PFIZER INC-202101707868",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ETANERCEPT"
},
"drugadditional": "3",
... |
{
"abstract": "Levetiracetam (LEV) is one of the newest antiepileptic drugs available on the market and is frequently used in neurosurgical patients requiring antiepileptic assistance. LEV is mainly excreted by the kidney with minimal hepatic metabolism, so it is considered to have a low liver toxicity. Drug-induced ... | [
{
"companynumb": "JP-UCBSA-2019040344",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VALPROIC ACID"
},
"drugadditional": "3",
... |
{
"abstract": "Pediatric low-grade gliomas (LGG) represent 30-50% of central nervous system pediatric tumors. Over the last decades, the combination of carboplatin and vincristine (CV) has become the first line of treatment in most centers. In a large clinical trial where the efficacy of CV was compared to another re... | [
{
"companynumb": "CA-PFIZER INC-2018291994",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "VINCRISTINE SULFATE"
},
"drugadditional": null... |
{
"abstract": "Tacrolimus, also known as FK506, is an immunosuppressive agent widely used for the prevention of acute allograft rejection in organ transplantation and for the treatment of immunological diseases. This study reports two male patients who underwent solid organ transplantation (liver and kidney). After t... | [
{
"companynumb": "PHHY2014IT149328",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "INSULIN NOS"
},
"drugadditional": null,
"dru... |
{
"abstract": "BACKGROUND\nIntestinal tuberculosis can mimic many conditions. The incidence of intestinal tuberculosis in developed countries has risen in tandem with the increase in patients with immunocompromised states. This is a condition which needs to be considered in patients who present with symptoms and sign... | [
{
"companynumb": "SG-ACCORD-034783",
"fulfillexpeditecriteria": "1",
"occurcountry": "SG",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
"dr... |
{
"abstract": "As a healthcare profession, dentists have a role in ensuring the safety of prescribed medicines by reporting adverse drug reactions using the Yellow Card Scheme. This article briefly describes a case where metronidazole, an antibiotic commonly prescribed by dentists, may have caused ototoxicity and exp... | [
{
"companynumb": "PHHY2017GB069324",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"drugadditional": null,
"d... |
{
"abstract": "Uterus transplantation has proven to be a successful treatment for women with absolute uterine infertility, caused either by the absence of a uterus or the presence of a nonfunctioning uterus. We report the first birth of a healthy child following uterus transplantation in the United States, from a rec... | [
{
"companynumb": "US-ASTELLAS-2018US022560",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS\\TACROLIMUS ANHYDROUS"
},
"drugaddi... |
{
"abstract": "Long-term use of lithium is a known risk factor for hypercalcemia often due to involvement of the parathyroid gland. Because of this, lithium-induced hypercalcemia typically occurs simultaneously with abnormal parathyroid hormone concentrations. This case report describes a 54-year-old white male who h... | [
{
"companynumb": "US-HETERO-HET2019US01308",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LITHIUM"
},
"drugadditional": "1",
"... |
{
"abstract": "OBJECTIVE\nCurrently, there is no recommendation for the treatment of breast cancer (BC) with bone-marrow cell infiltration (BMI). We evaluated the efficacy and safety of weekly-paclitaxel in this population.\n\n\nMETHODS\nThis retrospective study included all BC patients with BMI receiving weekly-pacl... | [
{
"companynumb": "FR-TEVA-2020-FR-1512632",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PACLITAXEL"
},
"drugadditional": "3",
... |
{
"abstract": "Acute dystonia is a side-effect associated with the use of antipsychotics. We describe the case of a 75-year-old patient with late-onset schizophrenia who used clozapine. During a hospital admission due to pneumonia, she developed a form of acute dystonia consisting of a rotational torticollis, which d... | [
{
"companynumb": "NL-MYLANLABS-2019M1002264",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OLANZAPINE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nThe benefit of aspirin in primary prevention of myocardial infarction and the associated gastro-intestinal bleeding risks have not been well established in the elderly population with diabetes.\n\n\nMETHODS\nUsing Quebec administrative databases, we conducted two nested case-control analyse... | [
