article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "A 39-year-old patient was admitted to the emergency department for acute abdominal pain. Physical examination showed a peritoneal syndrome. However, CT-scan, Doppler and blood analysis were unremarkable. As the patient had a history of auto-medication with benzodiazepines at high doses, a withdrawal sy... | [
{
"companynumb": "FR-MYLANLABS-2020M1064080",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "BROMAZEPAM"
},
"drugadditional": null,
... |
{
"abstract": "Opioids are becoming more common in the treatment of chronic nonmalignant pain. With increased availability of opioids for chronic pain we may expect an increased misuse of these as analgesics as well. The authors describe the case report of a young woman with chronic back pain and intranasal abuse of ... | [
{
"companynumb": "US-CURRAX PHARMACEUTICALS LLC-US-2021CUR000020",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROCODONE BITARTRATE"
},
... |
{
"abstract": "BACKGROUND\nFOLFOX and panitumumab combined chemotherapy plays an important role for metastatic colorectal cancer. However the usefulness of this regimen for neoadjuvant therapy is unclear.\n\n\nMETHODS\nA 67-year-old man with abdominal pain and pneumaturia was diagnosed with RAS wild-type sigmoid colo... | [
{
"companynumb": "JP-PFIZER INC-2017061787",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEUCOVORIN"
},
"drugadditional": "3",
... |
{
"abstract": "Simvastatin is among the most commonly used prescription medications for cholesterol reduction and the most common statin-related adverse drug reaction is skeletal muscle toxicity. Multiple factors have been shown to influence simvastatin-induced myopathy. In addition to age, gender, ethnicity, genetic... | [
{
"companynumb": "BE-BAYER-2015-183553",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "HYDROXYCHLOROQUINE"
},
"drugadditional": null,
... |
{
"abstract": "Off-label use of uncoated sulfasalazine tablets (TAB) by rheumatoid arthritis (RA) patients in the United States has resulted in poor gastrointestinal (GI) tolerance and compliance. Two studies have shown that treatment of inflammatory bowel disease with enteric-coated sulfasalazine ([EN] Azulfidine EN... | [
{
"companynumb": "US-PFIZER INC-2019495201",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SULFASALAZINE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nInsertion of an Intra gastric Balloon (IGB) has widely been used as a minimally invasive procedure for the treatment of obesity. Gastric balloons are usually inserted for a period of six months only. They have a high safety profile and one of their rare, reported, serious complications incl... | [
{
"companynumb": "AE-GLAXOSMITHKLINE-AE2020GSK246724",
"fulfillexpeditecriteria": "1",
"occurcountry": "AE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DICLOFENAC"
},
"drugadditional": "3"... |
{
"abstract": "Very early onset inflammatory bowel disease (VEO-IBD), diagnosed <6 years old, can be genetically and phenotypically distinct and more refractory than older-onset IBD. Identified causal monogenic defects have been targeted therapeutically in a small subset of VEO-IBD1; however, for most of these childr... | [
{
"companynumb": "US-002147023-NVSC2021US250725",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "RUXOLITINIB"
},
"drugadditional": "3",
... |
{
"abstract": "Multisystem inflammatory syndrome in children (MIS-C) with features resembling Kawasaki disease has been reported in association with coronavirus disease 2019 (COVID-19).\nWe report the rare case of a 22 months old boy with a history of operated simple transposition of the great arteries (TGA), who dev... | [
{
"companynumb": "DE-CELLTRION INC.-2021DE013389",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": "3",
... |
{
"abstract": "We report a case of Nocardia amamiensis pulmonary infection in a 43-year-old immunocompromised woman. The patient was treated with imipenem/cilastatin and trimethoprim/sulfamethoxazole and had a favourable outcome. It is important that laboratories perform species identification to understand the epide... | [
{
"companynumb": "MX-MYLANLABS-2017M1010305",
"fulfillexpeditecriteria": "1",
"occurcountry": "MX",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nTreatment of elderly patients with small cell lung cancer (SCLC) is based on scanty evidence.\n\n\nMETHODS\nPatients with extensive SCLC, age >70 years, and performance status 0-2 were eligible for a study looking for optimal two-drug combination of gemcitabine (Gem) with vinorelbine (Vin),... | [
{
"companynumb": "IT-CIPLA LTD.-2015IT01724",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GEMCITABINE\\GEMCITABINE HYDROCHLORIDE"
},
"d... |
{
"abstract": "We report on two cases of drug-drug interactions between ciprofloxacin and clozapine. The first case was a 46-year-old male patient receiving a daily dose of clozapine 900 mg. He was admitted to hospital with urosepsis and was treated with a 5-day course of ciprofloxacin and amoxicillin. Two days after... | [
{
"companynumb": "NL-BAXTER-2015BAX026016",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CITALOPRAM HYDROBROMIDE"
},
"drugadditional": ... |
{
"abstract": "BACKGROUND\nDirect-acting antivirals (DAAs), including sofosbuvir (SOF), are recommended for treatment of chronic hepatitis C virus (HCV) infection. However, few studies have investigated the effectiveness and safety of new DAAs in kidney transplant recipients (KTRs).\n\n\nOBJECTIVE\nTo assess the effe... | [
{
"companynumb": "PL-GILEAD-2019-0403242",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SOFOSBUVIR"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nAcute graft-versus-host disease (GVHD) remains a barrier to more widespread application of allogeneic haemopoietic stem-cell transplantation. Vorinostat is an inhibitor of histone deacetylases and was shown to attenuate GVHD in preclinical models. We aimed to study the safety and activity o... | [
