article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "Acute myocardial infarction is a common complication of thrombotic thrombocytopenic purpura (TTP), but rarely the presenting manifestation. Anti-thrombotic therapy for myocardial infarction is rarely utilized in the setting of TTP because of elevated bleeding risk. We report a case of TTP presenting wi... | [
{
"companynumb": "US-ROXANE LABORATORIES, INC.-2014-BI-31180GD",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "TENECTEPLASE"
},
"drugadd... |
{
"abstract": "BACKGROUND\nTranscatheter arterial chemoembolization (TACE) has been used to curtail tumor vasculature and delay tumor progression in hepatocellular carcinoma (HCC). We conducted a phase I trial to evaluate the efficacy and toxicity of thalidomide when combined with TACE in patients with advanced HCC.\... | [
{
"companynumb": "US-CELGENE-USA-2014113081",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "THALIDOMIDE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo evaluate and compare the efficacy and safety of telaprevir (TVR)-and simeprevir (SMV)-based triple therapies in elderly patients, specifically patients aged 66 years or older.\n\n\nMETHODS\nThe present study enrolled 112 and 76 Japanese patients with chronic hepatitis C virus genotype 1b ... | [
{
"companynumb": "JP-JNJFOC-20170317369",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SIMEPREVIR"
},
"drugadditional": null,
... |
{
"abstract": "A 37-year-old woman was diagnosed with chronic phase chronic myeloid leukemia. Nilotinib treatment was initiated; however, it had to be discontinued due to an allergic reaction one month later, and dasatinib treatment was provided. Although favorable response was obtained, she started complaining of sh... | [
{
"companynumb": "PHJP2017JP032653",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "NILOTINIB"
},
"drugadditional": "1",
"drugad... |
{
"abstract": "BACKGROUND\nDupuytren, Ledderhose, and Peyronie diseases are chronic fibrotic conditions related to progressive fibrosis of the palmar fascia, plantar fascia, and tunica albuginea, respectively. These conditions have been associated with antiepileptic drug use, mainly phenobarbital and primidone.\n\n\n... | [
{
"companynumb": "BR-AMNEAL PHARMACEUTICALS-2019-AMRX-01938",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PRIMIDONE"
},
"drugadditional... |
{
"abstract": "BACKGROUND\nAbiraterone acetate is an inhibitor of androgens biosynthesis, approved as first-line treatment in castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. Abiraterone has been rarely associated with severe rhabdomyolysis, but the mechanism of muscle toxicit... | [
{
"companynumb": "BE-JNJFOC-20200601890",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": null,
"d... |
{
"abstract": "Clozapine may be associated with cardiovascular adverse effects including QTc prolongation and, more rarely, with myocarditis and pericarditis. Although rare, these latter cardiovascular adverse effects may be life-threatening and must be immediately recognized and treated. Several cases of clozapine r... | [
{
"companynumb": "IT-MYLANLABS-2018M1088097",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CLOZAPINE"
},
"drugadditional": "1",
... |
{
"abstract": "This is a case report of a fatal intoxication in Cyprus related to 3,4-methylenedioxypyrovalerone (MDPV) and 2-(methylamino)-1-phenylpentan-1-one (pentedrone) intake combined with antipsychotic and antidepressant substances. A 42- year old man with a history of serious psychiatric illness was found unr... | [
{
"companynumb": "CY-MYLANLABS-2018M1004146",
"fulfillexpeditecriteria": "1",
"occurcountry": "CY",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "EPHEDRINE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nSome acute myeloid leukemia (AML) patients present with features mimicking the classical hypergranular subtype of acute promyelocytic leukemia (APL) but without the typical promyelocytic leukemia/retinoic acid receptor α (PML/RARα) rearrangement. Herein, we report an AML patient resembling ... | [
{
"companynumb": "CN-HEALTHCARE PHARMACEUTICALS LTD.-2101774",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
... |
{
"abstract": "Whole-genome sequencing was used to examine a persistent Enterococcus faecium bacteremia that acquired heteroresistance to three antibiotics in response to prolonged multidrug therapy. A comparison of the complete genomes before and after each change revealed the emergence of known resistance determina... | [
{
"companynumb": "US-WEST-WARD PHARMACEUTICALS CORP.-US-H14001-18-04173",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"... |
{
"abstract": "Brentuximab vedotin (BV) shows a high overall response rate (ORR) in relapsed/refractory (R/R) Hodgkin lymphoma (HL) after autologous transplant (ASCT). The aim of this multicenter study, conducted in nine Hematology Departments of Rete Ematologica Pugliese, was to retrospectively evaluate the efficacy... | [
{
"companynumb": "IT-SEATTLE GENETICS-2018SGN01903",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BRENTUXIMAB VEDOTIN"
},
"drugadditiona... |
{
"abstract": "Diarrhea, which is common after transplantation, may be due to infections and immunosuppressive therapy. Inflammatory bowel disease (IBD) de novo or as an exacerbation of pre-existent disease is a rare complication after kidney transplantation with pre-existing disease having a less aggressive clinical... | [
{
"companynumb": "PT-ACCORD-017599",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "3",
"druga... |
{
"abstract": "Prelabor rupture of the membranes (PROM) near the limit of viability is associated with significant risks for both mother and fetus. Preterm labor, intra-amniotic infection, and placental abruption are the immediate risks to the pregnancy; however, the fetus incurs additional risks related to the seque... | [