{
"companynumb": "CA-JNJFOC-20140901262",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": null,
... |
{
"abstract": "Low-grade serous carcinoma of the ovary/peritoneum is a rare epithelial cancer subtype characterized by younger age at diagnosis, relative chemoresistance, and prolonged overall survival compared with high-grade serous carcinoma. In addition, alterations in the mitogen activated protein kinase pathway ... | [
{
"companynumb": "NVSC2020US302451",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LETROZOLE"
},
"drugadditional": null,
"druga... |
{
"abstract": "Transient left ventricular hypertrophy or thickening (TLVH/T) is a phenomenon rarely observed in some patients with myocarditis and stress-induced takotsubo syndrome (TTS). Initial presentation on echocardiography can mimic hypertrophic cardiomyopathy (HCM), sometimes with a decreased ejection fraction... | [
{
"companynumb": "PL-MYLANLABS-2020M1003844",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "SERTRALINE HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "OBJECTIVE\nThe introduction of immunochemotherapy has led to a significant improvement in treatment results and prognosis of diffuse large B-cell non-Hodgkins lymphoma (DLBCL) both at initial diagnosis and in relapse. Trofosfamide, an oxazaphosphorine derivative, has been utilized as alternative treatm... | [
{
"companynumb": "PHHY2018DE135953",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TROFOSFAMIDE"
},
"drugadditional": null,
"dr... |
{
"abstract": "Historical anaplastic thyroid cancer (ATC) outcomes have been terrible, with a median survival of only five months and <20% one-year survival. Improved outcomes are now achieved with aggressive initial therapy in stages IVA and IVB disease, but patients with distant metastatic disease (stage IVC) still... | [
{
"companynumb": "US-DRREDDYS-USA/USA/17/0092374",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugaddit... |
{
"abstract": "The inv (4)(p13q13) cytogenetic abnormality is uncommon in hematologic malignancies. So far, it has not been previously reported in patients with essential thrombocythemia (ET). We report a first case of ET with inv (4)(p13q13) karyotype in a 69-year-old female patient who developed myelofibrosis at fo... | [
{
"companynumb": "TR-BAYER-2016-076258",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": null,
"dru... |
{
"abstract": "Adrenaline is the primary drug of choice for resuscitation from out-of-hospital cardiac arrest (OHCA). Although adrenaline may increase the chance of achieving return of spontaneous circulation (ROSC), there is limited evidence that repeated doses of adrenaline improves overall survival, and increasing... | [
{
"companynumb": "GB-MYLANLABS-2019M1051587",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "EPINEPHRINE"
},
"drugadditional": null,
... |
{
"abstract": "The increasing number of elderly psoriatic patients presents a challenge for dermatologists. Biologicals and small-molecule inhibitors in the general population have demonstrated a sufficient efficacy and safety profile; yet, studies about their use in the geriatric population are lacking. In this stud... | [
{
"companynumb": "GR-JNJFOC-20200927224",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "BRODALUMAB"
},
"drugadditional": null,
... |
{
"abstract": "We present an autopsy case involving benzodiazepines and diphenidine. Quantitative toxicological analysis showed concentrations of 7-aminoflunitrazepam (a flunitrazepam metabolite), 7-aminonimetazepam (a nimetazepam metabolite), chlorpheniramine and diphenidine in femoral blood of 0.086 µg/ml, 0.027 µg... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2019R1-206182",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DIPHENIDINE"
},
"dru... |
{
"abstract": "Progressive multifocal leukoencephalopathy (PML) is a rare opportunistic infection of the central nervous system caused by reactivation of JC virus (JCV). Typical PML shows confluent, bilateral but asymmetric, subcortical lesions in the supratentorial white matter on magnetic resonance imaging (MRI). W... | [
{
"companynumb": null,
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "4",
"drugadmi... |
{
