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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122652313 | 12265231 | 3 | F | 20140417 | 20160725 | 20160413 | 20160727 | EXP | CA-JNJFOC-20151206846 | JANSSEN | 21.46 | YR | A | F | Y | 57.15000 | KG | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122652313 | 12265231 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 122652313 | 12265231 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | INFUSION NUMBER 18 | Y | N | 103772 | 300 | MG | LYOPHILIZED POWDER | |||||
| 122652313 | 12265231 | 3 | SS | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Oral | U | 0 | 500 | MG | UNSPECIFIED | BID | ||||||
| 122652313 | 12265231 | 4 | SS | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 1 | Oral | U | 0 | 250 | MG | UNSPECIFIED | TID | ||||||
| 122652313 | 12265231 | 5 | C | ENTOCORT | BUDESONIDE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122652313 | 12265231 | 1 | Crohn's disease |
| 122652313 | 12265231 | 2 | Crohn's disease |
| 122652313 | 12265231 | 3 | Kidney infection |
| 122652313 | 12265231 | 4 | Kidney infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122652313 | 12265231 | LT |
| 122652313 | 12265231 | OT |
| 122652313 | 12265231 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122652313 | 12265231 | Crohn's disease | |
| 122652313 | 12265231 | Erythema of eyelid | |
| 122652313 | 12265231 | Eyelid oedema | |
| 122652313 | 12265231 | Injection site infection | |
| 122652313 | 12265231 | Intestinal stenosis | |
| 122652313 | 12265231 | Kidney infection | |
| 122652313 | 12265231 | Off label use | |
| 122652313 | 12265231 | Pneumonia | |
| 122652313 | 12265231 | Product use issue | |
| 122652313 | 12265231 | Staphylococcal infection | |
| 122652313 | 12265231 | Thrombosis | |
| 122652313 | 12265231 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 122652313 | 12265231 | 1 | 20140417 | 0 | ||
| 122652313 | 12265231 | 2 | 20150405 | 0 | ||
| 122652313 | 12265231 | 3 | 20151227 | 20160107 | 0 | |
| 122652313 | 12265231 | 4 | 20151227 | 20160107 | 0 |