article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "Dihydropyrimidine dehydrogenase (DPD) is the major enzyme in the catabolism of 5-Fluorouracil (5-FU) and its prodrug capecitabine. We report cases from our institute with colorectal cancer who experienced severe toxicities to standard dose 5-FU based chemotherapy. DPYD gene sequencing revealed rare dif... | [
{
"companynumb": "SA-ACCORD-155667",
"fulfillexpeditecriteria": "1",
"occurcountry": "SA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEUCOVORIN"
},
"drugadditional": "3",
"druga... |
{
"abstract": "OBJECTIVE\nLemierre's syndrome is often misdiagnosed as a common cold or viral infection. Fusobacterium necrophorum is the most common causative organism. The recommended treatment regimen is 6 weeks of a beta-lactam antibiotic along with metronidazole.\n\n\nMETHODS\nWe present two cases of Lemierre's ... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2021SP025609",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"drugaddition... |
{
"abstract": "BACKGROUND\nNatural and unexpected death that happens within less than one hour of first symptom occurrence is called sudden death. Cardiovascular diseases are the main known reason of sudden death and more than 75% of sudden deaths in athletes are assigned to it. Here we reported the autopsy results o... | [
{
"companynumb": "IR-JNJFOC-20160619083",
"fulfillexpeditecriteria": "1",
"occurcountry": "IR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "TRAMADOL HYDROCHLORIDE"
},
"drugadditional": nul... |
{
"abstract": "We report the disparate clinical progression of a couple infected by SARS-CoV-2 based on their immune checkpoint (IC) levels and immune cell distribution in blood from admission to exitus in patient 1 and from admission to discharge and recovery in patient 2. A detailed clinical follow-up accompanied b... | [
{
"companynumb": "ES-TEVA-2021-ES-1966440",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LINEZOLID"
},
"drugadditional": "3",
... |
{
"abstract": "Minocycline hepatotoxicity can present with prominent autoimmune features in previously healthy individuals. The aim of this study was to identify genetic determinants of minocycline drug-induced liver injury (DILI) in a well-phenotyped cohort of patients.\n\n\n\nCaucasian patients with minocycline DIL... | [
{
"companynumb": "US-DRREDDYS-USA/USA/17/0092407",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MINOCYCLINE\\MINOCYCLINE HYDROCHLORIDE"
},
... |
{
"abstract": "The prevalence of chemotherapy associated liver injuries (CALI), especially SOS (sinusoidal obstruction syndrome) and NRH (nodular regenerative hyperplasia) might be reduced since the introduction of routine use of biological agents with chemotherapy in colorectal liver metastases (CRLM).\n\n\n\nOne hu... | [
{
"companynumb": "BE-SA-2018SA311272",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUOROURACIL"
},
"drugadditional": "3",
"d... |
{
"abstract": "OBJECTIVE\nNon-tuberculous mycobacteria (NTM) represents an important etiology of cervicofacial lymphadenitis (CFL) and skin/soft tissue infections in children. It can also affect the salivary glands, including the parotid gland, which is unique due to the presence of intra-salivary lymph nodes. There ... | [
{
"companynumb": "US-LUPIN PHARMACEUTICALS INC.-2022-06073",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "RIFAMPIN"
},
"drugadditional":... |
{
"abstract": "The prevalence of opioid use in therapeutic and recreational settings has steadily increased throughout the western world. The addition of fentanyl into heroin products can produce potentially dangerous consequences, even to opioid tolerant individuals who may be unaware of such additions. Following an... | [
{
"companynumb": "AU-INSYS THERAPEUTICS, INC-INS201706-000378",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DIAMORPHINE"
},
"drugadditi... |
{
"abstract": "Autoimmune encephalitis can result in significant neurological and psychiatric morbidity and mortality in patients of all ages and often does not respond to standard therapies. Recent reports suggest efficacy of tocilizumab, a monoclonal antibody against interleukin 6, in refractory autoimmune encephal... | [
{
"companynumb": "US-ACCORD-094325",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AZATHIOPRINE"
},
"drugadditional": null,
"dr... |
{
"abstract": "BACKGROUND\nCytomegalovirus (CMV) infection has been well described as an opportunistic infection of patients with human immunodeficiency virus (HIV). To the best of our knowledge, this is the first case report of a patient with AIDS and lumbosacral polyradiculopathy, associated with gastroparesis resu... | [
{
"companynumb": "US-ROCHE-1671419",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "GANCICLOVIR"
},
"drugadditional": null,
"dru... |
{
"abstract": "Insulin autoimmune syndrome (IAS), defined as hyperinsulinemic hypoglycemia with high titers of anti-insulin antibodies, is frequently reported in Japanese patients but rarely observed in whites. We report in this study on a 79-year-old white male without diabetes who developed IAS following exposure t... | [
{
"companynumb": "US-TEVA-792064USA",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CLOPIDOGREL BISULFATE"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nBiomarkers may play an important role in identifying patients at risk for cancer therapy cardiotoxicity. Our objectives were to define the patterns of change in biomarkers with cancer therapy and their associations with cardiotoxicity.\n\n\nMETHODS\nIn a multicenter cohort of 78 breast canc... | [
{
"companynumb": "US-JNJFOC-20150413549",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional": n... |
{