{
"companynumb": "US-MYLANLABS-2017M1006175",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"drugadditional": "3",
... |
{
"abstract": "Xp11.2 translocation renal cell carcinoma (TRCC) is a rare and aggressive variant of renal cell carcinoma (RCC) when presenting in adults. We report a case of a man in his early 40s who was diagnosed with stage III Xp11.2 TRCC and underwent radical nephrectomy. Seven months following the surgery, an ad... | [
{
"companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-068867",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ZOLEDRONIC ACID"
},
"dr... |
{
"abstract": "We hypothesized that the addition of 4 doses of abatacept to our standard acute graft-versus-host disease (GVHD) prophylaxis would reduce the incidence of day +100 severe acute GVHD in children with transfusion-dependent beta-thalassemia major undergoing a myeloablative allogeneic hematopoietic stem ce... | [
{
"companynumb": "US-OTSUKA-2020_014039",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BUSULFAN"
},
"drugadditional": "3",
"dr... |
{
"abstract": "To assess temporal trends in pre-existing opioid exposure prior to hospitalization among elderly intensive care unit (ICU) patients and its association with adverse outcomes.\n\n\n\nWe performed a population-based retrospective cohort study using health administrative data from the province of Ontario,... | [
{
"companynumb": "CA-JNJFOC-20191142373",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "HYDROMORPHONE HYDROCHLORIDE"
},
"drugadditional":... |
{
"abstract": "BACKGROUND\nNeurocysticercosis is a growing public health problem in the United States. Albendazole is a mainstay of medical therapy for neurocysticercosis, and here we present a case of hypersensitivity to albendazole leading to life-threatening disease progression.\n\n\nOBJECTIVE\nTo report the first... | [
{
"companynumb": "US-AMNEAL PHARMACEUTICALS-2021-AMRX-01326",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ALBENDAZOLE"
},
"drugaddition... |
{
"abstract": "Renal colic is a frequently encountered diagnosis among emergency department patients. Point-of-care (POC) ultrasound has taken on an increasingly important role in the diagnostic strategy of this disease, as it has been shown to be an effective modality for diagnosis and for guiding management. The pr... | [
{
"companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-038765",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TAMSULOSIN HYDROCHLORIDE"
... |
{
"abstract": "OBJECTIVE\nAlthough there is one report on the possible reduced clearance of methotrexate in an adult patient when given concomitantly with imatinib, there is little information on the possible pharmacokinetic interaction. We report on three cases of delayed elimination of methotrexate in children with... | [
{
"companynumb": "FR-TEVA-596419ISR",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,
"d... |
{
"abstract": "OBJECTIVE\nThe objective of this medication utilization evaluation (MUE) was to determine the appropriateness of dabigatran and rivaroxaban while also reviewing outcomes for safety and effectiveness within a large, multi-center health system.\n\n\nMETHODS\nA retrospective chart review was performed usi... | [
{
"companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-12641BI",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DABIGATRAN ETEXILATE MESYLATE"
... |
{
"abstract": "A 48-year-old man was brought to our emergency room with acute abdominal pain and systemic edema, indicating acute circulatory failure with lactic acidosis. Furosemide treatment paradoxically worsened the systemic edema and induced confusion. He had no drinking history but hardly ate legumes or meats c... | [
{
"companynumb": "JP-AMNEAL PHARMACEUTICALS-2019-AMRX-02104",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FUROSEMIDE"
},
"drugadditiona... |
{
"abstract": "Purpose: o report and describe cognitive impairments during lenalidomide treatment in three patients. Despite the relevant clinical impact of chemotherapy-related cognitive deficit (known as \"chemobrain effect\"), very few data are available in the literature. Methods: We present three subjects who de... | [
{
"companynumb": "IT-BAUSCH-BL-2019-065171",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LENALIDOMIDE"
},
"drugadditional": "3",
... |
{
"abstract": "Data on older patients with primary central nervous system lymphoma (PCNSL) are scarce. Comorbidities and performance status frequently compromise outcomes in this group. Medical records for consecutive patients ≥65 years (n = 244) with PCNSL diagnosed 2012-2017 from 14 UK centres were retrospectively ... | [
{
"companynumb": "GB-PFIZER INC-2019176997",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHOTREXATE SODIUM"
},
"drugadditional": null... |
{
"abstract": "We present the case of a 49-year-old patient who was treated with Aripriprazole in context of Paranoid Schizophrenia. The patient had a history of numerous Panuveitis recurrences for the left eye, which led to a marked decrease of the vision VA-NLP and was diagnosed with Multifocal Choroiditis and Panu... | [
{
"companynumb": "RO-MYLANLABS-2018M1032232",
"fulfillexpeditecriteria": "1",
"occurcountry": "RO",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "VANCOMYCIN"
},
"drugadditional": null,
... |
{
"abstract": "Epinephrine is a frequently used catecholamine, particularly in emergencies and during resuscitation attempts. It is not without side effects. We report a rare case of epinephrine-induced cardiomyopathy. Epinephrine was administered for bradycardia in our patient. He was treated conservatively and resp... | [
{
