liver neoplasms |
Disease ID | 721 |
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Disease | liver neoplasms |
Manually Symptom | (Waiting for update.) |
Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:7) C0009450 | infection | 6 C0019204 | hepatocellular carcinoma | 5 C0426768 | o sign | 4 C0020437 | hypercalcemia | 1 C0153676 | lung metastasis | 1 C0002793 | dedifferentiation | 1 C0019158 | hepatitis | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
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(Waiting for update.) |
All Snps(Total Genotypes:11) | |||||||||||||
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snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
rs113488022 | 25549141 | 673 | BRAF | umls:C0023903 | BeFree | To summarize the usefulness of several recently discovered immunohistochemical markers in the study of gastrointestinal and liver tumors; to suggest the most current and effective immunohistochemical panels addressing common diagnostic challenges for these tumors; to share practical experience and useful tips for human epidermal growth factor receptor 2 testing in gastric and gastroesophageal junction adenocarcinoma and v-raf murine sarcoma viral oncogene homolog B V600E immunohistochemistry in colorectal carcinoma. | 0.122909916 | 2015 | BRAF | 7 | 140753336 | A | T,G,C |
rs113488022 | 25549141 | 2064 | ERBB2 | umls:C0023903 | BeFree | To summarize the usefulness of several recently discovered immunohistochemical markers in the study of gastrointestinal and liver tumors; to suggest the most current and effective immunohistochemical panels addressing common diagnostic challenges for these tumors; to share practical experience and useful tips for human epidermal growth factor receptor 2 testing in gastric and gastroesophageal junction adenocarcinoma and v-raf murine sarcoma viral oncogene homolog B V600E immunohistochemistry in colorectal carcinoma. | 0.001085767 | 2015 | BRAF | 7 | 140753336 | A | T,G,C |
rs13181 | 19919686 | 2068 | ERCC2 | umls:C0023903 | GAD | [XPD codon 751 polymorphism modifies the risk of hepatocellular carcinoma] | 0.002638474 | 2009 | ERCC2;KLC3 | 19 | 45351661 | T | A,G |
rs199475623 | 17408607 | 4153 | MBL2 | umls:C0023903 | BeFree | Expression analysis of the D129G mutation was performed in E. coli (expression as fusion protein MBP-PAH) and in a human hepatoma cell line with an N-terminal FLAG epitope. | 0.001085767 | 2007 | PAH | 12 | 102877517 | T | C,A |
rs199475623 | 17408607 | 5053 | PAH | umls:C0023903 | BeFree | Expression analysis of the D129G mutation was performed in E. coli (expression as fusion protein MBP-PAH) and in a human hepatoma cell line with an N-terminal FLAG epitope. | 0.001900093 | 2007 | PAH | 12 | 102877517 | T | C,A |
rs199475623 | 17408607 | 4155 | MBP | umls:C0023903 | BeFree | Expression analysis of the D129G mutation was performed in E. coli (expression as fusion protein MBP-PAH) and in a human hepatoma cell line with an N-terminal FLAG epitope. | 0.000814326 | 2007 | PAH | 12 | 102877517 | T | C,A |
rs199475623 | 17408607 | 5553 | PRG2 | umls:C0023903 | BeFree | Expression analysis of the D129G mutation was performed in E. coli (expression as fusion protein MBP-PAH) and in a human hepatoma cell line with an N-terminal FLAG epitope. | 0.000814326 | 2007 | PAH | 12 | 102877517 | T | C,A |
rs361525 | 20953524 | 7124 | TNF | umls:C0023903 | GAD | [This meta-analysis supports TNF rs361525 (-238G>A) polymorphism being associated with HCC in an Asian population.] | 0.158176291 | 2010 | TNF | 6 | 31575324 | G | A |
rs3811647 | 23588470 | 7018 | TF | umls:C0023903 | BeFree | Intronic SNP rs3811647 of the human transferrin gene modulates its expression in hepatoma cells. | 0.000542884 | 2012 | TF | 3 | 133765185 | G | A |
rs430397 | 19533686 | 3309 | HSPA5 | umls:C0023903 | GAD | [allele A and genotypes AA and AG of rs430397 may represent high risk and poor prognosis for HCC.] | 0.003181358 | 2009 | HSPA5 | 9 | 125238840 | C | T |
rs62508577 | 19629656 | 5053 | PAH | umls:C0023903 | BeFree | We analyzed p.S231F PAH protein in prokaryotic (Escherichia coli) and eukaryotic expression system (hepatoma cells). | 0.001900093 | 2009 | PAH | 12 | 102855150 | G | A |
