article dict | reports listlengths 1 3.97k |
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{
"abstract": "The use of a once-yearly IV infusion of 5 mg zoledronic acid has become more common, as the drug is being reported as safe, with few to minimal adverse reactions. This one-time annual administration has a favorable outcome for patients with osteoporosis and spares the burden of taking daily oral bispho... | [
{
"companynumb": "PHHY2016US115272",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ALENDRONATE SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "Quetiapine, an atypical antipsychotic, has been the subject of a series of case reports that suggest a potential for misuse/abuse. The available cases indicate a male predominance; oral, intranasal, or intravenous routes of administration; misuse/abuse in jail or inpatient psychiatric settings; and sub... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-PL-ALKEM-2018-01329",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "QUETIAPINE FUMARATE"
},
... |
{
"abstract": "A three-year-old girl was found altered with an unknown timeline. Gas chromatography mass spectrometry was positive for hydromorphone, dihydrocodeine, and hydrocodone. Initial computed tomography and magnetic resonance imaging suggested a malignant cerebellar edema not confined to a vascular distributi... | [
{
"companynumb": "US-DRREDDYS-USA/USA/19/0115200",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "FENTANYL CITRATE"
},
"drugadditional": "... |
{
"abstract": "We examined the effectiveness of plasma exchange (PE) therapy to reduce the mortality of rapidly progressive interstitial lung disease (RP-ILD) in patients positive for anti-melanoma differentiation-associated gene 5 (MDA5) antibodies.\n\n\n\nAmong 142 patients newly diagnosed with PM/DM or clinically ... | [
{
"companynumb": "JP-TEVA-2020-JP-1242088",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": "3",
... |
{
"abstract": "Perivascular epithelioid cell tumors (PEComas) form a family of rare mesenchymal neoplasms that typically display myomelanocytic differentiation. Upregulation of mTOR signaling due the inactivation of TSC1/2 (Tuberous Sclerosis 1 and 2) is believed to be a key oncogenic driver in this disease. Recently... | [
{
"companynumb": "DE-MYLANLABS-2021M1039815",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "EVEROLIMUS"
},
"drugadditional": null,
... |
{
"abstract": "Still disease is a rare systemic connective tissue disease of unknown etiology, which due to nonspecific symptoms, requires thorough diagnostics. Steroids are the basis treatment, while other immunosuppressive drugs should be applied for patients who are resistant to standard therapy.\nA 36-year-old wo... | [
{
"companynumb": "PL-LUPIN PHARMACEUTICALS INC.-2021-26674",
"fulfillexpeditecriteria": "2",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugad... |
{
"abstract": "The oncological treatment for advanced stage head and neck cancer is based on a combination of cisplatin and cetuximab, and radiotherapy. However, very few data are available on this multimodal approach for this type of cancer in pancreas and renal recipients. We report the case of a pancreas and renal... | [
{
"companynumb": "IT-ACCORD-041289",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUOROURACIL"
},
"drugadditional": null,
"dr... |
{
"abstract": "OBJECTIVE\nHodgkin's lymphoma (HL) is a well-curable disease. The treatment usually includes combined multiagent conventional chemotherapy and radiotherapy. One-fifth of the patients need repeated treatments because of relapse or primary progressive disease. Those HL patients, who cannot be cured at le... | [
{
"companynumb": "HU-PFIZER INC-2016393147",
"fulfillexpeditecriteria": "1",
"occurcountry": "HU",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": null,
... |
{
"abstract": "Imatinib is generally well tolerated in the treatment of advanced gastrointestinal stromal tumors (GIST). Gastrointestinal vascular ectasia (GIVE) and gastric antral vascular ectasia (GAVE), while rare, are significant under-reported complications of imatinib therapy.\n\n\n\nWe present one patient with... | [
{
"companynumb": "IL-SUN PHARMACEUTICAL INDUSTRIES LTD-2016RR-129735",
"fulfillexpeditecriteria": "1",
"occurcountry": "IL",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "IMATINIB MESYLATE"
},
... |
{
"abstract": "BACKGROUND\nLiver transplanted patients have excellent survival rates, but infectious complications are a major cause of morbidity and mortality. Diagnosis and treatment of tuberculosis (TB) in liver recipients are very challenging. Specific recommendations for anti-TB treatment in liver transplanted p... | [
{
"companynumb": "IT-PBT-000014",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PYRAZINAMIDE"
},
"drugadditional": "1",
"drugad... |
{
"abstract": "BACKGROUND\nThe contraceptive implant, Implanon NXT, was introduced in South Africa (SA) in 2014 and, although it offers multiple advantages, users may request to have it removed early for several reasons. The number of insertions of Implanon NXT has declined in SA and there have been concerns about ea... | [
{
"companynumb": "ZA-009507513-1910ZAF016374",
"fulfillexpeditecriteria": "1",
"occurcountry": "ZA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ETONOGESTREL"
},
"drugadditional": null,
... |
{
"abstract": "Malignant Pleural mesothelioma (MPM) is a rare disease which is associated with a poor prognosis. Front line chemotherapy represents the cornerstone in the management of MPM, and the place of radical surgery is controversial and reserve in early-stage disease. However prolonged survival (more than 24 m... | [
{
