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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 91382534 | 9138253 | 4 | F | 201301 | 20160722 | 20130305 | 20160728 | EXP | BR-AMGEN-BRASP2013014325 | AMGEN | 69.00 | YR | E | F | Y | 75.00000 | KG | 20160728 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 91382534 | 9138253 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, 1X/WEEK | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||||
| 91382534 | 9138253 | 2 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, ONCE A WEEK | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||||
| 91382534 | 9138253 | 3 | C | DICLOFENAC SODIUM. | DICLOFENAC SODIUM | 1 | UNK | 0 | |||||||||||
| 91382534 | 9138253 | 4 | C | DICLOFENAC SODIUM. | DICLOFENAC SODIUM | 1 | UNK, AS NEEDED | 0 | |||||||||||
| 91382534 | 9138253 | 5 | C | BUSCOPAN | BUTYLSCOPOLAMINE BROMIDE | 1 | UNK, AS NEEDED | 0 | |||||||||||
| 91382534 | 9138253 | 6 | C | OMEPRAZOL /00661201/ | OMEPRAZOLE | 1 | UNK | 0 | |||||||||||
| 91382534 | 9138253 | 7 | C | OMEPRAZOL /00661201/ | OMEPRAZOLE | 1 | UNK | 0 | |||||||||||
| 91382534 | 9138253 | 8 | C | NIMESULIDE | NIMESULIDE | 1 | UNK, DAILY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 91382534 | 9138253 | 1 | Rheumatoid arthritis |
| 91382534 | 9138253 | 3 | Pain |
| 91382534 | 9138253 | 5 | Pain |
| 91382534 | 9138253 | 6 | Abdominal discomfort |
| 91382534 | 9138253 | 7 | Abdominal discomfort |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 91382534 | 9138253 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 91382534 | 9138253 | Arthralgia | |
| 91382534 | 9138253 | Asthenia | |
| 91382534 | 9138253 | Balance disorder | |
| 91382534 | 9138253 | Blister | |
| 91382534 | 9138253 | Diabetes mellitus | |
| 91382534 | 9138253 | Gait disturbance | |
| 91382534 | 9138253 | Joint swelling | |
| 91382534 | 9138253 | Limb deformity | |
| 91382534 | 9138253 | Lung disorder | |
| 91382534 | 9138253 | Muscle spasms | |
| 91382534 | 9138253 | Pain in extremity | |
| 91382534 | 9138253 | Peripheral swelling | |
| 91382534 | 9138253 | Pruritus generalised | |
| 91382534 | 9138253 | Renal disorder | |
| 91382534 | 9138253 | Skin discolouration |
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 |
|---|---|---|---|---|---|---|
| 91382534 | 9138253 | 1 | 201211 | 201212 | 0 | |
| 91382534 | 9138253 | 2 | 20130301 | 201408 | 0 |