"abstract": "Hepatic angiosarcoma is an extremely rare diagnosis in children, with fewer than 50 pediatric cases reported in the literature worldwide. This aggressive vascular sarcoma carries a very dismal prognosis and is known to be resistant to radiation, chemotherapy, and other vascular-targeted agents. Complet... | [
{
"companynumb": "US-HETERO-HET2019US00933",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM"
},
"drugadditi... |
{
"abstract": "A 50-year-old male presented with atrial flutter 25 days after heart and kidney transplantation. Rejection was excluded, but he developed severe COVID-19 infection with cardiac allograft dysfunction. Despite continued corticosteroid and tacrolimus therapy, he remained aviremic. Respiratory and myocardi... | [
{
"companynumb": "US-PBT-000469",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
"drugadm... |
{
"abstract": "OBJECTIVE\nTo describe histopathologic features of an eye with retinal angiomatous proliferation (RAP) secondary to age-related macular degeneration treated with serial ranibizumab injections and to correlate these findings with spectral domain optical coherence tomography.\n\n\nMETHODS\nHistopathologi... | [
{
"companynumb": "US-ROCHE-1979793",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RANIBIZUMAB"
},
"drugadditional": "3",
"drug... |
{
"abstract": "Primary upper urinary tract small cell carcinoma (SCC) is exceedingly rare with < 30 cases reported in the literature. Little is known about the incidence, diagnosis, treatment, and outcomes in these patients. We present a series of three patients with primary upper tract SCC. Patient 1 is an 89-year-... | [
{
"companynumb": "US-009507513-1712USA003734",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TEMOZOLOMIDE"
},
"drugadditional": null,
... |
{
"abstract": "Considerable research has focused on patients with trinucleotide (CGG) repeat expansions in the fragile X mental retardation 1 (FMR1) gene that fall within either the full mutation (>200 repeats) or premutation range (55-200 repeats). Recent interest in individuals with gray zone expansions (41-54 CGG ... | [
{
"companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-63532BI",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ENTACAPONE"
},
... |
{
"abstract": "OBJECTIVE\nTo determine if repeated intravenous exposures to gadolinium-based contrast agents (GBCAs) are associated with neuronal tissue deposition.\n\n\nMETHODS\nIn this institutional review board-approved single-center study, signal intensities from T1-weighted magnetic resonance (MR) images and pos... | [
{
"companynumb": "US-GE HEALTHCARE MEDICAL DIAGNOSTICS-OSCN-PR-1503L-0048",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "GADODIAMIDE"
},
... |
{
"abstract": "A 41-year-old nurse was referred to our hospital with a fever and disturbed consciousness. She tested positive for influenza antigen. CT and MRI findings revealed low density and intensity areas in the right occipital and lateral lobes with remarkable brain edema, which led to a diagnosis of influenza ... | [
{
"companynumb": "JP-JNJFOC-20160323869",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": null,
... |
{
"abstract": "Ceftriaxone and linezolid are commonly used antibiotics in infective endocarditis. Here we present a rare case of severe anemia caused by both the drugs via different mechanisms. Drugs have shown significant contribution in inducing anemia via hemolysis and bone marrow suppression in an infective endoc... | [
{
"companynumb": "IN-NOVEL LABORATORIES, INC-2016-05662",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CEFTRIAXONE"
},
"drugadditional":... |
{
"abstract": "Mild overdosage of phenytoin produces reversible cerebellar symptoms (nystagmus, double vision, dysarthria and ataxia). Several case reports suggest that relatively mild and relatively short intoxication can lead to cerebellar degeneration. We observed 11 patients who had episodes of abnormally increas... | [
{
"companynumb": "AT-PFIZER INC-2015229186",
"fulfillexpeditecriteria": "1",
"occurcountry": "AT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PHENYTOIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nElderly patients with diffuse large B-cell lymphoma (DLBCL) are a heterogeneous population; clinical trials have evaluated a minority of these patients.\n\n\nMETHODS\nNinety-one elderly patients with DLBCL received tailored treatment based on a comprehensive geriatric assessment (CGA). Thre... | [
{
"companynumb": "IT-PFIZER INC-2020371944",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VINCRISTINE SULFATE"