"abstract": "Osimertinib is a third-generation, irreversible tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR-TKI) showing longer progression free survival and overall survival than other EGFR-TKI with an improvement in tolerability.\n\n\n\nWe report about an advanced lung adenocarcinoma pati... | [
{
"companynumb": "IT-AMGEN-ITASP2020058157",
"fulfillexpeditecriteria": "2",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FILGRASTIM"
},
"drugadditional": null,
... |
{
"abstract": "Adults treated with topiramate may develop nephrolithiasis, but its frequency in children on topiramate is unknown. Topiramate inhibits renal carbonic anhydrase, which can lead to renal tubular acidosis and hypercalciuria. We studied 40 consecutive children who initiated topiramate therapy for seizures... | [
{
"companynumb": "US-JNJFOC-20180714447",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TOPIRAMATE"
},
"drugadditional": "1",
"... |
{
"abstract": "Primary neuroendocrine tumour of the breast is a rare entity that first appeared in the 2003 World Health Organisation (WHO) classification of breast tumours. The data currently available on its prognosis are contradictory, although it seems clear that histological varieties such as small cell neuroend... | [
{
"companynumb": "PHHY2016ES057678",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LETROZOLE"
},
"drugadditional": null,
"druga... |
{
"abstract": "Psychiatric symptoms are historically thought a relative contraindication to DBS for advanced Parkinson's disease (PD). However, in the case of drug-induced mental illness, DBS may provide an acceptable alternative for the treatment of motor symptoms. This allows reduction of pharmacological dopaminerg... | [
{
"companynumb": "AU-MYLANLABS-2017M1077292",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CARBIDOPA\\LEVODOPA"
},
"drugadditional": "1"... |
{
"abstract": "Severe toxicity from ingestions of oral sustained-release potassium is rare. While acute hyperkalaemia requires urgent intervention given the risk of cardiac toxicity, there is a lack of clinical consensus on optimal management. The aim of this study was to characterise the clinical manifestations of a... | [
{
"companynumb": "AU-SUN PHARMACEUTICAL INDUSTRIES LTD-2022R1-329500",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DESVENLAFAXINE"
},
"... |
{
"abstract": "Thrombotic thrombocytopenic purpura (TTP) is a life threatening condition associated with formation of platelet thrombi. Deficiency of ADAM TS 13 with presence of inhibitory anti-ADAM TS 13 Immunoglobulin G antibody is seen in patients with acquired TTP. TTP in patients on interferon therapy for chroni... | [
{
"companynumb": "US-ROCHE-1194771",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PEGINTERFERON ALFA-2A"
},
"drugadditional": null,
... |
{
"abstract": "Induction chemotherapy with docetaxel improved outcome in advanced head and neck squamous cell carcinoma (HNSCC) patients, but docetaxel was not recommended in liver dysfunction patients for treatment toxicities. Severe neutropenic events (SNE) including severe neutropenia (SN) and febrile neutropenia ... | [
{
"companynumb": "TW-PFIZER INC-2017450563",
"fulfillexpeditecriteria": "1",
"occurcountry": "TW",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "Atraumatic acute carpal tunnel syndrome is a rare type of median nerve neuropathy caused by etiologies that increase compartment pressure in the carpal tunnel. This report describes a patient with flexor tendon abrasion as an unusual complication of distal radioulnar joint arthritis. This abrasion caus... | [
{
"companynumb": "JP-MYLANLABS-2017M1056236",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CILOSTAZOL"
},
"drugadditional": "1",
... |
{
"abstract": "OBJECTIVE\nTo describe the utility of microperimetry testing in the diagnosis of a bilateral occipital stroke.\n\n\nMETHODS\nRetrospective case report.\n\n\nRESULTS\nA 57-year-old male with hypertension presented with complaints of bilateral blurred central vision and bilateral hypertensive retinopathy... | [
{
"companynumb": "US-ALLERGAN-1816359US",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROCHLOROTHIAZIDE"
},
"drugadditional": "3",
... |
{
"abstract": "Since the introduction of lenalidomide into induction therapy for multiple myeloma (MM), there have been conflicting reports about its impact on autologous peripheral blood stem cell (PBSC) mobilization. We evaluated the impact of previous lenalidomide exposure in a large cohort of patients with MM und... | [
{
"companynumb": "US-AMGEN-USASP2021187631",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARFILZOMIB"
},
"drugadditional": "3",
... |
{
"abstract": "Risperidone is commonly prescribed by pediatricians for a variety of behavioral and psychological disorders. We report a boy with autism-spectrum disorder, who developed frequent penile erections after an increase in risperidone dosage for a month. The patient fully recovered 2 days after risperidone d... | [
{
"companynumb": "GB-ALKEM LABORATORIES LIMITED-GB-ALKEM-2018-03134",
"fulfillexpeditecriteria": "2",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RISPERIDONE"
},
"drug... |
{
"abstract": "BACKGROUND\nChronic refractory immune thrombocytopenic purpura can be a challenging condition to treat. By definition, the standard first and second line treatments have failed in these patients and modalities such as thrombopoiesis-stimulating agents and more intensive immunosuppressive drugs are ther... | [
{
"companynumb": "US-ROCHE-1336622",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "We commonly see patients presenting with either portal hypertensive gastropathy (PHG) or radiation gastritis. Radiation-induced hemorrhagic gastritis is an unusual lethal complication postradiation. Patients with preexisting PHG have very friable mucosa that can easily bleed after radiation for cancer ... | [
{
