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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123064244 | 12306424 | 4 | F | 20121205 | 20160809 | 20160426 | 20160816 | EXP | CA-JNJFOC-20160422135 | JANSSEN | 40.31 | YR | A | M | Y | 60.70000 | KG | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123064244 | 12306424 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FKM95012;FKM95011;GAM08011 +MORE | 0 | LYOPHILIZED POWDER | ||||||||
| 123064244 | 12306424 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FKM95012;FKM95011;GAM08011 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 123064244 | 12306424 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 155 INFUSION | N | FKM95012;FKM95011;GAM08011 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | |||||
| 123064244 | 12306424 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | INFUSION # 157 TODAY (AT THE TIME OF THIS REPORT) | N | FKM95012;FKM95011;GAM08011 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | |||||
| 123064244 | 12306424 | 5 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FKM95012;FKM95011;GAM08011 +MORE | 103772 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 123064244 | 12306424 | 6 | SS | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | U | 0 | 200 | MG | UNSPECIFIED | |||||||
| 123064244 | 12306424 | 7 | SS | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | U | 0 | 200 | MG | UNSPECIFIED | |||||||
| 123064244 | 12306424 | 8 | C | HYDROMORPHONE | HYDROMORPHONE | 1 | Unknown | 0 | 2 | MG | UNSPECIFIED | QID | |||||||
| 123064244 | 12306424 | 9 | C | NABILONE | NABILONE | 1 | Unknown | 0 | 1 | MG | TABLET | QD | |||||||
| 123064244 | 12306424 | 10 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123064244 | 12306424 | 11 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123064244 | 12306424 | 12 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 0 | 40 | MG | UNSPECIFIED | ||||||||
| 123064244 | 12306424 | 13 | C | GRAVOL | DIMENHYDRINATE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123064244 | 12306424 | 1 | Crohn's disease |
| 123064244 | 12306424 | 2 | Crohn's disease |
| 123064244 | 12306424 | 3 | Crohn's disease |
| 123064244 | 12306424 | 4 | Crohn's disease |
| 123064244 | 12306424 | 5 | Crohn's disease |
| 123064244 | 12306424 | 6 | Premedication |
| 123064244 | 12306424 | 7 | Premedication |
| 123064244 | 12306424 | 13 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123064244 | 12306424 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123064244 | 12306424 | Abdominal pain | |
| 123064244 | 12306424 | Fall | |
| 123064244 | 12306424 | Infusion related reaction | |
| 123064244 | 12306424 | Intestinal resection | |
| 123064244 | 12306424 | Ligament sprain | |
| 123064244 | 12306424 | Nausea | |
| 123064244 | 12306424 | Off label use | |
| 123064244 | 12306424 | Product use issue | |
| 123064244 | 12306424 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 123064244 | 12306424 | 1 | 20160714 | 0 | ||
| 123064244 | 12306424 | 2 | 20121205 | 0 | ||
| 123064244 | 12306424 | 3 | 20160421 | 0 | ||
| 123064244 | 12306424 | 4 | 20160616 | 0 | ||
| 123064244 | 12306424 | 5 | 201311 | 0 | ||
| 123064244 | 12306424 | 6 | 20160714 | 0 | ||
| 123064244 | 12306424 | 7 | 20160616 | 0 |