PedAM
Pediatric Disease Annotations & Medicines
| adenoma | ||||
| Disease ID | 899 |
|---|---|
| Disease | adenoma |
| Manually Symptom | (Waiting for update.) |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:16) C0020502 | hyperparathyroidism | 38 C0001418 | adenocarcinoma | 23 C1608408 | malignant transformation | 16 C0019080 | hemorrhage | 11 C1384514 | primary aldosteronism | 10 C0010481 | cushing's syndrome | 9 C0019204 | hepatocellular carcinoma | 5 C0007113 | rectal cancer | 4 C0009402 | colorectal cancer | 4 C0206635 | myelolipoma | 3 C0009402 | colorectal carcinoma | 3 C1609519 | adrenal myelolipoma | 2 C0020428 | hyperaldosteronism | 2 C1384514 | primary hyperaldosteronism | 1 C0020459 | hyperinsulinism | 1 C0001339 | acute pancreatitis | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
|---|
| (Waiting for update.) |
All Snps(Total Genotypes:50) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
| rs1042821 | 16771955 | 2956 | MSH6 | umls:C0001430 | BeFree | In a Minnesota-based case-control study of individuals with adenomas (N=401), hyperplastic polyps (N=195), or both adenomas and hyperplastic polyps (N=123) versus polyp-free controls (N=624), we investigated the role of hMLH1-93G>A, hMLH1 I219V, and hMSH6 G39E polymorphisms in increasing the risk of colorectal polyps. | 0.002171535 | 2006 | MSH6 | 2 | 47783349 | G | C,A |
| rs104893859 | 21810944 | 5308 | PITX2 | umls:C0001430 | BeFree | To better understand the role of Pitx2 on gonadotroph tumorigenesis and to explore new approach for inhibiting tumoral growth, the R91P mutant was transferred via a lentiviral vector in tumoral gonadotroph cells of two kinds: the αT3-1 cell line and human adenoma cells. | 0.000271442 | 2011 | PITX2 | 4 | 110618669 | C | G |
| rs1051266 | 21274745 | 6573 | SLC19A1 | umls:C0001430 | BeFree | Five SNPs in the SLC19A1 (RFC1) gene: rs1051266 (G80A), rs283895, rs2236484, rs12482346, and rs2838958 were associated with adenoma risk after correction for multiple testing (all corrected p values ≤ 0.043). | 0.120271442 | 2011 | SLC19A1 | 21 | 45537880 | T | C |
| rs1052133 | 17252231 | 4968 | OGG1 | umls:C0001430 | BeFree | Tubular adenomas or adenomas with none-to-mild dysplasia were significantly associated with polymorphic genotypes of OGG1 IVS4-15 and S326C. | 0.005905708 | 2007 | OGG1;CAMK1 | 3 | 9757089 | C | G |
| rs113488022 | 19126563 | 673 | BRAF | umls:C0001430 | BeFree | BRAF V600E mutation analysis was performed in 148 selected cases; mutations were found in 44/49 (90%) of lesions diagnosed as sessile serrated adenoma, in 10/34 (29%) of hyperplastic polyps of microvesicular type, in 4/11 (36%) of traditional serrated adenomas, in 10/10 (100%) of mixed hyperplastic adenomatous polyps, and in 2/42 (5%) of conventional adenomas. | 0.029770186 | 2009 | BRAF | 7 | 140753336 | A | T,G,C |
| rs113488022 | 23549875 | 673 | BRAF | umls:C0001430 | BeFree | Our BRAF(V600E) GEMM presented with sessile serrated adenomas/polyps, as seen in humans. | 0.029770186 | 2013 | BRAF | 7 | 140753336 | A | T,G,C |
| rs113488022 | 21457162 | 4255 | MGMT | umls:C0001430 | BeFree | KRAS codon 12/13 and 59/61 and BRAF V600E mutations, MSI, and MGMT and hMLH1 methylation and expression in 42 serrated adenocarcinomas and 17 serrated adenomas were compared with those in 59 non-serrated colorectal carcinomas (CRCs) and nine adenomas. | 0.005971721 | 2011 | BRAF | 7 | 140753336 | A | T,G,C |
