article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "Donor lymphocyte infusion (DLI) is typically used in 3 clinical situations: therapeutically for proven relapse of malignancy, prophylactically in patients with high-risk of relapse, and in case of mixed chimerism. Mixed chimerism, which occur after transplantation can be a sign of possible rejection. I... | [
{
"companynumb": "PL-MYLANLABS-2021M1058355",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "THIOTEPA"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nFor patients with metastatic pancreatic cancer, FOLFIRINOX (fluorouracil [5-FU], leucovorin [LV], irinotecan [IRI], and oxaliplatin) has shown improved survival rates compared with gemcitabine but with significant toxicity, particularly in patients with a high tumor burden. Because of repor... | [
{
"companynumb": "US-CIPLA LTD.-2014US01737",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "Amyloidosis is characterized by pathological deposition of abnormal protein aggregates in various tissues, AL protein being the commonest. Amyloidosis derived from leukocyte cell-derived chemotaxin 2 (LECT2) is a recently recognized form of amyloidosis in the United States with predominant involvement ... | [
{
"companynumb": "IN-ACCORD-201305",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
"drug... |
{
"abstract": "Toxicity from antimuscarinic agents precipitates a constellation of signs and symptoms; two of the most significant are agitation and delirium. Benzodiazepines are commonly used for treatment; physostigmine is also effective but is underutilized due to concerns for safety and short duration of action. ... | [
{
"companynumb": "US-JNJFOC-20201237052",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "NAPROXEN"
},
"drugadditional": "3",
"dr... |
{
"abstract": "Intravenous unfractionated heparin (UFH) remains one of the most commonly used anticoagulants in the hospital setting. The optimal protocol for initiation and maintenance of UFH has been difficult to determine. Over the past two decades, weight-based nomogram protocols have gained favor. Herein, we pre... | [
{
"companynumb": "US-PFIZER INC-2019104195",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "Bilateral anterior shoulder dislocation is a rare clinical entity with few case reports and limited series published in the literature. Bilateral shoulder dislocations are rare and of them, most are posterior. We present a highly unusual case of bilateral, atraumatic, anterior shoulder dislocation with... | [
{
"companynumb": "GB-IPCA LABORATORIES LIMITED-IPC201603-000360",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CHLOROQUINE PHOSPHATE"
},
... |
{
"abstract": "BACKGROUND\nImmediate hypersensitivity reaction to ursodiol is rare and there is no previously published protocol on ursodiol desensitization.\n\n\nMETHODS\nA 59-year-old woman with primary biliary cholangitis (PBC) developed an immediate hypersensitivity reaction to ursodiol-the first-line treatment f... | [
{
"companynumb": "CA-GLENMARK PHARMACEUTICALS-2021GMK067437",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "URSODIOL"
},
"drugadditional"... |
{
"abstract": "The optimal therapeutic approach for young diffuse large B-cell lymphoma (DLBCL) patients with high-intermediate and high-risk age-adjusted international prognostic index (aaIPI) remains unknown. Hereby we report a 10-year single-centre study of 63 consecutively treated patients. To optimize outcome, t... | [
{
"companynumb": "DE-ROCHE-1960568",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FILGRASTIM"
},
"drugadditional": null,
"drug... |
{
"abstract": "On-demand oral tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) has been approved for pre-exposure prophylaxis (PrEP) in MSM in France following the results of clinical studies, but data are limited on real-world experience.\n\n\n\nA single-center, open-label, prospective cohort study that rec... | [
{
"companynumb": "FR-MYLANLABS-2019M1046668",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "EMTRICITABINE\\TENOFOVIR DISOPROXIL FUMARATE"
},
... |
{
"abstract": "Hyperemesis gravidarum is not uncommon. Its pathogenies is multifactorial but not fully understood. We present a case of a middle class, Caucasian pregnant woman aged 24 years with coexisting type 1 diabetes, who had severe hyperemesis gravidarum from the sixth week of pregnancy and was resistant to al... | [
{
"companynumb": "GB-PFIZER INC-2018372346",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYCLIZINE"
},
"drugadditional": "3",
... |
{
"abstract": "The case study is a 33-year-old white female with persistently elevated serum human chorionic gonadotropin (hCG) levels following methotrexate treatment and emergency surgery for ectopic pregnancy. At the time of the first methotrexate dose, the serum hCG concentration was 27,995 IU/L. The laboratory w... | [
{
"companynumb": "US-ACCORD-036887",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,
"dr... |
{
"abstract": "Inferior vena cava syndrome is rare and often difficult to diagnose because of its rarity and consequent low suspicion. We describe the case of a 28-year-old female patient with a history of nephroblastoma of the right kidney, stage IV, with a favourable histology with epidural metastasis (D5-D9), diag... | [
{
"companynumb": "PT-FRESENIUS KABI-FK202100901",
"fulfillexpeditecriteria": "1",
"occurcountry": "PT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "Exogenous anabolic androgen steroid use is associated with adverse cardiovascular outcomes. A 53-year-old bodybuilder presented with 3 months of exertional dyspnoea. Physical examination showed tachycardia and pan-systolic murmur; an echocardiogram showed a left ventricular ejection fraction (EF) of 15... | [
{
