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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121618842 | 12161884 | 2 | F | 20160729 | 20160309 | 20160806 | EXP | GB-MHRA-ADR 23368731 | GB-ACCORD-038418 | ACCORD | 35.00 | YR | A | F | Y | 0.00000 | 20160806 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121618842 | 12161884 | 1 | PS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | N | 40716 | 5 | MG | /wk | |||||||
| 121618842 | 12161884 | 2 | SS | ADALIMUMAB | ADALIMUMAB | 1 | Unknown | DOSAGE FORM: UNSPECIFIED | N | 0 | |||||||||
| 121618842 | 12161884 | 3 | SS | INFLIXIMAB | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | INFLIXIMAB RECOMBINANT INFUSION, DOSAGE FORM: LYOPHILIZED POWDER | N | 0 | |||||||||
| 121618842 | 12161884 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | U | 0 | 40 | MG | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121618842 | 12161884 | 1 | Psoriatic arthropathy |
| 121618842 | 12161884 | 2 | Psoriatic arthropathy |
| 121618842 | 12161884 | 3 | Psoriatic arthropathy |
| 121618842 | 12161884 | 4 | Colitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121618842 | 12161884 | HO |
| 121618842 | 12161884 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121618842 | 12161884 | Hepatic steatosis | |
| 121618842 | 12161884 | Inappropriate schedule of drug administration | |
| 121618842 | 12161884 | Lupus-like syndrome | |
| 121618842 | 12161884 | Off label use | |
| 121618842 | 12161884 | Psoriatic arthropathy | |
| 121618842 | 12161884 | Therapeutic response decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |