article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "BACKGROUND\nCT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®) and is approved in Europe and elsewhere, mostly for the same indications as RP. The aim of this study was to compare the 54-week efficacy, immunogenicity, pharmacokinetics (PK) and safety of CT... | [
{
"companynumb": "KR-JNJFOC-20160122172",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "Penicillium marneffei infection is an endemic opportunistic infection for AIDS patients that can be found in south Asia. Fever and typical skin lesions are the most commonly seen symptoms. Our case describes an AIDS patient with Immune Reconstitution Inflammatory Syndrome (IRIS) presented with liver ma... | [
{
"companynumb": "CN-GILEAD-2016-0192361",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "EFAVIRENZ"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nThis is a phase II, single-center, single-arm study of patients with resectable adenocarcinoma of the pancreas who were treated with adjuvant interferon-based chemoradiation followed by gemcitabine. The primary end point was 2-year overall survival, with secondary endpoints being 2-year dise... | [
{
"companynumb": "US-CIPLA LTD.-2015US02856",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GEMCITABINE\\GEMCITABINE HYDROCHLORIDE"
},
"d... |
{
"abstract": "We report a case of intraocular relapse of extranodal NK/T-cell lymphoma with anterior chamber hypopyon and retinal infiltrates. A 55-year-old man developed fever, malaise, anorexia, and hepatosplenomegaly, and was diagnosed with NK/T-cell lymphoma by liver biopsy. He underwent 2 courses of SMILE (dexa... | [
{
"companynumb": "JP-FRESENIUS KABI-FK201600691",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": null,
... |
{
"abstract": "A decade after the alarming association of cabergoline-associated valvulopathy (CAV) in Parkinson disease, only two confirmed cases have occurred in patients with prolactinoma. Routine screening for CAV by echocardiography has not proved to be of diagnostic utility, has several limitations, and is not ... | [
{
"companynumb": "AU-PFIZER INC-2018460782",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CABERGOLINE"
},
"drugadditional": "1",
... |
{
"abstract": "Posterior reversible encephalopathy syndrome (PRES) is a rare clinicoradiographic disorder characterized by acute neurological symptoms with typical neuroimaging findings of vasogenic edema in posterior regions of the brain. This complication is linked to a number of medical conditions, and is increasi... | [
{
"companynumb": "NO-SUN PHARMACEUTICAL INDUSTRIES LTD-2019RR-203516",
"fulfillexpeditecriteria": "1",
"occurcountry": "NO",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CETUXIMAB"
},
"druga... |
{
"abstract": "BACKGROUND\nThere is a lack of evidence-based data on aged patients with newer direct-acting antivirals (DAAs) and with shorter duration of treatment regimens involving DAAs with or without ribavirin (RBV) and pegylated interferon (Peg IFN).\n\n\nMETHODS\nMedical records of 240 patients treated with DA... | [
{
"companynumb": "US-JNJFOC-20170708926",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "SOFOSBUVIR"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nAdenosine is the first-line pharmacotherapy for termination of supraventricular tachycardia through its action on the atrioventricular node. However, pro-arrhythmic effects of adenosine are also recognised, most notably in the presence of pre-excited atrial fibrillation. In this case report... | [
{
"companynumb": "GB-MYLANLABS-2017M1014073",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ADENOSINE"
},
"drugadditional": null,
... |
{
"abstract": "Although outbreaks of Neisseria meningitidis serogroup X occured in a couple of African countries, a limited number of serogroup X meningococcal cases were reported in America and Europe as well as Turkey. Additionally, serogroup X is still not represented in current conjugated meningococcal vaccines. ... | [
{
"companynumb": "TR-BAUSCH-BL-2018-004827",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CEFTRIAXONE"
},
"drugadditional": "3",
... |
{
"abstract": "Chronic scrotal content pain, chronic orchialgia, or testicular pain can present after trauma, vasectomy, and hernia repair, among other triggers. Microsurgical denervation of the spermatic cord is an option for definitive pain control. While this practice is established in adult urology, access to dia... | [
{
"companynumb": "CA-LUPIN PHARMACEUTICALS INC.-2021-23295",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "GABAPENTIN"
},
"drugadditional... |
{
"abstract": "WHAT IS KNOWN AND OBJECTIVE?: Antiretroviral (ARV) resistance may result during periods of consistently poor adherence. We report the successful use of a novel once-daily (QD) ARV regimen in a patient with multidrug-resistant (MDR) HIV. CASE SUMMARY: Once-daily darunavir 1200 mg/ritonavir 100 mg, dolut... | [
{
"companynumb": "US-JNJFOC-20201252606",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DARUNAVIR ETHANOLATE"
},
"drugadditional": "3",
... |
{
"abstract": "We report the case of a 75-year-old man with appendicular peritonitis in whom we observed oesophageal tissue perfusion, using a new photoplethysmographic probe. As the patient suffered from lactic acidosis, we chose to increase the mean arterial pressure (MAP) using norepinephrine. Thanks to an oesopha... | [
{
"companynumb": "FR-PFIZER INC-2019561515",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "NOREPINEPHRINE BITARTRATE"
},
"drugadditional"... |
{
"abstract": "Levetiracetam is a second-generation anticonvulsant that was approved by the Federal Drug Administration in 1999 for the treatment of epilepsy. Recently, levetiracetam has become more popular for the prevention of posttraumatic seizures. Some of the well-known adverse effects of levetiracetam are somno... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2015US-101514",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"d... |