GWASdb Annotation(Total Genotypes:0) | |
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(Waiting for update.) |
GWASdb Snp Trait(Total Genotypes:0) | |
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(Waiting for update.) |
Mapped by lexical matching(Total Items:0) |
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(Waiting for update.) |
Mapped by homologous gene(Total Items:0) |
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(Waiting for update.) |
Chemical(Total Drugs:48) | |||||||||
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CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
C0023903 | acetaminophen | D000082 | 103-90-2 | liver neoplasms | MESH:D008113 | marker/mechanism | 22084566 | ||
C0023903 | s-adenosylmethionine | D012436 | 29908-03-0 | liver neoplasms | MESH:D008113 | therapeutic | 12163149 | ||
C0023903 | arsenic trioxide | C006632 | 1327-53-3 | liver neoplasms | MESH:D008113 | marker/mechanism | 14682389 | ||
C0023903 | betaine | D001622 | 107-43-7 | liver neoplasms | MESH:D008113 | therapeutic | 19642983 | ||
C0023903 | caffeine | D002110 | 1958/8/2 | liver neoplasms | MESH:D008113 | therapeutic | 1995187 | ||
C0023903 | capsaicin | D002211 | 404-86-4 | liver neoplasms | MESH:D008113 | therapeutic | 1888447 | ||
C0023903 | carbamazepine | D002220 | 298-46-4 | liver neoplasms | MESH:D008113 | marker/mechanism | 25058030 | ||
C0023903 | cerivastatin | C086276 | - | liver neoplasms | MESH:D008113 | marker/mechanism | 25058030 | ||
C0023903 | chlorambucil | D002699 | 305-03-3 | liver neoplasms | MESH:D008113 | therapeutic | 3465877 | ||
C0023903 | choline | D002794 | 62-49-7 | liver neoplasms | MESH:D008113 | marker/mechanism | 3554467 | ||
C0023903 | cyclophosphamide | D003520 | 50-18-0 | liver neoplasms | MESH:D008113 | therapeutic | 18298334 | ||
C0023903 | cisplatin | D002945 | 15663-27-1 | liver neoplasms | MESH:D008113 | therapeutic | 2933968 | ||
C0023903 | diethylstilbestrol | D004054 | 56-53-1 | liver neoplasms | MESH:D008113 | marker/mechanism | 15890375 | ||
C0023903 | epirubicin | D015251 | 56420-45-2 | liver neoplasms | MESH:D008113 | therapeutic | 3465877 | ||
C0023903 | floxuridine | D005467 | 50-91-9 | liver neoplasms | MESH:D008113 | therapeutic | 11677951 | ||
C0023903 | fluconazole | D015725 | 86386-73-4 | liver neoplasms | MESH:D008113 | marker/mechanism | 25058030 | ||
C0023903 | fluorouracil | D005472 | 51-21-8 | liver neoplasms | MESH:D008113 | therapeutic | 15113037 | ||
C0023903 | leucovorin | D002955 | 1958/5/9 | liver neoplasms | MESH:D008113 | therapeutic | 21208846 | ||
C0023903 | gemcitabine | C056507 | 103882-84-4 | liver neoplasms | MESH:D008113 | therapeutic | 10965557 | ||
C0023903 | glutathione | D005978 | 70-18-8 | liver neoplasms | MESH:D008113 | therapeutic | 7852184 | ||
C0023903 | griseofulvin | D006118 | 126-07-8 | liver neoplasms | MESH:D008113 | marker/mechanism | 2445643 | ||
C0023903 | indomethacin | D007213 | 53-86-1 | liver neoplasms | MESH:D008113 | marker/mechanism | 1477515 | ||
C0023903 | lindane | D001556 | 58-89-9 | liver neoplasms | MESH:D008113 | marker/mechanism | 18951770 | ||
C0023903 | lovastatin | D008148 | 75330-75-5 | liver neoplasms | MESH:D008113 | marker/mechanism | 25058030 | ||
C0023903 | melphalan | D008558 | 148-82-3 | liver neoplasms | MESH:D008113 | therapeutic | 12606622 | ||
C0023903 | methotrexate | D008727 | 1959/5/2 | liver neoplasms | MESH:D008113 | therapeutic | 3465877 | ||
C0023903 | methylphenidate | D008774 | 113-45-1 | liver neoplasms | MESH:D008113 | marker/mechanism | 8545847 | ||
C0023903 | mitomycin | D016685 | 1950/7/7 | liver neoplasms | MESH:D008113 | therapeutic | 15113037 | ||
C0023903 | norepinephrine | D009638 | 51-41-2 | liver neoplasms | MESH:D008113 | therapeutic | 1530348 | ||
C0023903 | oxaliplatin | C030110 | - | liver neoplasms | MESH:D008113 | therapeutic | 21208846 | ||
C0023903 | paclitaxel | D017239 | - | liver neoplasms | MESH:D008113 | therapeutic | 11468447 | ||
C0023903 | pantoprazole | C064276 | 102625-70-7 | liver neoplasms | MESH:D008113 | marker/mechanism | 25058030 | ||
C0023903 | phenytoin | D010672 | 57-41-0 | liver neoplasms | MESH:D008113 | marker/mechanism | 25058030 | ||
