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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125081706 | 12508170 | 6 | F | 2016 | 20160811 | 20160629 | 20160823 | EXP | BR-JNJFOC-20160621282 | JANSSEN | 11.41 | YR | C | M | Y | 30.00000 | KG | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125081706 | 12508170 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | FLL05011A;FKL97013;UNKNOWN | 0 | 3 | DF | LYOPHILIZED POWDER | |||||
| 125081706 | 12508170 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | FLL05011A;FKL97013;UNKNOWN | 103772 | 1 | DF | LYOPHILIZED POWDER | |||||
| 125081706 | 12508170 | 3 | C | MESALAZINE | MESALAMINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125081706 | 12508170 | 4 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125081706 | 12508170 | 1 | Crohn's disease |
| 125081706 | 12508170 | 2 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125081706 | 12508170 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125081706 | 12508170 | Arthralgia | |
| 125081706 | 12508170 | Back pain | |
| 125081706 | 12508170 | Blood pressure decreased | |
| 125081706 | 12508170 | Chest pain | |
| 125081706 | 12508170 | Diarrhoea | |
| 125081706 | 12508170 | Haemorrhage | |
| 125081706 | 12508170 | Headache | |
| 125081706 | 12508170 | Heart rate decreased | |
| 125081706 | 12508170 | Infusion related reaction | |
| 125081706 | 12508170 | Off label use | |
| 125081706 | 12508170 | Oxygen saturation decreased | |
| 125081706 | 12508170 | Pain | |
| 125081706 | 12508170 | Product use issue | |
| 125081706 | 12508170 | Pyrexia | |
| 125081706 | 12508170 | Vomiting | |
| 125081706 | 12508170 | Weight fluctuation |
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 |
|---|---|---|---|---|---|---|
| 125081706 | 12508170 | 2 | 20160301 | 0 | ||
| 125081706 | 12508170 | 3 | 2015 | 0 | ||
| 125081706 | 12508170 | 4 | 2015 | 0 |