"companynumb": "US-SA-2015SA028715",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ATROPINE"
},
"drugadditional": null,
"dru... |
{
"abstract": "Many drugs can cause neuromuscular blockade. Clindamycin-related neuromuscular blockade is commonly reported, but fatal clindamycin-induced neuromuscular blockade is rarely reported. We describe a 47-year-old woman who initially presented with endometrial carcinoma. She underwent a laparoscopic-assiste... | [
{
"companynumb": "PHHY2015CN069683",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ETOMIDATE"
},
"drugadditional": null,
"drug... |
{
"abstract": "Neoadjuvant chemotherapy (NAC) with anthracyclines followed by taxane chemotherapy has become the standard treatment for patients with locally advanced, operable breast cancer. Recently, the efficacy of nanoparticle albumin-bound paclitaxel (nab-PTX) for metastatic breast cancer was reported. However, ... | [
{
"companynumb": "JP-CELGENEUS-JPN-20171103119",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PACLITAXEL"
},
"drugadditional": "3",
... |
{
"abstract": "Osteotoxic effect is a common adverse effect of chemotherapy for childhood acute lymphoblastic leukemia. The pathophysiology of impaired bone growth is multifactorial and can affect both osteoblast and osteoclast function. Significant contribution in affecting skeletal metabolism belongs to high-dose c... | [
{
"companynumb": "IL-MYLANLABS-2018M1054673",
"fulfillexpeditecriteria": "1",
"occurcountry": "IL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VINCRISTINE"
},
"drugadditional": "3",
... |
{
"abstract": "Prolonged immunosuppression in solid organ transplant recipients has been considered a risk for developing opportunistic infections and malignancies. Acute leukemia is a rare complication. We report a case of acute promyelocytic leukemia (APL) (FAB M3) after cadaveric renal transplant for focal segment... | [
{
"companynumb": "US-ACCORD-045000",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": "1",
... |
{
"abstract": "An 8-year-old Japanese girl was admitted with an ovarian yolk sac tumor. Regarding birth history, the patient had been delivered by cesarean section at 25 weeks of gestation with a birthweight of 711g. She had required neonatal intensive care including oxygenation, various medications, and tests. After... | [
{
"companynumb": "JP-PFIZER INC-2016392480",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SPIRONOLACTONE"
},
"drugadditional": "3",
... |
{
"abstract": "Levothyroxine (L-T4) is used as a standard-of-care treatment in patients with hypothyroidism. L-T4 is absorbed throughout the small intestine, and consistent drug absorption is required for successful treatment. Patients with Hashimoto's disease (autoimmune thyroiditis) often have food and medication s... | [
{
"companynumb": "US-Merck Healthcare KGaA-9302424",
"fulfillexpeditecriteria": "1",
"occurcountry": null,
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
"drugaddit... |
{
"abstract": "Denosumab is a human monoclonal antibody that binds to RANKL (receptor activator of nuclear factor-kappa B ligand). It has mainly been used in the treatment of osteoporosis for a variety of causes especially in situations refractory to bisphosphonates or when kidney function is impaired. It is also use... | [
{
"companynumb": "MY-AMGEN-MYSSP2021076095",
"fulfillexpeditecriteria": "2",
"occurcountry": "MY",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PYRIDOXINE"
},
"drugadditional": null,
... |
{
"abstract": "Buprenorphine/naloxone maintenance therapy is often prescribed in primary care to treat opioid dependence. Previous reports have described concomitant abuse of opioids and clonidine. In this case, a primary care patient on buprenorphine/naloxone maintenance therapy demonstrating altered mental status, ... | [
{
"companynumb": "US-IMPAX LABORATORIES, INC-2015-IPXL-00183",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "HYDROCHLOROTHIAZIDE"
},
"dr... |
{
"abstract": "BACKGROUND\nOxaliplatin is a platinum-based antineoplastic agent used for the treatment of colorectal cancer and other gastrointestinal tumors. In combination with 5-fluorouracil for instance it is given in the so-called FOLFOX regimen in patients with colorectal cancer in the adjuvant as well as the p... | [
{
"companynumb": "DE-CIPLA LTD.-2018DE06679",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "RAMIPRIL"
},
"drugadditional": null,
... |
{
"abstract": "Two recent trials have suggested that docetaxel improves survival in the second-line treatment of non small-cell lung cancer (NSCLC) refractory to first-line platinum-based regimens. Given this, it is appropriate to continue to address the role of new agents in the second-line treatment of refractory N... | [
{
"companynumb": "US-PFIZER INC-2019495807",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GEMCITABINE HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "BACKGROUND Takotsubo cardiomyopathy is characterized by a transient left ventricular dysfunction without obstructive coronary artery disease that mimics an acute myocardial infarction. The electrocardiogram findings of Takotsubo cardiomyopathy usually present with ST-segment elevation or depression, T-... | [
{
"companynumb": "US-009507513-2005USA004199",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "ALBUTEROL"
},
"drugadditional": "1",
... |
{
"abstract": "Patients with chronic hepatitis C virus (HCV) infection who have failed to respond to direct-acting antiviral (DAA) treatment often acquire drug resistance-associated variants (RAVs). The NS5A-P32 deletion (P32del) RAV confers potent resistance to NS5A inhibitors; therefore, patients who acquire this d... | [
{
"companynumb": "JP-GILEAD-2018-0337354",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LEDIPASVIR\\SOFOSBUVIR"
},
"drugadditional": nul... |
{