C0023903 | pregabalin | D000069583 | - | liver neoplasms | MESH:D008113 | marker/mechanism | 22539615 | ||
C0023903 | propranolol | D011433 | 525-66-6 | liver neoplasms | MESH:D008113 | therapeutic | 19743301 | ||
C0023903 | sorafenib | C471405 | - | liver neoplasms | MESH:D008113 | therapeutic | 25489883 | ||
C0023903 | spironolactone | D013148 | 1952/1/7 | liver neoplasms | MESH:D008113 | marker/mechanism | 25058030 | ||
C0023903 | streptozocin | D013311 | 18883-66-4 | liver neoplasms | MESH:D008113 | marker/mechanism | 2532796 | ||
C0023903 | streptozocin | D013311 | 18883-66-4 | liver neoplasms | MESH:D008113 | therapeutic | 227055 | ||
C0023903 | toremifene | D017312 | 89778-26-7 | liver neoplasms | MESH:D008113 | marker/mechanism | 7586193 | ||
C0023903 | toremifene | D017312 | 89778-26-7 | liver neoplasms | MESH:D008113 | therapeutic | 8402624 | ||
C0023903 | triamterene | D014223 | 396-01-0 | liver neoplasms | MESH:D008113 | marker/mechanism | 25058030 | ||
C0023903 | troglitazone | C057693 | 97322-87-7 | liver neoplasms | MESH:D008113 | therapeutic | 10503899 | ||
C0023903 | vinblastine | D014747 | 865-21-4 | liver neoplasms | MESH:D008113 | therapeutic | 3686684 | ||
C0023903 | vinorelbine | C030852 | 71486-22-1 | liver neoplasms | MESH:D008113 | therapeutic | 9849468 | ||
C0023903 | vitamin a | D014801 | 11103-57-4 | liver neoplasms | MESH:D008113 | marker/mechanism | 2055368 | ||
C0023903 | vorinostat | C111237 | - | liver neoplasms | MESH:D008113 | therapeutic | 17593366 | ||
C0023903 | zidovudine | D015215 | 30516-87-1 | liver neoplasms | MESH:D008113 | marker/mechanism | 10558926 |
FDA approved drug and dosage information(Total Drugs:20) | ||||||||
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DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
MESH:D008113 | mevacor | lovastatin | 10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET;ORAL | Discontinued | None | Yes | No |
MESH:D008113 | daytrana | methylphenidate | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
MESH:D008113 | daytrana | methylphenidate | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
MESH:D008113 | daytrana | methylphenidate | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
MESH:D008113 | eloxatin | oxaliplatin | 50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | INJECTABLE;IV (INFUSION) | Discontinued | None | Yes | No |
MESH:D008113 | eloxatin | oxaliplatin | 50MG/10ML (5MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | AP | Yes | Yes |
MESH:D008113 | oxaliplatin | oxaliplatin | 50MG/10ML (5MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | AP | Yes | Yes |
MESH:D008113 | retrovir | zidovudine | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
MESH:D008113 | retrovir | zidovudine | 50MG/5ML | SYRUP;ORAL | Prescription | AA | Yes | Yes |
MESH:D008113 | retrovir | zidovudine | 10MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
MESH:D008113 | retrovir | zidovudine | 200MG | TABLET;ORAL | Discontinued | None | No | No |
MESH:D008113 | zidovudine | zidovudine | 60MG | TABLET;ORAL | Discontinued | None | No | No |
MESH:D008113 | zidovudine | zidovudine | 60MG | TABLET;ORAL | Discontinued | None | No | No |
MESH:D008113 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
MESH:D008113 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
MESH:D008113 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
MESH:D008113 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
MESH:D008113 | lyrica | pregabalin | 25MG | CAPSULE;ORAL | Prescription | None | Yes | No |
MESH:D008113 | lyrica | pregabalin | 25MG | CAPSULE; ORAL | Prescription | None | No | No |
MESH:D008113 | lyrica | pregabalin | 25MG | CAPSULE; ORAL | Prescription | None | No | No |
FDA labeling changes(Total Drugs:20) | |||||||||||||
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DiseaseID | Pediatric_Labeling_Date | Trade_Name | Generic_Name_or_Proper_Name | Indications Studied | Label Changes Summary | Product Labeling | BPCA(B) | PREA(P) | BPCA(B) and PREA(P) | Pediatric Rule (R) | Sponsor | Pediatric Exclusivity Granted Date | NNPS |