{
"companynumb": "US-009507513-1810USA001575",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BETAMETHASONE ACETATE\\BETAMETHASONE SODIUM PHOSPHATE"
... |
{
"abstract": "OBJECTIVE\nTo determine from single-centre data the treatment continuation, discontinuation, and reasons for discontinuation among the patients with active rheumatoid arthritis (RA) or spondyloarthropathies (SpA) who were treated with infliximab as their first biological anti-rheumatic drug.\n\n\nMETHO... | [
{
"companynumb": "FI-JNJFOC-20080402072",
"fulfillexpeditecriteria": "1",
"occurcountry": "FI",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "Despite recent advances and well-known treatment options, cure rates for resistant tuberculosis (TB) cases remain extraordinarily low. We present in first person the case of a patient who suffered from TB for over 7 years, and travelled to four countries in search of a cure. This experience shows how r... | [
{
"companynumb": "PHHY2017FR106278",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "ETHAMBUTOL HYDROCHLORIDE\\ISONIAZID\\PYRAZINAMIDE\\RIFAMPIN"
},
... |
{
"abstract": "Familial hypercholesterolaemia (FH) is a primary genetic dyslipidaemia characterized by elevation in serum low-density lipoprotein cholesterol and its deposition in systemic arteries, which causes premature atherosclerosis.\nA 10-year-old girl presented with severe symptomatic coronary artery disease. ... | [
{
"companynumb": "IN-LUPIN LIMITED-2021-22103",
"fulfillexpeditecriteria": "2",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ROSUVASTATIN"
},
"drugadditional": "4",
... |
{
"abstract": "OBJECTIVE\nTo characterize and compare both the outcome and cost of treatment of outpatient (OP) and inpatient (IP) ifosfamide therapy.\n\n\nMETHODS\nA single-center retrospective chart review of patients 18 years and older receiving ifosfamide therapy. The primary endpoint compares and evaluates the s... | [
{
"companynumb": "US-NOVARTISPH-NVSC2021US272239",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "Oxaliplatin is a platinum compound commonly used in the treatment of advanced colorectal cancer. This report describes two patients who had received repetitive combination chemotherapy including oxaliplatin for the treatment of metastatic colon cancer and who visited the emergency department with acute... | [
{
"companynumb": "KR-FRESENIUS KABI-FK201801896",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LEUCOVORIN"
},
"drugadditional": null,
... |
{
"abstract": "The present study selected two patients with lung cancer and epidermal growth factor receptor (EGFR) mutations who were treated with a programmed cell death protein 1 (PD-1) antibody and an immunomodulatory arabinomannan extracted from Mycobacterium tuberculosis. In the first case, a 67-year-old female... | [
{
"companynumb": "2021A900842",
"fulfillexpeditecriteria": "1",
"occurcountry": null,
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OSIMERTINIB"
},
"drugadditional": "3",
"drugadmin... |
{
"abstract": "Mycoplasma infection may lower the threshold for drug allergy in particular patients. We present a case of drug reaction with eosinophilia and systemic symptoms (DRESS), with drug etiology and non-drug etiology (Mycoplasma infection). Possible synergism between previously known drug allergy and the acu... | [
{
"companynumb": "IL-GLAXOSMITHKLINE-IL2021GSK019964",
"fulfillexpeditecriteria": "1",
"occurcountry": "IL",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CEPHALEXIN"
},
"drugadditional": "1"... |
{
"abstract": "To define optimal thromboprophylaxis strategy after stent implantation in superior or total cavopulmonary connections.\nStent thrombosis is a rare complication of intravascular stenting, with a perceived higher risk in single-ventricle patients.\nAll patients who underwent stent implantation within sup... | [
{
"companynumb": "US-PFIZER INC-2019276989",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": "3",
... |
{
"abstract": "Hydroxocobalamin is an effective cyanide antidote. While erythema, hypertension, and chromaturia are recognized side effects, methemoglobinemia has not been reported. Methemoglobin levels are most accurately measured by co-oximetry. We describe an extensively burned patient who developed methemoglobine... | [
{
"companynumb": "US-WEST-WARD PHARMACEUTICALS CORP.-US-H14001-18-04314",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FENTANYL"
},
"dr... |
{
"abstract": "OBJECTIVE\nTumor resistance is an emerging problem for Smoothened (SMO) inhibitor-treated metastatic basal cell carcinoma (BCC). Arsenic trioxide and itraconazole antagonize the hedgehog (HH) pathway at sites distinct from those treated by SMO inhibitors.\n\n\nOBJECTIVE\nTo determine whether administra... | [
{
"companynumb": "US-MYLANLABS-2017M1039481",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ITRACONAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nThe purpose of this study was to investigate the incidence of drug-related pneumonitis during mammalian target of rapamycin (mTOR) inhibitor therapy in patients with neuroendocrine tumours (NET) and characterise radiographic patterns of pneumonitis.\n\n\nMETHODS\nSixty-six patients (39 males... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2022-01887",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "EVEROLIMUS"
},
"druga... |
{
"abstract": "Cutaneous basosquamous carcinoma is a variant of basal cell carcinoma that is characterized by histopathological features of both basal and squamous cell carcinoma. Due to its local invasiveness, high frequency of recurrence, and its metastatic potential, it is considered to be one of the most aggressi... | [
{
"companynumb": "RO-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-105865",
"fulfillexpeditecriteria": "1",
"occurcountry": "RO",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "APIXABAN"
