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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125869041 | 12586904 | 1 | I | 20151230 | 20160617 | 20160725 | 20160725 | EXP | US-JNJFOC-20160616830 | JANSSEN | 23.63 | YR | A | F | Y | 0.00000 | 20160725 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125869041 | 12586904 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FIL75015P1;15FO63P1 | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 125869041 | 12586904 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FIL75015P1;15FO63P1 | 0 | LYOPHILIZED POWDER | |||||||
| 125869041 | 12586904 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FIL75015P1;15FO63P1 | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 125869041 | 12586904 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FIL75015P1;15FO63P1 | 103772 | 300 | MG | LYOPHILIZED POWDER | |||||
| 125869041 | 12586904 | 5 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | U | 0 | 50 | MG | UNSPECIFIED | |||||||
| 125869041 | 12586904 | 6 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | U | 0 | 50 | MG | UNSPECIFIED | |||||||
| 125869041 | 12586904 | 7 | SS | ATIVAN | LORAZEPAM | 1 | Intravenous (not otherwise specified) | U | 0 | 2 | MG | UNSPECIFIED | |||||||
| 125869041 | 12586904 | 8 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 0 | 1000 | MG | UNSPECIFIED | ||||||||
| 125869041 | 12586904 | 9 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 0 | 1000 | MG | UNSPECIFIED | ||||||||
| 125869041 | 12586904 | 10 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 0 | 1000 | MG | UNSPECIFIED | ||||||||
| 125869041 | 12586904 | 11 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 0 | 40 | MG | UNSPECIFIED | ||||||||
| 125869041 | 12586904 | 12 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 0 | 40 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125869041 | 12586904 | 1 | Crohn's disease |
| 125869041 | 12586904 | 2 | Crohn's disease |
| 125869041 | 12586904 | 3 | Crohn's disease |
| 125869041 | 12586904 | 4 | Crohn's disease |
| 125869041 | 12586904 | 5 | Premedication |
| 125869041 | 12586904 | 6 | Premedication |
| 125869041 | 12586904 | 7 | Product used for unknown indication |
| 125869041 | 12586904 | 8 | Premedication |
| 125869041 | 12586904 | 9 | Premedication |
| 125869041 | 12586904 | 10 | Premedication |
| 125869041 | 12586904 | 11 | Premedication |
| 125869041 | 12586904 | 12 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125869041 | 12586904 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125869041 | 12586904 | Dizziness | |
| 125869041 | 12586904 | Flushing | |
| 125869041 | 12586904 | Heart rate increased | |
| 125869041 | 12586904 | Infusion related reaction | |
| 125869041 | 12586904 | Nausea | |
| 125869041 | 12586904 | Sensation of foreign body | |
| 125869041 | 12586904 | Throat tightness |
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 |
|---|---|---|---|---|---|---|
| 125869041 | 12586904 | 1 | 20160120 | 0 | ||
| 125869041 | 12586904 | 3 | 20151216 | 0 | ||
| 125869041 | 12586904 | 4 | 20151230 | 0 | ||
| 125869041 | 12586904 | 5 | 20151230 | 0 | ||
| 125869041 | 12586904 | 6 | 20160120 | 0 | ||
| 125869041 | 12586904 | 8 | 20160120 | 0 | ||
| 125869041 | 12586904 | 9 | 20151230 | 0 | ||
| 125869041 | 12586904 | 10 | 20151216 | 0 | ||
| 125869041 | 12586904 | 11 | 20151216 | 0 | ||
| 125869041 | 12586904 | 12 | 20160120 | 0 |