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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117866237 | 11786623 | 7 | F | 20091201 | 20160824 | 20151130 | 20160831 | EXP | BR-JNJFOC-20151126750 | JANSSEN | 50.13 | YR | A | F | Y | 61.00000 | KG | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117866237 | 11786623 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 117866237 | 11786623 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | LYOPHILIZED POWDER | ||||||||
| 117866237 | 11786623 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 117866237 | 11786623 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | LYOPHILIZED POWDER | ||||||||
| 117866237 | 11786623 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 117866237 | 11786623 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | LYOPHILIZED POWDER | ||||||||
| 117866237 | 11786623 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 117866237 | 11786623 | 8 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | LYOPHILIZED POWDER | ||||||||
| 117866237 | 11786623 | 9 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 117866237 | 11786623 | 10 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | LYOPHILIZED POWDER | ||||||||
| 117866237 | 11786623 | 11 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 117866237 | 11786623 | 12 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 103772 | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117866237 | 11786623 | 1 | Psoriatic arthropathy |
| 117866237 | 11786623 | 2 | Psoriatic arthropathy |
| 117866237 | 11786623 | 3 | Psoriatic arthropathy |
| 117866237 | 11786623 | 4 | Psoriatic arthropathy |
| 117866237 | 11786623 | 5 | Psoriasis |
| 117866237 | 11786623 | 6 | Psoriasis |
| 117866237 | 11786623 | 7 | Psoriasis |
| 117866237 | 11786623 | 8 | Psoriasis |
| 117866237 | 11786623 | 9 | Rheumatoid arthritis |
| 117866237 | 11786623 | 10 | Rheumatoid arthritis |
| 117866237 | 11786623 | 11 | Rheumatoid arthritis |
| 117866237 | 11786623 | 12 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117866237 | 11786623 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117866237 | 11786623 | Alopecia | |
| 117866237 | 11786623 | Arthropathy | |
| 117866237 | 11786623 | Decreased appetite | |
| 117866237 | 11786623 | Incorrect dose administered | |
| 117866237 | 11786623 | Joint swelling | |
| 117866237 | 11786623 | Off label use | |
| 117866237 | 11786623 | Pain | |
| 117866237 | 11786623 | Pain in extremity | |
| 117866237 | 11786623 | Pruritus | |
| 117866237 | 11786623 | Psoriasis | |
| 117866237 | 11786623 | Pyrexia | |
| 117866237 | 11786623 | Swelling | |
| 117866237 | 11786623 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 117866237 | 11786623 | 1 | 20091201 | 0 | ||
| 117866237 | 11786623 | 2 | 20160518 | 0 | ||
| 117866237 | 11786623 | 3 | 20151202 | 0 | ||
| 117866237 | 11786623 | 4 | 2010 | 0 | ||
| 117866237 | 11786623 | 5 | 20091201 | 0 | ||
| 117866237 | 11786623 | 6 | 20160518 | 0 | ||
| 117866237 | 11786623 | 7 | 20151202 | 0 | ||
| 117866237 | 11786623 | 8 | 2010 | 0 | ||
| 117866237 | 11786623 | 9 | 20151202 | 0 | ||
| 117866237 | 11786623 | 10 | 2010 | 0 | ||
| 117866237 | 11786623 | 11 | 20091201 | 0 | ||
| 117866237 | 11786623 | 12 | 20160518 | 0 |