"abstract": "BACKGROUND\nMedication administration via intravenous push presents multiple potential advantages; however, there may be an increased risk of adverse drug reactions. In 2020, Brigham and Women's Hospital changed levetiracetam intravenous administration to intravenous push (IVP).\n\n\nOBJECTIVE\nThe pur... | [
{
"companynumb": "US-UCBSA-2021053580",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "3",
... |
{
"abstract": "Levetiracetam (LEV) is a second-generation antiepileptic drug with high efficacy and tolerability in children and adults with epilepsy. We aimed to retrospectively assess the long-term efficacy, tolerability, and safety of LEV monotherapy in children with epilepsy.\n\n\n\nAll patients who received LEV ... | [
{
"companynumb": "TR-UCBSA-2021006165",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEVETIRACETAM"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nSuccessful ultrasound-assisted catheter-directed thrombolysis (USAT) with low-dose alteplase and argatroban in a patient with bilateral pulmonary embolism (PE) secondary to heparin-induced thrombocytopenia (HIT) is reported.\n\n\nCONCLUSIONS\nHIT is a life-threatening complication associated... | [
{
"companynumb": "US-WEST-WARD PHARMACEUTICALS CORP.-US-H14001-17-03096",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
... |
{
"abstract": "Inverted papilloma is a rare sinonasal neoplasm. It can be locally invasive and potentially degenerate to a malignant tumor. We present a case report of a 36-year-old woman who was treated for nasal inverted papilloma for over 10 years and presented bilateral temporal bone, and pulmonary involvement. S... | [
{
"companynumb": "BR-LUPIN PHARMACEUTICALS INC.-2021-23092",
"fulfillexpeditecriteria": "2",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "HYDROXYCHLOROQUINE"
},
"drugad... |
{
"abstract": "We present 2 elderly patients who developed lung infiltrates associated with eosinophilia during intravenous daptomycin treatment. Both patients improved quickly after daptomycin was stopped and steroid treatment was initiated. However, complete recovery did not occur, and both patients became chronica... | [
{
"companynumb": "US-PFIZER INC-2018049656",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "DAPTOMYCIN"
},
"drugadditional": "1",
... |
{
"abstract": "We report a case of chronic hepatosplenic aspergillosis following immune reconstitution complicating colic aspergillosis in an AIDS patient with multicentric Castleman disease. Symptoms mimicked the clinical presentation of chronic disseminated candidiasis and responded to corticosteroid. This emerging... | [
{
"companynumb": "FR-CELLTRION INC.-2021FR006891",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nNovel formulations (gastro-resistant tablet and intravenous solution) of posaconazole (POS) have been approved in prophylaxis and therapy of invasive fungal diseases (IFDs). Study aim was to analyze treatment strategies and clinical effectiveness.\n\n\nMETHODS\nWe set up a web-based registry... | [
{
"companynumb": "DE-MYLANLABS-2019M1110300",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CASPOFUNGIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nGallbladder perforation is a serious clinical condition and associated with high morbidity and mortality. A definitive diagnosis is contentious before surgery.\nWe herein report a case of perforation of the gallbladder neck secondary to chemotherapy and radiation for nasopharyngeal carcinom... | [
{
"companynumb": "CN-MYLANLABS-2018M1037909",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": "3",
... |
{
"abstract": "Saccharomyces cerevisiae or boulardii, also known as baker's yeast or brewer's yeast, is normally a nonpathogenic microbe. It is commonly used as a probiotic to prevent antibiotic-associated diarrhea. We present a case of a 77-year-old woman with uncontrolled diabetes who developed Saccharomyces fungem... | [
{
"companynumb": "IN-PFIZER INC-2020397210",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MEROPENEM"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nLevetiracetam is being increasingly utilized for post-traumatic brain injury seizure prophylaxis, in part because of its more favourable adverse effect profile compared to other anti-epileptics. This report highlights an unusual, clinically significant adverse drug reaction attributed to le... | [
{
"companynumb": "US-UCBSA-2014012207",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PANTOPRAZOLE SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "COVID-19 (coronavirus disease 2019) has impacted solid organ transplantation (SOT) in many ways. Transplant centers have initiated SOT despite the COVID-19 pandemic. Although it is suggested to wait for 4 weeks after COVID-19 infection, there are no data to support or refute the timing of liver transpl... | [
{
"companynumb": "IN-ASTELLAS-2021US032795",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "3",
... |
{
"abstract": "The social impairments of autism spectrum disorder (ASD) have a major impact on quality of life, yet there are no medications that effectively treat these core social behavior deficits. Preclinical research suggests that arginine vasopressin (AVP), a neuropeptide involved in promoting mammalian social ... | [
{
"companynumb": "US-OTSUKA-2019_026708",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ARIPIPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "We report the case of a 39-year-old woman who presented with serotonin syndrome and hypoglycaemia likely due to intoxication with a very high dose of venlafaxine. This case of venlafaxine-associated hypoglycaemia was treated first by glucose perfusion, but despite large doses, hypoglycaemia recurred. B... | [
{
"companynumb": "FR-ALKEM LABORATORIES LIMITED-FR-ALKEM-2021-07446",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VENLAFAXINE HYDROCHLORIDE"