},
"drugaddit... |
{
"abstract": "Leflunomide (LEF) is an isoxazole derivative used as disease-modifying anti-rheumatic drug (DMARD) in the treatment of rheumatoid arthritis (RA). It is effective and safe in patients with active RA, in whom standard treatment is insufficient or contraindicated, but it can cause interstitial lung diseas... | [
{
"companynumb": "PL-SA-2015SA011086",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "SULFASALAZINE"
},
"drugadditional": null,
... |
{
"abstract": "Gastrointestinal stromal tumor is a rare mesenchymal tumor. Sorafenib is an effective medication in these tumors based on two phase II clinical trials and a retrospective analysis. We report a rare case of a 57-year-old male with acute hepatotoxicity from sorafenib. He was treated conservatively with I... | [
{
"companynumb": "US-BAYER-2015-388939",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "TAMSULOSIN"
},
"drugadditional": null,
... |
{
"abstract": "Multiple myeloma (MM) is a hematologic neoplasm characterized by plasma tumor cell proliferation in the bone marrow. It's a rare malignancy before a 40-year-old and it is extremely uncommon during pregnancy. We report the case of a 37-year-old woman with a newly diagnosed IgG λ MM (Durie-Salmon stage I... | [
{
"companynumb": "ES-GLAXOSMITHKLINE-ES2016GSK099324",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVOTHYROXINE"
},
"drugadditional": ... |
{
"abstract": "Squamous cell carcinoma of the prostate is rare and represents 0.5% to 1% of prostatic carcinomas. Transformation of prostatic adenocarcinoma into squamous cell carcinoma after LH-RH agonist intake has been reported in only 8 cases in the literature. To our knowledge, our case is the second pure squamo... | [
{
"companynumb": "TN-ALLERGAN-2001741US",
"fulfillexpeditecriteria": "1",
"occurcountry": "TN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TRIPTORELIN PAMOATE"
},
"drugadditional": null,
... |
{
"abstract": "Histoplasmosis is a systemic fungal infection caused by dimorphic fungus, Histoplasma capsulatum. Immunocompetent individuals usually have self-limiting or localized disease whereas immunocompromised individuals develop disseminated disease. The occurrence of progressive disseminated histoplasmosis in ... | [
{
"companynumb": "IN-MYLANLABS-2016M1056034",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "3",
... |
{
"abstract": "Cutaneous hyperpigmentation is a recognized adverse effect of chronic minocycline use occurring in up to 50% of patients. In this report we present a rare case of extensive skin hyperpigmentation involving both lower extremities in a patient receiving long term minocycline. The patient was receiving mi... | [
{
"companynumb": "US-DRREDDYS-USA/USA/17/0087129",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MINOCYCLINE HYDROCHLORIDE"
},
"drugaddit... |
{
"abstract": "OBJECTIVE\nTo present a forme fruste variant of hemorrhagic occlusive retinal vasculitis (HORV) after uncomplicated cataract surgery performed with vancomycin in the irrigating solution.\n\n\nMETHODS\nA report of a single patient who developed HORV; the clinical features and course are described and co... | [
{
"companynumb": "US-PENTEC HEALTH-2018PEN00054",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "VANCOMYCIN HYDROCHLORIDE"
},
"drugadditio... |
{
"abstract": "Germ cell tumours (GCT) are the most common malignancy in men between the ages of 15 and 35 years. Pure choriocarcinoma is a very rare entity of non- seminomatous germ cell tumour and comprises only 1% -3% of all the testicular tumours. Choriocarcinoma syndrome is a clinical condition in which haemorrh... | [
{
"companynumb": "PK-STRIDES ARCOLAB LIMITED-2022SP001594",
"fulfillexpeditecriteria": "1",
"occurcountry": "PK",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional":... |
{
"abstract": "Enterocytozoon bieneusi microsporidiosis is an emerging disease in immunocompromised patients. We report 2 cases of this disease in allogeneic hematopoietic stem cell transplant patients successfully treated with fumagillin. Thrombocytopenia occurred but without major adverse events. Modifications of i... | [
{
"companynumb": "FR-ACCORD-064408",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": null,
... |
{
"abstract": "Smooth muscle tumors of uncertain malignant potential (STUMP) are mesenchymal uterine tumors lying between benign leiomyomas and leiomyosarcomas. Although lung metastases from uterine leiomyosarcoma are common, \"STUMP\" usually does not metastasize. A case of a 51-year-old woman with progressive dyspn... | [
{
"companynumb": "GR-MYLANLABS-2022M1036369",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "EPIRUBICIN"
},
"drugadditional": "4",
... |
{
"abstract": "BACKGROUND\nAdvances in cancer treatment have led to improved long-term survival after childhood cancer, but often at a price of impaired future fertility. Fertility preservation (FP) in male children and early adolescents poses unique challenges as efficacy is unproven.\n\n\nOBJECTIVE\nTo describe cha... | [
{
"companynumb": "PHHY2018AU051626",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DAUNORUBICIN"
},
"drugadditional": null,
"dr... |
{
"abstract": "Propofol is one of the most commonly used sedating agents in critical care units worldwide. It is generally well tolerated and preferred for its pharmacokinetic profile. Here, we describe a rare and devastating adverse effect of propofol, the propofol-related infusion syndrome.",
"affiliations": "Dep... | [
{
"companynumb": "US-TEVA-603490USA",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PROPOFOL"
},
"drugadditional": null,
"druga... |
{
"abstract": "A six-week-old infant presented in extremis and was diagnosed with dextro-transposition of the great arteries, intact ventricular septum, features of left ventricular deconditioning, and abnormal coronary arteries. Treatment with prostaglandin E1 and balloon atrial septostomy was insufficient, necessit... | [