"companynumb": "FR-PFIZER INC-2021747781",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "A 53-year-old male, without any prior history of psychosis, developed schizophrenia 4 days after starting low-dose bromocriptine therapy for a macroprolactinoma. Five days after discontinuation of this medication his mental status returned to normal. This case is reported in support of the dopamine hyp... | [
{
"companynumb": "US-VALIDUS PHARMACEUTICALS LLC-US-2016VAL000083",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "BROMOCRIPTINE MESYLATE"
},
... |
{
"abstract": "OBJECTIVE\nThe aim of this study is to assess international guidelines implementation concerning thromboprophylaxis strategy in myeloma patients treated with immunomodulatory drugs.\n\n\nMETHODS\nThis retrospective study includes multiple myeloma patients treated with immunomodulatory drugs between 201... | [
{
"companynumb": "FR-AMGEN-FRASP2022059966",
"fulfillexpeditecriteria": "2",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARFILZOMIB"
},
"drugadditional": "3",
... |
{
"abstract": "Immune checkpoint inhibitors (ICIs) are highly efficacious for treating many solid tumor types. Because of their immune-activating mechanism of action, ICIs can trigger various immune-mediated toxicities. We present three cases: i) a woman with anti-Ri brainstem encephalitis; ii) a man with anti-Hu sen... | [
{
"companynumb": "US-BEH-2019103682",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "Methotrexate, a methyl derivative of aminopterin, is a folic acid antagonist and a known human teratogen; misoprostol is a synthetic prostaglandin E1 analog that causes uterine contractions. Recently, there has been resurgence in the use of methotrexate in combination with misoprostol or of methotrexat... | [
{
"companynumb": "US-PFIZER INC-HQWYE700017DEC03",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE SODIUM"
},
"drugadditional"... |
{
"abstract": "Metastatic pancreatic cancer is characterised by poor prognosis. High toxicity of chemotherapy limits its use in elderly patients with severe comorbidities. Meanwhile, in metastatic disease, local treatment did not show the positive effect on life expectancy. We present a clinical case of a 72-year-old... | [
{
"companynumb": "RU-TEVA-2018-RU-966454",
"fulfillexpeditecriteria": "1",
"occurcountry": "RU",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "Epidermolysis bullosa (EB) is an inherited skin disease with four main subtypes that cannot be distinguished clinically at birth. All subtypes may present with widespread life-threatening blisters and fragile skin, making treatment and handling of the newborn with EB challenging. The prognosis of EB de... | [
{
"companynumb": "DK-PURDUE PHARMA-GBR-2016-0036781",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "KETAMINE"
},
"drugadditional": null,... |
{
"abstract": "Vemurafenib (Zelboraf; Genentech, CA) is a highly effective oral chemotherapy agent for patients with metastatic melanoma who carry the BRAF V600E mutation. Side effects of this protein kinase inhibitor (PKI) include arthralgia, rash, and fatigue, which are reported in up to one third of treated patien... | [
{
"companynumb": "US-ROCHE-1892096",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ATENOLOL"
},
"drugadditional": null,
"druga... |
{
"abstract": "Infectious complications are a major cause of morbidity and mortality in patients with chronic lymphocytic leukemia (CLL) due to impaired immunity secondary to the disease itself and to the immunosuppressive therapies administered to these patients. We report a 78-year-old woman with CLL who was treate... | [
{
"companynumb": "FR-SUN PHARMACEUTICAL INDUSTRIES LTD-2015R1-109344",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drug... |
{
"abstract": "BACKGROUND\nTapentadol is a novel atypical opioid. Anecdotal evidence suggests that tapentadol has a lower toxicity than conventional opioids.\n\n\nOBJECTIVE\nTo evaluate all single-drug mortality due to tapentadol and assess serious adverse events caused by tapentadol.\n\n\nMETHODS\nThe Preferred Repo... | [
{
"companynumb": "AU-COLLEGIUM PHARMACEUTICAL, INC.-US-2019COL000084",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TAPENTADOL"
},
"drug... |
{
"abstract": "BACKGROUND\nWe report the case of a multiple drug interaction involving clozapine, antifungals and oral contraceptives, which resulted in an increased clozapine plasma level, pericarditis with pericardial effusion and eosinophilia in a young Caucasian woman. These symptoms and signs disappeared a few d... | [
{
"companynumb": "IT-PFIZER INC-2015132548",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CLOZAPINE"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nDrug-induced urolithiasis falls into two categories: drug-induced and metabolically-induced. Certain antimicrobials are associated with each; sulfonamides are associated with drug- or metabolite-containing calculi when taken in large doses over a long period of time. Trimethoprim-sulfametho... | [
{
"companynumb": "US-TEVA-2021-US-1966681",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM"
},
"drugadditio... |
{
"abstract": "Outcomes continue to improve in relapsed myeloma as more effective treatment options emerge. We report a multicenter single-arm phase 2 trial evaluating toxicity and efficacy of the histone deacetylase (HDAC) inhibitor vorinostat in combination with bortezomib and dexamethasone.\n\n\n\nSixteen patients... | [
{
"companynumb": "GB-TAKEDA-2021TUS005691",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BORTEZOMIB"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nTo report a case of increases in vancomycin concentrations without additional vancomycin doses being given.\n\n\nMETHODS\nA 64 year-old morbidly obese female received three total doses of vancomycin for surgical prophylaxis and for ventilator-associated pneumonia. Subsequent vancomycin conc... | [