},
... |
{
"abstract": "Methylphenidate (MPH) reduces hyperactive-impulsive symptoms common in children with autism spectrum disorders (ASDs), however, response and tolerability varies widely. We hypothesized monoaminergic gene variants may moderate MPH effects in ASD, as in typically developing children with attention-defici... | [
{
"companynumb": "US-JNJFOC-20140518339",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "METHYLPHENIDATE HYDROCHLORIDE"
},
"drugadditional... |
{
"abstract": "BACKGROUND\nThe aim of this study was to test the efficacy and safety of olanzapine + topiramate versus olanzapine monotherapy in the treatment of bipolar disorder (BPD) and treatment-attendant weight gain in children and adolescents.\n\n\nMETHODS\nSubjects (N = 40) were outpatients of both sexes, 6-17... | [
{
"companynumb": "US-JNJFOC-20130907113",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TOPIRAMATE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nVancomycin is one of the most widely used antibiotics for the treatment of serious infectious caused by methicillin-resistant Staphylococcus aureus (MRSA). However, reduced susceptibility of S. aureus to vancomycin has been observed in recent years. We report on a case of vancomycin resista... | [
{
"companynumb": "JP-TEVA-2018-JP-977191",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FLUOROURACIL"
},
"drugadditional": "3",
... |
{
"abstract": "Renal damage is a progressive complication of sickle cell disease (SCD). Microalbuminuria is common in children with SCD, while a smaller number of children have more severe renal manifestations necessitating kidney biopsy. There is limited information on renal biopsy findings in children with SCD and ... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2020SP008209",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"dru... |
{
"abstract": "A 68-year-old man with end-stage renal disease and a history of orthotopic cardiac transplantation on chronic immune suppression therapy presented to the emergency department with fever and purulent urethral discharge. He was diagnosed with pyocystis (bladder abscess). Culture of the urethral discharge... | [
{
"companynumb": "US-WATSON-2016-10088",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo present a case of nonparaneoplastic autoimmune retinopathy in association with myasthenia gravis in a young woman, and to report the effect of plasmapheresis as well as passage of antiretinal antibodies through the placenta.\n\n\nMETHODS\nCase report.\n\n\nRESULTS\nA 31-year-old woman pre... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2018-01852",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LEVOTHYROXINE"
},
"d... |
{
"abstract": "BACKGROUND\nSystemic lupus erythematosus (SLE) increases the incidence of adverse pregnancy outcomes (APOs). Nevertheless, most of the data on SLE pregnancies were derived from database studies in which details of the pregnancies were unavailable, and no consensus exists on the risk of APO in patients ... | [
{
"companynumb": "JP-ASTELLAS-2021JP016387",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nTo report the unsafe herb-drug interactions between a commercial product of noni juice and phenytoin in a human case.\n\n\nMETHODS\nA 49-year-old-male has been treated with phenytoin for epilepsy for more than ten years. In spite of his medication adherence, persistent sub-therapeutic phenyt... | [
{
"companynumb": "TW-PFIZER INC-2015247941",
"fulfillexpeditecriteria": "1",
"occurcountry": "TW",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "HERBALS"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nIdarucizumab is a specific reversal agent for patients with bleeding related to the anticoagulant dabigatran. There are no prior descriptions of Idarucizumab administration in the prehospital setting for intracranial hemorrhage.\nAn 82-year-old woman treated with dabigatran for atrial fibri... | [
{
"companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2020-BI-028730",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DABIGATRAN ETEXILATE MESYLATE"
... |
{
"abstract": "Levetiracetam and zonisamide are licensed as monotherapy for patients with focal epilepsy, but there is uncertainty as to whether they should be recommended as first-line treatments because of insufficient evidence of clinical effectiveness and cost-effectiveness. We aimed to assess the long-term clini... | [
{
"companynumb": "GB-GLAXOSMITHKLINE-GB2021GSK085256",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LAMOTRIGINE"
},
"drugadditional": nu... |
{
"abstract": "Thrombotic microangiopathies (TMA) are disorders characterized by microangiopathic hemolytic anemia, thrombocytopenia, and microthrombi leading to organ dysfunction. Atypical hemolytic uremic syndrome (aHUS) is a rare subtype of TMA mediated by complement dysregulation. We present a case of a 59-year-o... | [
{
"companynumb": "US-ALXN-A202110980",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ECULIZUMAB"
},
"drugadditional": null,
"dr... |
{
"abstract": "Immunocompromised patients are susceptible to infections from common and unusual microorganisms. Protothecosis is seldom suspected on clinical grounds, yet it is readily diagnosed once detected in the laboratory. We report the first pediatric liver transplant recipient with pulmonary protothecosis, det... | [
{
"companynumb": "PHHY2015SG081148",
"fulfillexpeditecriteria": "1",
"occurcountry": "SG",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
"dr... |
{
"abstract": "OBJECTIVE\nTo study the clinical effect and safety of dexmedetomidine in children with agitation during ventilator weaning.\n\n\nMETHODS\nA prospective open observational study was performed for children who were admitted to the intensive care unit and experienced mechanical ventilation between March 2... | [