"companynumb": "US-LUPIN PHARMACEUTICALS INC.-2021-25233",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "NADOLOL"
},
"drugadditional": ... |
{
"abstract": "This is the second reported case of minocycline-induced Sweet's syndrome (and the first such case to appear in the American literature). The syndrome developed in a 32-year-old man 10 days after minocycline therapy for acne was begun and resolved rapidly after discontinuation of the medication and star... | [
{
"companynumb": "AU-ALVOGEN-2020-ALVOGEN-108841",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null... |
{
"abstract": "Chemotherapy is associated with significant toxicity in elderly patients treated for hematological malignancies. Adequate tools to identify the best tailored treatment are essential.\n\n\n\nMedical charts of patients treated with adjusted chemotherapy for diffuse large B-cell lymphoma according to frai... | [
{
"companynumb": "MX-JNJFOC-20190220088",
"fulfillexpeditecriteria": "1",
"occurcountry": "MX",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VINCRISTINE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nSince there are only a few reports on pediatric systemic lupus erythematosus (pSLE) in Chinese populations, therefore we retrospectively report the clinical and immunological features as well as renal outcome in Chinese pSLE.\n\n\nMETHODS\nPatients diagnosed with pSLE at Shanghai Children's ... | [
{
"companynumb": "CN-ROCHE-2358454",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": "3",
... |
{
"abstract": "The CD45RA T cell depletion (TCD) method has been used to deplete naive T cells, preventing graft-versus-host disease (GVHD) but preserving memory cells, providing immediate functional T cells with anti-infection, antileukemia, and antirejection effects. We describe a series of 25 consecutive high-risk... | [
{
"companynumb": "ES-MYLANLABS-2020M1001083",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "THIOTEPA"
},
"drugadditional": "3",
... |
{
"abstract": "Colchicine overdose is uncommon but potentially life threatening. Due to its serious adverse systemic effects, overdose must be recognized and treated. We report a case of an 18-year-old female who ingested 18 mg (~0.4 mg/kg) of colchicine in a suicide attempt. The patient's clinical manifestations inc... | [
{
"companynumb": "IL-INGENUS PHARMACEUTICALS NJ, LLC-ING201712-000678",
"fulfillexpeditecriteria": "1",
"occurcountry": "IL",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "TAZOBACTAM"
},
"dr... |
{
"abstract": "BACKGROUND\nMultiple myeloma (MM) is the second most frequent hematologic malignancy after lymphoma, contributing to approximately 10% of all hematologic malignancies. The prognosis of patients with MM is impacted by the heterogeneity of the disease, with worse outcomes reported in patients classified ... | [
{
"companynumb": "US-AMGEN-USASP2021128111",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CARFILZOMIB"
},
"drugadditional": null,
... |
{
"abstract": "73-year-old man with ulcerative colitis was diagnosed with Campylobacter jejuni prosthetic knee infection. No preceding gastrointestinal illness was reported. Joint aspirate and operative cultures were negative; however, blood cultures were positive for Campylobacter jejuni. The role of ulcerative coli... | [
{
"companynumb": "US-DRREDDYS-USA/USA/21/0131232",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ROSUVASTATIN"
},
"drugadditional": null... |
{
"abstract": "The optimal therapy to achieve higher rates of survival in pediatric relapsed/refractory acute leukemia (AL) is still unknown. In developing countries, it is difficult to obtain some of the recent drugs for optimal therapy and mostly well-known drugs proven to be effective are used. We assessed the eff... | [
{
"companynumb": "TR-MYLANLABS-2017M1026300",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FLUDARABINE PHOSPHATE"
},
"drugadditional": n... |
{
"abstract": "OBJECTIVE\nTo evaluate the frequency of adverse events (AEs) across 4 treatment conditions in the Child/Adolescent Anxiety Multimodal Study (CAMS), and to compare the frequency of AEs between children and adolescents.\n\n\nMETHODS\nParticipants ages 7 to 17 years (mean = 10.7 years) meeting the DSM-IV ... | [
{
"companynumb": "US-CIPLA LTD.-2015US02170",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SERTRALINE HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "OBJECTIVE\nThere are limited data on the risk of non-melanoma skin cancer (NMSC) and melanoma skin cancer (MSC) among thiopurine-treated patients with ulcerative colitis (UC). Our aim was to investigate the risk while on, by cumulative years, and after stopping thiopurine therapy.\n\n\nMETHODS\nNationw... | [
{
"companynumb": "US-JNJFOC-20150303004",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nSynthetic antithyroid drugs are often used in the treatment of hyperthyroidism, regardless of aetiology. They may cause various side effects, including the development of anti-neutrophil cytoplasmic antibodies (ANCA), ANCA-associated vasculitis, and neutrophilic dermatoses. Propylthiouracil... | [
{
"companynumb": "AU-ENDO PHARMACEUTICALS INC-2017-003308",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PROPYLTHIOURACIL"
},
"drugaddit... |
{
"abstract": "Metreleptin, a recombinant methionyl -human -leptin, was approved to treat patients with generalized lipodystrophy (GL) in February 2014. However, leptin therapy has been associated with the development of lymphoma. We present a unique case of a patient with prior history of T cell lymphoma in remissio... | [
{
"companynumb": "US-FRESENIUS KABI-FK201905339",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": null,
... |
{