{
"companynumb": "US-AXELLIA-001018",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"drugadditional": null,
"dru... |
{
"abstract": "Pulmonary Mycobacterium abscessus infection in cystic fibrosis (CF) patients is difficult to treat and considered a contra-indication for lung transplantation in most centers. We present four CF patients with chronic pulmonary M abscessus infection, in whom lung transplantation was performed. Through i... | [
{
"companynumb": "BE-FRESENIUS KABI-FK201905418",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IMIPENEM"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nPreoperative chemoradiotherapy and local excision via transanal endoscopic surgery (TEM) in T2-3s,N0,M0 rectal cancer achieve promising results in selected patients. We describe our long-term follow-up experience with this combination, and evaluate complete clinical and pathological response... | [
{
"companynumb": "ES-ROCHE-1797225",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUOROURACIL"
},
"drugadditional": "3",
"dru... |
{
"abstract": "The number of transmen seeking gender-confirming surgery has risen steadily throughout the last decade. Pathologists are increasingly confronted with transmale mastectomy specimens. It is not clear whether routine histopathological examination is useful. This study explored the possible benefit of rout... | [
{
"companynumb": "BE-ENDO PHARMACEUTICALS INC-2020-005518",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TESTOSTERONE"
},
"drugadditiona... |
{
"abstract": "Calcinosis cutis results from the deposition of insoluble calcium salts in the skin and subcutaneous tissue. Herein, we report a case of extensive metastatic calcinosis cutis in an 18-year-old woman with stage IV Hodgkin lymphoma with skeletal involvement. With combination therapy including radiation d... | [
{
"companynumb": "US-TEVA-2019-US-1067933",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": "3",
... |
{
"abstract": "As part of a retrospective study on bronchoscopies performed at the Clinic of Pneumonology and Phthisiatry of the University Hospital - Pleven by autofluorescence bronchoscopy we found 3 cases diagnosed with carcinoma in situ. They were treated in different ways - endobronchial electrocoagulation, extr... | [
{
"companynumb": "BG-ASTRAZENECA-2018SE60479",
"fulfillexpeditecriteria": "1",
"occurcountry": "BG",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BUDESONIDE\\FORMOTEROL FUMARATE DIHYDRATE"
},
... |
{
"abstract": "A 55-year-old woman with concurrent active thyroid orbitopathy and B-cell lymphoma developed acute exacerbation of thyroid orbitopathy after receiving Rituximab, cyclophosphamide, hydroxydaunorubicin, Prednisone (R-CHOP) chemotherapy, presenting with subtotal loss of vision and severe eyelid edema. Int... | [
{
"companynumb": "NL-MYLANLABS-2018M1029216",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nCentral diabetes insipidus is a heterogeneous condition characterized by decreased release of antidiuretic hormone by the neurohypophysis resulting in a urine concentration deficit with variable degrees of polyuria. The most common causes include idiopathic diabetes insipidus, tumors or inf... | [
{
"companynumb": "BE-Accord-205254",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TEMOZOLOMIDE"
},
"drugadditional": "1",
"dru... |
{
"abstract": "Treatment with asfotase alfa has transformed the prognosis of hypophosphatasia in children and improves the bone and muscle signs in adults. The doses used in adults are the same as in children, whereas bone remodeling is different between them. We report on the cases of two patients treated with 1 mg/... | [
{
"companynumb": "FR-ALXN-A202018357",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "ASFOTASE ALFA"
},
"drugadditional": "1",
"... |
{
"abstract": "Tuberculosis (TB) is a common post-transplant infection with high prevalence in developing countries due to reactivation. Post-transplant TB involves the respiratory system in 50% of patients, followed by disseminated involvement in 30%. The risk of tuberculosis of renal allograft post-transplantation ... | [
{
"companynumb": "QA-ACCORD-215154",
"fulfillexpeditecriteria": "1",
"occurcountry": "QA",
"patient": {
"drug": [
{
"actiondrug": "3",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
"drug... |
{
"abstract": "We report the case of a 57-year-old Caucasian woman with AIDS-related disseminated Kaposi sarcoma (KS) characterised by the combination of several unusual features. The chylous nature of the pleural effusions, the documented parietal pleural involvement at thoracoscopy and the marked clinical worsening... | [
{
"companynumb": "CA-GILEAD-2020-0456430",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "RALTEGRAVIR"
},
"drugadditional": null,
... |
{
"abstract": "Bile reflux into the gastric stump and then into the oesophagus is a common event after distal gastrectomy and Billroth II reconstruction. In addition to typical symptoms of nausea, epigastric pain and bile vomiting, acid reflux can also occur in patients with concomitant hiatus hernia and lower oesoph... | [
{
"companynumb": "IT-ALLERGAN-1833365US",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SUCRALFATE"
},
"drugadditional": "3",
"... |
{
"abstract": "Part B of this phase 1b study (ClinicalTrials.gov number, NCT02283775) evaluated safety and efficacy of a fixed-volume infusion of isatuximab, an anti-CD38 monoclonal antibody, in combination with pomalidomide and dexamethasone (Pd) in relapsed/refractory multiple myeloma patients. Isatuximab (10 mg/kg... | [
{
"companynumb": "US-CELGENEUS-USA-20210601016",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "POMALIDOMIDE"
},