{
"companynumb": "CN-SUN PHARMACEUTICAL INDUSTRIES LTD-2019R1-216585",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DEXMEDETOMIDINE"
},
... |
{
"abstract": "Nivolumab, an anti-programmed cell death-1 monoclonal antibody, is currently used to treat many types of advanced cancers including recurrent and metastatic head and neck cancer. However, there are increasing reports concerning immune-related adverse events related to nivolumab therapy. Here, we report... | [
{
"companynumb": "JP-SA-2019SA176249",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": "3",
"drug... |
{
"abstract": "METHODS\nA 43-year-old woman presented with right upper abdominal pain, on and off for 3-4 years. One year prior to her presentation, a space-occupying lesion was found in the right lobe of the liver, which was suspected to be hemangioma, as the patient had history of combined oral contraceptive pill u... | [
{
"companynumb": "IN-PFIZER INC-2015315981",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ETHINYL ESTRADIOL\\LEVONORGESTREL"
},
"drugadd... |
{
"abstract": "A 79-year-old man with a history of tuberculosis was found to have chronic empyema in the right lung and was diagnosed with malignant diffuse large-cell lymphoma (Ann Arbor stage IIE). After completion of one course of rituximab plus cyclophosphamide, pirarubicin, vincristine, and prednisolone (R-CHOP)... | [
{
"companynumb": "JP-VISTAPHARM, INC.-VER201707-000210",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PIRARUBICIN"
},
"drugadditional": ... |
{
"abstract": "Pulmonary mucormycosis is a highly lethal invasive fungal infection usually found in immunocompromised patients. We report herein the case of an adult woman who developed pulmonary mucormycosis with possible systemic dissemination after recovering from acute liver failure secondary to acetaminophen ove... | [
{
"companynumb": "CA-SUN PHARMACEUTICAL INDUSTRIES LTD-2020R1-234138",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"d... |
{
"abstract": "Low intraocular pressure and hypotony secondary to overfiltration is a recognized complication after trabeculectomy, particularly when augmented with antimetabolites such as 5-fluorouracil and mitomycin C. The relatively recent introduction of minimally invasive glaucoma surgery such as the ab interno ... | [
{
"companynumb": "GB-ACCORD-113255",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MITOMYCIN"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "In the field of breast cancer tumor biology, triple-negative breast cancer patients are the main focus of current clinical trials exploring the use of immune checkpoint inhibitors due to higher frequencies of somatic mutations, neoantigens, and resulting tumor-specific T-cell reactivity.\nHere, we pres... | [
{
"companynumb": "PHHY2019DE068467",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "EXEMESTANE"
},
"drugadditional": null,
"drug... |
{
"abstract": "Objective We examined the clinical course and treatment method of a case series of radiation-induced hemorrhagic gastroduodenitis with clinical signs. Methods This was a single-center retrospective observational study. Patients We included seven patients with radiation-induced hemorrhagic gastroduodeni... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2022RR-340079",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLOPIDOGREL BISULFATE"
},
... |
{
"abstract": "Neoadjuvant chemotherapy of colorectal liver metastases can induce hepatotoxicity in noncancerous liver. The aim of the present study was to describe the chemotherapy-induced major changes in the hepatic parenchyma and their prognostic impact. We undertook a retrospective study of 48 cases of colorecta... | [
{
"companynumb": "TN-SA-2018SA336795",
"fulfillexpeditecriteria": "1",
"occurcountry": "TN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OXALIPLATIN"
},
"drugadditional": "3",
"dr... |
{
"abstract": "BACKGROUND\nAn acetominophen overdose (AOD) is the leading cause of acute liver failure (ALF) in the UK and USA. For patients who meet the King's College Hospital criteria, (mortality risk > 85%), an emergency orthotopic liver transplantation (OLT) is conventionally performed with subsequent life-long ... | [
{
"companynumb": "GB-JNJFOC-2008004077",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ACETAMINOPHEN"
},
"drugadditional": "3",
... |
{
"abstract": "Mycoplasma pneumonia affects 1% of the population in the United States. The majority of patients infected with Mycoplasma experience upper respiratory tract infection symptoms, and about 10% of patients infected with Mycoplasma develop pneumonia. A rare complication is a pulmonary embolism (PE), which ... | [
{
"companynumb": "US-MYLANLABS-2020M1049924",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": "3",
... |
{
"abstract": "We are reporting a case of spontaneous acute esophageal necrosis \"black esophagus\" of unclear etiology in a kidney transplant recipient. A patient with end-stage renal disease due to IgA nephropathy received a deceased-donor kidney transplant. The surgical procedure was uneventful, without hemodynami... | [
{
"companynumb": "US-FRESENIUS KABI-FK202107566",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drugadditiona... |
{
"abstract": "Pseudomelanosis is a rare finding during upper gastrointestinal endoscopy, and is most commonly seen in the duodenum. Involvement of other organs in the upper gastrointestinal tract is extremely rare, with only 1 reported case involving the stomach, duodenum, and jejunum. We present a case of a 60-year... | [
{
"companynumb": "US-WEST-WARD PHARMACEUTICALS CORP.-US-H14001-17-00495",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "HYDRALAZINE HYDROCHLORIDE"
... |
{