| rs113488022 | 23825589 | 673 | BRAF | umls:C0001430 | BeFree | Lkb1 loss promotes tumor progression of BRAF(V600E)-induced lung adenomas. | 0.029770186 | 2013 | BRAF | 7 | 140753336 | A | T,G,C |
| rs113488022 | 23825589 | 3845 | KRAS | umls:C0001430 | BeFree | Contrary to KRAS mutant tumors, BRAF(V600E)-induced tumors are benign adenomas that fail to progess. | 0.160104841 | 2013 | BRAF | 7 | 140753336 | A | T,G,C |
| rs113488022 | 17119056 | 673 | BRAF | umls:C0001430 | BeFree | These findings indicate that adenomas might be less important in the cancer development in the group of families with BRAF-V600E mutations and indirectly support a previous hypothesis that tumors might develop through the hyperplastic polyp-serrated adenoma pathway. | 0.029770186 | 2006 | BRAF | 7 | 140753336 | A | T,G,C |
| rs113488022 | 21457162 | 4292 | MLH1 | umls:C0001430 | BeFree | KRAS codon 12/13 and 59/61 and BRAF V600E mutations, MSI, and MGMT and hMLH1 methylation and expression in 42 serrated adenocarcinomas and 17 serrated adenomas were compared with those in 59 non-serrated colorectal carcinomas (CRCs) and nine adenomas. | 0.009500466 | 2011 | BRAF | 7 | 140753336 | A | T,G,C |
| rs113488022 | 23887306 | 673 | BRAF | umls:C0001430 | BeFree | We investigated 194 serrated lesions of the colon, comprising 42 sessile serrated adenomas/polyps, 16 traditional serrated adenomas, 136 hyperplastic polyps and 20 tubular/tubulovillous adenomas (conventional adenomas) with the novel BRAF V600E mutation-specific antibody VE1. | 0.029770186 | 2013 | BRAF | 7 | 140753336 | A | T,G,C |
| rs113488022 | 23825589 | 6794 | STK11 | umls:C0001430 | BeFree | Lkb1 loss promotes tumor progression of BRAF(V600E)-induced lung adenomas. | 0.001085767 | 2013 | BRAF | 7 | 140753336 | A | T,G,C |
| rs121912532 | 11857565 | 3973 | LHCGR | umls:C0001430 | BeFree | Recently, it was demonstrated that a somatic heterozygous activating mutation of the LHR gene (Asp578His), limited to the tumor, was the cause of Leydig cell adenomas in three unrelated patients. | 0.004353001 | 2002 | LHCGR;STON1-GTF2A1L | 2 | 48688065 | C | T,G,A |
| rs121913228 | 18541010 | 1499 | CTNNB1 | umls:C0001430 | BeFree | In CTNNB1 exon 3, we detected a stabilizing mutation (S37A) in 3 out of 20 analyzed adenomas. | 0.135240471 | 2008 | CTNNB1 | 3 | 41224621 | T | C,G |
| rs121913529 | 23959381 | 3845 | KRAS | umls:C0001430 | BeFree | Using genetically engineered mouse models (GEMMs) for human non-small-cell lung cancer (NSCLC), we found that deletion of the essential autophagy gene, Atg7, in KRAS(G12D)-driven NSCLC inhibits tumor growth and converts adenomas and adenocarcinomas to benign oncocytomas characterized by the accumulation of respiration-defective mitochondria. | 0.160104841 | 2014 | KRAS | 12 | 25245350 | C | T,G,A |
| rs121918464 | 24480804 | 5781 | PTPN11 | umls:C0001430 | BeFree | Atypical adenomatous hyperplasia and small adenomas were observed in CCSP-rtTA/tetO-SHP2(E76K) bitransgenic mice induced with Dox for 2-6 months and progressed to larger adenoma and adenocarcinoma by 9 months. | 0.000271442 | 2015 | PTPN11 | 12 | 112450406 | G | A,C |
| rs12429692 | 23404351 | 241 | ALOX5AP | umls:C0001430 | BeFree | One SNP in FLAP (rs12429692) was associated with adenoma risk. | 0.000271442 | 2013 | ALOX5AP | 13 | 30738041 | A | T |
| rs12482346 | 21274745 | 6573 | SLC19A1 | umls:C0001430 | BeFree | Five SNPs in the SLC19A1 (RFC1) gene: rs1051266 (G80A), rs283895, rs2236484, rs12482346, and rs2838958 were associated with adenoma risk after correction for multiple testing (all corrected p values ≤ 0.043). | 0.120271442 | 2011 | SLC19A1 | 21 | 45517713 | C | T |