{
"abstract": "A 26-year-old man presented to our syncope service with debilitating daily palpitations, shortness of breath, presyncope and syncope following a severe viral respiratory illness 4 years previously. Mobitz type II block had previously been identified, leading to a permanent pacemaker and no further epis... | [
{
"companynumb": "GB-SUN PHARMACEUTICAL INDUSTRIES LTD-2017R1-142574",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IVABRADINE"
},
"drug... |
{
"abstract": "BACKGROUND\nHolmes tremor (HT) is an irregular, low-frequency rest tremor associated with prominent action and postural tremors. Currently, the most effective stereotactic target and neurophysiologic characterization of HT, specifically local field potentials (LFPs) are uncertain. We present the outcom... | [
{
"companynumb": "US-UCBSA-2016037462",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "3",
... |
{
"abstract": "Infections by Nocardia spp. are generally regarded as opportunistic diseases in immunocompromised patients, but can also affect immunocompetent subjects. Such infections represent an important diagnostic challenge for clinicians and microbiologists, and diagnosis is frequently delayed or even conducted... | [
{
"companynumb": "IT-TEVA-681339ACC",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMOXICILLIN\\CLAVULANIC ACID"
},
"drugadditional": "3... |
{
"abstract": "Rheumatic heart disease is one of the leading causes of valve dysfunction, resulting in prosthetic valve implantation. Changes in physiology and the haemodynamics of pregnancy increase the susceptibility of thrombosis to the prosthetic valve in the pregnant woman. Valve redo surgery carries a considera... | [
{
"companynumb": "ZA-CIPLA LTD.-2022ZA03807",
"fulfillexpeditecriteria": "1",
"occurcountry": "ZA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "WARFARIN"
},
"drugadditional": "3",
... |
{
"abstract": "Myeloid and lymphoid neoplasms with fibroblastic growth factor receptor-1 (FGFR1) abnormalities originate from mutated pluripotent stem cells and have a heterogeneous clinical presentation. There are 12 identified partner genes commonly involved in FGFR1 translocation at an 8p11 breakpoint. In FGFR1-re... | [
{
"companynumb": "PHHY2015US155827",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": null,
"dr... |
{
"abstract": "This study evaluated the virological efficacy of dolutegravir 50 mg twice daily in 190 HIV-1 failing antiretroviral-experienced patients with previous exposure to first-generation integrase strand transfer inhibitor (INSTI) over a 5 year follow-up using data from clinical practice.\nThis analysis inclu... | [
{
"companynumb": "IT-VIIV HEALTHCARE LIMITED-IT2018012586",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOLUTEGRAVIR"
},
"drugadditiona... |
{
"abstract": "Cholestatic jaundice developed in a 64-year-old woman who had received phenytoin sodium for more than 40 years. Discontinuation of phenytoin therapy resulted in resolution of the hepatic abnormalities, which recurred on rechallenge, strongly suggesting a causal relation to the drug. Phenytoin therapy w... | [
{
"companynumb": "US-PFIZER INC-2015224066",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "MEPHOBARBITAL"
},
"drugadditional": null,
... |
{
"abstract": "Cockayne syndrome (CS) is a rare autosomal recessive genetic disorder characterized by growth failure and progressive multisystem dysfunction caused by deficient nucleotide excision repair. Whereas metronidazole (MTZ) hepatotoxicity is quite rare in the general population, cases of severe hepatic react... | [
{
"companynumb": "FR-AUROBINDO-AUR-APL-2021-048235",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"drugadditional": "1... |
{
"abstract": "Pregnancy-associated breast cancer is the most common solid tumor in pregnancy after cervical carcinoma but still has a low incidence. It has been associated with a poor prognosis; though based on a limited number of retrospective case-control studies, some authors have reported no differences from tha... | [
{
"companynumb": "PHHY2016ES096080",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LEVOTHYROXINE"
},
"drugadditional": null,
"... |
{
"abstract": "The objective of this study was to determine the incidence and predictors of Fanconi Syndrome (FS) in a cohort of patients taking tenofovir disoproxil fumarate (TDF). Clinical records and laboratory investigations from patients receiving TDF between 2002 and 2016 were extracted. FS was defined as normo... | [
{
"companynumb": "AU-LANNETT COMPANY, INC.-AU-2018LAN000571",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ATAZANAVIR SULFATE"
},
"druga... |
{
"abstract": "OBJECTIVE\nThe tolerance of the concurrent use of radiotherapy, pertuzumab and trastuzumab is unknown. The purpose of this study was to evaluate the toxicity of this association in patients treated for HER2 positive metastatic and/or locally recurrent unrespectable breast cancer.\n\n\nMETHODS\nA retros... | [
{
"companynumb": "FR-MYLANLABS-2021M1064197",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DOCETAXEL"
},
"drugadditional": null,
... |
{
"abstract": "This case discusses the course of a woman with a history of epilepsy, alcohol use disorder, herpes simplex virus (HSV) encephalitis, and Wernicke encephalopathy (WE) who presented with altered mental status following approximately 48 hours of vomiting. After experiencing a tonic-clonic seizure in the e... | [
{
"companynumb": "US-UCBSA-2018050042",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LACOSAMIDE"
},
"drugadditional": "1",
"dr... |
{
"abstract": "Brain metastases commonly develop in melanoma and are associated with poor overall survival of about five to nine months. Fortunately, new therapies, including immune checkpoint inhibitors and BRAF/MEK inhibitors, have been developed. The aim of this study was to identify outcomes of different treatmen... | [
{
"companynumb": "US-AMGEN-USASP2021056455",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TALIMOGENE LAHERPAREPVEC"
},
"drugadditional":... |
{
"abstract": "We describe a 67-year-old female demonstrating symptomatic multiple myeloma (MM) with anemia and bone lesions initially diagnosed in 2009. Although a partial response was achieved after bortezomib and dexamethasone treatment, MM recurred in 2012. Therefore, treatment with lenalidomide, cyclophosphamide... | [
{
"companynumb": "JP-CELGENE-JPN-2015064042",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LENALIDOMIDE"
},
"drugadditional": null,
... |
{
"abstract": "Drug-induced interstitial lung disease (DILD) is a life-threatening adverse reaction. The Japanese population is more susceptible to DILD as compared with other populations, suggesting its pathogenesis could vary depending on ethnic genetic background. We conducted case-control studies to elucidate the... | [
{
"companynumb": "JP-009507513-2012JPN004270",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SITAGLIPTIN"
},
"drugadditional": "3",
... |
{
"abstract": "Immune checkpoint inhibitors (ICI) may cause eruptions resembling cutaneous autoimmune diseases. There are six cases of immunotherapy-associated subacute cutaneous lupus erythematosus (SCLE) in the literature. We present details of five patients referred to the Skin Toxicity Program at the Dana-Farber ... | [
{
"companynumb": "US-TEVA-2021-US-1910228",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "LISINOPRIL"
},
"drugadditional": null,
... |
{
"abstract": "Managing medication during pregnancy and lactation in multiple sclerosis (MS) patients needs to balance potential risks to the newborn with the substantial risks of ongoing disease activity.\n\n\n\nTo evaluate the potential transfer of natalizumab (NAT) into breast milk and into the serum of newborn ba... | [
{
"companynumb": "DE-BIOGEN-2017BI00457609",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "NATALIZUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Dose-dense induction and up-front consolidation with autologous stem cell transplantation (ASCT) remain controversial issues when treating patients with high-risk diffuse large B-cell lymphoma. GELA designed a randomized phase 2 trial evaluating the efficacy of either rituximab, doxorubicin, cyclophosp... | [
{
"companynumb": "FR-JNJFOC-20171004714",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional": "... |
{
"abstract": "BACKGROUND\nSeveral drugs can cause immune hemolytic anemia. Here a patient who developed hemolytic anemia after treatment with teicoplanin is described.\n\n\nMETHODS\nOwing to a two-vessel disease, a 68-year-old white man underwent coronary artery bypass grafting. He was readmitted for superficial ste... | [
{
"companynumb": "IT-RANBAXY-2014R1-91391",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TEICOPLANIN"
},
"drugadditional": "3",
... |
{
"abstract": "Dasatinib, a tyrosine kinase inhibitor (TKI), induces pulmonary hypertension (PH) in patients with chronic myeloid leukemia (CML). However, information on other TKIs is limited.We retrospectively analyzed PH prevalence by reviewing transthoracic echocardiography (TTE) findings in a population of Korean... | [
{
"companynumb": "KR-LUPIN PHARMACEUTICALS INC.-2021-20440",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "IMATINIB MESYLATE"
},
"drugadd... |
{
"abstract": "To evaluate the approach to diagnosis and management of caesarean scar pregnancy (CSP) at a regional New Zealand hospital.\n\n\n\nA retrospective case series of ten patients between June 2015 and May 2020. The data review included demographic information, ultrasound findings, human chorionic gonadotrop... | [
{
"companynumb": "NZ-PFIZER INC-202101018702",
"fulfillexpeditecriteria": "1",
"occurcountry": "NZ",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "POTASSIUM CHLORIDE"
},
"drugadditional": "3"... |
{
"abstract": "The prevalence of prescription opioid use among drivers has increased markedly in the past two decades. The purpose of this study is to assess the associations of prescription opioid use and alcohol use with the risk of fatal crash involvement in US drivers.\nWe performed a population-based case-contro... | [
{
"companynumb": "US-JNJFOC-20190913408",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MEPERIDINE"
},
"drugadditional": null,
... |
{
"abstract": "Vancomycin is a commonly used antibiotic with potent activity against Gram-positive organisms, but prolonged use and high doses can lead to toxicity. While vancomycin-associated nephrotoxicity is widely reported, few cases of ototoxicity have been described. The objective of this study was to determine... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2019SP012346",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"drugadditional... |
{
"abstract": "Genetic causes of many familial arrhythmia syndromes remain elusive. In this study, whole-exome sequencing (WES) was carried out on patients from three different families that presented with life-threatening arrhythmias and high risk of sudden cardiac death (SCD). Two French Canadian probands carried i... | [
{
"companynumb": "NL-MYLANLABS-2017M1008635",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "EPINEPHRINE"
},
"drugadditional": "3",
... |
{
"abstract": "Carcinoma of the collecting ductsof Bellini isa rare histological subtype of renal cell carcinoma and mostly has unfavorable prognosis. Radical nephrectomy is generally chosen for the 1st line treatment but therapeutic approaches for the metastasis/recurrence have not been established. We report a case... | [