"companynumb": "US-UPSHER-SMITH LABORATORIES, LLC-2018USL00218",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TESTOSTERONE"
},
"drugad... |
{
"abstract": "Visceral leishmaniasis is a disease caused by the protozoan Leishmania and is transmitted by Lutzomyia longipalpis (sand fly). It is an endemic parasitic infection in numerous areas around the Mediterranean basin. Though immunocompetent patients may not develop the disease, in transplant recipients the... | [
{
"companynumb": "ES-ALKEM LABORATORIES LIMITED-ES-ALKEM-2018-02717",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"druga... |
{
"abstract": "We report 2 fatal exacerbations of systemic capillary leak syndrome (SCLS), also known as Clarkson disease, associated with coronavirus disease (COVID-19) in the United States. One patient carried an established diagnosis of SCLS and the other sought treatment for new-onset hypotensive shock, hemoconce... | [
{
"companynumb": "US-drreddys-LIT/USA/21/0144774",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ICATIBANT ACETATE"
},
"drugadditional": ... |
{
"abstract": "Therapeutic agents targeting the PD-1/PD-L1 axis have shown durable clinical responses in patients with various cancer types. Although objective responses are common, intrapatient heterogeneous responses have been described, and the mechanism for the different organ responses remains unknown. We presen... | [
{
"companynumb": "US-009507513-1811USA011338",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PEMBROLIZUMAB"
},
"drugadditional": null,
... |
{
"abstract": "We report a patient who presented with acute abdominal pain during the COVID-19 pandemic. His work-up revealed rupture of a 5.8 cm abdominal aortic aneurysm. He also had fever, cough, and shortness of breath and radiologic evidence of COVID-19 infection. After careful consideration, he underwent succes... | [
{
"companynumb": "US-BAYER-2020-177448",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CLOPIDOGREL BISULFATE"
},
"drugadditional": null,... |
{
"abstract": "OBJECTIVE\nTo better understand the risk of fatal toxic shock caused by Clostridium sordellii in women who had a recent medical abortion with mifepristone and misoprostol.\n\n\nMETHODS\nWe performed active and passive surveillance for cases of toxic shock associated with medical or spontaneous abortion... | [
{
"companynumb": "US-PFIZER INC-2017160732",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MISOPROSTOL"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nPrevertebral soft-tissue swelling (PSTS) after anterior cervical spine surgery may result in postoperative catastrophic airway complications and persistent dysphagia. Systemic or local corticosteroids have been used to decrease complications related to PSTS. To date, studies using retrophar... | [
{
"companynumb": "KR-PFIZER INC-2015335118",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE ACETATE"
},
"drugadditiona... |
{
"abstract": "OBJECTIVE\nThe management of the drug interaction between atazanavir and tacrolimus in a renal transplant recipient is described.\n\n\nCONCLUSIONS\nA 53-year-old African-American man with human immunodeficiency virus (HIV) received a renal transplant and was treated in accordance with a corticosteroid-... | [
{
"companynumb": "NVSC2020US013749",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": "3",
... |
{
"abstract": "To assess the prevalence and isotypes of anti-nodal/paranodal antibodies to nodal/paranodal proteins in a large chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) cohort, compare clinical features in seronegative vs seropositive patients, and gather evidence of their isotype-specific path... | [
{
"companynumb": "IT-TAKEDA-2021TUS022914",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HUMAN IMMUNOGLOBULIN G"
},
"drugadditional": "3... |
{
"abstract": "We report a rare case of severe acute rhabdomyolysis in association with coadministration of levofloxacin and simvastatin in a patient with normal renal function. A 70-year-old Caucasian male was treated due to community acquired pneumonia with levofloxacin in a dosage of 500 mg once and then twice a d... | [
{
"companynumb": "DE-RANBAXY-2015RR-94491",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "3",
"activesubstance": {
"activesubstancename": "LEVOFLOXACIN"
},
"drugadditional": null,
... |
{
"abstract": "Immune checkpoint inhibitors (ICPIs) are a breakthrough therapy in oncology and have been approved by the Food and Drug Administration for the treatment of several malignancies. ICPIs have been reported to cause immune-mediated damage of islet cells leading to ICPI-induced type 1 diabetes mellitus (T1D... | [
{
"companynumb": "US-009507513-1912USA003254",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PEMETREXED DISODIUM"
},
"drugadditional": n... |
{
"abstract": "RTX could be an effective and safe alternative treatment for refractory EF. Rituximab (RTX) is a successful therapeutic option for various autoimmune diseases. Our aim is to report our experience with RTX in eosinophilic fasciitis (EF) and review published data on its efficacy for the treatment of EF. ... | [
{
"companynumb": "GR-MYLANLABS-2022M1000797",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,
... |
{
"abstract": "Cytomegalovirus is an opportunistic virus that commonly affects immunosuppressed patients. Cutaneous involvement by this virus is rare and occurs in significantly immunocompromised hosts, with a poor prognosis. Skin ulcers may represent the first sign of systemic infection by cytomegalovirus in these p... | [
{
"companynumb": "BR-ALKEM LABORATORIES LIMITED-BR-ALKEM-2022-01143",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
... |
{
