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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125927632 | 12592763 | 2 | F | 201605 | 20160719 | 20160726 | 20160728 | EXP | GB-JNJFOC-20160715743 | JANSSEN | 67.00 | YR | E | F | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125927632 | 12592763 | 1 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | 0 | 5 | DF | LYOPHILIZED POWDER | |||||||
| 125927632 | 12592763 | 2 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | 0 | 5 | DF | LYOPHILIZED POWDER | |||||||
| 125927632 | 12592763 | 3 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | 0 | 5 | DF | LYOPHILIZED POWDER | |||||||
| 125927632 | 12592763 | 4 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | 103772 | 5 | DF | LYOPHILIZED POWDER | |||||||
| 125927632 | 12592763 | 5 | C | CYCLIZINE | CYCLIZINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125927632 | 12592763 | 6 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125927632 | 12592763 | 7 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125927632 | 12592763 | 8 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125927632 | 12592763 | 9 | C | TRAMADOL. | TRAMADOL | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125927632 | 12592763 | 1 | Erythema nodosum |
| 125927632 | 12592763 | 2 | Arthritis |
| 125927632 | 12592763 | 3 | Colitis microscopic |
| 125927632 | 12592763 | 4 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125927632 | 12592763 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125927632 | 12592763 | Lupus-like syndrome |
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 |
|---|---|---|---|---|---|---|
| 125927632 | 12592763 | 1 | 201507 | 0 | ||
| 125927632 | 12592763 | 2 | 201507 | 0 | ||
| 125927632 | 12592763 | 3 | 201507 | 0 | ||
| 125927632 | 12592763 | 4 | 201507 | 0 |