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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126363062 | 12636306 | 2 | F | 20160727 | 20160825 | 20160809 | 20160908 | EXP | JP-AMGEN-JPNSP2016101515 | AMGEN | 78.00 | YR | E | F | Y | 0.00000 | 20160908 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126363062 | 12636306 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | 500 | MG | Y | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||
| 126363062 | 12636306 | 2 | SS | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | UNK | 0 | ||||||||||
| 126363062 | 12636306 | 3 | SS | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | UNK UNK, DAILY | 0 | ||||||||||
| 126363062 | 12636306 | 4 | SS | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | UNK UNK, AS NEEDED | 0 | ||||||||||
| 126363062 | 12636306 | 5 | SS | ISONIAZID. | ISONIAZID | 1 | Oral | UNK | 0 | ||||||||||
| 126363062 | 12636306 | 6 | SS | ISONIAZID. | ISONIAZID | 1 | Oral | UNK UNK, DAILY | 0 | ||||||||||
| 126363062 | 12636306 | 7 | SS | ISONIAZID. | ISONIAZID | 1 | Oral | UNK UNK, AS NEEDED | 0 | ||||||||||
| 126363062 | 12636306 | 8 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | UNK | 0 | |||||||||||
| 126363062 | 12636306 | 9 | C | VALSARTAN. | VALSARTAN | 1 | UNK | 0 | |||||||||||
| 126363062 | 12636306 | 10 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | UNK | 0 | |||||||||||
| 126363062 | 12636306 | 11 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | UNK | 0 | |||||||||||
| 126363062 | 12636306 | 12 | C | URSO | URSODIOL | 1 | 0 | ||||||||||||
| 126363062 | 12636306 | 13 | C | PROHEPARUM | CHOLINE BITARTRATECYSTEINEINOSITOLMAMMAL LIVER | 1 | UNK | 0 | |||||||||||
| 126363062 | 12636306 | 14 | C | GRIMAC | 2 | UNK | 0 | ||||||||||||
| 126363062 | 12636306 | 15 | C | RHEUMATREX | METHOTREXATE SODIUM | 1 | UNK | 0 | |||||||||||
| 126363062 | 12636306 | 16 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | UNK | 0 | |||||||||||
| 126363062 | 12636306 | 17 | C | HERBESSER | DILTIAZEM HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 126363062 | 12636306 | 18 | C | EDIROL | ELDECALCITOL | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126363062 | 12636306 | 1 | Rheumatoid arthritis |
| 126363062 | 12636306 | 2 | Product used for unknown indication |
| 126363062 | 12636306 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126363062 | 12636306 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126363062 | 12636306 | Hepatic function abnormal |
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 |
|---|---|---|---|---|---|---|
| 126363062 | 12636306 | 1 | 20160513 | 20160719 | 0 | |
| 126363062 | 12636306 | 2 | 20151030 | 0 | ||
| 126363062 | 12636306 | 3 | 201605 | 2016 | 0 | |
| 126363062 | 12636306 | 4 | 2016 | 20160726 | 0 | |
| 126363062 | 12636306 | 5 | 20151030 | 0 | ||
| 126363062 | 12636306 | 6 | 201605 | 2016 | 0 | |
| 126363062 | 12636306 | 7 | 2016 | 20160726 | 0 |