"abstract": "To describe the features of chronic sinusitis associated with the use of tumour necrosis factor (TNF) inhibitors.\n\n\n\nA retrospective review of the medical records between 2003 and 2011 revealed that five patients had developed chronic sinusitis after the start of TNF inhibitor administration and re... | [
{
"companynumb": "JP-JNJFOC-20120517478",
"fulfillexpeditecriteria": "2",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ABATACEPT"
},
"drugadditional": null,
"... |
{
"abstract": "The goal of the present cohort study was to review outcomes of patients exposed to interferon beta-1b during pregnancy.\nPregnancy cases with exposure to interferon beta-1b reported to Bayer's pharmacovigilance (PV) database from worldwide sources from January 1995 through February 2018 were retrieved ... | [
{
"companynumb": "DE-DRREDDYS-GER/GER/20/0122907",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TRETINOIN"
},
"drugadditional": null,
... |
{
"abstract": "A 49-year-old man with chronic obstructive pulmonary disease (COPD) presented with significant tachypnoea, fevers, productive cough and increased work of breathing for the previous 4 days. Laboratory data showed elevated lactate of 3.2 mEq/L. Continuous inhaled ipratropium and albuterol nebuliser treat... | [
{
"companynumb": "US-VISTAPHARM, INC.-VER201709-000766",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "IPRATROPIUM"
},
"drugadditional":... |
{
"abstract": "Exposure to hydrocarbon compounds, such as benzene may cause injury to several organ systems. It occurs accidentally or intentionally by ingestion, inhalation, cutaneous exposure and either subcutaneous injection or intravenous injection. We report a patient who injected benzene into the left hemithora... | [
{
"companynumb": "NL-APOTEX-2018AP014029",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BENZENE"
},
"drugadditional": null,
"d... |
{
"abstract": "BACKGROUND\nData regarding clinical characteristics, therapy, maternal and fetal outcomes of pregnancy-associated acute leukemia are limited.\n\n\nMETHODS\nWe herein, present the data of 27 pregnancy associated acute leukemia [18 acute myeloid leukemia (AML) and 9 acute lymphatic leukemia (ALL)]. Their... | [
{
"companynumb": "EG-MYLANLABS-2018M1064511",
"fulfillexpeditecriteria": "1",
"occurcountry": "EG",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYTARABINE"
},
"drugadditional": "3",
... |
{
"abstract": "Clozapine has proved to be an effective antipsychotic for the treatment of refractory schizophrenia - characterised by the persistence of symptoms despite optimal treatment trials with at least two different antipsychotics at adequate dose and duration - but its use is hampered by adverse effects. The ... | [
{
"companynumb": "ES-MYLANLABS-2018M1082699",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CLOZAPINE"
},
"drugadditional": "1",
... |
{
"abstract": "Eccrine poromas arise from the intraepidermal region of the eccrine sweat duct and most often occur as a benign solitary tumor. There are few reports of the occurrence of multiple lesions, defined as poromatosis, which may present in patients who have undergone radiotherapy and/or polychemotherapy. We ... | [
{
"companynumb": "US-HIKMA PHARMACEUTICALS USA INC.-US-H14001-20-51158",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "VINCRISTINE"
},
"d... |
{
"abstract": "The effectiveness of the tumor necrosis-α (TNF-α) blockade has changed the treatment of several chronic inflammatory diseases, including inflammatory bowel disease; however, this treatment also has disadvantages. The use of immunosuppressants in combination with infliximab has been associated with grea... | [
{
"companynumb": "KR-JNJFOC-20150504602",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "The combination of personalized therapy with immunotherapy might lead to rapid complete remission in patients who are too sick to be eligible for clinical trials. We report 2 such extraordinary responders. A discussion on the use and purpose of clinical trials in this new era of very active anticancer ... | [
{
"companynumb": "US-FRESENIUS KABI-FK201703236",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"drugadditional": null,
... |
{
"abstract": "Central diabetes insipidus (CDI) may occur in the setting of intracranial abnormalities that affect the hypothalamus-pituitary system. It occurs rarely in neonates, especially in the premature population, and represents a challenging disease process to treat pharmacologically. Little is known regarding... | [
{
"companynumb": "US-MYLANLABS-2022M1028882",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DESMOPRESSIN"
},
"drugadditional": "1",
... |
{
"abstract": "Background: Infection of Chlamydia psittaci (C. psittaci) could lead to serious clinical manifestations in humans, including severe pneumonia with rapid progression, adult respiratory distress syndrome (ARDS), sepsis, multiple organ dysfunction syndromes (MODS), and probably death. Implementation of ex... | [
{
"companynumb": "CN-SLATE RUN PHARMACEUTICALS-22CN001109",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AZITHROMYCIN"
},
"drugadditiona... |
{
"abstract": "The incidence of perinatal and neonatal Listeriosis is underestimated due undiagnosed stillbirths, misdiagnosis of NL and underreporting of single case reports. Recent outbreaks reinforce the need for better surveillance and targeted health education in certain population groups especially during pregn... | [
{
"companynumb": "PHHY2017US156618",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMPICILLIN"
},
"drugadditional": "3",
"druga... |
{
"abstract": "Sofosbuvir is a direct-acting antiviral drug used to treat chronic hepatitis C infection. In 2015, Gilead Sciences, the manufacturer of sofosbuvir, warned that bradycardia could occur when sofosbuvir is administered in combination with amiodarone. Interestingly, among the reported cases of patients wit... | [