{
"companynumb": "JP-PFIZER INC-2017314084",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TEMSIROLIMUS"
},
"drugadditional": null,
... |
{
"abstract": "Resistance to chemotherapy is a complex and very frequent problem in the treatment of breast cancer. It is associated with a poor prognosis and short overall survival. We report a patient with advanced breast cancer without response to anthracyclines or taxanes but who controlled the disease for 15 mon... | [
{
"companynumb": "PHHY2015PE084331",
"fulfillexpeditecriteria": "1",
"occurcountry": "PE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CAPECITABINE"
},
"drugadditional": null,
"d... |
{
"abstract": "Ataxia-telangiectasia (A-T) is an infrequent autosomal recessive disorder that involves multiple systems and is characterized by progressive cerebellar ataxia, oculocutaneous telangiectasias, radiosensitivity, immune deficiency with recurrent respiratory infections, and a tendency to develop lymphoid m... | [
{
"companynumb": "CN-SUN PHARMACEUTICAL INDUSTRIES LTD-2018R1-187985",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drug... |
{
"abstract": "OBJECTIVE\nMetformin combined with the mTOR inhibitor rapamycin showed potential synergistic anti-tumor activity in preclinical studies in pancreatic ductal adenocarcinoma (PDA). This phase 1b study (NCT02048384) was conducted to evaluate the feasibility and activity of metformin +/- rapamycin in the m... | [
{
"companynumb": "US-PFIZER INC-2020431054",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SIROLIMUS"
},
"drugadditional": null,
... |
{
"abstract": "A 67-year-old woman presented with a history of dilated cardiomyopathy with congestive heart failure since 2003, who subsequently developed lower rectal cancer (adenocarcinoma) with liver, bone, and lymph node metastasis. Abdominoperineal resection and hepatectomy were performed. The patient received t... | [
{
"companynumb": "PHHY2013TW088875",
"fulfillexpeditecriteria": "1",
"occurcountry": "TW",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": null,
"dru... |
{
"abstract": "Non-tuberculous mycobacteria (NTM) are recognized as an important cause of human diseases and infections. It is commonly known to cause infections of the skin, soft tissue infections, and pulmonary infection as well as bacteraemia. We report a challenging case of severe mycobacterium abscessus bacterae... | [
{
"companynumb": "MY-CONCORDIA PHARMACEUTICALS INC.-E2B_00010971",
"fulfillexpeditecriteria": "1",
"occurcountry": "MY",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugad... |
{
"abstract": "Central sleep apnea (CSA) and continuous positive airway pressure (CPAP) emergent CSA are common in patients for whom opioids have been prescribed for chronic pain management. It is not known if opioids are the potential cause of CSA. We report the case of a patient who underwent multiple full nights o... | [
{
"companynumb": "US-ALVOGEN-2017-ALVOGEN-092926",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HYDROCODONE"
},
"drugadditional": "1",
... |
{
"abstract": "Fludarabine combination chemotherapy achieves high response rates in chronic lymphocytic leukemia (CLL) and indolent lymphoma. The aim of this study was to investigate the incidence and characteristics of treatment-related myelodysplasia and acute myeloid leukemia (t-MDS/AML) after treatment with fluda... | [
{
"companynumb": "AU-PFIZER INC-2018149472",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FLUDARABINE PHOSPHATE"
},
"drugadditional": nu... |
{
"abstract": "Ovarian small cell carcinoma is a rare and highly malignant neoplasm carrying a poor prognosis. Although combination chemotherapy remains the cornerstone of treatment due to the rarity of these tumors, no regimen can be recommended as standard of care although in the majority of cases platinum-based re... | [
{
"companynumb": "GR-TEVA-2017-GR-831365",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": "3",
"... |
{
"abstract": "Prosthetic valve endocarditis due to Cardiobacterium hominis is rare and recommended therapy includes a third generation cephalosporin. We report a case of Cardiobacterium hominis endocarditis post transcatheter aortic valve replacement in a patient with significant beta-lactam antimicrobial sensitivit... | [
{
"companynumb": "US-BAYER-2018-033785",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CIPROFLOXACIN"
},
"drugadditional": null,
... |
{
"abstract": "Following acetaminophen (APAP) overdose there is an inflammatory response triggered by the release of cellular contents from necrotic hepatocytes into the systemic circulation which initiates the recruitment of neutrophils into the liver. It has been demonstrated that neutrophils do not contribute to A... | [
{
"companynumb": "US-JNJFOC-20140410824",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": null,
... |
{
"abstract": "Congenital bilateral perisylvian syndrome (CBPS) is a rare neurological disorder associated with typical clinical and imaging features such as bilateral symmetrical polymicrogyria, either exclusively or mainly affecting the perisylvian region of the brain. We present a girl with the typical clinical pi... | [
{
"companynumb": "DE-MYLANLABS-2021M1023119",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": null,
... |
{
"abstract": "Background Although indomethacin (IND) is the standard treatment for hemodynamically significant patent ductus arteriosus (hsPDA) in Japan, it may be associated with renal impairment and gastrointestinal complications. The use of paracetamol for hsPDA closure has recently increased. Unlike IND, parace... | [
{
"companynumb": "JP-FRESENIUS KABI-FK201906344",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "INDOMETHACIN"