| rs13181 | 16542436 | 2068 | ERCC2 | umls:C0001430 | BeFree | Interestingly, individuals with the XPD Lys751Gln polymorphism had an increased risk of low-risk adenomas. | 0.002638474 | 2006 | ERCC2;KLC3 | 19 | 45351661 | T | A,G |
| rs146462069 | 25527509 | 2688 | GH1 | umls:C0001430 | BeFree | Immunohistochemistry showed increased IGSF1 staining in the GH-producing tumor from the patient with the IGSF1 p.N604T variant compared with a GH-producing adenoma from a patient negative for any IGSF1 variants and with normal control pituitary tissue. | 0.021639405 | 2015 | IGSF1 | X | 131278706 | T | C,G |
| rs146462069 | 25527509 | 3547 | IGSF1 | umls:C0001430 | BeFree | Immunohistochemistry showed increased IGSF1 staining in the GH-producing tumor from the patient with the IGSF1 p.N604T variant compared with a GH-producing adenoma from a patient negative for any IGSF1 variants and with normal control pituitary tissue. | 0.000271442 | 2015 | IGSF1 | X | 131278706 | T | C,G |
| rs17503908 | 21504893 | 472 | ATM | umls:C0001430 | BeFree | Among the top findings, an SNP (rs17503908) in ataxia telangiectasia mutated (ATM) was inversely related to adenoma risk (OR = 0.75, 95% CI = 0.63-0.91). | 0.001900093 | 2011 | ATM;C11orf65 | 11 | 108344670 | T | G |
| rs1799977 | 16771955 | 2956 | MSH6 | umls:C0001430 | BeFree | In a Minnesota-based case-control study of individuals with adenomas (N=401), hyperplastic polyps (N=195), or both adenomas and hyperplastic polyps (N=123) versus polyp-free controls (N=624), we investigated the role of hMLH1-93G>A, hMLH1 I219V, and hMSH6 G39E polymorphisms in increasing the risk of colorectal polyps. | 0.002171535 | 2006 | MLH1 | 3 | 37012077 | A | C,G |
| rs1799998 | 12107246 | 1585 | CYP11B2 | umls:C0001430 | BeFree | The aim of our study was to identify genetic variants that influence the phenotype of patients with PA. We hypothesized that genetic variants potentially affecting aldosterone production (aldosterone synthase, CYP11B2), renal proximal tubule reabsorption (alpha-adducin), or the mechanisms of counterbalance leading to vasodilatation and sodium excretion (bradykinin B(2)-receptor, B(2)R) could influence the clinical and biochemical characteristics of patients with PA. We studied three polymorphisms of these genes (C-344T of CYP11B2, G460W of alpha-adducin, and C-58T of B(2)R) in 167 primary aldosteronism patients (56 with aldosterone-producing adenoma and 111 with idiopathic hyperaldosteronism). | 0.004614512 | 2002 | CYP11B2;LOC105375793 | 8 | 142918184 | A | G |
| rs1801155 | 12533824 | 324 | APC | umls:C0001430 | BeFree | It is therefore possible that many APC I1307K carriers with multiple adenomas have a susceptibility to tumours additional to that resulting from the A(8) tract. | 0.190731622 | 2003 | APC | 5 | 112839514 | T | A |
| rs1801155 | 9724771 | 324 | APC | umls:C0001430 | BeFree | Recently, however, a missense variant of APC (I1307K) was described that confers an increased risk of colorectal tumors, including multiple adenomas, in Ashkenazim. | 0.190731622 | 1998 | APC | 5 | 112839514 | T | A |
| rs1801155 | 9973276 | 324 | APC | umls:C0001430 | BeFree | We conclude that the APC I1307K variant leads to increased adenoma formation and directly contributes to 3%-4% of all Ashkenazi Jewish colorectal cancer. | 0.190731622 | 1999 | APC | 5 | 112839514 | T | A |