"drugadditional": null,
... |
{
"abstract": "A 60-year-old woman was referred to the otolaryngologist for 18 months of left-sided tongue pain and taste changes. Surgeon-performed ultrasound of the submandibular region revealed a hyperechoic mass. Wharton's duct was dilated proximally and the submandibular gland demonstrated normal vascularity. Wh... | [
{
"companynumb": "US-APOTEX-2020AP014909",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "GABAPENTIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nResults from clinical trials and observational studies suggest that lamivudine plus dolutegravir (3TC+DTG) could be an effective and tolerated option for simplification in human immunodeficiency virus (HIV)-1-positive patients.\n\n\nMETHODS\nThis observational study enrolled HIV-1-infected,... | [
{
"companynumb": "IT-MYLANLABS-2020M1017817",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TENOFOVIR DISOPROXIL"
},
"drugadditional": nu... |
{
"abstract": "Tumor lysis syndrome is a constellation of metabolic disturbances commonly seen during therapy of bulky, rapidly proliferative tumors. Multiple myeloma is a low proliferation tumor with rare incidence of tumor lysis syndrome in the pre-Bortezomib era. Post Bortezomib use, a rise in the incidence of tum... | [
{
"companynumb": "US-TAKEDA-2016MPI009194",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": "3",
... |
{
"abstract": "Pharmacological stimulant therapies are routinely administered to promote recovery in patients with subacute and chronic disorders of consciousness (DoC). However, utilization rates and adverse drug event (ADE) rates of stimulant therapies in patients with acute DoC are unknown. We aimed to determine t... | [
{
"companynumb": "NVSC2021US167181",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMANTADINE HYDROCHLORIDE"
},
"drugadditional": "3",
... |
{
"abstract": "Intratumoral or intraperitoneal hemorrhage is a recognized complication of liver adenomatosis. We report a case of multifocal massive liver adenomatosis presenting as chronic iron deficiency anemia. Clinicians' awareness about this atypical presentation not highlighted in the literature is important to... | [
{
"companynumb": "PT-MYLANLABS-2018M1005566",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DESOGESTREL\\ETHINYL ESTRADIOL"
},
"drugaddit... |
{
"abstract": "Cerebral aneurysms associated with systemic lupus erythematosus (SLE) are more likely to grow rapidly and rupture, compared to those found in the general population. The main underlying pathology of intracranial aneurysm and its rupture is presumed to be SLE-related intracranial vasculitis and fragilit... | [
{
"companynumb": "NVSC2020KR170638",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": "3",
"drugadmi... |
{
"abstract": "Despite numerous case reports, the incidence of a secondary diagnosis of head and neck squamous cell carcinoma (HNC) following pegylated liposomal doxorubicin (PLD) treatment is unknown. Computerized pharmacy records were searched at a large, multi-center healthcare system for patients who received PLD... | [
{
"companynumb": "US-MYLANLABS-2020M1097377",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"drugadditional": null,
... |
{
"abstract": "To better understand this cancer, we here report the case of a 43-year old patient diagnosed with localized and isolated primary colonic NK/T-cell lymphoma without associated enteropathy, treated wih 3 cycles of AspaMetDex with a poor response who died during treatment with a clinical picture of acute ... | [
{
"companynumb": "MA-BAUSCH-BL-2017-022828",
"fulfillexpeditecriteria": "1",
"occurcountry": "MA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nSusac's Syndrome (SS) consists of the triad of encephalopathy, branch retinal artery occlusions (BRAO) and hearing loss (HL). Histopathologically, SS is characterised by a microangiopathy, and some observations suggest that an immune-mediated damage of endothelial cells might play a role. T... | [
{
"companynumb": "DE-MYLANLABS-2021M1064309",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HUMAN IMMUNOGLOBULIN G"
},
"drugadditional": ... |
{
"abstract": "Background: Enoxaparin is not recommended for venous thromboembolism (VTE) prophylaxis in the end-stage renal disease (ESRD) on hemodialysis (HD) population due to concerns for drug accumulation and increased bleeding risk. Due to the paucity of literature with clinical outcomes to support this theoret... | [
{
"companynumb": "US-BAYER-2022A033021",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": null,
"dr... |
{
"abstract": "We present the case of an 18-year-old woman who suffered from complications of Ehlers-Danlos syndrome (EDS). Her pain was poorly controlled despite being on a myriad of analgesic medications at the time. On initiating cannabinoid-based treatment, her pain was drastically reduced, immediately enhancing ... | [
{
"companynumb": "GB-MYLANLABS-2022M1032473",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FENTANYL"
},
"drugadditional": "3",
... |
{
"abstract": "Some studies have shown that a high neutrophil/lymphocyte ratio (NLR) ≥4 before initiating ipilimumab treatment is an independent prognostic indicator of poor survival in patients with metastatic melanoma (MM). To determine whether the NLR before starting BRAF inhibitor (BRAFi) treatment in patients wi... | [
{
"companynumb": "FR-ROCHE-2117981",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VEMURAFENIB"
},
"drugadditional": "3",
"drug... |
{
"abstract": "OBJECTIVE\nTo compare the efficacy, safety, and tolerability of 6 dosages of oral tofacitinib (CP-690,550) with placebo for the treatment of active rheumatoid arthritis (RA) in patients receiving a stable background regimen of methotrexate (MTX) who have an inadequate response to MTX monotherapy.\n\n\n... | [