{
"companynumb": "GB-PFIZER INC-2021355450",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOPAMINE HYDROCHLORIDE"
},
"drugadditional": "... |
{
"abstract": "Tumour lysis syndrome (TLS) is a potentially fatal complication of malignancy or its treatment. This uncommon syndrome comprises laboratory findings of hyperuricaemia, hypocalcaemia, hyperkalaemia and hyperphosphataemia. A literature search revealed a total of eight patients, with testicular cancer, wh... | [
{
"companynumb": "SG-MYLANLABS-2022M1018443",
"fulfillexpeditecriteria": "1",
"occurcountry": "SG",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "INSULIN GLARGINE"
},
"drugadditional": "4",
... |
{
"abstract": "MRI findings of four hemiballism cases are described, and pathophysiology, pathogenesis and treatment of hemiballism are discussed. All cases had no family history. The lesions revealed by MRI and the pathogenesis were different each other. Case 1, a 17 years aged girl with a history of hyperthyroidism... | [
{
"companynumb": "US-ABBVIE-14P-163-1251330-00",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "VALPROATE SODIUM"
},
"drugadditional": nul... |
{
"abstract": "Objective The treatment of refractory lupus nephritis (LN) remains challenging for clinicians because these patients either do not respond to conventional therapy or relapse during the maintenance treatment period. The aim of this study was to investigate the efficacy and safety of bortezomib combined ... | [
{
"companynumb": "CN-MYLANLABS-2017M1055813",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": null... |
{
"abstract": "BACKGROUND\nComplex injuries to the central part of the face are difficult to reconstruct with the current plastic surgery methods. The ultimate one-staged approach to restore anatomy and vital facial functions is to perform a vascularized composite allotransplantation (VCA).\n\n\nMETHODS\nA 54-year-ol... | [
{
"companynumb": "PHHY2015BE041189",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ITRACONAZOLE"
},
"drugadditional": null,
"dr... |
{
"abstract": "A 32-year-old Indian female 38 weeks pregnant, with a history of multiple sclerosis since 2008 was admitted in obstetric ward for safe confinement. She had a history of diminution of vision in both eyes and limb weakness, relapsing - remitting type with movement-induced muscle spasms, in all the four l... | [
{
"companynumb": "IN-BIOGENIDEC-2014BI091202",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DIMETHYL FUMARATE"
},
"drugadditional": null... |
{
"abstract": "Opioids are utilized frequently for the treatment of moderate to severe acute pain in the perioperative setting, as well as in the treatment of cancer-related pain. When prescribing chronic opioid therapy to patients with chronic pain, it is crucial for the practitioner to be aware not only of the issu... | [
{
"companynumb": "US-ZYDUS-010333",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OXYCODONE"
},
"drugadditional": null,
"drugad... |
{
"abstract": "There are limited data on the incidence of delirium in children with cancer. We performed a retrospective chart review of all pediatric oncology admissions over a 1 year period to determine the incidence of delirium in this population. We identified seven patients with delirium (10% incidence). Deliriu... | [
{
"companynumb": "US-MYLANLABS-2015M1040374",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo assess effectiveness and safety of certolizumab PEGol (CZP) in rheumatoid arthritis (RA) patients after 12 months of treatment and to detect predictors of response.\n\n\nMETHODS\nObservational longitudinal prospective study of RA patients from 35 sites in Spain. Variables (baseline, 3- an... | [
{
"companynumb": "ES-UCBSA-2015032313",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CERTOLIZUMAB PEGOL"
},
"drugadditional": null,
... |
{
"abstract": "Reporting of new or unexpected adverse drug reactions of medicines that are subject to additional monitoring (\"black triangle\" label), such as the antipsychotic drug cariprazine, is of paramount importance to improve pharmacotherapy safety.",
"affiliations": "Institute for Clinical Pharmacology Han... | [
{
"companynumb": "DE-MACLEODS PHARMACEUTICALS US LTD-MAC2021032911",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "QUETIAPINE"
},
"drugad... |
{
"abstract": "BACKGROUND\nFour direct oral anticoagulants (DOACs) have been licensed for the treatment of atrial fibrillation (AF); efficacy and safety have been shown in clinical trials, but its real use in elderly and very elderly people is still unclear.\n\n\nOBJECTIVE\nTo evaluate the impact of DOACs in our pati... | [
{
"companynumb": "IT-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-69593BI",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DABIGATRAN ETEXILATE MESYLATE"
... |
{
"abstract": "Primary Mediastinal B cell lymphoma (PMBCL) is a biologically and clinically distinct subset of diffuse large B cell lymphoma. We analysed the outcomes of our cohort of PMBCL patients treated with Dose adjusted (DA)-R-EPOCH regimen.\nThis is a retrospective analysis of consecutive PMBCL patients who re... | [
{
"companynumb": "IN-SUN PHARMACEUTICAL INDUSTRIES LTD-2022R1-328874",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"dru... |
{
"abstract": "BACKGROUND\nFocusing on glomerular thrombotic microangiopathy (TMA), we detected urinary podocytes to evaluate podocyte damage following glomerular endothelial cell injury.\n\n\nMETHODS\nWe analyzed the relationship between urinary podocytes as biomarkers for podocyte injuries and clinical manifestatio... | [
{
"companynumb": "JP-ACCORD-048670",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": null,
"drug... |
{