"abstract": "The combined squamous cell carcinoma (SCC) with neuroendocrine (atypical carcinoid (AC)) tumor is extremely rare in the head and neck. We present here the first case of SCC with AC arising in the floor of the mouth of 65-year-old man. The tumor is comprised of two components of SCC and AC in the biopsy... | [
{
"companynumb": "JP-ACCORD-048045",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "The use of daptomycin (DAP) in septic pulmonary emboli (SPE) remains controversial. We analyzed 29 cases of MRSA bacteremia complicated by SPE treated with DAP (n = 14) or DAP-ceftaroline fosamil (CPT; n = 15). Initial treatment with DAP monotherapy was found to have a success rate comparable with DAP-... | [
{
"companynumb": "US-DRREDDYS-USA/USA/20/0130202",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DAPTOMYCIN"
},
"drugadditional": "1",
... |
{
"abstract": "Cytarabine is a pyrimidine analogue that is used for the treatment of acute myeloid leukemia at different doses. Standard doses of cytarabine are used for induction therapy, while high doses are used for post-remission (consolidation) and relapsed/refractory treatment. One of the major side effects of ... | [
{
"companynumb": "IR-PFIZER INC-2020044007",
"fulfillexpeditecriteria": "1",
"occurcountry": "IR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LEVOFLOXACIN"
},
"drugadditional": null,
... |
{
"abstract": "An 86-year-old man with paroxysmal atrial fibrillation on flecainide, a class IC antiarrhythmic, presented with cardiac arrest. The patient had extremely wide QRS complexes with inconsistent pacemaker capture on electrocardiography. Due to cardiac failure and renal failure, the patient developed progre... | [
{
"companynumb": "US-BEXIMCO-2021BEX00013",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FLECAINIDE ACETATE"
},
"drugadditional": null,
... |
{
"abstract": "Alice in Wonderland Syndrome (AIWS) is characterized by a rare constellation of perceptual disturbances including distorted body image, metamorphopsia, and visual hallucinations. In this report, we relate a unique case of AIWS in a woman with a right temporo-parietal cavernoma. AIWS in this patient may... | [
{
"companynumb": "US-UCBSA-2015025230",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "3",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": null,
... |
{
"abstract": "Multiple myeloma (MM) is a slow-growing malignancy characterized by a low proliferation rate of plasma cells and a relatively rare incidence of tumour lysis syndrome (TLS). Three myeloma patients developed TLS following cytotoxic therapy (two after radiation treatment) that was associated with an abrup... | [
{
"companynumb": "US-HIKMA PHARMACEUTICALS USA INC.-US-H14001-20-01549",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
... |
{
"abstract": "OBJECTIVE\nThis study aimed to assess the diagnostic ramifications of vascular occlusion of the ocular vein and artery as a first thrombotic event associated with factor V Leiden (FVL) and/or prothrombin gene (PTG) heterozygosity.\n\n\nMETHODS\nPatients with ocular vein (n=191) and artery (n=74) occlus... | [
{
"companynumb": "US-SA-2015SA076396",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLOMIPHENE"
},
"drugadditional": null,
"dr... |
{
"abstract": "OBJECTIVE\nWe suspect that the life-threatening complication of metformin-associated lactic acidosis, solely due to drug accumulation following renal impairment, occurs more frequently than that previously reported and is not necessarily associated with other predisposing factors for lactic acidosis.\n... | [
{
"companynumb": "DE-BAUSCH-BL-2019-057090",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
"drugadditional": ... |
{
"abstract": "Despite the good prognosis in patients with transplant organs, limited evidence is available on how immunosuppressants affect pregnancy. The aim of this study was to determine whether immunosuppressant use affects the pregnancy outcome and to identify whether there is any need to change the immunosuppr... | [
{
"companynumb": "KR-PTC THERAPEUTICS, INC.-KR-2019PTC001216",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEFLAZACORT"
},
"drugadditio... |
{
"abstract": "Tramadol concentrations and analgesic effect are dependent on the CYP2D6 enzymatic activity. It is well known that some genetic polymorphisms are responsible for the variability in the expression of this enzyme and in the individual drug response. The detection of allelic variants described as non-func... | [
{
"companynumb": "PT-MYLANLABS-2018M1035136",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TRAMADOL"
},
"drugadditional": "3",
... |
{
"abstract": "A 45-year-old woman presented to us in March 2019 with complaints of fever and right lower quadrant abdominal pain for 1 month. She had undergone renal transplantation in 2017 for end-stage renal disease and developed four episodes of urinary tract infection in the next 16 months post transplantation, ... | [
{
"companynumb": "IN-STRIDES ARCOLAB LIMITED-2021SP028267",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional"... |
{
"abstract": "The aims were to characterise paediatric medication errors and to identify the prevalence of known high-alert substances in these errors.\n\n\n\nAll paediatric drug-related incident reports and complaints nationally reported to the Health and Social Care Inspectorate in Sweden 2011-2017 regarding inpat... | [
{
"companynumb": "SE-ALKEM LABORATORIES LIMITED-SE-ALKEM-2020-08934",
"fulfillexpeditecriteria": "1",
"occurcountry": "SE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "OXYCODONE HYDROCHLORIDE"
},
... |
{
"abstract": "BACKGROUND\nAlthough serological tests are useful for identifying celiac disease, it is well established that a minority of celiacs are seronegative.\n\n\nOBJECTIVE\nTo define the prevalence and features of seronegative compared to seropositive celiac disease, and to establish whether celiac disease is... | [