{
"companynumb": "BG-PFIZER INC-2008029097",
"fulfillexpeditecriteria": "1",
"occurcountry": "BG",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FOLIC ACID"
},
"drugadditional": null,
... |
{
"abstract": "To review the pathophysiology of rhabdomyomas and the emerging option of prenatal treatment of fetal cardiac rhabdomyomas.\n\n\n\nWe present a case of fetal rhabdomyomas causing significant hemodynamic compromise that received in utero treatment of maternal sirolimus. Genetic amniocentesis confirmed a ... | [
{
"companynumb": "US-NVP-000039",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SIROLIMUS"
},
"drugadditional": "1",
"drugadmin... |
{
"abstract": "Management of patients with relapsed or refractory (R/R) AL amyloidosis is complex. Some initial reports have shown positive results with daratumumab in heavily pre-treated AL amyloidosis patients. In this retrospective multicentric study, 38 patients (mean age 64 ± 9 years) with R/R AL amyloidosis tre... | [
{
"companynumb": "ES-TAKEDA-2020TUS035308",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BORTEZOMIB"
},
"drugadditional": "3",
... |
{
"abstract": "Limited data exist on intravenous (IV) posaconazole dosing and the risk for hepatotoxicity it confers to children. In this study, we evaluated dosing and resulting trough levels in 10 pediatric patients on IV posaconazole. A therapeutic level in these patients was achieved 95% of the time. We found a m... | [
{
"companynumb": "US-009507513-1810USA008466",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "POSACONAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "Corticosteroid hypersensitivity is a complex phenomenon in which many factors interact, such as idiosyncrasy, intolerance or allergic reactions. The prevalence of immediate hypersensitivity reactions to corticosteroids is 0.2%-0.5%. Corticosteroids have major therapeutic implications; thus, when hypers... | [
{
"companynumb": "MX-ACTAVIS-2014-18475",
"fulfillexpeditecriteria": "1",
"occurcountry": "MX",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": null,
... |
{
"abstract": "Worldwide eight children have been born as a result of transplanting frozen/thawed ovarian tissue. Two of these children were born in Denmark following transport of the ovarian tissue for a period of 5 h prior to cryopreservation. One of these women, who was originally transplanted with six pieces of o... | [
{
"companynumb": "DK-BAXTER-2018BAX030582",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"drugadditional": "3",
... |
{
"abstract": "We describe a group of 26 children with no prior history of seizures consistent with benign rolandic epilepsy who had rolandic spikes found coincidentally on EEG. A retrospective chart review as well as phone and email follow-ups with families were completed to assess long-term outcomes. A subset of th... | [
{
"companynumb": "US-DRREDDYS-USA/USA/15/0050394",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": null... |
{
"abstract": "Perry syndrome, also recognized as Perry disease, is a rare autosomal dominant disorder characterized by midlife-onset atypical parkinsonism, apathy or depression, respiratory failure and weight loss caused by a mutation in the Dynactin (DCTN1) gene.\n\n\n\nA fifty-six years-old adopted male presented ... | [
{
"companynumb": "US-009507513-2008USA008867",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CARBIDOPA\\LEVODOPA"
},
"drugadditional": nu... |
{
"abstract": "Reports of crizotinib-induced pleural effusion in non-small cell lung cancer (NSCLC) are limited. A 35-year-old Japanese woman was diagnosed with ROS1-rearranged lung adenocarcinoma (primary left lower lobe, cT4N3M1c). Crizotinib was administered as first-line therapy, and the primary and mediastinal h... | [
{
"companynumb": "JP-MYLANLABS-2020M1066204",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": "1",
... |
{
"abstract": "An adult lymphoma patient developed Cushing syndrome after short-term, high-dose dexamethasone administration and presented with a distinctive Cushingoid fat redistribution pattern and associated increased 18F-FDG uptake in white adipose tissue. Recognition of the unique 18F-FDG uptake manifestation ma... | [
{
"companynumb": "US-BAUSCH-BL-2021-022916",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": "1",
... |
{
"abstract": "Retinoblastoma is the prototypic genetic tumor. Caused by mutations in the RB1 gene, retinoblastomas are heritable in 40% of the cases and, in such cases, tumors are bilateral in 80%, unilateral in 15%, and trilateral in 5% of the cases. Trilateral retinoblastoma is a term that describes bilateral reti... | [
{
"companynumb": "US-FRESENIUS KABI-FK202105556",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "The use of granulocyte-colony stimulating factor (G-CSF) with or without chemotherapy to mobilize hematopoietic progenitor cells (HPCs) can result in significant morbidity in light chain (AL) amyloidosis patients. Plerixafor, a strong inducer and mobilizer of HPCs, can be used as an adjunct to G-CSF to... | [
{
"companynumb": "US-AMGEN-USASP2019214398",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ANHYDROUS CITRIC ACID\\DEXTROSE MONOHYDRATE\\SODIUM CITRATE"
... |
{
"abstract": "BACKGROUND\nDrug reaction with eosinophilia and systemic symptoms (DRESS) [also called drug-induced hypersensitivity syndrome (DIHS)] includes severe reactions to drugs that need to be promptly recognized by physicians.\n\n\nOBJECTIVE\nTo explore heterogeneity in the clinical presentation of DRESS/DIHS... | [
{
"companynumb": "BR-IPCA LABORATORIES LIMITED-IPC201512-000872",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "NIMESULIDE"
},
"drugaddit... |
{
