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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118856482 | 11885648 | 2 | F | 2015 | 20160803 | 20160104 | 20160809 | EXP | CA-JNJFOC-20151023130 | JANSSEN | 0.00 | A | M | Y | 80.00000 | KG | 20160809 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118856482 | 11885648 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FHM67012;FLM04014 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 118856482 | 11885648 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FHM67012;FLM04014 | 0 | 800 | MG | LYOPHILIZED POWDER | ||||||
| 118856482 | 11885648 | 3 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FHM67012;FLM04014 | 103772 | 800 | MG | LYOPHILIZED POWDER | ||||||
| 118856482 | 11885648 | 4 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 25 | MG | UNSPECIFIED | ||||||||
| 118856482 | 11885648 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | 0 | 15 | MG | UNSPECIFIED | /wk | |||||||
| 118856482 | 11885648 | 6 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intravenous (not otherwise specified) | 0 | 200 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118856482 | 11885648 | 1 | Crohn's disease |
| 118856482 | 11885648 | 2 | Crohn's disease |
| 118856482 | 11885648 | 3 | Crohn's disease |
| 118856482 | 11885648 | 4 | Premedication |
| 118856482 | 11885648 | 5 | Crohn's disease |
| 118856482 | 11885648 | 6 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118856482 | 11885648 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118856482 | 11885648 | Dehydration | |
| 118856482 | 11885648 | Diarrhoea | |
| 118856482 | 11885648 | Fatigue | |
| 118856482 | 11885648 | Intestinal resection |
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 |
|---|---|---|---|---|---|---|
| 118856482 | 11885648 | 1 | 20150226 | 2015 | 0 | |
| 118856482 | 11885648 | 2 | 20151230 | 0 | ||
| 118856482 | 11885648 | 3 | 20160122 | 0 |