"abstract": "Fungemia caused by uncommon Candida species (UCS) (other than C.albicans, C.glabrata, C.parapsilosis, C.tropicalis, C.krusei) is a rare but emerging threat with their potential to exhibit reduced susceptibility or resistance to antifungal agents. We identified 25 patients with UCS fungemia (9 C.kefyr, ... | [
{
"companynumb": "TR-PFIZER INC-202101419388",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "VORICONAZOLE"
},
"drugadditional": "4",
... |
{
"abstract": "In this report, we describe two patients with white globe appearance in the non-cancerous stomach. The patient in Case 1 was an 82-year-old Japanese man who had been taking vonoprazan, dimethicone, acotiamide, sitagliptin, candesartan, dutasteride, etizolam and zolpidem. The patient in Case 2 was a 74-... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2018RR-189525",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVOCETIRIZINE"
},
"... |
{
"abstract": "Lithium is an effective mood stabiliser used to treat bipolar affective disorder (BPAD); however, it can also adversely affect the kidneys, causing acute toxic effects, nephrogenic diabetes insipidus, chronic renal dysfunction and end-stage kidney disease (ESKD) in a minority of patients. We describe t... | [
{
"companynumb": "GB-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-310120",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "OLANZAPINE"
},
"drug... |
{
"abstract": "BACKGROUND\nThe aim of this study was to report an unusual case of chronic postoperative endophthalmitis following cataract surgery, secondary to Ochrobactrum anthropi that was found to be resistant to vancomycin.\n\n\nRESULTS\nAnterior chamber paracentesis cultures grew gram negative bacilli Ochrobact... | [
{
"companynumb": "US-BAYER-2016-149256",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "MOXIFLOXACIN"
},
"drugadditional": null,
... |
{
"abstract": "Papulopustular rash, an acneiform rash, appears on the seborrheic region during the first to second week of treatment with an epidermal growth factor receptor inhibitor (EGFRi). The rash gradually disappears after the fourth week; however, it persists or newly develops in other regions during EGFRi tre... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2020RR-242511",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ERLOTINIB"
},
"druga... |
{
"abstract": "The proliferation signal inhibitors (PSIs)-sirolimus, everolimus, and temsirolimus-have been associated with a noninfectious pneumonitis characterized by lymphocytic alveolitis and bronciolitis obliterans with organizing pneumonia (BOOP). This condition usually occurs within the first year. Herein we p... | [
{
"companynumb": "NVSC2020US008783",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMLODIPINE BESYLATE"
},
"drugadditional": "3",
... |
{
"abstract": "We report a case of a 36-year-old man with a medical history of human immunodeficiency virus (HIV) infection who presented with hypomimia, hypophonia, bradykinesia, rigidity, and freezing of gait. His clinical presentation and magnetic resonance imaging were consistent with HIV encephalopathy with invo... | [
{
"companynumb": "US-009507513-1711USA006135",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "AMANTADINE HYDROCHLORIDE"
},
"drugadditiona... |
{
"abstract": "BACKGROUND\nSAPHO (synovitis, acne, pustolosis, hyperostosis and osteitis) syndrome is a rare autoinflammatory chronic disorder, presenting with non-infectious osteitis, sterile joint inflammation and skin manifestations including palmoplantar pustolosis and severe acne. It could be often misdiagnosed ... | [
{
"companynumb": "IT-TEVA-2020-IT-1851733",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ISOTRETINOIN"
},
"drugadditional": "1",
... |
{
"abstract": "Here, we present a somewhat unusual suicide attempt where, despite an unbelievable overdose with transdermal fentanyl patches, the patient survived. The patient-a woman aged 70 years, who has suffered from chronic back pain despite starting transdermal fentanyl patches in 2007. The unconventional metho... | [
{
"companynumb": "GB-JNJFOC-20170122899",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FENTANYL"
},
"drugadditional": null,
"d... |
{
"abstract": "BACKGROUND\nEffects of mechanical cardiac support on renal function in children with end-stage heart failure are unknown. The objective of this study was to investigate the impact of ventricular assist device (VAD) and extracorporeal membrane oxygenation (ECMO) on renal function in children.\n\n\nMETHO... | [
{
"companynumb": "US-MYLANLABS-2015M1007589",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"drugadditional": null,
... |
{
"abstract": "L-asparaginase is frequently used in combination therapy for the treatment of lymphoid malignancies. We report 5 children aged between 8 and 14 years with neurologic complications presenting with headache and seizures during the first three weeks of L-asparaginase treatment. Three patients had venous t... | [
{
"companynumb": "DE-JAZZ-2016-DE-021964",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "VINCRISTINE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nThe effect of individual dose adjustment of 5-fluorouracil (5-FU) based on pharmacokinetic monitoring on the outcome of FOLFOX for metastatic colorectal cancer was analyzed retrospectively.\n\n\nMETHODS\nTwenty patients with metastatic colorectal cancer underwent FOLFOX chemotherapy from Jan... | [
{
"companynumb": "JP-ACCORD-040033",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUOROURACIL"
},
"drugadditional": null,
"dr... |
{
"abstract": "BACKGROUND\nHepatitis C infection is highly prevalent worldwide and has a well-known association with B-cell lymphoid malignancies. Antiviral therapy has successfully decreased the rate of liver cirrhosis and improved the outcome in patients with hepatitis C-associated lymphomas. However, although ther... | [
{