"abstract": "Natural killer (NK) cell-mediated antibody-dependent toxicity is a potent mechanism of action of the anti-GD2 murine monoclonal antibody 3F8 (m3F8). Killer immunoglobulin-like receptor (KIR) and HLA genotypes modulate NK activity and are key prognostic markers in m3F8-treated patients with neuroblastom... | [
{
"companynumb": "US-MYLANLABS-2018M1077562",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TOPOTECAN HYDROCHLORIDE"
},
"drugadditional":... |
{
"abstract": "BACKGROUND\nSpontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark... | [
{
"companynumb": "PHHY2017DK023965",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ZOLEDRONIC ACID"
},
"drugadditional": null,
... |
{
"abstract": "Transarterial chemoembolization with irinotecan loaded beads (DEBIRI-TACE) represents an investigative treatment option for patients with metastatic colorectal cancer (mCRC). The present study examined DEBIRI-TACE with concomitant mFOLOFX6-bevacizumab as a first-line treatment for mCRC and explored the... | [
{
"companynumb": "DK-PFIZER INC-2018287491",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "Differentiating between anaphylaxis and hypotension during general anaesthesia is difficult, especially when patients present with only hypotension and without any of the other classical features of anaphylaxis. We report the successful management of an anaphylactic reaction to rocuronium that presente... | [
{
"companynumb": "MY-FRESENIUS KABI-FK202110743",
"fulfillexpeditecriteria": "1",
"occurcountry": "MY",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PROPOFOL"
},
"drugadditional": "4",
... |
{
"abstract": "At present, intrahepatic cholangiocarcinoma is a contraindication for liver transplantation. However, previous studies in this field did not preselect patients on the basis of chemosensitivity or disease trajectory after neoadjuvant therapy. Experience with hilar cholangiocarcinoma has indicated that n... | [
{
"companynumb": "US-ACCORD-065275",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GEMCITABINE\\GEMCITABINE HYDROCHLORIDE"
},
"drugadditi... |
{
"abstract": "BACKGROUND\nAdenomyosis remains an enigma for the reproductive endocrinologist. It is thought to contribute to sub-fertility, and its only curative treatment is hysterectomy. However, studies have documented increased live birth rates in women with adenomyosis who were treated with gonadotropin releasi... | [
{
"companynumb": "US-ORGANON-O2105USA002258",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BETAMETHASONE ACETATE\\BETAMETHASONE SODIUM PHOSPHATE"
... |
{
"abstract": "Dabigatran is a direct thrombin inhibitor used to reduce the risk of stroke in patients with nonvalvular atrial fibrillation. For patients who present with an acute stroke despite dabigatran therapy, clinical data on the use of intravenous tissue plasminogen activator (IV-tPA) is limited. There is an a... | [
{
"companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2017-BI-022966",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DABIGATRAN ETEXILATE MESYLATE"
... |
{
"abstract": "We evaluated the efficacy of combination enzastaurin (LY317615) and bevacizumab for recurrent malignant gliomas and explored serologic correlates. We enrolled 81 patients with glioblastomas (GBM, n = 40) and anaplastic gliomas (AG, n = 41). Patients received enzastaurin as a loading dose of 1125 mg, fo... | [
{
"companynumb": "US-ROCHE-1688585",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BEVACIZUMAB"
},
"drugadditional": null,
"dru... |
{
"abstract": "Bacteremia causes considerable morbidity among children with acute leukemia and those undergoing hematopoietic stem cell transplantation (HSCT). There are limited data on the effect of antibiotic prophylaxis in children.\n\n\n\nTo determine the efficacy and risks of levofloxacin prophylaxis in children... | [
{
"companynumb": "CA-JNJFOC-20181014224",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVOFLOXACIN"
},
"drugadditional": "3",
... |
{
"abstract": "We describe the case of a 41-year-old male that underwent laser in situ keratomileusis (LASIK) complicated by Urrets-Zavalia syndrome with interface fluid syndrome and epithelial ingrowth.\nThe patient presented at our institution with headache and blurred vision three weeks after a right microkeratome... | [
{
"companynumb": "GB-MYLANLABS-2019M1006232",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TOBRAMYCIN"
},
"drugadditional": "3",
... |
{
"abstract": "This study prospectively compared immunoprophylaxis with a single intraoperative dose (2 mg/kg) of monoclonal interleukin-2 receptor (IL-2R) antibody vs. noninduction in kidney transplant recipients treated with tacrolimus (FK 506), mycophenolate mofetil (MMF) and a prednisone-based immunosuppression r... | [
{
"companynumb": "US-ROCHE-1884152",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "3",
"druga... |
{
"abstract": "Plasma cell leukemia (PCL) is a rare disease and is the least common variant of multiple myeloma accounting for 2-3% of all plasma cell dyscrasias. We report a patient who was diagnosed with multiple myeloma, 12 months earlier; he was treated with VBCMP, VCMP regime, and after 12 months he presented of... | [
{
"companynumb": "US-009507513-1705USA001829",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARFILZOMIB"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nThe BCR-ABL mutation, T315I, is a common mutation and is resistant to both imatinib and second-generation Abl kinase inhibitors. Although strategies to overcome resistance-mediated T315I mutation may improve the survival of BCR-ABL-positive leukemia patients, there is little information on c... | [
{
"companynumb": "PHHY2018JP138180",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "VINCRISTINE"
},
"drugadditional": null,