},
"drugadditional": null,
... |
{
"abstract": "The use of high-dose chemotherapy followed by hematopoietic rescue is increasing worldwide for solid tumors. Several studies have suggested that the period of absolute neutrophil count (ANC, < 500/ml) may be shortened in patients who receive peripheral blood progenitor cells (PBPC). To estimate the cli... | [
{
"companynumb": "IT-AMGEN-ITASP2021039936",
"fulfillexpeditecriteria": "2",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "IFOSFAMIDE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nPomalidomide and dexamethasone is a standard of care for patients with multiple myeloma in whom bortezomib and lenalidomide treatment has failed. KEYNOTE-183 assessed efficacy and safety of pomalidomide and dexamethasone with or without pembrolizumab in patients with relapsed or refractory ... | [
{
"companynumb": "ES-MYLANLABS-2019M1098224",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "AMIODARONE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nFor patients with locally advanced cutaneous squamous cell carcinoma (LA-cSCC), radiotherapy alone (RT) is often the only treatment option with modest tumor response. We report the outcomes of using combination of programmed cell death protein-1 (PD-1) inhibitor and RT in the treatment of i... | [
{
"companynumb": "CA-SA-2021SA417734",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CEMIPLIMAB-RWLC"
},
"drugadditional": "1",
... |
{
"abstract": "Inflammatory bowel disease (IBD) commonly affects women of reproductive age. Many patients lacking knowledge about IBD and reproduction make uninformed decisions, such as voluntary childlessness and medication cessation. Education should be individualized to the patient's knowledge base and include top... | [
{
"companynumb": "US-UCBSA-2019043480",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CERTOLIZUMAB PEGOL"
},
"drugadditional": "3",
... |
{
"abstract": "Purpose. To report a rare case of pseudotumor cerebri (PTC) in a child two months after receiving treatment with recombinant human growth hormone (rhGH) and to emphasize the need of close collaboration between ophthalmologists and pediatric endocrinologists in monitoring children receiving rhGH. Method... | [
{
"companynumb": "CY-EMD SERONO-7101208",
"fulfillexpeditecriteria": "1",
"occurcountry": "CY",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SOMATROPIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nEssential thrombocytosis (ET) is a myeloproliferative neoplasm characterized by clonal proliferation of the megakaryocytic lineage within the bone marrow and phenotypically by an elevated platelet count in peripheral blood. Common vascular complications include thrombosis, microvascular dis... | [
{
"companynumb": "CN-SUN PHARMACEUTICAL INDUSTRIES LTD-2019R1-218087",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"... |
{
"abstract": "OBJECTIVE\nA prospective phase II study was initiated to assess the response rate, survival, and late effects of treatment in patients with newly diagnosed CNS germ cell tumors (GCT), using etoposide plus cisplatin followed by radiation therapy prescribed by extent of disease, histology, and response t... | [
{
"companynumb": "US-PFIZER INC-2021148651",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MANNITOL"
},
"drugadditional": "3",
... |
{
"abstract": "Very few cases of lung transplant patients affected by coronavirus disease 2019 (COVID-19) have been reported to date. A 31-year-old patient who underwent bilateral lung transplantation for cystic fibrosis in 2012 was admitted for severe acute lower limb pain. He had a confirmed exposure to COVID-19 an... | [
{
"companynumb": "FR-ACCORD-194725",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "BACKGROUND Acute bacterial pericarditis is rare, and the incidence numbers have been declining in the modern antibiotic era. Purulent bacterial pericarditis is a fatal disease in which mortality rates can reach 100% if left untreated. CASE REPORT We present a case of primary purulent bacterial pericard... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2020SP005893",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IBUPROFEN"
},
"drugadditional":... |
{
"abstract": "Amyloid A nephropathy is a possible complication of chronic inflammatory disease. Proteinuria and kidney failure are the main features of the disease. Tocilizumab (TCZ), an IL6-R antibody approved for rheumatoid arthritis, is a promising choice for histologically demonstrated nephropathy. We describe a... | [
{
"companynumb": "IT-MYLANLABS-2021M1012676",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": null... |
{
"abstract": "Patients with acute myeloid leukemia (AML) and a FLT3 internal tandem duplication (ITD) have poor outcomes to current treatment. A phase 2 hypothesis-generating trial was conducted to determine whether the addition of the multitargeted kinase inhibitor midostaurin to intensive chemotherapy followed by ... | [
{
"companynumb": "PHHY2019DE051775",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MIDOSTAURIN"
},
"drugadditional": "3",
"drug... |
{
"abstract": "Kawasaki disease is an acute multisystemic vasculitis occurring predominantly in infants and young children and rarely in adolescents and adults. At elderly age, Kawasaki disease may remain unrecognized with a subsequent delay in appropriate therapy and an increased risk of coronary artery aneurysms. W... | [
{
"companynumb": "LT-SUN PHARMACEUTICAL INDUSTRIES LTD-2015RR-98439",
"fulfillexpeditecriteria": "1",
"occurcountry": "LT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugaddi... |
{
"abstract": "BACKGROUND\nThe prognosis of advanced (stage IV) cancer of the digestive organs is very poor. We have previously reported a case of advanced breast cancer with bone metastasis that was successfully treated with combined treatments including autologous formalin-fixed tumor vaccine (AFTV). Herein, we rep... | [