"abstract": "Diaphragmatic dysfunction is a rare cause of dyspnea that can lead to hypercapnic respiratory failure. A variety of causes of diaphragmatic dysfunction have been identified, including myopathies and neuropathies, the latter of which can be further subdivided into infectious, idiopathic, demyelinating, ... | [
{
"companynumb": "US-TEVA-2021-US-1935898",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
... |
{
"abstract": "In a 32-year-old woman with an ulcer that had persisted for more than 13 months despite treatment with the H2 blocker ranitidine, the latter was replaced by the H+K(+)-ATPase inhibitor omeprazole. Treatment with omeprazole also failed to bring about healing of the ulceration which, at times, measured u... | [
{
"companynumb": "DE-MYLANLABS-2018M1021016",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "OMEPRAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "We investigated the brain magnetic susceptibility changes induced by natalizumab-associated progressive multifocal leukoencephalopathy. We retrospectively included 12 patients with natalizumab-progressive multifocal leukoencephalopathy, 5 with progressive multifocal leukoencephalopathy from other cause... | [
{
"companynumb": "FR-BIOGENIDEC-2015BI128755",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "NATALIZUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Doxorubicin and trabectedin are considered active drugs in soft tissue sarcoma (STS). The combination of both drugs was hypothesized to be advantageous and safe on the basis of preclinical evidence and a previous phase I trial, respectively. The aim of this study was to compare the clinical outcome of ... | [
{
"companynumb": "ES-JNJFOC-20101103588",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TRABECTEDIN"
},
"drugadditional": null,
... |
{
"abstract": "Allogeneic hemopoietic stem cell transplantation (allo-HSCT) is the only curative therapy for refractory hematological malignancies. However, there are many treatment-related complications, including organ disorders, graft-versus-host disease (GVHD), and infectious diseases. Furthermore, there are many... | [
{
"companynumb": "JP-STRIDES ARCOLAB LIMITED-2022SP000279",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional... |
{
"abstract": "OBJECTIVE\nTo report a case of local transmission of invasive lobular carcinoma from a donor to a recipient in a keratolimbal allograft after cessation of systemic immunosuppressive therapy.\n\n\nMETHODS\nThis is a case report including the clinicopathologic findings. Sections of the donor breast tumor... | [
{
"companynumb": "US-DRREDDYS-USA/USA/17/0092094",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TACROLIMUS"
},
"drugadditional": null,
... |
{
"abstract": "METHODS\nWe present the case of a 55-year-old man with a non-small cell lung adenocarcinoma, who presented with choroidal metastasis. The patient showed a decrease in visual acuity. His evaluation revealed unilateral choroidal metastasis secondary to carcinoma of the lung. The patient received afatinib... | [
{
"companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2017-BI-056276",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "AFATINIB"
},
"dr... |
{
"abstract": "We present longitudinal imaging data of a child with Sturge-Weber syndrome (SWS). At age 8 months, 3 weeks after initial seizures and prolonged motor deficit, MRI showed extensive right hemispheric SWS involvement with severe glucose hypometabolism on PET. She was treated with levetiracetam and aspirin... | [
{
"companynumb": "US-UCBSA-2018015555",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": null,
"drug... |
{
"abstract": "OBJECTIVE\nTo evaluate, in long-term open label prospective study, infliximab as therapeutic choice for Juvenile Idiopathic Arthritis (JIA) non responsive to conventional therapy.\n\n\nMETHODS\nWe enrolled to treat with infliximab 78 JIA patients (66 females, 12 males): the mean age was 20.7+/-7.1 year... | [
{
"companynumb": "IT-JNJFOC-20171026154",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "SULFASALAZINE"
},
"drugadditional": null,
... |
{
"abstract": "We describe a female-to-male trans-sexual, aged 33, who developed breast cancer 10 years after cosmetic bilateral subcutaneous mastectomy and nipple reimplantation. The complex hormonal pathways involved and the implications for women undergoing prophylactic mastectomy because of a high risk of familia... | [
{
"companynumb": "GB-ENDO PHARMACEUTICALS INC-2020-005509",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "2",
"activesubstance": {
"activesubstancename": "TESTOSTERONE"
},
"drugadditiona... |
{
"abstract": "OBJECTIVE\nAnti-tumor-necrosis-factor-alpha (anti-TNF-α) medications are effective in inflammatory bowel disease (IBD), but have an increased risk of tuberculosis (TB) and serious infections. The aim of this study was to examine the Australian/New Zealand experience of serious infections and TB in IBD ... | [
{
"companynumb": "AU-PFIZER INC-2304642",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE SODIUM"
},
"drugadditional": "3",
... |
{
"abstract": "Surgical repair of transposition of great arteries has undergone various evolutionary changes over the years. The initial of these treatment options was atrial septectomy followed by atrial switch and the current preferred treatment option is arterial switch operation worldwide. Due to various reasons,... | [
{
"companynumb": "PK-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-294591",
"fulfillexpeditecriteria": "1",
"occurcountry": "PK",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FUROSEMIDE"
},
"drug... |
{
"abstract": "Cisplatin-based neoadjuvant chemotherapy (NAC) for muscle-invasive urothelial carcinoma of the bladder confers only a modest survival advantage. Patients with pathologic progression on NAC have poor outcomes related to a delay in definitive surgical management.\n\n\n\nTo characterize the value of epith... | [