{
"companynumb": "DZ-IMPAX LABORATORIES, INC-2017-IPXL-03841",
"fulfillexpeditecriteria": "1",
"occurcountry": "DZ",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "RIBAVIRIN"
},
"drugadditiona... |
{
"abstract": "Background Argentina is considered a region of low seroprevalence of hepatitis E virus (HEV), however; no studies have evaluated its burden among acute hepatitis cases.\n\n\n\nWe aimed to estimate the proportion of acute HEV and outcome in a cohort of patients with acute hepatitis from 6 liver units in... | [
{
"companynumb": "NVSC2020AR099805",
"fulfillexpeditecriteria": "1",
"occurcountry": "AR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": "3",
"dr... |
{
"abstract": "OBJECTIVE\nPhysiologic uptake of 18F-fluorodeoxyglucose (FDG) in brown adipose tissue (adipose tissue) of cancer patients may confound interpretation of positron emission tomography (PET) scans. Uptake in adipose tissue occurs in up to half of pediatric oncology patients undergoing PET scans, and is es... | [
{
"companynumb": "US-PFM-2020-22790",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PROPRANOLOL HYDROCHLORIDE"
},
"drugadditional": "4",
... |
{
"abstract": "BACKGROUND\nIdentifying specific endotypes within the broad picture of chronic rhinosinusitis with nasal polyps (CRSwNP), by using biomarkers for instance, remains a challenge. The prognostic role of the neutrophil-to-lymphocyte ratio (NLR) and the eosinophil-to-lymphocyte ratio (ELR) as potential mark... | [
{
"companynumb": "IT-009507513-1709ITA004598",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": "3"... |
{
"abstract": "Refractory hypotension is a known entity in liver transplantation. Catecholamine and vasopressin infusions are first-line therapies. There has been recent interest in angiotensin II (Ang-2) as an alternative vasopressor; however, liver failure patients were excluded from the original trials. Ang-2 has ... | [
{
"companynumb": "US-TEVA-2021-US-1944753",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "3",
"activesubstance": {
"activesubstancename": "NOREPINEPHRINE"
},
"drugadditional": null,
... |
{
"abstract": "Pegylated liposomal doxorubicin (PLD) is an anthracycline anticancer agent used in ovarian cancer and a form of doxorubicin enclosed in pegylated liposomes. There are only a few reports on intertrigo-like eruptions caused by PLD. We describe the first case of severe bullous erythema, including intertri... | [
{
"companynumb": "JP-PFIZER INC-2019209228",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DOXORUBICIN"
},
"drugadditional": "1",
... |
{
"abstract": "BACKGROUND\nWe evaluated the clinical effectiveness of variable courses of paracetamol on patent ductus arteriosus (PDA) closure and examined its effect on the in vitro term and preterm murine ductus arteriosus (DA).\n\n\nMETHODS\nNeonates received one of the following three paracetamol regimens: short... | [
{
"companynumb": "IE-JNJFOC-20140906690",
"fulfillexpeditecriteria": "1",
"occurcountry": "IE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": null,
... |
{
"abstract": "Valproate-induced hypothyroidism is a rare condition and has been considered asymptomatic. Here, we report a case of bipolar I disorder who developed symptomatic valproate-induced hypothyroidism.\nA 44-year-old woman with bipolar I disorder complained of severe fatigue after starting valproate. She sho... | [
{
"companynumb": "JP-VISTAPHARM, INC.-VER202009-001641",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "VALPROIC ACID"
},
"drugadditional"... |
{
"abstract": "Baclofen (BLF) has been prescribed in the UK since 1972 for the alleviation of spasticity. However, evidence suggests BLF is also recreationally misused. It has been associated with ethanol, gamma-hydroxybutyric acid (GHB), pregabalin (PGL) and gabapentin (GBP) use/abuse, and deaths have been reported.... | [
{
"companynumb": "GB-ENDO PHARMACEUTICALS INC-2021-011838",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BACLOFEN"
},
"drugadditional": ... |
{
"abstract": "We describe a 64-year-old male of Indian descent with a history of atrial fibrillation who was started on warfarin after hospital admission for acute stroke. He received genotype-guided warfarin dosing as per the standard-of-care at our hospital, with daily dose recommendations provided by the pharmaco... | [
{
"companynumb": "US-ROXANE LABORATORIES, INC.-2014-BI-55472GD",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugad... |
{
"abstract": "Optimal conditioning regimens for older patients with myelofibrosis undergoing allogeneic hematopoietic cell transplant are not known. Likewise, the role of dose intensity is not clear. We conducted a nonrandomized, prospective, phase II trial using low-dose, later escalated to high-dose (myeloablative... | [
{
"companynumb": "NVSC2020US177629",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FLUDARABINE PHOSPHATE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nBecause of relatively small treatment numbers together with low adverse drug reaction (ADR) reporting rates the timely identification of ADRs affecting children and young people is problematic. The primary objective of this study was to assess the utility of unplanned medication discontinua... | [
{
"companynumb": "GB-ROCHE-1490484",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ORLISTAT"
},
"drugadditional": null,
"druga... |
{
"abstract": "Association of immunotherapy and/or chemotherapy and/or targeted therapy, in sequence or as single therapies, may induce osteonecrosis of the jaw. Multidisciplinary team management of these patients should be provided.",
"affiliations": "Maxillo-facial and ENT Surgery Unit INT - IRCCS \"Fondazione G.... | [
{
"companynumb": "IT-ROCHE-2742974",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "IPILIMUMAB"