MESH:D008113 | 02/14/2002 | mevacor | lovastatin | Heterozygous Familial Hypercholesterolemia | New indication in adolescent boys and girls (at least one year post-menarche) 10-17 years of age | Labeling | B | - | - | - | Merck | 07/17/2001 | FALSE' |
MESH:D008113 | 6/4/2006 | daytrana | methylphenidate | ADHD | Summary is pending | Labeling | - | P | - | - | Shire | - | FALSE' |
MESH:D008113 | 12/14/2009 | daytrana | methylphenidate | Postmarketing safety study | Information added to Warnings and Adverse Reactions on skin reactions observed in a postmarketing dermal study in pediatric patients | Labeling | - | P | - | - | Shire | - | FALSE' |
MESH:D008113 | 06/29/2010 | daytrana | methylphenidate | ADHD | Expanded pediatric indication to include adolescent patients ages13-17 years The most commonly reported adverse reactions in a trial in patients 13-17 years included appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia. The majority of patients had erythema at the application site Information on PK parameters, Adverse Event profile and clinical studies | Labeling | - | P | - | - | Shire | - | FALSE' |
MESH:D008113 | 10/1/2007 | eloxatin | oxaliplatin | Solid tumors | The effectiveness of oxaliplatin in children has not been established No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors Information on clinical studies and AEs | Labeling | B | - | - | - | Sanofi-Aventis | 09/27/2006 | FALSE' |
MESH:D008113 | 10/1/2007 | eloxatin | oxaliplatin | Solid tumors | The effectiveness of oxaliplatin in children has not been established No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors Information on clinical studies and AEs | Labeling | B | - | - | - | Sanofi-Aventis | 09/27/2006 | FALSE' |
MESH:D008113 | 10/1/2007 | eloxatin | oxaliplatin | Solid tumors | The effectiveness of oxaliplatin in children has not been established No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors Information on clinical studies and AEs | Labeling | B | - | - | - | Sanofi-Aventis | 09/27/2006 | FALSE' |
MESH:D008113 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
MESH:D008113 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
MESH:D008113 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
MESH:D008113 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
MESH:D008113 | 09/19/2008 | retrovir syrup, capsules and tablets | zidovudine | Used in combination with 18 other antiretroviral agents for the treatment of HIV-1 infection | Dosing and administration information provided to children 6 weeks to less than 18 years of age Macrocytosis was reported in the majority of pediatric patients receiving Retrovir 180 mg/m2 every 6 hours in open-label studies New dosing regimen | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
MESH:D008113 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
MESH:D008113 | 2/11/2010 | ofirmev | acetaminophen | Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever | The safety and effectiveness of Ofirmev for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Ofirmev in adults. Additional safety and PK data was collected in 355 from premature neonates to adolescents. The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.The PK exposure of Ofirmev observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from PK data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a PK exposure similar to that observed in children age 2 years and olderMost common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.Information on dosing, clinical studies, adverse reactions and PK parametersNew dosage form and route of administration | Labeling | - | P | - | - | Cadence | - | FALSE' |