{
"companynumb": "JP-ROCHE-2002366",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CAPECITABINE"
},
"drugadditional": null,
"dr... |
{
"abstract": "OBJECTIVE\nIt is not known whether specific characteristics of medication are associated with type of drug-induced liver injury (DILI) or outcome. We examined the relationships among select characteristics of medications and DILI phenotype and outcome.\n\n\nMETHODS\nWe analyzed 383 cases of DILI caused... | [
{
"companynumb": "US-JNJFOC-20140912419",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPHENIDATE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nTumor necrosis factor (TNF)-α inhibitors increase the risk of tuberculosis (TB). The objective of the present study was to determine the rate of active TB infection in inflammatory bowel disease (IBD) patients receiving anti-TNF therapy and to determine the results of their latent TB infect... | [
{
"companynumb": "TR-JNJFOC-20150422116",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "The use of angiotensin converting enzyme (ACE) inhibitors in combination with diuretics is a common strategy used for the treatment of patients affected by heart failure. An infant affected by initial congestive cardiac failure, after starting the treatment with enalapril in association with furosemide... | [
{
"companynumb": "IT-WATSON-2015-27177",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "FUROSEMIDE"
},
"drugadditional": null,
"... |
{
"abstract": "This is a 20-year-old wheelchair athlete with history of caudal regression syndrome and cervical canal stenosis who developed spinal segmental myoclonus following routine intubation for an elective procedure.\n\n\n\nThis patient is a 20-year-old man with history of caudal regression syndrome and chroni... | [
{
"companynumb": "US-MYLANLABS-2022M1023542",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": null,
... |
{
"abstract": "In this report, we describe the case of a 17-year-old boy with progressive respiratory failure requiring extracorporeal support who met clinical criteria for a presumptive diagnosis of electronic cigarette or vaping-associated acute lung injury (EVALI), with clinical, pathologic, and laboratory evidenc... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2020R1-268030",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AZITHROMYCIN ANHYDROUS"
},
... |
{
"abstract": "BACKGROUND\nThe etiology of tako-tsubo cardiomyopathy, defined as a transient left ventricular dysfunction in the absence of significant coronary artery stenosis, still remains unclear. This syndrome mainly occurs in postmenopausal women and is often associated with emotional stress or miscellaneous di... | [
{
"companynumb": "PL-ACCORD-027084",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": null,
... |
{
"abstract": "The recently reported benefit of telbivudine for renal function has not been systematically studied in long-term liver transplantation (LT) recipients who are at high risk for renal impairment. We aimed to examine whether switching lamivudine therapy to telbivudine could improve renal function in LT re... | [
{
"companynumb": "TR-CIPLA LTD.-2015TR06664",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LAMIVUDINE"
},
"drugadditional": null,
... |
{
"abstract": "A 26-year-old woman with Takayasu's arteritis (TAK) experienced back and neck pain during tocilizumab (TCZ) treatment. The levels of C-reactive protein were normal, and ultrasonography revealed no significant changes. Diffusion-weighted whole-body imaging with background body signal suppression (DWIBS)... | [
{
"companynumb": "JP-BEH-2019103588",
"fulfillexpeditecriteria": "2",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
"... |
{
"abstract": "Torsades de Pointes (TdP) is a polymorphic ventricular tachycardia that occurs in the presence of an acquired or congenital long QT syndrome (LQTS). We present the case of a 57 year-old man with end-stage renal disease on methadone maintenance in which there occurred multiple episodes of TdP during sle... | [
{
"companynumb": "US-MALLINCKRODT-T201902118",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "SIMVASTATIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nHypersensitivity reactions to non-steroidal anti-inflammatory drugs (NSAIDs) are the most common reactions to drugs. The prevalence varies from 0.6 to 5.7% in general population, but there are no data available in children. The aim of this study is to determine the frequency of patients dia... | [
{
"companynumb": "ES-JNJFOC-20160323681",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IBUPROFEN"
},
"drugadditional": null,
"... |
{
"abstract": "OBJECTIVE\nGastrointestinal toxicity is common in patients receiving common therapy of ixazomib with lenalidomide and low-dose dexamethasone (IRd) for relapsed/refractory multiple myeloma. Here, we investigated the safety and effectiveness of ixazomib dosing schedules.\n\n\nMETHODS\nWe retrospectively ... | [
{
"companynumb": "JP-TAKEDA-2020TJP019005",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IXAZOMIB CITRATE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nInitiation of chemotherapy in patients with cancer near end-of-life (EOL) has become more frequent due to an increasing number of treatment options. We aimed to analyze the proportion of metastatic colorectal cancer patients (mCRC) in Alberta, Canada, who were started on a new chemotherapy ... | [
{
"companynumb": "CA-AMGEN-CANSP2020125308",
"fulfillexpeditecriteria": "2",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PANITUMUMAB"
},
"drugadditional": null,
... |
{