},
"drugadditional": null,
"drug... |
{
"abstract": "OBJECTIVE\nTo observe the efficacy and safety of chemotherapy regimens oxaliplatin combined with capecitabine (CAPOX) or oxaliplatin combined with tegafur, gimeracil and oteracil potassium capsules (S-1)(SOX), and to investigate the value of expression of thymidine phosphorylase (TP) and dihydropyrimid... | [
{
"companynumb": "CN-ROCHE-1713762",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IRINOTECAN"
},
"drugadditional": null,
"drug... |
{
"abstract": "OBJECTIVE\nTo compare intravitreal ranibizumab and dexamethasone implant in patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).\n\n\nMETHODS\nParticipants were 42 treatment naive patients with ME due to CRVO, who received either intravitreal 0.5 mg ranibizumab (n = 25) ... | [
{
"companynumb": "GR-ALLERGAN-1726329US",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nProgressive multifocal leukoencephalopathy results from lytic infection of the glia by the JC polyomavirus (JCV); JCV granule cell neuronopathy is caused by infection with a mutated form of JCV, leading to a shift in viral tropism from the glia to cerebellar granule cells. This shift results... | [
{
"companynumb": "US-ROCHE-1351825",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RITUXIMAB"
},
"drugadditional": null,
"druga... |
{
"abstract": "To estimate the incidence of pulmonary aspiration and other anesthesia-related adverse events in women undergoing dilation and evacuation (D&E) under intravenous deep sedation without tracheal intubation in an outpatient setting.\n\n\n\nWe reviewed all D&Es done under anesthesiologist-administered intr... | [
{
"companynumb": "PHHY2019US117854",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXYCYCLINE"
},
"drugadditional": "3",
"drug... |
{
"abstract": "Pyoderma gangrenosum is a rare, chronic, non infectious ulcerative skin disease. It is an inflammatory neutrophilic dermatosis. It is associated in 50% with a systemic disorder. Unfortunately, there are no randomized controlled studies concerning PG treatment. Immunosuppression is the mainstay of treat... | [
{
"companynumb": "BE-PFIZER INC-2020301925",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AZATHIOPRINE"
},
"drugadditional": "3",
... |
{
"abstract": "Background Nontuberculous mycobacterial (NTM) flexor tenosynovitis represents a rare but potentially devastating manifestation of upper extremity infection. We present a novel case of NTM flexor tenosynovitis in which Mycobacter iumimmunogenum was found to be the causative agent. Case Description The... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2022R1-325413",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AZITHROMYCIN"
},
"dr... |
{
"abstract": "An immunocompetent adult received corticosteroids for chest pain, which later was clinically found to be herpes zoster (HZ). She developed severe disease and rapid viral dissemination that elicited an exceptionally strong varicella zoster virus-specific B-cell and CD8 T-cell response. Clinicians should... | [
{
"companynumb": "US-FRESENIUS KABI-FK201910477",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACYCLOVIR SODIUM"
},
"drugadditional": "3... |
{
"abstract": "The programmed-death-1 inhibitors selectively block programmed-death-1 interaction with its receptor, which restores active T-cell response directed at tumor cells, inducing an anti-tumor effect. This nonspecific activation of the immune system can also lead to a wide spectrum of side effects. Nivoluma... | [
{
"companynumb": "US-SA-2017SA259045",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DIFLUPREDNATE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nEndoscopic endonasal approaches have been shown to be as effective as transcranial approaches for sinonasal malignancies involving the skull base. Although they are associated with less risk than an open cranial resection, cerebrospinal fluid (CSF) leaks remain a main concern. Some drugs ca... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2019R1-213388",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEUPROLIDE"
},
"drug... |
{
"abstract": "OBJECTIVE\nSerotonin syndrome (SS) can occur when linezolid is combined with other serotonergic agents.\n\n\nMETHODS\nWe report a case of possible SS in an elderly patient receiving linezolid in combination with carbidopa-levodopa (CL).\n\n\nCONCLUSIONS\nAlthough certain classes of agents are commonly ... | [
{
"companynumb": "US-IMPAX LABORATORIES, INC-2016-IPXL-00183",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FUROSEMIDE"
},
"drugadditio... |
{
"abstract": "A 47-year-old live kidney-donor woman presented with headaches and blurred vision. Neuro-ophthalmological examination demonstrated papilledema and right eye inferior nasal defect. Brain MRV showed no sinus thrombosis but solitary right venous sinus draining the torcular Herophili to right jugular bulb.... | [
{
"companynumb": "US-TARO-2021TAR00162",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ACETAZOLAMIDE"
},
"drugadditional": null,
... |
{
"abstract": "This randomised, double-blind study compared pharmacokinetics, efficacy, safety and immunogenicity of PF-05280014 (potential trastuzumab biosimilar) and trastuzumab reference product (Herceptin) sourced from the European Union (trastuzumab-EU) as neoadjuvant treatment for operable human epidermal growt... | [
{
"companynumb": "US-SA-2018SA201970",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": null,
"d... |
{
"abstract": "Patients with monoclonal gammopathy of undetermined significance (MGUS) have a higher risk for the development of concomitant primary cancers such as multiple myeloma (MM) and myelodysplastic syndrome (MDS). We report the case of patient initially suffering from MGUS of the IgG lambda subtype for more ... | [