| rs1801155 | 16228836 | 324 | APC | umls:C0001430 | BeFree | The prevalence of polyps and adenomas in specimens of colorectal cancer who are carriers and noncarriers of the APC I1307K polymorphism is compared. | 0.190731622 | 2005 | APC | 5 | 112839514 | T | A |
| rs1801166 | 14578138 | 324 | APC | umls:C0001430 | BeFree | In the present study, 608 cases (377 patients with CRC, 145 patients with 4-100 lifetime adenomas, and 86 with < or =3 lifetime adenomas), and 679 controls (362 spouses and 317 patients with normal colonoscopy) were screened for the APC E1317Q variant. | 0.190731622 | 2003 | APC | 5 | 112839543 | G | C |
| rs2228000 | 16492920 | 7508 | XPC | umls:C0001430 | BeFree | Smoking was related to adenoma risk and XPC polymorphisms (R492H, A499V, K939Q) modified these effects (P(interaction) from 0.03-0.003). | 0.002995792 | 2006 | XPC | 3 | 14158387 | G | A |
| rs2228001 | 16492920 | 7508 | XPC | umls:C0001430 | BeFree | Smoking was related to adenoma risk and XPC polymorphisms (R492H, A499V, K939Q) modified these effects (P(interaction) from 0.03-0.003). | 0.002995792 | 2006 | XPC | 3 | 14145949 | G | T |
| rs2229995 | 15824157 | 324 | APC | umls:C0001430 | BeFree | APC Asp1822Val and Gly2502Ser polymorphisms and risk of colorectal cancer and adenoma. | 0.190731622 | 2005 | APC | 5 | 112843098 | G | A |
| rs2236484 | 21274745 | 6573 | SLC19A1 | umls:C0001430 | BeFree | Five SNPs in the SLC19A1 (RFC1) gene: rs1051266 (G80A), rs283895, rs2236484, rs12482346, and rs2838958 were associated with adenoma risk after correction for multiple testing (all corrected p values ≤ 0.043). | 0.120271442 | 2011 | SLC19A1;COL18A1 | 21 | 45511770 | G | A |
| rs2302615 | 21930798 | 4953 | ODC1 | umls:C0001430 | BeFree | Previous studies suggest that a single-nucleotide polymorphism (SNP) in the promoter of the ODC gene (rs2302615) may be associated with adenoma risk and/or response to aspirin chemoprevention. | 0.006091273 | 2011 | ODC1;SNORA80B;LOC101929715 | 2 | 10448012 | C | T |
| rs283895 | 21274745 | 6573 | SLC19A1 | umls:C0001430 | BeFree | Five SNPs in the SLC19A1 (RFC1) gene: rs1051266 (G80A), rs283895, rs2236484, rs12482346, and rs2838958 were associated with adenoma risk after correction for multiple testing (all corrected p values ≤ 0.043). | 0.120271442 | 2011 | NA | 2 | 79099089 | T | C |
| rs28936409 | 21810944 | 5308 | PITX2 | umls:C0001430 | BeFree | To better understand the role of Pitx2 on gonadotroph tumorigenesis and to explore new approach for inhibiting tumoral growth, the R91P mutant was transferred via a lentiviral vector in tumoral gonadotroph cells of two kinds: the αT3-1 cell line and human adenoma cells. | 0.000271442 | 2011 | PITX2 | 4 | 110621303 | C | T,G |
| rs28937584 | 24480816 | 7253 | TSHR | umls:C0001430 | BeFree | We reviewed papers describing 16 autonomous adenomas due to a somatic mutation activating the TSHR and diagnosed in patients younger than 18 years, to which we added two of our own unpublished observations in a 4- and 8-year-old with the same TSHR mutation (c.CAG>CAC; p.Asp633His). | 0.124885954 | 2013 | TSHR;LOC101928462 | 14 | 81143955 | G | C |
| rs3789243 | 23977225 | 5243 | ABCB1 | umls:C0001430 | BeFree | The ABCB1 C-rs3789243-T and NFKB1 -94ins/del homozygous variant genotypes were associated with low ABCB1 mRNA levels in morphologically normal sigmoid tissue from adenoma cases (P<0.05 for both). | 0.000814326 | 2013 | ABCB1 | 7 | 87591570 | A | G |