MESH:D008113 | 01/27/2017 | ofirmev | acetaminophen | Treatmeny of pain and fever in pediatric patients birth to 2 years | Treatment of pain Efficacy was not demonstrated in pediatric patients younger than 2 years in a double-blind, placebo-controlled study of 198 pediatric patients younger than 2 years. Pediatric patients less than 2 years of age, including neonates from 28 to 40 weeks gestational age at birth, were randomized to receive opioid plus acetaminophen or opioid plus placebo. No difference in analgesic effect of intravenous acetaminophen, measured by assessment of reduced need for additional opioid treatment for pain control, was observed. Treatment of fever The safety and effectiveness for the treatment of fever in pediatric patients, including premature neonates born at 32 weeks or greater gestation is supported by adequate and well-controlled studies of Ofirmev in adults, clinical studies in 244 pediatric patients 2 years and older, and safety and pharmacokinetic data from 239 patients younger than 2 years including neonates 32 weeks or greater gestational age. Information on dosing, clinical trials. Postmarketing study. | Labeling | - | - | B,P | - | Mallinckrodt | 11/7/2016 | FALSE |
MESH:D008113 | 2/11/2010 | ofirmev | acetaminophen | Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever | The safety and effectiveness of Ofirmev for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Ofirmev in adults. Additional safety and PK data was collected in 355 from premature neonates to adolescents. The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.The PK exposure of Ofirmev observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from PK data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a PK exposure similar to that observed in children age 2 years and olderMost common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.Information on dosing, clinical studies, adverse reactions and PK parametersNew dosage form and route of administration | Labeling | - | P | - | - | Cadence | - | FALSE' |
MESH:D008113 | 01/27/2017 | ofirmev | acetaminophen | Treatmeny of pain and fever in pediatric patients birth to 2 years | Treatment of pain Efficacy was not demonstrated in pediatric patients younger than 2 years in a double-blind, placebo-controlled study of 198 pediatric patients younger than 2 years. Pediatric patients less than 2 years of age, including neonates from 28 to 40 weeks gestational age at birth, were randomized to receive opioid plus acetaminophen or opioid plus placebo. No difference in analgesic effect of intravenous acetaminophen, measured by assessment of reduced need for additional opioid treatment for pain control, was observed. Treatment of fever The safety and effectiveness for the treatment of fever in pediatric patients, including premature neonates born at 32 weeks or greater gestation is supported by adequate and well-controlled studies of Ofirmev in adults, clinical studies in 244 pediatric patients 2 years and older, and safety and pharmacokinetic data from 239 patients younger than 2 years including neonates 32 weeks or greater gestational age. Information on dosing, clinical trials. Postmarketing study. | Labeling | - | - | B,P | - | Mallinckrodt | 11/7/2016 | FALSE |
MESH:D008113 | 12/22/2016 | lyrica | pregabalin | Fibromyalgia | Safety and efficacy in pediatric patients have not been established. A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years . The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. The most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. The overall safety profile in adolescents was similar to that observed in adults with fibromyalgia. Postmarketing study. | Labeling | - | P | - | - | PF Prism CV | - | FALSE |
MESH:D008113 | 12/22/2016 | lyrica | pregabalin | Fibromyalgia | Safety and efficacy in pediatric patients have not been established. A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years . The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. The most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. The overall safety profile in adolescents was similar to that observed in adults with fibromyalgia. Postmarketing study. | Labeling | - | P | - | - | PF Prism CV | - | FALSE |
MESH:D008113 | 12/22/2016 | lyrica | pregabalin | Fibromyalgia | Safety and efficacy in pediatric patients have not been established. A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years . The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. The most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. The overall safety profile in adolescents was similar to that observed in adults with fibromyalgia. Postmarketing study. | Labeling | - | P | - | - | PF Prism CV | - | FALSE |