},
"drugadditional": "3",... |
{
"abstract": "Background: Papulopustular rash is the most common cutaneous adverse effect during targeted tumour therapy particularly with epidermal growth factor receptor inhibitors (EGFRIs). Objective: To evaluate the adverse skin reactions, mainly papulopustular rash, caused by targeted tumour therapy. Materials ... | [
{
"companynumb": "TR-ALKEM LABORATORIES LIMITED-TR-ALKEM-2019-09782",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LAPATINIB"
},
"drugad... |
{
"abstract": "Pill packs are novel packaging systems designed to contain multiple medications and increase medication access but are not child-resistant and increase the risk of pediatric ingestions. We present two pediatric ingestion cases suspected to involve pill packs. Case 1 describes a 19-month-old male presen... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-313656",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLONIDINE"
},
"druga... |
{
"abstract": "Thymic carcinoma is a relatively rare and aggressive thymic epithelial tumor. Herein, we report successful treatment of thymic carcinoma with pembrolizumab. A 68-year-old woman was admitted to our hospital for evaluation of chest pain. Chest computed tomography showed a mass in the anterior mediastinum... | [
{
"companynumb": "JP-CELGENEUS-JPN-20190108818",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "PEMBROLIZUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Temozolomide, an oral alkylating agent, is used in the treatment of glioblastoma. We describe a case of a 62-year-old woman developing jaundice with significant derangement of liver function tests on day 17 of focal radiotherapy with concomitant temozolomide. There was no structural abnormality on imag... | [
{
"companynumb": "CA-SUN PHARMACEUTICAL INDUSTRIES LTD-2015US-103171",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "GLICLAZIDE"
},
"dru... |
{
"abstract": "OBJECTIVE\nTo evaluate the efficacy and safety of mycophenolate mofetil (MMF) in adult primary central nervous system vasculitis (PCNSV).\n\n\nMETHODS\nWe studied a cohort of 163 patients with PCNSV who were seen at the Mayo Clinic from 1983 to 2011. We compared patients treated with MMF and those rece... | [
{
"companynumb": "NVSC2019IT013481",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": null,
... |
{
"abstract": "A 62-year-old man was referred to our university hospital for treatment of advanced adenocarcinoma of the lung after disease progression on two lines of EGFR TKI and one line of chemotherapy. Fluorescent in situ hybridization analysis upon progression showed an HER2 amplification. At our weekly Molecul... | [
{
"companynumb": "NL-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-029840",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AFATINIB"
},
"dr... |
{
"abstract": "Cerebellar atrophy occurring in patients with chronic epilepsy is considered either to be a sequel of cumulative seizure-mediated cell loss or a side effect of phenytoin treatment but there is little neuropathological data regarding the distribution of this cerebellar damage. We aimed to address if the... | [
{
"companynumb": "GB-PFIZER INC-2015229067",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PHENYTOIN"
},
"drugadditional": null,
... |
{
"abstract": "Foreign-body ingestion is a common event, but in only less than 1% of the cases complications occur. Hepatic abscesses induced by foreign-body penetration are rare. To date, there are only 62 reported cases of hepatic abscess secondary to fish bone perforation of the gastrointestinal tract.\nA 78-year-... | [
{
"companynumb": "PHHY2019PT128110",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"drugadditional": null,
"d... |
{
"abstract": "A relevant case of pulmonary sporotrichosis due to Sporothrix brasiliensis is reported in a 50-year-old immunocompetent woman who had no history of skin trauma, but was in close contact with several stray cats at her nap time. The patient was hospitalized after 7 months of illness. The survey was condu... | [
{
"companynumb": "BR-FRESENIUS KABI-FK202007904",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "UNSPECIFIED INGREDIENT"
},
"drugaddition... |
{
"abstract": "Nonketotic hyperglycinemia (NKH) is a rare, inborn error of metabolism. In this case report, a Chinese male infant was diagnosed with NKH caused by GLDC gene mutation. The clinical characteristics and genetic diagnosis were reported. The infant presented with an onset of early metabolic encephalopathy ... | [