{
"companynumb": "IT-DSJP-DSE-2016-123654",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OLMESARTAN MEDOXOMIL"
},
"drugadditional": "3",... |
{
"abstract": "Lymphoid interstitial pneumonia (LIP) is categorized as a rare form of interstitial lung disease. Most cases are associated with autoimmune disease.\nA 78-year-old male with Crohn's disease, presented with progressive dyspnea and dry cough for few weeks. The pathology of transbronchial lung biopsy was ... | [
{
"companynumb": "TH-JNJFOC-20200526614",
"fulfillexpeditecriteria": "1",
"occurcountry": "TH",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "5-Fluorouracil (5-FU), the mainstay of solid tumor chemotherapy over the past 40 years, induces grade III-IV toxicities in up to 15% of patients with polymorphisms in the dihydropyrimidine dehydrogenase (DPYD), thymidylate synthase (TYMS), and methylenetetrahydrofolate reductase (MTHFR) genes. These to... | [
{
"companynumb": "TR-MYLANLABS-2015M1013065",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUOROURACIL"
},
"drugadditional": null,
... |
{
"abstract": "A pregnant woman with a non-IgE-mediated penicillin allergy was treated for syphilis with doxycycline with resolution of infection and no evidence of adverse outcome for mother or infant.",
"affiliations": "University of New Mexico Health Sciences Center, Department of Internal Medicine University of... | [
{
"companynumb": "US-NOVARTISPH-NVSC2022US108796",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "AZITHROMYCIN"
},
"drugadditional": "4",
... |
{
"abstract": "We have reported a patient who had had renal transplantation for end-stage renal disease; she was treated for fever and presumed sepsis with intravenous tobramycin and vancomycin, with subsequent development of persistent fever, eosinophilia, and a maculopapular rash that progressed to linear bullae. F... | [
{
"companynumb": "US-BAXTER-2020BAX003215",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"drugadditional": null,
... |
{
"abstract": "Low-molecular-weight heparin (LMWH) is a recommended anticoagulant for thromboprophylaxis after major orthopedic surgery. Dabigatran etexilate is an oral anticoagulant recognized as noninferior to LMWH. We aimed to assess the incidence of symptomatic venous thromboembolic events (VTEs) after discharge ... | [
{
"companynumb": "CA-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-027567",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DABIGATRAN ETEXILATE MESYLATE"
... |
{
"abstract": "Hypersensitivity to proton pump inhibitors (PPI) is rare but potentially severe. An increase in hypersensitivity reactions to PPI is expected as these drugs are widely prescribed and some have become available over-the-counter. Allergy to PPI has to be considered in patients presenting anaphylaxis, lat... | [
{
"companynumb": "PHHY2014PT123007",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": "3",
"dr... |
{
"abstract": "Ischemic stroke patients with active cancer are known to have poor clinical outcomes. However, the efficacy and safety of intravenous alteplase (IV t-PA) in this group are still unclear. In this study, we aimed to evaluate whether stroke patients with cancer had poor clinical outcomes after use of IV t... | [
{
"companynumb": "KR-ROCHE-1960688",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "Botulinum toxin (Botox) injection into the lower esophageal sphincter (LES) has been used for the treatment of achlasia cardia since the 1990s. Currently it is indicated for patients who are not candidates for definitive therapy like Heller's myotomy or pneumatic dilation and in those who have recurren... | [
{
"companynumb": "US-ALLERGAN-1318197US",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FENTANYL"
},
"drugadditional": null,
"... |
{
"abstract": "Ogilvie syndrome or intestinal pseudo-obstruction is a clinical syndrome characterized by autonomic imbalance affecting peristalsis of colon leading to obstructive signs and symptoms. The etiologies commonly implicated are drugs affecting the cholinergic system, narcotics, electrolyte imbalance, severe... | [
{
"companynumb": "IN-MYLANLABS-2020M1094396",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "VINBLASTINE"
},
"drugadditional": "1",
... |
{
"abstract": "OBJECTIVE\nTo report a case of optic neuritis with visual field defect associated with ibuprofen.\n\n\nMETHODS\nA 41-year-old white man developed blurred vision in his right eye and pain with eye and head movements that lasted 2 days after use of ibuprofen 400 mg 3 times daily during the preceding 3 we... | [
{
"companynumb": "DE-DRREDDYS-GER/GER/18/0105746",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "IBUPROFEN"
},
"drugadditional": "1",
... |
{
"abstract": "There have been several case reports of risperidone-associated dysphagia. Risperidone-induced bulbar palsy-like syndrome has not been previously described. We report on a 58-year-old gentleman with prior history of schizophrenia and remote chlorpromazine use with no history of extrapyramidal symptoms w... | [
{
"companynumb": "US-JNJFOC-20121210272",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RISPERIDONE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nImmune dysregulation, polyendocrinopathy, enteropathy, X-linked (IPEX; OMIM 304930) syndrome is a congenital syndrome characterized by autoimmune enteropathy, endocrinopathy, dermatitis, and other autoimmune phenomena. In the present work, we aimed to uncover the molecular basis of a distinc... | [
{
"companynumb": "US-PFIZER INC-2019246774",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ALBUMIN HUMAN"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nThe purpose of this study is to describe a possible association between unintentional secondary exogenous corticosteroid exposure and central serous chorioretinpathy (CSCR).\n\n\nMETHODS\nA retrospective review of three patients diagnosed with CSCR in one or both eyes and a history of possib... | [