{
"companynumb": "DE-CELGENEUS-062-21880-13084211",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LENALIDOMIDE"
},
"drugadditional": null... |
{
"abstract": "Diffuse involvement of colorectal lymphoma masquerading as colitis is a very rare presentation of primary colorectal lymphoma. Detecting occult lymphoma is difficult in the setting of diffuse colonic involvement with no definite mass and inflammatory mucosal changes. We encountered a case of diffuse-ty... | [
{
"companynumb": "KR-BAXTER-2019BAX020802",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nFOLFOX is a standard chemotherapy regimen used to treat colorectal cancer. Adverse events associated with FOLFOX treatment include peripheral neuropathy and myelosuppression. This report discusses the case of a 64-year-old man with rectal cancer who developed hyperammonemia and impaired cons... | [
{
"companynumb": "JP-ACCORD-231136",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEUCOVORIN"
},
"drugadditional": "1",
"druga... |
{
"abstract": "Atypical teratoid/rhabdoid tumor (AT/RT) is a rare tumor that is most frequently encountered in the pediatric patient population. AT/RT accounts for approximately 1%-2% of all pediatric central nervous system tumors and roughly 10%-20% of tumors in patients younger than 3 years of age. While AT/RT has ... | [
{
"companynumb": "US-TEVA-2020-US-1848936",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": null,
... |
{
"abstract": "We present the case of a man with acute lymphoblastic leukemia and prolonged profound neutropenia, who developed an invasive infection by Fusarium graminearum, acquired via non-cutaneous entry, with gastrointestinal symptoms, sigmoid perforation and liver abscesses due to portal dissemination. The etio... | [
{
"companynumb": "MX-AMGEN-MEXSP2021084725",
"fulfillexpeditecriteria": "2",
"occurcountry": "MX",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
... |
{
"abstract": "Immune-checkpoint inhibitors (ICIs) provide a promising treatment option for advanced tumors including small cell lung cancer (SCLC). Nevertheless, in addition to immune-related adverse events (irAEs), an increased risk of infection including tuberculosis has been previously described. Here, we report ... | [
{
"companynumb": "DE-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-009440",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "IPILIMUMAB"
},
"drugadd... |
{
"abstract": "BACKGROUND\nCisplatin is commonly used in hyperthermic intraperitoneal chemotherapy (HIPEC) for the management of peritoneal carcinomatosis. Little is known about the nephrotoxic effects of cisplatin use in HIPEC.\n\n\nOBJECTIVE\nTo report the incidence of nephrotoxicity post-HIPEC using cisplatin 50 m... | [
{
"companynumb": "SA-MYLANLABS-2015M1015050",
"fulfillexpeditecriteria": "1",
"occurcountry": "SA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LOSARTAN"
},
"drugadditional": null,
... |
{
"abstract": "Hepatic angiosarcoma is an extremely rare disease entity that accounts for approximately 0.1%-2% of primary liver malignancy. It is three times more common in men than women and usually affects the former in their sixth or seventh decade of life. Risk factors for the development of hepatic angiosarcoma... | [
{
"companynumb": "AU-ACCORD-072070",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": "3",
"dru... |
{
"abstract": "We investigated the hypothesis that gemtuzumab ozogamicin (GO), an anti-CD33 immunotoxin would improve the efficacy of fludarabine/melphalan as a preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT) in a phase I/II trial. Toxicity was defined as grades III-IV organ damage, ... | [
{
"companynumb": "US-PFIZER INC-2018148082",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GEMTUZUMAB OZOGAMICIN"
},
"drugadditional": "3... |
{
"abstract": "Invasive fungal disease of the head and neck is a potentially fatal infection most commonly seen in immunocompromised patients. Even in the setting of combined surgical and medical treatment, prognosis is generally poor. We report the first pediatric case of invasive fungal pharyngitis and summarize a ... | [
{
"companynumb": "US-APOTEX-2022AP005321",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": "1",
... |
{
"abstract": "We present a 74-year-old woman who developed a portal vein thrombosis following an elective total knee replacement. She had atrial fibrillation for which she was taking warfarin for anticoagulation. Seven days prior to surgery, she was instructed to discontinue warfarin and replace it with prophylactic... | [
{
"companynumb": "GB-MYLANLABS-2017M1004412",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "WARFARIN"
},
"drugadditional": "3",
... |
{
"abstract": "One of the primary targets of immune checkpoint inhibition is the negative immune regulatory molecule CTLA-4. Immune-related adverse events are commonly observed following CTLA-4 inhibition in melanoma treatment, and a spectrum of these conditions are also observed in individuals with germline haploins... | [
{
"companynumb": "NVSC2019AU007220",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": "2",
... |
{
"abstract": "OBJECTIVE\nInter-individual thiopurine metabolism variability can influence treatment outcomes in inflammatory bowel disease (IBD) patients. Genetic polymorphisms in thiopurine methyltransferase (TPMT) and inosine triphosphate pyrophosphatase (ITPA) were linked with toxicity of azathioprine (AZA). The ... | [
{
"companynumb": "LT-ALKEM LABORATORIES LIMITED-LT-ALKEM-2022-01228",
"fulfillexpeditecriteria": "1",
"occurcountry": "LT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AZATHIOPRINE"
},
"dru... |
{