"dru... |
{
"abstract": "OBJECTIVE\nCancer can escape the immune system through different mechanisms. One such mechanism is the expression of program death ligand-1 which binds to PD-1 receptor on activated T cells, subsequently leading to inhibition of the immune response against cancer cells. Nivolumab is a novel antibody th... | [
{
"companynumb": "SA-SUN PHARMACEUTICAL INDUSTRIES LTD-2019R1-225417",
"fulfillexpeditecriteria": "1",
"occurcountry": "SA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GEMCITABINE"
},
"dru... |
{
"abstract": "Orlistat is a gastrointestinal lipase inhibitor used for weight reduction in obese individuals. Enteric hyperoxaluria caused by orlistat leads to oxalate absorption. Acute oxalate nephropathy is a rare complication of treatment with orlistat. Herein we report a patient presenting with acute renal failu... | [
{
"companynumb": "US-ROCHE-1351791",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ORLISTAT"
},
"drugadditional": "3",
"drugadm... |
{
"abstract": "BACKGROUND\nThe 4H syndrome (hypomyelination, hypodontia, hypogonadotropic hypogonadism) is a newly recognized leukodystrophy. The classical form is characterized by the association of hypomyelination, abnormal dentition, and hypogonadotropic hypogonadism, but the recent identification of two genes (PO... | [
{
"companynumb": "IT-ROCHE-1624439",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "SOMATROPIN"
},
"drugadditional": null,
"drug... |
{
"abstract": "OBJECTIVE\nCarfilzomib-lenalidomide-dexamethasone therapy yields deep responses in patients with newly diagnosed multiple myeloma (NDMM). It is important to gain an understanding of this combination's tolerability and impact on minimal residual disease (MRD) negativity because this end point has been a... | [
{
"companynumb": "US-CELGENE-163-21880-14011623",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARFILZOMIB"
},
"drugadditional": null,
... |
{
"abstract": "We report a multicenter controlled trial comparing renal recovery and tolerance profile of doublet versus triplet bortezomib-based regimens in patients with initial myeloma cast nephropathy (CN) and acute kidney injury (AKI) without need for dialysis.\n\n\n\nAfter symptomatic measures and high-dose dex... | [
{
"companynumb": "FR-TAKEDA-2020TUS036576",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": null,... |
{
"abstract": "A 70-year-old man presented with left loin pain without urinary symptoms. Initial investigations with CT showed enlarged para-aortic, mediastinal lymph nodes, right-side renal mass and enlarged prostate. A prostatic-specific antigen (PSA) was alarmingly high at 4750 μg/L (normal <4.0 μg/L). Further inv... | [
{
"companynumb": "AU-MYLANLABS-2018M1025646",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nHyperekplexia is a rare neurologic disorder characterized by pronounced startle responses to tactile or acoustic stimuli and increase tone. Acquired hyperekplexia is usually seen in brainstem pathologies and when it develops acutely it can be easily misdiagnosed as a convulsive seizure.\n\n... | [
{
"companynumb": "US-UCBSA-2020041592",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "4",
... |
{
"abstract": "BACKGROUND\nBiologic therapies with anti-tumor necrosis factor agents are promising treatments for hidradenitis suppurativa (HS).\n\n\nOBJECTIVE\nWe assessed the efficacy and safety of infliximab (IFX) for the treatment of moderate to severe HS.\n\n\nMETHODS\nA prospective double-blind treatment phase ... | [
{
"companynumb": "US-JNJFOC-20200615192",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": "3",
"... |
{
"abstract": "Osteonecrosis has been well-documented in the past. We present an example of this complication that we recently saw in our department which on initial presentation appeared to be squamous cell carcinoma. This case is particularly important as the condition will become more and more prevalent and theref... | [
{
"companynumb": "GB-PFIZER INC-2008008107",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUOROURACIL"
},
"drugadditional": "3",
... |
{
"abstract": "There have been important advances in the treatment of severe forms of ulcerative colitis (UC). They include biologic therapy and immunomodulators such as cyclosporine. The primary end-point of these therapies is to avoid colectomy in patients with severe disease when intravenous steroids have failed. ... | [
{
"companynumb": "MX-WATSON-2014-15719",
"fulfillexpeditecriteria": "1",
"occurcountry": "MX",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MESALAMINE"
},
"drugadditional": null,
"... |
{
"abstract": "BACKGROUND\nCompression of the internal carotid artery (ICA) in the cavernous sinus area is a rare event and is mostly associated with pituitary adenomas and meningiomas. Other causes of ICA compression are less well known. We present a rare case of granulomatous hypophysitis causing compression of the... | [
{
"companynumb": "DE-TEVA-2020-DE-1224830",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nBleeding remains a common occurrence in surgery. Data describing the burden of difficult-to-control bleeding and topical absorbable hemostat use are sparse. This study was conducted to estimate the clinical and economic impact that remains associated with uncontrolled surgical bleeding, eve... | [
{
"companynumb": "US-JNJFOC-20150912194",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "UNSPECIFIED INGREDIENT"
},
"drugadditional": nul... |
{
"abstract": "OBJECTIVE\nTo evaluate the efficacy and safety of infliximab in the treatment of Crohn's disease in children.\n\n\nMETHODS\nThirteen children who were diagnosed with Crohn's disease and received routine comprehensive treatment and infliximab (5 mg/kg) between January 2011 and December 2014 were enrolle... | [
