Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125488161 | 12548816 | 1 | I | 20160210 | 20160409 | 20160712 | 20160712 | EXP | JP-GLAXOSMITHKLINE-JP2016049161 | GLAXOSMITHKLINE | 50.42 | YR | M | Y | 74.00000 | KG | 20160712 | MD | JP | JP |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125488161 | 12548816 | 1 | SS | Denosumab | DENOSUMAB | 1 | Subcutaneous | 60 MG, Q3MO | 0 | 60 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 125488161 | 12548816 | 2 | SS | Denosumab | DENOSUMAB | 1 | Subcutaneous | 60 MG, Q3MO | 0 | 60 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 125488161 | 12548816 | 3 | SS | Metolate | METHOTREXATE | 1 | Oral | 6 MG, QWK | U | 0 | 6 | MG | |||||||
| 125488161 | 12548816 | 4 | SS | Foliamin | FOLIC ACID | 1 | Oral | 5 MG, QWK | U | 0 | 5 | MG | |||||||
| 125488161 | 12548816 | 5 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 2 MG, QD | U | 0 | 2 | MG | QD | ||||||
| 125488161 | 12548816 | 6 | SS | Bayaspirin | ASPIRIN | 1 | Oral | 100 MG, QD | U | 0 | 100 | MG | QD | ||||||
| 125488161 | 12548816 | 7 | SS | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Oral | 5 MG, QD | U | 0 | 5 | MG | QD | ||||||
| 125488161 | 12548816 | 8 | SS | Enalapril | ENALAPRIL | 1 | Oral | 5 MG, QD | U | 0 | 5 | MG | QD | ||||||
| 125488161 | 12548816 | 9 | PS | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 15 MG, QD | U | 22327 | 15 | MG | QD | ||||||
| 125488161 | 12548816 | 10 | SS | ZETIA | EZETIMIBE | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | QD | ||||||
| 125488161 | 12548816 | 11 | SS | AZULFIDINE | SULFASALAZINE | 1 | Oral | 500 MG, QD | U | 0 | 500 | MG | QD | ||||||
| 125488161 | 12548816 | 12 | SS | RIMATIL | BUCILLAMINE | 1 | Oral | 100 MG, QD | U | 0 | 100 | MG | QD | ||||||
| 125488161 | 12548816 | 13 | SS | LOXOPROFEN NA | LOXOPROFEN SODIUM | 1 | Oral | 60 MG, AS NECESSARY | U | 0 | 60 | MG | |||||||
| 125488161 | 12548816 | 14 | SS | REBAMIPIDE | REBAMIPIDE | 1 | Oral | 100 MG, AS NECESSARY | U | 0 | 100 | MG | |||||||
| 125488161 | 12548816 | 15 | SS | MICAMLO | AMLODIPINE BESYLATETELMISARTAN | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | QD | ||||||
| 125488161 | 12548816 | 16 | SS | NATRIX | INDAPAMIDE | 1 | Oral | 1 MG, QD | U | 0 | 1 | MG | QD | ||||||
| 125488161 | 12548816 | 17 | SS | DENOTAS | CALCIUM CARBONATECHOLECALCIFEROLMAGNESIUM CARBONATE | 1 | Oral | 2 DF, QD | U | 0 | 2 | DF | QD | ||||||
| 125488161 | 12548816 | 18 | SS | DENOTAS | CALCIUM CARBONATECHOLECALCIFEROLMAGNESIUM CARBONATE | 1 | U | 0 | |||||||||||
| 125488161 | 12548816 | 19 | SS | URSO | URSODIOL | 1 | Oral | 300 MG, QD | U | 0 | 300 | MG | QD | ||||||
| 125488161 | 12548816 | 20 | SS | URSO | URSODIOL | 1 | U | 0 | |||||||||||
| 125488161 | 12548816 | 21 | SS | FUROZIN | CARPRONIUM CHLORIDE | 1 | Transdermal | UNK, BID | U | 0 | |||||||||
| 125488161 | 12548816 | 22 | SS | PRASUGREL HYDROCHLORIDE | PRASUGREL HYDROCHLORIDE | 1 | Oral | 3.75 MG, QD | U | 0 | 3.75 | MG | QD | ||||||
| 125488161 | 12548816 | 23 | SS | SUMILU | FELBINAC | 1 | Transdermal | UNK, AS NECESSARY | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125488161 | 12548816 | 1 | Rheumatoid arthritis |
| 125488161 | 12548816 | 3 | Rheumatoid arthritis |
| 125488161 | 12548816 | 4 | Prophylaxis |
| 125488161 | 12548816 | 5 | Rheumatoid arthritis |
| 125488161 | 12548816 | 6 | Prophylaxis |
| 125488161 | 12548816 | 7 | Prophylaxis |
| 125488161 | 12548816 | 8 | Hypertension |
| 125488161 | 12548816 | 9 | Gastritis prophylaxis |
| 125488161 | 12548816 | 10 | Prophylaxis |
| 125488161 | 12548816 | 11 | Rheumatoid arthritis |
| 125488161 | 12548816 | 12 | Rheumatoid arthritis |
| 125488161 | 12548816 | 13 | Rheumatoid arthritis |
| 125488161 | 12548816 | 14 | Prophylaxis |
| 125488161 | 12548816 | 15 | Hypertension |
| 125488161 | 12548816 | 16 | Hypertension |
| 125488161 | 12548816 | 17 | Vitamin supplementation |
| 125488161 | 12548816 | 18 | Mineral supplementation |
| 125488161 | 12548816 | 19 | Aspartate aminotransferase increased |
| 125488161 | 12548816 | 20 | Alanine aminotransferase increased |
| 125488161 | 12548816 | 21 | Alopecia areata |
| 125488161 | 12548816 | 22 | Prophylaxis |
| 125488161 | 12548816 | 23 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125488161 | 12548816 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125488161 | 12548816 | Large intestine polyp |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125488161 | 12548816 | 1 | 20140307 | 0 | ||
| 125488161 | 12548816 | 2 | 20150320 | 0 | ||
| 125488161 | 12548816 | 3 | 20151021 | 0 | ||
| 125488161 | 12548816 | 4 | 20151024 | 0 | ||
| 125488161 | 12548816 | 5 | 20130907 | 0 | ||
| 125488161 | 12548816 | 6 | 20150715 | 0 | ||
| 125488161 | 12548816 | 7 | 20150715 | 0 | ||
| 125488161 | 12548816 | 8 | 20150715 | 0 | ||
| 125488161 | 12548816 | 9 | 20160119 | 0 | ||
| 125488161 | 12548816 | 10 | 20160109 | 0 | ||
| 125488161 | 12548816 | 11 | 20151016 | 0 | ||
| 125488161 | 12548816 | 12 | 20151016 | 0 | ||
| 125488161 | 12548816 | 13 | 20150915 | 0 | ||
| 125488161 | 12548816 | 14 | 20120824 | 0 | ||
| 125488161 | 12548816 | 15 | 20150317 | 0 | ||
| 125488161 | 12548816 | 16 | 20150317 | 0 | ||
| 125488161 | 12548816 | 17 | 20140214 | 0 | ||
| 125488161 | 12548816 | 19 | 20150915 | 0 | ||
| 125488161 | 12548816 | 21 | 20150826 | 0 | ||
| 125488161 | 12548816 | 22 | 20150715 | 0 | ||
| 125488161 | 12548816 | 23 | 20160209 | 0 |