"abstract": "To describe the possible association between central serous chorioretinopathy (CSCR) and desmopressin use.\nThe case histories of 2 middle-aged men with CSCR using desmopressin nasal spray were studied.\nThe diagnosis of CSCR was made on the basis of clinical features and ancillary testing (fluorescein... | [
{
"companynumb": "GB-HERITAGE PHARMACEUTICALS-2018HTG00055",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DESMOPRESSIN ACETATE"
},
"drug... |
{
"abstract": "BACKGROUND\nFixed Drug Eruption (FDE) is a drug reaction involving the skin and less commonly the mucosal membranes. Tamsulosin is an alpha-1 adrenergic receptor blocker used to treat benign prostatic hyperplasia. Dizziness and headache are among its most common side effects (Singapore Med J, 2018;59:3... | [
{
"companynumb": "SG-ALKEM LABORATORIES LIMITED-SG-ALKEM-2019-08663",
"fulfillexpeditecriteria": "1",
"occurcountry": "SG",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CETIRIZINE HYDROCHLORIDE"
},
... |
{
"abstract": "Rhabdomyolysis is an uncommon but life-threatening adverse effect of simvastatin therapy. A 73-year-old male on chronic simvastatin therapy received azithromycin for acute bronchitis. He presented with weakness of all extremities with a significant increase in creatinine phosphokinase levels and acute ... | [
{
"companynumb": "US-APOTEX-2019AP022109",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BUMETANIDE"
},
"drugadditional": null,
... |
{
"abstract": "A child with a de novo STXBP1 heterozygous missense mutation, believed to be a pathogenic variant, presented with clustering focal seizures affecting both hemispheres. These had begun at the age of 10 months with a phenotype similar to that of PCDH19 encephalopathy. MRI suggested a similarity to focal ... | [
{
"companynumb": "RU-PFIZER INC-2021670669",
"fulfillexpeditecriteria": "1",
"occurcountry": "RU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ETHOSUXIMIDE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nToxic epidermal necrolysis (TEN) is a rare severe acute exfoliative drug-induced skin disorder which has recently been ascribed to alterations in the control of keratinocyte apoptosis, mediated by an interaction between the cell surface death receptor Fas and its respective ligand. A therap... | [
{
"companynumb": "IT-PFIZER INC-2019402382",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CIPROFLOXACIN"
},
"drugadditional": "3",
... |
{
"abstract": "Paecilomyces variotii is a commonly occurring species in air and food, and it is also associated with many types of human infections. Pneumonia due to Paecilomyces variotii has been rarely reported in the medical literature. The authors report a 48-year-old patient with refractory lymphoma who underwen... | [
{
"companynumb": "BR-PFIZER INC-202101297607",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "VORICONAZOLE"
},
"drugadditional": "4",
... |
{
"abstract": "BACKGROUND\nNeoadjuvant imatinib therapy has been proposed for routine practice with favorable long-term results for patients with locally advanced gastrointestinal stromal tumors (GISTs). However, clarification of the optimal duration, safety, and oncological outcomes of neoadjuvant imatinib use befor... | [
{
"companynumb": "PHHY2019TW099024",
"fulfillexpeditecriteria": "1",
"occurcountry": "TW",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IMATINIB MESYLATE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nGeneralized tonic-clonic (GTC) seizures are the most common type of generalized seizure and more common in children than adults. This phase 3 study evaluated the efficacy and safety of pregabalin for GTC seizures in adults and children with epilepsy.\n\n\nMETHODS\nThis randomized, double-bli... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2021-03653",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PREGABALIN"
},
"druga... |
{
"abstract": "Metabolic acidosis is one of the common manifestations of Isoniazid toxicity but rare with normally used doses of the drug. Among anti tubercular drugs, rifampicin, streptomycin and capreomycin are commonly implicated in renal injury. Here we report the first case of metabolic acidosis and renal injury... | [
{
"companynumb": "IN-CMP PHARMA-2016CMP00018",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ISONIAZID"
},
"drugadditional": "1",
... |
{
"abstract": "Prostate cancer is the second-most common cause of male cancer-related death among US men. The American Cancer Society estimates that in 2014 there will be about 233,000 new cases of prostate cancer and about 29,500 deaths due to prostate cancer. Sixty percent of cases are diagnosed in men aged 65 year... | [
{
"companynumb": "US-JNJFOC-20140813270",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
... |
{
"abstract": "Patients with durable left ventricular assist devices pose special problems for management in the setting of COVID-19 infection. We describe the successful management of a 44-year-old man with severe COVID-19 infection and HeartMate 3 left ventricular assist device. His course was complicated by cytoki... | [
{
"companynumb": "US-TEVA-2020-US-1858042",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PIPERACILLIN SODIUM\\TAZOBACTAM SODIUM"
},
"dru... |
{
"abstract": "A single carbapenem-resistant, hypervirulent Klebsiella pneumoniae strain has attracted major public concern. The aim of the present study was to better understand the antimicrobial resistance and genetic characteristics of Klebsiella pneumoniae strain XJ-K1.\n\n\n\nKlebsiella pneumoniae strain XJ-K1 w... | [
{
"companynumb": "CN-GLAXOSMITHKLINE-CNCH2021GSK016458",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IBUPROFEN"
},
"drugadditional": "3... |
{
"abstract": "Sudden, severe thrombocytopenia developed in each of three patients receiving diphenylhydantion, diazepam, and sulfisoxazole, respectively. Recovery followed discontinuance of the drugs. An antiplatelet antibody requiring the presence of an appropriate drug for interaction with platelets was deomonstra... | [