"abstract": "Beta-thalassemia major is a subtype component of hemoglobinopathies; autosomal recessive disorders complicated with anemia that affect at least 50,000 babies each year. It contributes to problems in reproductive entities such as infertility due to iron deposition in the endocrine organs, which leads to... | [
{
"companynumb": "MY-VALIDUS PHARMACEUTICALS LLC-MY-2020VAL000199",
"fulfillexpeditecriteria": "1",
"occurcountry": "MY",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DEFEROXAMINE MESYLATE"
},
... |
{
"abstract": "Purpose: To describe tuberculous uveitis (TU) presenting as a bullous retinal detachment (RD) and to perform a comprehensive literature review on TU with similar features. Methods: Observational case report and systematic literature review. Results: An 84-year-old woman presented with bilateral granulo... | [
{
"companynumb": "KR-SA-2019SA254777",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
"dr... |
{
"abstract": "Subcutaneous (SC) administration of ertapenem in outpatient parenteral antimicrobial therapy (OPAT) services may be a practical alternative to intravenous delivery for complicated infections. The clinical features and outcomes according to route of administration were compared from a large Australian O... | [
{
"companynumb": "AU-009507513-2110AUS008931",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ERTAPENEM SODIUM"
},
"drugadditional": "1",
... |
{
"abstract": "We have reviewed the histopathological features of 11 patients with pustular drug eruptions. Two main histological patterns were seen. Eight cases revealed features of toxic pustuloderma with the presence of spongiform intraepidermal pustules in association with papillary oedema and a mixed inflammator... | [
{
"companynumb": "GB-PFIZER INC-2019273593",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SULFASALAZINE"
},
"drugadditional": "3",
... |
{
"abstract": "This review will summarize the most recent and pertinent evidence regarding immune checkpoint inhibitor (ICI)-induced hypophysitis to describe diagnostic and management algorithm with the help of a case report.\n\n\n\nHypophysitis is the most common endocrine adverse event from CTLA-4 inhibitors and mu... | [
{
"companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-073569",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IPILIMUMAB"
},
"drugadd... |
{
"abstract": "BACKGROUND Radial artery access during coronary angiography has gained popularity as there are fewer associated complications when compared with femoral artery access. However sporadic complications can occur following radial artery catheterization. A rare case of axillary, chest wall and abdominal hem... | [
{
"companynumb": "US-DRREDDYS-USA/USA/19/0107231",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLOPIDOGREL BISULFATE"
},
"drugadditiona... |
{
"abstract": "Current guidelines recommend deferring liver transplantation (LT) in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection until clinical improvement occurs and two PCR tests collected at least 24 hours apart are negative. We report a case of an 18-year-old, previously he... | [
{
"companynumb": "US-TEVA-2021-US-1984952",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
"drugadditional": "4",
... |
{
"abstract": "Primary cauda equina lymphoma (CEL) is a rare malignant tumor among various neoplasms that affects the cauda equina nerve roots. The present case report described the case of a 65-year-old man who presented with cauda equina syndrome with progressive motor palsy in the legs and gait disturbance over th... | [
{
"companynumb": "JP-TEVA-2018-JP-922840",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CYTARABINE"
},
"drugadditional": null,
... |
{
"abstract": "Sarcomas are a relatively rare cancer, but often incurable at the late metastatic stage. Oncolytic immunotherapy has gained attention over the past years, and a wide range of oncolytic viruses have been delivered via intratumoral injection with positive safety and promising efficacy data. Here, we repo... | [
{
"companynumb": "FI-ROXANE LABORATORIES, INC.-2015-RO-01087RO",
"fulfillexpeditecriteria": "1",
"occurcountry": "FI",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEXAMETHASONE"
},
"drugadd... |
{
"abstract": "Recent literature has demonstrated concern over the risk of Pneumocystis jirovecii pneumonia (PJP) when administering rituximab with combination chemotherapy such as in R-CHOP; however, the exact risk and potential need for prophylaxis is unknown. We sought to determine the incidence of PJP infection f... | [
{
"companynumb": "US-JNJFOC-20161119118",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional": "... |
{
"abstract": "Fatal pulmonary hemorrhages and rapidly progressive glomerulonephritis occurred in three patients with Wilson's disease (hepatolenticular degeneration) who had been treated with penicillamine for 2 to 31/2 years. Light microscopic studies of the kidneys showed severe glomerulonephritis with crescent fo... | [
{
"companynumb": "US-BAUSCH-BL-2019-007545",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PENICILLAMINE"
},
"drugadditional": null,
... |
{
"abstract": "The incidence of treatment related mortality in children with acute lymphoblastic leukemia (ALL) is reported to be between 2% and 4% with infections being the leading cause.\n\n\n\nTo establish a relationship between body mass index at diagnosis (BMI 0), after protocol I therapy completion (BMI I) and ... | [
{
"companynumb": "PL-JNJFOC-20190529536",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VINCRISTINE"
},
"drugadditional": "3",
... |
{
"abstract": "Parkinsonian symptoms are common adverse effects of antipsychotics. Older adults are particularly vulnerable to drug-induced parkinsonism. Nonetheless, parkinsonian symptoms in seniors treated with antipsychotics cannot be straightforwardly attributed to antipsychotic medication. A comprehensive diagno... | [
