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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 89513954 | 8951395 | 4 | F | 20121114 | 20130204 | 20121207 | 20160722 | EXP | BR-JNJFOC-20121200122 | JANSSEN | 48.79 | YR | A | M | Y | 80.00000 | KG | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 89513954 | 8951395 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 1RMKA85801;FFL51013A;UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 89513954 | 8951395 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 1RMKA85801;FFL51013A;UNKNOWN | 103772 | 400 | MG | LYOPHILIZED POWDER | |||||
| 89513954 | 8951395 | 3 | C | MESALAZINE | MESALAMINE | 1 | Oral | 0 | 500 | MG | TABLET | ||||||||
| 89513954 | 8951395 | 4 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | 5 | MG | TABLET | QD | |||||||
| 89513954 | 8951395 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Cutaneous | 0 | 20 | MG | CAPSULE | BID | |||||||
| 89513954 | 8951395 | 6 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 500 | MG | TABLET | Q6H | |||||||
| 89513954 | 8951395 | 7 | C | GLUTAMINE | GLUTAMINE | 1 | Oral | 0 | 10 | G | SACHET | QD | |||||||
| 89513954 | 8951395 | 8 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 20 | MG | TABLET | QD | |||||||
| 89513954 | 8951395 | 9 | C | FERRIC OXIDE, SACCHARATED | 2 | Intravenous (not otherwise specified) | 0 | 20 | MG | SOLUTION | |||||||||
| 89513954 | 8951395 | 10 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Oral | 0 | 50 | MG | TABLET | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 89513954 | 8951395 | 1 | Crohn's disease |
| 89513954 | 8951395 | 2 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 89513954 | 8951395 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 89513954 | 8951395 | Blood pressure fluctuation | |
| 89513954 | 8951395 | Blood pressure increased | |
| 89513954 | 8951395 | Eye irritation | |
| 89513954 | 8951395 | Headache | |
| 89513954 | 8951395 | Heart rate increased | |
| 89513954 | 8951395 | Infusion related reaction | |
| 89513954 | 8951395 | Paraesthesia | |
| 89513954 | 8951395 | Rash |
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 |
|---|---|---|---|---|---|---|
| 89513954 | 8951395 | 1 | 20111206 | 0 | ||
| 89513954 | 8951395 | 2 | 20121114 | 0 |