| rs3789243 | 23977225 | 4790 | NFKB1 | umls:C0001430 | BeFree | The ABCB1 C-rs3789243-T and NFKB1 -94ins/del homozygous variant genotypes were associated with low ABCB1 mRNA levels in morphologically normal sigmoid tissue from adenoma cases (P<0.05 for both). | 0.000271442 | 2013 | ABCB1 | 7 | 87591570 | A | G |
| rs3817672 | 15668490 | 7037 | TFRC | umls:C0001430 | BeFree | In the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial, 679 persons with advanced distal adenoma and 697 control persons were genotyped for the two major HFE mutations (C282Y and H63D), one HFE polymorphism (IVS2+4), and one polymorphism (G142S) in the transferrin receptor gene (TFRC). | 0.000271442 | 2005 | TFRC | 3 | 196073940 | C | T |
| rs386514057 | 21274745 | 6573 | SLC19A1 | umls:C0001430 | BeFree | Five SNPs in the SLC19A1 (RFC1) gene: rs1051266 (G80A), rs283895, rs2236484, rs12482346, and rs2838958 were associated with adenoma risk after correction for multiple testing (all corrected p values ≤ 0.043). | 0.120271442 | 2011 | NA | NA | NA | NA | NA |
| rs386561659 | 16492920 | 7508 | XPC | umls:C0001430 | BeFree | Smoking was related to adenoma risk and XPC polymorphisms (R492H, A499V, K939Q) modified these effects (P(interaction) from 0.03-0.003). | 0.002995792 | 2006 | NA | NA | NA | NA | NA |
| rs386561660 | 16492920 | 7508 | XPC | umls:C0001430 | BeFree | Smoking was related to adenoma risk and XPC polymorphisms (R492H, A499V, K939Q) modified these effects (P(interaction) from 0.03-0.003). | 0.002995792 | 2006 | NA | NA | NA | NA | NA |
| rs4539 | 16118341 | 1585 | CYP11B2 | umls:C0001430 | BeFree | Association of Lys173Arg polymorphism with CYP11B2 expression in normal adrenal glands and aldosterone-producing adenomas. | 0.004614512 | 2005 | CYP11B2;GML | 8 | 142915123 | T | C |
| rs459552 | 15824157 | 324 | APC | umls:C0001430 | BeFree | APC Asp1822Val and Gly2502Ser polymorphisms and risk of colorectal cancer and adenoma. | 0.190731622 | 2005 | APC | 5 | 112841059 | T | A |
| rs496601 | 24194259 | 3480 | IGF1R | umls:C0001430 | BeFree | One SNP (rs496601) in IGF1R was associated with adenomas in Caucasians only; the per allele adjusted OR is 0.73 (95 % CI 0.57-0.93). | 0.003452799 | 2013 | NA | 11 | 58863970 | A | G |
| rs5443 | 16178055 | 2784 | GNB3 | umls:C0001430 | BeFree | Different genotype distribution of the GNB3 C825T polymorphism of the G protein beta3 subunit in adenomas and differentiated thyroid carcinomas of follicular cell origin. | 0.005276948 | 2005 | GNB3;CDCA3 | 12 | 6845711 | C | T |
| rs5443 | 21979884 | 2784 | GNB3 | umls:C0001430 | BeFree | Clinically silent adrenal adenomas - their relation to the metabolic syndrome and to GNB3 C825T gene polymorphism. | 0.005276948 | 2011 | GNB3;CDCA3 | 12 | 6845711 | C | T |
| rs6586714 | 22552404 | 10991 | SLC38A3 | umls:C0001430 | BeFree | An interaction was observed between 2-amino-3,8-dimethylimidazo[4,5-f]quinoxaline (MeIQx) intake and the NAT1 polymorphism rs6586714 in the adenoma study (P(interaction) = 0.001). | 0.000814326 | 2012 | NAT1 | 8 | 18216433 | A | G |
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:10) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0001430 | caffeine | D002110 | 1958/8/2 | adenoma | MESH:D000236 | therapeutic | 17145898 | ||
| C0001430 | folic acid | D005492 | 59-30-3 | adenoma | MESH:D000236 | therapeutic | 16963246 | ||
| C0001430 | gabapentin | C040029 | 60142-96-3 | adenoma | MESH:D000236 | marker/mechanism | 7870083 | ||
| C0001430 | indomethacin | D007213 | 53-86-1 | adenoma | MESH:D000236 | therapeutic | 11497255 | ||
