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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110960914 | 11096091 | 4 | F | 201504 | 20160715 | 20150507 | 20160727 | EXP | GB-MHRA-ADR 22965323 | GB-ACCORD-030357 | ACCORD | 60.00 | YR | A | F | Y | 0.00000 | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110960914 | 11096091 | 1 | PS | METHOTREXATE. | METHOTREXATE | 1 | Y | 40716 | |||||||||||
| 110960914 | 11096091 | 2 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | Y | 0 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110960914 | 11096091 | 1 | Product used for unknown indication |
| 110960914 | 11096091 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110960914 | 11096091 | OT |
| 110960914 | 11096091 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110960914 | 11096091 | Abdominal distension | |
| 110960914 | 11096091 | Arthralgia | |
| 110960914 | 11096091 | Constipation | |
| 110960914 | 11096091 | Drug hypersensitivity | |
| 110960914 | 11096091 | Malaise | |
| 110960914 | 11096091 | Rash pruritic | |
| 110960914 | 11096091 | Urinary retention | |
| 110960914 | 11096091 | Urinary tract infection | |
| 110960914 | 11096091 | Urine output decreased | |
| 110960914 | 11096091 | 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 |
|---|---|---|---|---|---|---|
| 110960914 | 11096091 | 2 | 20150405 | 0 |