{
"companynumb": "US-TARO PHARMACEUTICALS USA.,INC-2016SUN00285",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "HYDROCORTISONE"
},
"drug... |
{
"abstract": "BACKGROUND\nAllogeneic haemopoietic stem cell transplant (Allo-HSCT) is a specialised and costly intervention, associated with significant morbidity and mortality. It is used to treat a broad range of paediatric conditions. South Africa (SA) is an upper middle-income country with limitations on healthc... | [
{
"companynumb": "PHHY2017ZA039257",
"fulfillexpeditecriteria": "1",
"occurcountry": "ZA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM"
},
"drugadditional": n... |
{
"abstract": "BACKGROUND\nSeveral cases of hearing loss induced by hydroxychloroquine have been reported in the literature but the role of hydroxychloroquine still remains debated.\n\n\nMETHODS\nWe report the first case, to our knowledge, of hearing loss induced by hydroxychloroquine with a positive re challenge in ... | [
{
"companynumb": "FR-IPCA LABORATORIES LIMITED-IPC201702-000150",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HYDROXYCHLOROQUINE SULFATE"
},
... |
{
"abstract": "Recent case reports suggest a possible causal correlation between antecollis and pramipexole. Here, we report the case of a 62-year-old Italian man with a 2-year history of Parkinson's disease (PD) and cervical spondylosis for which he was treated with pramipexole. He developed severe neck rigidity imm... | [
{
"companynumb": "PHHY2015GB124638",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PRAMIPEXOLE"
},
"drugadditional": null,
"dru... |
{
"abstract": "Systemic Lupus Erythematosus (SLE) and Tuberculosis (TB) are intricately related with an increase in the risk of TB in SLE. Primary mechanisms pertaining to the increased susceptibility for TB are the inherent immunodeficient state of SLE and use of immunosuppressant agents in the treatment of SLE. We ... | [
{
"companynumb": "IN-CONCORDIA PHARMACEUTICALS INC.-GSH201704-002590",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROXYCHLOROQUINE"
},
... |
{
"abstract": "Contrast echocardiography demonstrating microbubbles in the pericardial space has often been cited as evidence of ventricular rupture requiring emergent surgical intervention. We report a case where no myocardial perforation was found during post-myocardial infarction surgery despite prior echocardiogr... | [
{
"companynumb": "US-ROCHE-1709341",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TENECTEPLASE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "The incidence of malignancy is greater in kidney transplant recipients compared to the general population, though the higher risk is not equally distributed to all types of cancers. In face of the increased longevity of renal transplant recipients, certain cancers, such as acute leukemias, are becoming... | [
{
"companynumb": "US-TEVA-2018-US-864528",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DAUNORUBICIN"
},
"drugadditional": "3",
... |
{
"abstract": "Endoscopic obturation by cyanoacrylate glue is currently the treatment of reference of gastric varices bleeding in patients with portal hypertension with a good efficacy for bleeding control and secondary prophylaxis. However, several adverse events related to this treatment have been described includi... | [
{
"companynumb": "FR-GUERBET-FR-20200192",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ETHIODIZED OIL"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nLamotrigine is a sodium channel blocking agent that is widely prescribed for treatment of seizure. Although life-threatening effects are rarely observed in overdose, some previous reports have described the occurrence of cardiac toxicity. The management of sodium channel blocking agent-indu... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2018-03273",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LAMOTRIGINE"
},
"drug... |
{
"abstract": "OBJECTIVE\nMesalazine is a widely prescribed medication, developed as an alternative to sulfasalazine in the treatment of inflammatory bowel disease. In contrast to sulfasalazine, there are only a few case reports on its causing hepatic injury. We here report on a patient with cholestasis after mesalaz... | [
{
"companynumb": "DE-SHIRE-DE201938032",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MESALAMINE"
},
"drugadditional": "1",
"d... |
{
"abstract": "We report a case of leukocytoclastic vasculitis-induced penile necrosis in a 69-year-old male with no previous urologic history. After suffering an ischemic event to the distal shaft of the penis as well as an ischemic event involving the right side of the bladder, he underwent suprapubic tube placemen... | [
{
"companynumb": "US-MYLANLABS-2021M1094549",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "WARFARIN"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nAdministering intravenous IV tissue plasminogen activator (tPA) is the recommended standard of care in acute ischemic stroke (AIS), although it is not recommended to administer intravenous thrombolysis with tPA following heparin reversal with protamine sulfate in patients with AIS.\n\n\nMET... | [
{
"companynumb": "US-PFIZER INC-2019334341",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": "1",
... |
{
"abstract": "We describe a case of septic arthritis in a native knee due to Corynebacterium striatum, gram-positive bacilli that are usually commensal organisms of skin and mucosal membranes, but are seldom implicated in native septic arthritis. An 84-year-old man with Corynebacterium striatum septic arthritis of h... | [
{