"companynumb": "US-009507513-1802USA005913",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "SOFOSBUVIR"
},
"drugadditional": null,
... |
{
"abstract": "Beta-lactam (BL) antibiotics are the most frequent cause of drug hypersensitivity in children, inducing both immediate and non-immediate reactions. Here we report a case of a 4-year-old child with a disseminated maculopapular exanthema 7 days after the first dose of amoxicillin-clavulanate, referred to... | [
{
"companynumb": "PT-TEVA-2021-PT-1898138",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AMOXICILLIN\\CLAVULANIC ACID"
},
"drugadditiona... |
{
"abstract": "OBJECTIVE\nSynergism between gemcitabine and platinum is known clinically. Bevacizumab in combination with single-agent chemotherapy has demonstrated significant clinical activity in platinum-resistant recurrent ovarian cancer in AURELIA study. However, the efficacy of platinum-gemcitabine-bevacizumab ... | [
{
"companynumb": "US-PFIZER INC-2017135346",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GEMCITABINE HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "We report the case of an 18-year-old woman with personality disorders who was hospitalized a few hours after suicidal ingestion of acetaminophen, quetiapine, acetylsalicylic acid, and ethanol. Twelve hours after admission, severe liver damage was evident, but the patient was stable and awaiting hepatic... | [
{
"companynumb": "CA-AUROBINDO-AUR-APL-2017-39428",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "QUETIAPINE FUMARATE"
},
"drugadditional... |
{
"abstract": "BACKGROUND\nMethadone is a standard treatment for opioid dependence in pregnancy; however, its impact on maternal corrected QT interval (QTc) has not been evaluated. We studied the association between methadone dose and enantiomer-specific plasma concentrations and QTc among pregnant and postpartum wom... | [
{
"companynumb": "US-SPECGX-T202001010",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MORPHINE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "BACKGROUND\nPrevious observational studies in the US suggest that opioid analgesic use increases the risk of cardiovascular (CV) events. The current study provides additional background event rates for five prespecified CV outcomes of interest in patients from three countries.\n\n\nMETHODS\nThree obser... | [
{
"companynumb": "US-JNJFOC-20140908742",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TRAMADOL HYDROCHLORIDE"
},
"drugadditional": null... |
{
"abstract": "Systemic retinoids such as isotretinoin and acitretin are associated with numerous side effects but are therapeutically valuable in dermatological practice. Several studies have reported the wound-healing effects of treatment with concurrent systemic retinoids in addition to surgical treatments. Herein... | [
{
"companynumb": "TR-GLAXOSMITHKLINE-TR2019012198",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACITRETIN"
},
"drugadditional": "3",
... |
{
"abstract": "It is relatively unknown that some of the possible side effects of antibiotic treatment can be transient psychotic episodes and other encephalopathies such as seizure disorders. Since these are rare events, there have not been many studies about them, nor is there a clear understanding of the underlyin... | [
{
"companynumb": "US-SHIRE-US201703667",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "3",
"activesubstance": {
"activesubstancename": "CARBAMAZEPINE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nWe aimed to investigate the longitudinal changes in bone metabolic markers and bone mineral density (BMD) after starting or switching from bisphosphonate (BP) to romosozumab (ROMO) or denosumab (DENO) therapies over 12 months and to determine predictors that establish associations with chang... | [
{
"companynumb": "JP-AMGEN-JPNSP2021063000",
"fulfillexpeditecriteria": "2",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ROMOSOZUMAB"
},
"drugadditional": "3",
... |
{
"abstract": "Tumor-induced osteomalacia (TIO), caused by phosphaturic mesenchymal tumors (PMTs), is a rare paraneoplastic syndrome characterized by frequent bone fractures, bone pain, muscle weakness, and affected gait. These tumors typically secrete high levels of Fibroblastic Growth Factor 23 (FGF23), a hormone w... | [
{
"companynumb": "US-KYOWAKIRIN-2021BKK000869",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "BUROSUMAB-TWZA"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND Cardioversion is a safe, commonly used procedure throughout the world. It is performed over 30 000 times per year in the United States, specifically for atrial fibrillation. Procedural risks from cardioversion include clot dislodgement, sedation effects, site pain, burns, hypotension, dysrhy... | [
{
"companynumb": "US-MYLANLABS-2021M1010368",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "KETOROLAC TROMETHAMINE"
},
"drugadditional": ... |
{
"abstract": "The recently revised ISSVA classification approved in Melbourne in April 2014 recognizes generalized lymphatic anomaly and lymphatic malformation in Gorham-Stout disease. The 2 entities can overlap in presentation, as both are characterized by destructive lymphatic vessel invasion of the axial skeleton... | [
{
"companynumb": "US-BAXTER-2015BAX063465",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo describe the off-label medication use in a cohort of pregnant women.\n\n\nMETHODS\nWe performed a multicenter prospective longitudinal observational study in the Haute-Vienne department (France) called the NéHaVi cohort (\"Né en Haute-Vienne\" meaning \"born in Haute-Vienne\"). Women who ... | [
{
"companynumb": "FR-ALKEM LABORATORIES LIMITED-FR-ALKEM-2020-00239",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "HYDROXYZINE HYDROCHLORIDE"
},
... |
{