{
"companynumb": "US-PFIZER INC-2020114562",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DIAZEPAM"
},
"drugadditional": "1",
... |
{
"abstract": "Neostigmine is the anticholinesterase drug most commonly used to reverse blockade or speed up recovery from neuromuscular blockade from nondepolarizing neuromuscular blocking drugs. Because of its cardiac muscarinic effects, prior or simultaneous administration of glycopyrrolate or atropine is usually ... | [
{
"companynumb": "CA-JOURNEY MEDICAL CORPORATION-2021JNY00032",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "SEVOFLURANE"
},
"drugaddit... |
{
"abstract": "OBJECTIVE\nMedication-related osteonecrosis of the jaw (MRONJ) is a commonly reported side effect of antiresorptive drugs prescribed for osteoporosis. Oral bisphosphonates (BPs) are the most frequently administered antiresorptive drugs for osteoporosis, but because of low compliance of the patients wit... | [
{
"companynumb": "IT-TEVA-814240ACC",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": "3",
"drug... |
{
"abstract": "IMPORTANCE Medications as well as chemical and food exposures have been causally linked to the development of pigmented purpuric dermatosis (PPD). We describe herein what is to our knowledge the first reported case of isotretinoin-induced PPD. OBSERVATIONS A woman in her 30s presented with purpura annu... | [
{
"companynumb": "US-RANBAXY-2014US-79680",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ISOTRETINOIN"
},
"drugadditional": "1",
... |
{
"abstract": "Spontaneous palatal perforation can be rarely developed by several causes, such as tumor, trauma, and infection. This article reports a patient with large mid-palatal perforation after suffering from severe oral mucositis, which occurred about a month after taking methotrexate (MTX) for rheumatoid arth... | [
{
"companynumb": "KR-TEVA-2018-KR-959385",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": "1",
... |
{
"abstract": "Patients with isolated methylmalonic acidemia (MMA) may present with a wide range of hematological complications including anemia, leukopenia, thrombocytopenia, and pancytopenia. However, there are very limited data on the development of hemophagocytosis or myelodysplasia in these patients. We report t... | [
{
"companynumb": "SA-AMGEN-SAUSP2018174175",
"fulfillexpeditecriteria": "1",
"occurcountry": "SA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FILGRASTIM"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are causes of rare but life-threatening emergencies characterized by desquamation of the skin and mucosa. As SJS most commonly presents with skin rash followed by mucosal involvement, we present a case of vulvovaginal lesion... | [
{
"companynumb": "US-TEVA-2019-US-1041262",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM"
},
"drugadditio... |
{
"abstract": "Amantadine hydrochloride is an antiviral agent that is also effective in the treatment of Parkinson's disease. In the literature, cardiac arrhythmia is reported in toxic doses of amantadine, but in this paper we report a patient with right ventricular outflow tract (RVOT) tachycardia after an initial d... | [
{
"companynumb": "TR-BANPHARM-20154453",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "AMANTADINE"
},
"drugadditional": null,
... |
{
"abstract": "Over the last 10 years we have registered in our district (about 500,000 inhabitants) 36 cases of fatal methadone poisoning, involving both patients on treatment and naive subjects: this is a significant increase of deaths due to methadone use, misuse or abuse compared with previous years. Twenty-four ... | [
{
"companynumb": "IT-ROXANE LABORATORIES, INC.-2016-RO-00697RO",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "NORDAZEPAM"
},
"drugaddit... |
{
"abstract": "Opportunistic infection with Pneumocystis jiroveci pneumonia (PCP) has not been recognized as a significant complication of early-stage breast cancer treatment. However, we have observed an increase in PCP incidence among patients receiving chemotherapy for early-stage breast cancer. Herein we identify... | [
{
"companynumb": "US-PFIZER INC-2015411235",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": null,
... |
{
"abstract": "Following clonidine ingestion, naloxone is seldom administered as it is considered ineffective in reversing somnolence, bradycardia, or hypotension. However, this conclusion has been based on administration of small doses (2 mg or less) of naloxone. The somnolence is frequently treated with endotrachea... | [
{
"companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-018687",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLONIDINE HYDROCHLORIDE"
}... |
{
"abstract": "A clinical scenario of a young female on 800 mg of sodium valproate (VPA) who has recently failed lamotrigine (LTG) and levetiracetam (LEV) and who is currently planning a pregnancy is presented. Currently available data pertaining to the longer-term development of children exposed to antiepileptic dru... | [
{
"companynumb": "GB-CIPLA LTD.-2015GB03147",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LAMOTRIGINE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nMinocycline black bone disease is a rare finding that can cause concern when unexpectedly encountered during routine arthroplasty. Prolonged minocycline use can cause selective staining of subchondral bone, whilst peri-articular soft tissue and cartilage appear uninvolved.\n\n\nMETHODS\nA s... | [
{
"companynumb": "AU-LUPIN PHARMACEUTICALS INC.-2021-24675",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MINOCYCLINE HYDROCHLORIDE"
},
... |
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