{
"companynumb": "CN-JNJFOC-20151022841",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "Hidradenitis suppurativa (HS) is a chronic inflammatory disease characterised by pain, inflamed nodules, abscess, sinus tract, and fistula. HS is more common in patients with axial spondyloarthritis and Familial Mediterranean Fever (FMF) compared to the normal population. Mediterranean fever gene mutat... | [
{
"companynumb": "TR-PFIZER INC-202200186075",
"fulfillexpeditecriteria": "2",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ETANERCEPT"
},
"drugadditional": "1",
... |
{
"abstract": "To evaluate ocular disease characteristics and successful therapeutic regimens in patients with scleritis associated with relapsing polychondritis (RP). To compare these features with those seen in patients with scleritis associated with other systemic immune-mediated diseases (SIMD).\n\n\n\nElectronic... | [
{
"companynumb": "US-JNJFOC-20181004099",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": "2",
"... |
{
"abstract": "Hepatic arterial infusion (HAI) of chemotherapy can be performed in cases of liver-confined metastatic disease, resulting in increased local drug concentrations. Here we report the case of a 61-year-old man who presented with an isolated large unresectable liver metastasis of colon cancer after failure... | [
{
"companynumb": "FR-MYLANLABS-2021M1018958",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nOver 50% of colorectal cancer (CRC) patients develop metastases. The aim of this study was to evaluate efficacy and tolerance of first-line FOLFIRI® + bevacizumab (B) treatment for metastatic CRC, and to assess genetic polymorphisms as potential markers.\n\n\nMETHODS\nAdult patients with hi... | [
{
"companynumb": "FR-CIPLA LTD.-2016FR17088",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEUCOVORIN"
},
"drugadditional": null,
... |
{
"abstract": "A 66-year-old woman with no relevant medical history presented at the emergency department with new-onset atrial fibrillation. We initiated intravenous amiodarone therapy. At 20 hours, the patient experienced severe neurologic symptoms, hyponatremia, and syndrome of inappropriate antidiuretic hormone. ... | [
{
"companynumb": "US-DRREDDYS-USA/USA/20/0128452",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AMIODARONE HYDROCHLORIDE"
},
"drugadditi... |
{
"abstract": "Treatment of drug-resistant tuberculosis requires extended use of more toxic and less effective drugs and may result in retreatment cases due to failure, abandonment or disease recurrence. It is therefore important to understand the evolutionary process of drug resistance in Mycobacterium tuberculosis.... | [
{
"companynumb": "BR-LUPIN PHARMACEUTICALS INC.-2022-05144",
"fulfillexpeditecriteria": "2",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "RIFAMPIN"
},
"drugadditional":... |
{
"abstract": "Familial Mediterranean fever (FMF) is an autoinflammatory disease characterized by recurrent serosal inflammation with fever, which can result in amyloid deposition. Anti-interleukin-1 drugs emerge as a therapeutic option for colchicine-resistant patients. In this study, we aimed to document our experi... | [
{
"companynumb": "TR-ALKEM LABORATORIES LIMITED-TR-ALKEM-2019-03048",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "COLCHICINE"
},
"druga... |
{
"abstract": "When coupled with classical clinical signs and symptoms, magnetic resonance imaging can significantly aid in the diagnosis of multiple sclerosis (MS). However, the differential diagnosis of multiple sclerosis is large and, in the absence of pathognomonic clinical features, can be challenging to diagnos... | [
{
"companynumb": "US-BIOGEN-2013BI007297",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "GLATIRAMER ACETATE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nChemotherapy in childhood leukemia potentially induces brain lesions and neurological sequelae. Paroxysmal sympathetic hyperactivity (PSH) is known as a treatment-associated complication; however, the full clinical spectra of PSH remain to be elusive.\n\n\nMETHODS\nA 5-year-old girl was dia... | [
{
"companynumb": "JP-LUPIN PHARMACEUTICALS INC.-2022-04857",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditio... |
{
"abstract": "Polyethylene glycol with electrolytes (PEG-ELS, Golytely) is a widely used osmotic solution for colonic preparation in adults who are undergoing colonoscopy or colon surgeries. In pediatric patients, It is approved for the same indications and as a treatment for severe chronic constipation. PEG-ELS has... | [
{
"companynumb": "SA-BRAINTREE LABORATORIES, INC.-2021BTE00634",
"fulfillexpeditecriteria": "1",
"occurcountry": "SA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "POLYETHYLENE GLYCOL 3350\\POTASSIUM CHLORIDE\\... |
{
"abstract": "OBJECTIVE\nTo report our experience in treating infants and toddlers with central diabetes insipidus (DI) with thiazide diuretics.\n\n\nMETHODS\nA retrospective chart review of all infants and toddlers who were treated with thiazide diuretics for central DI at the Mayo Clinic between 1996 and 2014.\n\n... | [
{
"companynumb": "US-APOTEX-2015AP012836",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HYDROCHLOROTHIAZIDE"
},
"drugadditional": null,
... |
{
"abstract": "Recently, chronic hepatitis E virus (HEV) infections gained increasing attention as a possible cause for elevated liver enzymes of unknown origin and liver cirrhosis in solid organ transplant recipients. Reduction of immunosuppressive therapy and/or use of antiviral drug ribavirin have been established... | [
{
"companynumb": "DE-ACCORD-218092",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "3",
"druga... |
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