{
"companynumb": "CN-ACCORD-049681",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DEXTROMETHORPHAN"
},
"drugadditional": null,
... |
{
"abstract": "Neonatal nonoliguric hyperkalemia (NOHK) is a metabolic abnormality that occurs in extremely premature neonates at approximately 24 h after birth and is mainly due to the immature functioning of the sodium (Na+)/potassium (K+) pump. Magnesium sulfate is frequently used in obstetrical practice to preven... | [
{
"companynumb": "JP-PENTEC HEALTH-2018PEN00001",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MAGNESIUM SULFATE"
},
"drugadditional": n... |
{
"abstract": "To verify the frequency and severity of metabolic abnormalities occurring as a result of intentional theophylline overdose, we retrospectively analyzed admission laboratory data from 22 cases of theophylline poisoning. Hypokalemia, hyperglycemia, and leukocytosis were frequent findings, and the magnitu... | [
{
"companynumb": "US-PFIZER INC-2020410738",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "THEOPHYLLINE ANHYDROUS"
},
"drugadditional": "... |
{
"abstract": "Several lines of scientific evidence showed that topiramate may induce psychotic symptoms when used as monotherapy. It has been postulated that this topiramate effect may be caused by the inhibition of frontal and prefrontal areas induced by topiramate. The clinical history of the patient described sho... | [
{
"companynumb": "IT-JNJFOC-20140112505",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nCalcium channel blockers (CCBs) are commonly used agents in the treatment of hypertension as part of monotherapy or combination therapy. Peripheral edema is the most common side effect that requires discontinuation or replacement of treatment. Some studies in the literature have shown that ... | [
{
"companynumb": "TR-OXFORD PHARMACEUTICALS, LLC-2020OXF00154",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditiona... |
{
"abstract": "We report a 64-year-old woman who underwent craniotomy and gross total resection of a left frontal lobe tumor initially diagnosed as glioblastoma. Multiple wound revisions were necessary due to repeated wound healing disorders under concomitant radio-chemotherapy. After 9 months there was local cranial... | [
{
"companynumb": "DE-TEVA-2020-DE-1849231",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IRINOTECAN"
},
"drugadditional": "3",
... |
{
"abstract": "Although hypersensitivity pneumonitis is the most common pulmonary complication described during treatment with methotrexate, other complications like lymphoproliferative and infectious disease may be considered in the study of respiratory disease associated to methotrexate. The existence of an increas... | [
{
"companynumb": "ES-MYLANLABS-2016M1032576",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMLODIPINE BESYLATE"
},
"drugadditional": "3"... |
{
"abstract": "Neurotoxicity is a rare side effect of metronidazole therapy. Shown here are findings of metronidazole toxicity in a patient, who received chronic metronidazole as prophylaxis for pseudomembranous colitis following bowel resection as an infant. Findings depicted include increased T2 signal in the denta... | [
{
"companynumb": "US-ALEMBIC PHARMACUETICALS LIMITED-2018SCAL000847",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"dr... |
{
"abstract": "BACKGROUND\nIn recent years, liver transplantation (LT) has become a well-accepted therapeutic modality for children with end-stage liver disease, with transplantation surgery being performed at a younger age. Human herpes virus 6 (HHV-6) infection occurs in most children within the first 2 years of li... | [
{
"companynumb": "IL-TEVA-2019-IL-1019556",
"fulfillexpeditecriteria": "1",
"occurcountry": "IL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": "3",
... |
{
"abstract": "Gram-negative bacteria are the major pathogens detected in neonatal intensive care units. In the last few years, outbreaks of multidrug-resistant (MDR) Klebsiella pneumonia have become a major health concern, especially given this population's limited antimicrobial choices. In the present case series, ... | [
{
"companynumb": "SA-PFIZER INC-202200063497",
"fulfillexpeditecriteria": "1",
"occurcountry": "SA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MEROPENEM"
},
"drugadditional": "4",
... |
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