"abstract": "BACKGROUND\nGanciclovir (GCV) is effective for prevention of cytomegalovirus (CMV) disease. In animals it may cause some teratogenicity. There is little information on the effect of GCV on a human fetus.\n\n\nMETHODS\nThe chart of a liver transplant recipient who received oral GCV during the first trim... | [
{
"companynumb": "US-ROCHE-2036348",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "3",
"druga... |
{
"abstract": "Idiopathic pulmonary hemosiderosis is characterized by the triad of hemoptysis, iron deficiency anemia and pulmonary infiltrates. Though idiopathic pulmonary hemosiderosis has classically been described as a childhood disease, survival into adulthood is possible. Treatment options for advanced and/or r... | [
{
"companynumb": "NVSC2020CA199220",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": "3",
"druga... |
{
"abstract": "Rhodococcus equi is a gram positive bacterium most commonly presenting clinically as pneumonia, however can disseminate to cause disease in virtually any human tissue. Although it is predominantly an opportunistic pathogen, a number of case series have described infection occurring among individuals wi... | [
{
"companynumb": "PHHY2019AU038378",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CIPROFLOXACIN"
},
"drugadditional": "3",
"dr... |
{
"abstract": "BACKGROUND\nPhotodynamic therapy (PDT) is an effective treatment of pachychoroid spectrum disease. PDT can cause a rare complication known as PDT-associated exudative maculopathy (PAEM). Treatments including intravitreal anti-vascular endothelial growth factor (anti-VEGF) medications, local or systemic... | [
{
"companynumb": "US-BAUSCH-BL-2021-034646",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VERTEPORFIN"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nHemophagocytic syndrome (HPS) is an infrequent complication of transplantation caused by an inflammatory response with a benign proliferation of macrophages and defective lytic capability of T lymphocytes and NK cells that can lead to multiorgan failure. Transplant patients are particularly... | [
{
"companynumb": "ES-SA-2021SA343834",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BELATACEPT"
},
"drugadditional": "3",
"dru... |
{
"abstract": "Safinamide (SF) is a third-generation monoamine-oxidase-B inhibitor that proved efficacy as add-on to levodopa in fluctuating Parkinson's disease (PD) patients. Despite the high prevalence of complicated PD in older population, the data on the tolerability, safety and efficacy of SF in elderly patients... | [
{
"companynumb": "IT-MDD US OPERATIONS-E2B_00003389",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DOPAMINE HYDROCHLORIDE"
},
"drugaddi... |
{
"abstract": "Skin cancers are the most common malignancies in renal transplant recipients, with squamous-cell and basal-cell cancers accounting for the majority of all skin cancer cases. Melanoma is relatively rare in this group of patients. From 1973 to May 2017, out of 1889 patients who received allografts at our... | [
{
"companynumb": "HR-MYLANLABS-2018M1029626",
"fulfillexpeditecriteria": "1",
"occurcountry": "HR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BASILIXIMAB"
},
"drugadditional": "3",
... |
{
"abstract": "Congenital factor XIII deficiency is a very rare bleeding disorder affecting 33 patients in France. Besides its role in fibrin clot stabilization, factor XIII is involved in placental attachment. Fetal miscarriages represent a frequent and concerning issue for these patients. The aim of the present stu... | [
{
"companynumb": "FR-BEH-2020117765",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FACTOR XIII CONCENTRATE (HUMAN)"
},
"drugadditional"... |
{
"abstract": "Topiramate is an anticonvulsant that has been widely used in psychiatric conditions. The most common treatment-related adverse effects of topiramate were diarrhea, nausea, loss of appetite, fatigue, paresthesia, cognitive impairment, and metabolic acidosis. The following is a case report intended to dr... | [
{
"companynumb": "TW-WATSON-2015-12304",
"fulfillexpeditecriteria": "1",
"occurcountry": "TW",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VALPROATE SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nSystemic chemotherapy is the main treatment of diffuse and/or aggressive classic Kaposi's sarcoma (KS) but there are no standard treatment guidelines and published literature regarding vinorelbine is lacking.\n\n\nOBJECTIVE\nTo assess the safety and effectiveness of intravenous vinorelbine ... | [
{
"companynumb": "IT-ACTAVIS-2016-12166",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VINORELBINE\\VINORELBINE TARTRATE"
},
"drugadditi... |
{
"abstract": "The early intravesical Instillation of mitomycin C (MMC) is accepted as safe adjuvant therapy after TURBT by non-muscle- invasive bladder cancer if there is no perforation. In our case we report a female patient undergoing resection of papillary recurrent tumor on the anterior bladder wall. In the earl... | [
{
"companynumb": "DE-MYLANLABS-2019M1070849",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MITOMYCIN"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nIntoxications with the tricyclic antidepressant amitriptyline frequently occur in the clinical setting and require immediate treatment. Although various poisonings can be counteracted with specific remedies, treatment options for amitriptyline intoxication remain sparse. Besides conventional... | [
{
"companynumb": "NVSC2021DE084829",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMITRIPTYLINE"
},
"drugadditional": "3",
"dr... |
{
"abstract": "BACKGROUND\nThe role of PI3K/AKT/mTOR pathway hyperactivation in localized brain overgrowth is evolving. We describe two patients with focal cortical dysplasia (FCD) who demonstrated somatic mutations in TSC1 and TSC2 genes in the dysplastic brain tissue but not peripheral blood.\n\n\nMETHODS\nPaired w... | [
{