"companynumb": "ES-MYLANLABS-2019M1055891",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LINEZOLID"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND Malignant hypercalcemia is a rare finding in the pediatric population, even more rare in hematological malignancies, such as leukemia. CASE REPORT We present a case of a 6-year-old female patient who was diagnosed with acute lymphoblastic leukemia, with secondary hypercalcemia. She started c... | [
{
"companynumb": "RO-FRESENIUS KABI-FK201910225",
"fulfillexpeditecriteria": "1",
"occurcountry": "RO",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": n... |
{
"abstract": "OBJECTIVE\nAseptic meningitis is a rare and aggressive complication of rheumatoid arthritis (RA), usually histologically characterised by rheumatoid nodules and lymphocytic aggregates in leptomeninges. The aim of this study was to describe the clinical onset and evolution of aseptic meningitis occurrin... | [
{
"companynumb": "IT-JNJFOC-20141006117",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "LMB-100 is a recombinant immunotoxin (iTox) consisting of a mesothelin-binding Fab for targeting and a modified Pseudomonas exotoxin A payload. Preclinical studies showed that combining taxanes with iTox results in synergistic antitumor activity. The objectives of this phase I/II study were to determin... | [
{
"companynumb": "US-MYLANLABS-2020M1034140",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DIPHENHYDRAMINE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nTo report the incidence and risk factors for contrast material ( CM contrast material )-induced nephropathy ( CIN CM-induced nephropathy ) in patients with no history of chronic kidney disease and estimated glomerular filtration rate that exceeded 30 mL/min/1.73 m(2) after a relatively high ... | [
{
"companynumb": "US-GE HEALTHCARE MEDICAL DIAGNOSTICS-OMPQ-PR-1502L-0095",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "IOHEXOL"
},
"d... |
{
"abstract": "PREGNANCY AND TUBERCULOSIS (TB): To assess TB cases during pregnancy in a developing region retrospectively and to present two case reports.\n\n\nOBJECTIVE\nSince TB cases activated by HIV infection during pregnancy are well reported in the literature, we aimed to investigate the aggressiveness of pulm... | [
{
"companynumb": "TR-ALKEM LABORATORIES LIMITED-TR-ALKEM-2021-01677",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ISONIAZID"
},
"drugad... |
{
"abstract": "Propranolol is an effective, safe treatment for complicated infantile haemangiomas (IH). We evaluated all patients (n = 44) with IH treated with propranolol in our department. Of the 44 patients who were begun on propranolol therapy, 26 patients have completed the treatment to date and all had a good r... | [
{
"companynumb": "IE-ROXANE LABORATORIES, INC.-2015-RO-00820RO",
"fulfillexpeditecriteria": "1",
"occurcountry": "IE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PROPRANOLOL\\PROPRANOLOL HYDROCHLORIDE"
... |
{
"abstract": "OBJECTIVE\nSeveral clinical trials have highlighted general favorable outcomes of intravenous tissue type plasminogen activator (rt-PA) in acute ischemic stroke using different measures including, National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS). Findings from most of ... | [
{
"companynumb": "US-ROCHE-1620886",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ALTEPLASE"
},
"drugadditional": null,
"druga... |
{
"abstract": "BACKGROUND\nPoor response to anti-tumour necrosis factor biologicals like infliximab (IFX) is observed in patients with ulcerative colitis (UC), which may lead to prolonged morbidity and waste of medical resources. We aimed to look for potential biomarkers of response to IFX in patients with UC who wer... | [
{
"companynumb": "JP-JNJFOC-20150818493",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "Intractable pruritus without visible primary skin lesions and refractory to antihistamines as a primary presentation of chronic myelomonocytic leukaemia (CMML) and myelodysplastic syndrome (MDS) is not well recognised. We present two cases of CMML and two cases of MDS with this challenging symptom. In ... | [
{
"companynumb": "GB-DRREDDYS-USA/UKI/19/0117081",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CETIRIZINE HYDROCHLORIDE"
},
"drugadditi... |
{
"abstract": "Oxaliplatin is a platinum compound mainly used in the treatment of colorectal cancer. According to its manufacturer it is not considered vesicant agent though it has been shown to cause severe tissue damage if extravasation occurs in large doses. Several cases of extravasation have been reported; most ... | [
{
"companynumb": "GB-ACTAVIS-2015-05670",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "Drug-induced lupus (DIL) is due to an autoimmune reaction to a drug with an estimated incidence of 15,000 to 30,000 cases every year in the US. Hydralazine is a well-known offender. Antinuclear antibody (ANA) is present in most cases, though four cases of ANA-negative DIL have been reported. In this re... | [
{
"companynumb": "US-TEVA-2020-US-1222456",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HYDRALAZINE HYDROCHLORIDE"
},
"drugadditional":... |
{
"abstract": "To examine the characteristics and outcomes of a multicenter patient cohort with indeterminate pediatric acute liver failure (IND-PALF) and with aplastic anemia with acute hepatitis treated with corticosteroids.\n\n\n\nRetrospective study of patients age 1-17 years with IND-PALF and aplastic anemia wit... | [
{
"companynumb": "US-AMNEAL PHARMACEUTICALS-2019AMN00228",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PREDNISOLONE SODIUM PHOSPHATE"
},
... |
{
"abstract": "OBJECTIVE\nOur study describes the 10-year followup data of the Belgian Expanded Access Program (EAP) for infliximab (IFX), which included patients with active rheumatoid arthritis who were refractory to methotrexate. The objectives of the study were to evaluate the continuation rate, reasons for disco... | [
