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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111023687 | 11102368 | 7 | F | 201504 | 20160715 | 20150511 | 20160726 | EXP | GB-TEVA-559557ACC | TEVA | 60.00 | YR | F | Y | 0.00000 | 20160726 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111023687 | 11102368 | 1 | PS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | DOSAGE FORM: UNSPECIFIED | Y | U | 81099 | ||||||||
| 111023687 | 11102368 | 2 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | Y | U | 0 | SOLUTION FOR INJECTION | ||||||||
| 111023687 | 11102368 | 3 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | Y | U | 0 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111023687 | 11102368 | 1 | Product used for unknown indication |
| 111023687 | 11102368 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111023687 | 11102368 | OT |
| 111023687 | 11102368 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111023687 | 11102368 | Abdominal distension | |
| 111023687 | 11102368 | Arthralgia | |
| 111023687 | 11102368 | Constipation | |
| 111023687 | 11102368 | Drug hypersensitivity | |
| 111023687 | 11102368 | Malaise | |
| 111023687 | 11102368 | Rash pruritic | |
| 111023687 | 11102368 | Urinary retention | |
| 111023687 | 11102368 | Urinary tract infection | |
| 111023687 | 11102368 | Urine output decreased | |
| 111023687 | 11102368 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 111023687 | 11102368 | 2 | 20150405 | 0 | ||
| 111023687 | 11102368 | 3 | 20150417 | 0 |