"companynumb": "IN-CIPLA LTD.-2022IN03239",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TOPIRAMATE"
},
"drugadditional": "3",
... |
{
"abstract": "Catecholamine-induced cardiomyopathy due to chronic excess of endogenous catecholamines has been recognized for decades as a clinical phenomenon. In contrast, reports of myocardial dysfunction due to acute iatrogenic overdose are rare. A 35-year-old woman whose cervix uteri was inadvertently injected w... | [
{
"companynumb": "US-PFIZER INC-2017132059",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "EPINEPHRINE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nTo assess the relationship between Takayasu arteritis (TAK) and pregnancy outcome.\n\n\nMETHODS\nThis study included 240 pregnancies in 96 patients fulfilling the American College of Rheumatology 1990 criteria for the classification of TAK and/or the 1994 Chapel Hill Consensus Conference nom... | [
{
"companynumb": "AT-NOVARTISPH-NVSC2021AT236879",
"fulfillexpeditecriteria": "1",
"occurcountry": "AT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METOPROLOL"
},
"drugadditional": "3",
... |
{
"abstract": "Female sex workers (FSW) have increased risk of HIV infection. Antiretroviral treatment (ART) can improve HIV outcomes and prevent HIV transmission. We analyzed antiretroviral (ARV) drug use and HIV drug resistance among HIV-positive FSW in the Dominican Republic and Tanzania.\n\n\n\nPlasma samples col... | [
{
"companynumb": "US-GLAXOSMITHKLINE-DO2021GSK020456",
"fulfillexpeditecriteria": "1",
"occurcountry": "DO",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TENOFOVIR DISOPROXIL FUMARATE"
},
"d... |
{
"abstract": "Scopolamine is an alkaloid which acts as competitive antagonists to acetylcholine at central and peripheral muscarinic receptors. We report the case of a 41-year-old male convict with a 27-year history of cannabis abuse who suddenly died in the bed of his cell after having smoked buscopan® tablets. Sin... | [
{
"companynumb": "IT-PFIZER INC-2021707888",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TRIAZOLAM"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nTreatment with biological agents such as anti-tumor necrosis factors (TNFs) has become standard of care in moderate to severe pediatric inflammatory bowel disease (IBD). However, a significant proportion of patients experience loss of response to anti-TNFs, need treatment escalation, or dev... | [
{
"companynumb": "NO-CELLTRION INC.-2019NO022733",
"fulfillexpeditecriteria": "1",
"occurcountry": "NO",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "USTEKINUMAB"
},
"drugadditional": "3",
... |
{
"abstract": "We investigated efficacy and safety of rabbit anti-thymocyte globulin (rATG), cyclosporine and granulocyte colony-stimulating factor (G-CSF) as first-line therapy for patients with aplastic anemia (AA) and low or intermediate-1 or hypoplastic myelodysplastic syndrome (MDS). rATG 3.5 mg/kg (or 2.5 mg/kg... | [
{
"companynumb": "US-AMGEN-USASP2021172065",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FILGRASTIM"
},
"drugadditional": "3",
... |
{
"abstract": "Inverse psoriasis is a rare form of psoriasis characterized by the involvement of skin fold areas rather than the more common psoriatic involvement of the extensor surfaces of the extremities, trunk, and scalp. In addition, it requires a modified therapeutic approach because it is often less responsive... | [
{
"companynumb": "SI-ROXANE LABORATORIES, INC.-2014-RO-01446RO",
"fulfillexpeditecriteria": "1",
"occurcountry": "SI",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugaddi... |
{
"abstract": "BACKGROUND\nSmall-cell lung cancer with epidermal growth factor receptor (EGFR) gene mutation typically manifests as a transformation occurring after EGFR tyrosine kinase inhibitor therapy for adenocarcinoma with EGFR mutation, whereas primary small-cell lung cancer showing EGFR mutation is extremely r... | [
{
"companynumb": "JP-CIPLA LTD.-2016JP17546",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nPatients being treated with anti-tumor necrosis factor-alpha (anti-TNF-alpha) agents were reported to have better prognosis related to COVID-19. We evaluated the factors affecting the frequency, clinical course, and outcome of COVID-19 in patients treated with anti-TNF-alpha agents.\n\n\nMET... | [
{
"companynumb": "TR-AMGEN-TURSP2022010302",
"fulfillexpeditecriteria": "2",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ADALIMUMAB"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nThe combination of an mTOR inhibitor with 5-fluorouracil-based anticancer therapy is attractive because of preclinical evidence of synergy between these drugs. According to our phase I study, the combination of capecitabine and everolimus is safe and feasible, with potential activity in panc... | [
{
"companynumb": "NL-ROCHE-1563871",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CAPECITABINE"
},
"drugadditional": null,
"dr... |
{
"abstract": "Adverse reactions with an outcome of death are inherently important for pharmacovigilance organizations to evaluate. Prior efforts to systematically evaluate individual case safety reports (ICSRs) with an outcome of death have been limited to high-level summaries.\n\n\n\nThe aim of this study was to ch... | [
{
"companynumb": "US-ACTELION-A-CH2020-205698",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BOSENTAN"
},
"drugadditional": "3",
... |
{
"abstract": "Oral ulceration is a non-specific clinical finding with many potential causes. The persistence of oral ulcers in the context of a patient post-SOT is concerning for PTLD. There is growing evidence that SOT recipients may also be at higher risk of autoimmune diseases. This case report describes a pediat... | [
{
"companynumb": "PHHY2018GB048018",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "1",
"druga... |
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