{
"companynumb": "BE-JNJFOC-20120601495",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nA case of probable drug-induced liver injury (DILI) attributed to use of the antihypertensive agent aliskiren is reported.\n\n\nCONCLUSIONS\nA 61-year-old woman undergoing routine liver function monitoring in conjunction with long-term antiepileptic therapy was noted to have an asymptomatic ... | [
{
"companynumb": "FR-MYLANLABS-2019M1060642",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CHOLECALCIFEROL"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nVentricular septal defect (VSD) is the most common congenital heart disease in the pediatric population. Nowadays, trans-catheter closure is considered a feasible method of therapy for most muscular and some perimembranous types of VSDs.\n\n\nOBJECTIVE\nAssess the safety, efficacy and outco... | [
{
"companynumb": "SA-HIKMA PHARMACEUTICALS USA INC.-SA-H14001-20-05244",
"fulfillexpeditecriteria": "1",
"occurcountry": "SA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
... |
{
"abstract": "BACKGROUND\nSchistosomiasis is a severe parasitic infestation with debilitating complications and is the third most devastating tropical disease in the world. It is one of the neglected tropical diseases (NTDs) with a high disease-burden. We present two rare cases of bladder outlet obstruction: one whi... | [
{
"companynumb": "GB-BAYER-2017-039871",
"fulfillexpeditecriteria": "1",
"occurcountry": "CM",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PRAZIQUANTEL"
},
"drugadditional": null,
... |
{
"abstract": "Primary pulmonary tumors are extremely rare in the pediatric population; however, sporadic cases of invasive pulmonary adenocarcinoma as a second malignant neoplasm (SMN) have been described in survivors of pediatric cancers. Pediatric patients with rhabdomyosarcoma (RMS) have a particularly increased ... | [
{
"companynumb": "US-PFIZER INC-2017065937",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo report a case of central retinal artery occlusion (CRAO) in a young human immunodeficiency virus (HIV)-infected patient recently started on highly active antiretroviral therapy.\n\n\nMETHODS\nCase report observation of a 33-year-old HIV-infected patient who developed a CRAO after starting... | [
{
"companynumb": "US-CIPLA LTD.-2016US04759",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "EFAVIRENZ\\EMTRICITABINE\\TENOFOVIR DISOPROXIL FUMARATE"
... |
{
"abstract": "BACKGROUND\nAdrenocortical carcinoma (ACC) is a rare and aggressive disease that is often diagnosed at an advanced stage. There is no standard treatment for metastatic ACC; EDP-M (etoposide, doxorubicin, and cisplatin plus mitotane) is one treatment option. A randomized controlled trial (FIRM-ACT) eval... | [
{
"companynumb": "JP-TEVA-2022-JP-2009314",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": null,
... |
{
"abstract": "Sulfasalazine is an anti-inflammatory agent commonly used in the treatment of autoimmune conditions such as inflammatory bowel disease and rheumatoid arthritis. Sulfasalazine is converted by gut bacteria into sulfapyridine and the clinically active metabolite 5-aminosalicylic acid (5-ASA), and its effi... | [
{
"companynumb": "US-PFIZER INC-2017294361",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SULFASALAZINE"
},
"drugadditional": "1",
... |
{
"abstract": "This case report highlights the merits of using fine needle aspiration biopsy to obtain gene expression profiling of individual choroidal melanomas when more than one tumor arises in the same eye. It is also the first such case to document laser ablation therapy as the primary treatment.\n\n\n\nThis re... | [
{
"companynumb": "US-ROCHE-2924490",
"fulfillexpeditecriteria": "1",
"occurcountry": null,
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BEVACIZUMAB"
},
"drugadditional": "4",
"drug... |
{
"abstract": "We describe a 66-year-old woman who received folinic acid, leucovorin, fluorouracil and oxaliplatin for advanced rectal carcinoma. These drugs were initiated on day 1, and a pelvic abscess was identified on day 7. Piperacillin-tazobactam was initially administered, but was changed to ceftriaxone and me... | [
{
"companynumb": "JP-VIVIMED-2018SP004392",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CEFTRIAXONE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nStreptococcus pseudoporcinus (S. pseudoporcinus) was first identified in 2006. It cross-reacts with Lancefield group B antigen agglutination reagents and has been misidentified as S. agalactiae. Sites of S. pseudoporcinus isolation include the female genitourinary tract, urine, wounds, and ... | [
{
"companynumb": "GR-PFIZER INC-2021623799",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DAPTOMYCIN"
},
"drugadditional": "4",
... |
{
"abstract": "Autoimmune-mediated bowel disease has been reported after pediatric heart transplantation. Recognition and treatment of these patients has been difficult. We describe a patient who responded to steroids and basiliximab therapy after an inflammatory process secondary to abnormal T-cell activation. Our p... | [
{
"companynumb": "PHHY2016US106578",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": null,
... |
{
"abstract": "Kaposi sarcoma (KS) herpesvirus-associated multicentric Castleman disease (KSHV-MCD) is a lymphoproliferative disorder, most commonly seen in HIV-infected patients, that has a high mortality if untreated. Concurrent KS is common. Although rituximab has reported activity in KSHV-MCD, its use is often as... | [
{
"companynumb": "US-CIPLA LTD.-2014US01643",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VALGANCICLOVIR"
},
"drugadditional": null,
... |
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