| C0001430 | medroxyprogesterone acetate | D017258 | 71-58-9 | adenoma | MESH:D000236 | marker/mechanism | 8751273 | ||
| C0001430 | octreotide | D015282 | 83150-76-9 | adenoma | MESH:D000236 | therapeutic | 1518435 | ||
| C0001430 | piroxicam | D010894 | 36322-90-4 | adenoma | MESH:D000236 | therapeutic | 9617344 | ||
| C0001430 | pravastatin | D017035 | 81093-37-0 | adenoma | MESH:D000236 | marker/mechanism | 10813127 | ||
| C0001430 | sulindac | D013467 | 38194-50-2 | adenoma | MESH:D000236 | therapeutic | 10223192 | ||
| C0001430 | temozolomide | C047246 | 85622-93-1 | adenoma | MESH:D000236 | therapeutic | 20045804 | ||
FDA approved drug and dosage information(Total Drugs:9) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D000236 | neurontin | gabapentin | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D000236 | neurontin | gabapentin | 600MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D000236 | neurontin | gabapentin | 250MG/5ML | SOLUTION;ORAL | Prescription | AA | Yes | Yes |
| MESH:D000236 | neurontin | gabapentin | 0 | SOLUTION; ORAL | Prescription | None | No | No |
| MESH:D000236 | neurontin | gabapentin | 600MG | TABLET; ORAL | Prescription | None | No | No |
| MESH:D000236 | neurontin | gabapentin | 800MG | CAPSULE; ORAL | Prescription | None | No | No |
| MESH:D000236 | neurontin | gabapentin | 250MG/5ML | SOLUTION; ORAL | Prescription | None | No | No |
| MESH:D000236 | temodar | temozolomide | 5MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D000236 | temodar | temozolomide | 100MG/VIAL | POWDER;INTRAVENOUS | Prescription | None | Yes | Yes |
FDA labeling changes(Total Drugs:9) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D000236 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D000236 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D000236 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D000236 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D000236 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D000236 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D000236 | 12/10/2000 | neurontin | gabapentin | Adjunctive therapy in the treatment of partial seizures | Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children | Labeling | B | - | - | - | Parke-Davis | 2/2/2000 | FALSE' |
| MESH:D000236 | 11/3/2003 | temodar | temozolomide | Recurrent CNS tumors | Temozolomide effectiveness in children has not been demonstrated New data from 2 open-label Phase 2 studies in pediatric patients 3-18 years of age. In one study there were 29 patients with recurrent brain stem glioma and 34 patients with recurrent high grade astrocyoma. In a second study there were 122 patients enrolled with various types of tumors; 113 CNS tumors and 9 non-CNS tumors. The temozolomide toxicity profile in children is similar to adults | Labeling | B | - | - | - | Schering | 11/20/2002 | FALSE' |
| MESH:D000236 | 11/3/2003 | temodar | temozolomide | Recurrent CNS tumors | Temozolomide effectiveness in children has not been demonstrated New data from 2 open-label Phase 2 studies in pediatric patients 3-18 years of age. In one study there were 29 patients with recurrent brain stem glioma and 34 patients with recurrent high grade astrocyoma. In a second study there were 122 patients enrolled with various types of tumors; 113 CNS tumors and 9 non-CNS tumors. The temozolomide toxicity profile in children is similar to adults | Labeling | B | - | - | - | Schering | 11/20/2002 | FALSE' |