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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125885791 | 12588579 | 1 | I | 20160707 | 20160725 | 20160725 | PER | US-JNJFOC-20160708942 | JANSSEN | 0.00 | F | Y | 0.00000 | 20160725 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125885791 | 12588579 | 1 | PS | TYLENOL | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | 1000 | MG | UNSPECIFIED | ||||||
| 125885791 | 12588579 | 2 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | INTRAVENOUS EVERY 8 WEEKS. | 0 | 4 | MG/KG | LYOPHILIZED POWDER | |||||||
| 125885791 | 12588579 | 3 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | RECEIVED THREE 100 MG VIALS. | 0 | 300 | MG | LYOPHILIZED POWDER | |||||||
| 125885791 | 12588579 | 4 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | INTRAVENOUS EVERY 8 WEEKS. | 0 | 4 | MG/KG | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125885791 | 12588579 | 1 | Premedication |
| 125885791 | 12588579 | 2 | Rheumatoid arthritis |
| 125885791 | 12588579 | 3 | Rheumatoid arthritis |
| 125885791 | 12588579 | 4 | Rheumatoid arthritis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125885791 | 12588579 | Off label use | |
| 125885791 | 12588579 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 125885791 | 12588579 | 2 | 20160428 | 0 | ||
| 125885791 | 12588579 | 3 | 20151214 | 0 | ||
| 125885791 | 12588579 | 4 | 20050620 | 0 |