{
"companynumb": "GB-SUN PHARMACEUTICAL INDUSTRIES LTD-2022R1-342359",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "ALPRAZOLAM"
},
"drug... |
{
"abstract": "Chronic granulomatous disease (CGD) is an autosomal recessive or X-linked disorder caused by NADPH oxidase deficiency leading to an impaired ability of reactive superoxide anion and metabolite formation and recurring severe bacterial and fungal infections, with a high mortality rate. Diarrhea, colitis,... | [
{
"companynumb": "TR-PFIZER INC-2016003539",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SULFASALAZINE"
},
"drugadditional": null,
... |
{
"abstract": "The authors report two cases of patients with advanced gastroenteric carcinoma, which developed different cardiotoxicity patterns after the administration of cytotoxic drugs. The first patient showed a picture of dilatative cardiomyopathy with associated symptoms of angina pectoris and congestive heart... | [
{
"companynumb": "IT-BAXTER-2020BAX021253",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional":... |
{
"abstract": "Metronidazole is an antimicrobial agent mainly used in the treatment of several protozoal and anaerobic infections, additionally, is often used in hepatic encephalopathy and Crohn disease. Apart from peripheral neuropathy, metronidazole can also cause symptoms of central nervous system dysfunction like... | [
{
"companynumb": "IN-VIVIMED-2018SP006086",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "Candida species are infrequently grown in bile cultures. An association between biliary candidiasis and regional malignancy may exist. The role of fungus membranes in frequent biliary stent occlusion is also presented in this case series.\nWe retrospectively identified patients who underwent percutaneo... | [
{
"companynumb": "JO-009507513-2109JOR000869",
"fulfillexpeditecriteria": "1",
"occurcountry": "JO",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FLUCONAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND Cancer in pregnancy is extremely rare, and gastric cancers are rarer still. Diagnosis is difficult in pregnancy due to overlapping symptoms with pregnancy such as nausea, pain, anemia, and fatigue. CASE REPORT A 26-year-old G1 woman at 32 weeks gestation with a past medical history of system... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2020R1-244182",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CEFTRIAXONE"
},
"dru... |
{
"abstract": "Recent discussions and proposed rules and regulations regarding outpatient surgery facilities have raised the question of the appropriateness of general anesthesia versus heavy sedation. The controversy is based mostly on anecdotal information and the prejudice of the authors. A recent article that des... | [
{
"companynumb": "US-ROCHE-1478270",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DIAZEPAM"
},
"drugadditional": null,
"drugad... |
{
"abstract": "Variations in the activity, up to absolute deficiency, of the enzyme dihydropyrimidine dehydrogenase (DPD), result in the occurrence of adverse reactions to chemotherapy, and have been included among the pharmacogenetic factors underlying inter-individual variability in response to fluoropyrimidines. T... | [
{
"companynumb": "IT-MYLANLABS-2019M1036908",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "EXEMESTANE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nToxoplasmosis is a rare but life-threatening infection occurring in immunocompromised hosts, including allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients. However, thus far, the clinical features and incidence of toxoplasmosis in autologous HSCT (auto-HSCT) recipients... | [
{
"companynumb": "JP-TEVA-2022-JP-2033022",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "4",
... |
{
"abstract": "Hematologic malignances are more common and often higher risk in older patients. Allogeneic hematopoietic cell transplantation (alloHCT) best enables long-term disease control for patients with poor risk or relapsed/refractory hematologic malignancies such as acute myeloid leukemia, myelodysplastic syn... | [
{
"companynumb": "US-FRESENIUS KABI-FK202202813",
"fulfillexpeditecriteria": "1",
"occurcountry": null,
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CYTARABINE"
},
"drugadditional": "3",
... |
{
"abstract": "Treatment of symptomatic candiduria is notoriously challenging because of the limited repository of antifungals that achieve adequate urinary concentrations. Fluconazole, amphotericin B-based products, and flucytosine are established treatment options for most Candida species. Candida krusei exhibits i... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2020SP000253",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditiona... |
{
"abstract": "Use of adoptive immunotherapy with virus-specific T cells (VST) in patients with inborn errors of immunity prior to hematopoietic stem cell transplantation (HSCT) has been reported in few patients. We report our experience, reviewing all the cases previously reported.\n\n\n\nWe report four children wit... | [
{
"companynumb": "ES-TEVA-2021-ES-1942252",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEFLUNOMIDE"
},
"drugadditional": "3",
... |
{
"abstract": "The authors report a case of intraoperative reversal of apixaban with andexanet alfa in a patient supported with venoarterial extracorporeal membrane oxygenation due to low- cardiac-output immediately after surgery for acute type A aortic dissection and massive intraoperative transfusion with administr... | [
{
"companynumb": "AT-BION-009036",
"fulfillexpeditecriteria": "1",
"occurcountry": "AT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": null,
"dr... |
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