{
"companynumb": "US-JNJFOC-20190903716",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": "3",
"d... |
{
"abstract": "BACKGROUND\nFrequent causes of high anion gap metabolic acidosis are well known: ethanol, methanol, and ethylene glycol intoxication; hyperglycemia; lactic or D-lactic acidosis; and impaired renal function. There are other causes, less frequent but also important. This report illustrates a rare case of... | [
{
"companynumb": "BE-FRESENIUS KABI-FK201604700",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "METFORMIN HYDROCHLORIDE"
},
"drugadditio... |
{
"abstract": "Zoledronic acid is widely used for the treatment of various skeletal disorders. While acute phase reactions are commonly seen, hypocalcaemia, femoral shaft fractures, osteonecrosis of the jaw and renal failure are rare. Two cases of fatal thrombocytopaenic purpura have been reported following zoledroni... | [
{
"companynumb": "PHHY2016US040126",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MANNITOL"
},
"drugadditional": null,
"drugad... |
{
"abstract": "Of a series of 211 episodes of diabetic metabolic decompensation 37 had severe euglycaemic ketoacidosis (a blood sugar level of less than 300 mg/100 ml and a plasma bicarbonate of 10 mEq/1. or less). All were young insulin-dependent diabetics, only one being previously undiagnosed. Vomiting was a commo... | [
{
"companynumb": "MY-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2019-BI-030777",
"fulfillexpeditecriteria": "1",
"occurcountry": "MY",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "EMPAGLIFLOZIN"
},
... |
{
"abstract": "Stevens-Johnson syndrome and toxic epidermal necrolysis are some of the most serious, usually drug-induced, skin reactions. We report a case of severe toxic epidermal necrolysis in a child, which in addition to ophthalmic sequelae, caused extensive hypertrophic scarring of the skin. Such a course is un... | [
{
"companynumb": "DE-APOTEX-2018AP006948",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "AMOXICILLIN"
},
"drugadditional": "1",
... |
{
"abstract": "Following a generalized tonic-clonic seizure, a previously healthy 27-year-old pregnant woman (18-week pregnancy) was admitted to our emergency department. She experienced lethargy, forgetfulness and persecutory hallucinations the day before hospitalization. Cerebrospinal fluid examination revealed mod... | [
{
"companynumb": "TR-SUN PHARMACEUTICAL INDUSTRIES LTD-2019RR-208426",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VALPROIC ACID"
},
"d... |
{
"abstract": "OBJECTIVE\nTo report on the incidence of nab-paclitaxel hypersensitivity reactions (HSRs) in patients with prior taxane HSR.\n\n\nMETHODS\nFrom 2005 to 2015, all patients who received nab-paclitaxel for a gynecologic malignancy were identified. Chart abstraction included pathology, prior therapy, indic... | [
{
"companynumb": "US-TEVA-796158USA",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": null,
"dr... |
{
"abstract": "Pseudomonas aeruginosa exploits intrinsic and acquired resistance mechanisms to resist almost every antibiotic used in chemotherapy. Antimicrobial resistance in P. aeruginosa isolates recovered from cystic fibrosis (CF) patients is further enhanced by the occurrence of hypermutator strains, a hallmark ... | [
{
"companynumb": "AR-BAYER-2020-144214",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CIPROFLOXACIN"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo report an unusual case of hydroxychloroquine toxicity after short-term therapy.\n\n\nMETHODS\nObservational case report.\n\n\nRESULTS\nA 56-year-old woman presented to the Ophthalmology Clinic at Walter Reed Army Medical Center (WRAMC) with a 6-month history of gradually decreasing vision... | [
{
"companynumb": "US-MYLANLABS-2014S1010122",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROXYCHLOROQUINE"
},
"drugadditional": null... |
{
"abstract": "BACKGROUND\nHyperammonemia is an infrequent adverse drug reaction (ADR) of chemotherapy. A few cases of 5-fluorouracil (5-FU) related hyperammonemia have been reported. However, hyperammonemia induced by capecitabine, an oral prodrug of 5-FU, has not been reported till date.\n\n\nMETHODS\nA patient wit... | [
{
"companynumb": "CN-CIPLA LTD.-2017CN13956",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CAPECITABINE"
},
"drugadditional": null,
... |
{
"abstract": "We report 3 patients with coronavirus disease who had a decline in respiratory status during their hospital course that responded well to intravenous steroids and interleukin-6 receptor antagonist therapy. These patients later showed development of persistent hypoxia with increased levels of d-dimer le... | [
{
"companynumb": "NVSC2020US228207",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AZITHROMYCIN ANHYDROUS"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nAn optimal approach for providing sufficient antenatal surveillance for fetal growth restriction (FGR) has yet to be elucidated. Moreover, there is scant literature on the fetal response to betamethasone and its effect on fetal Dopplers.\n\n\nOBJECTIVE\nTo compare persistence of umbilical a... | [
{
"companynumb": "US-009507513-2011USA013104",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BETAMETHASONE ACETATE\\BETAMETHASONE SODIUM PHOSPHATE"
... |
{
"abstract": "The majority of patients with high-risk neuroblastoma (HR-NB) in low- and middle-income countries (LMIC) do not have access to autologous stem cell transplant (ASCT) and dinutuximab. Consolidation with nonmyeloablative chemotherapy is not well-defined, and the outcomes are variable. We report a single-... | [
{
"companynumb": "IN-PFIZER INC-2021262017",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "VINCRISTINE"
},
"drugadditional": "3",
... |
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