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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117587556 | 11758755 | 6 | F | 2004 | 20160806 | 20151120 | 20160817 | EXP | CA-JNJFOC-20151114787 | JANSSEN | 43.82 | YR | A | F | Y | 80.00000 | KG | 20160817 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117587556 | 11758755 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FDM39014;UNKNOWN;UNKNOWN | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 117587556 | 11758755 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FDM39014;UNKNOWN;UNKNOWN | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 117587556 | 11758755 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FDM39014;UNKNOWN;UNKNOWN | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 117587556 | 11758755 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FDM39014;UNKNOWN;UNKNOWN | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 117587556 | 11758755 | 5 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FDM39014;UNKNOWN;UNKNOWN | 103772 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 117587556 | 11758755 | 6 | C | DEXILANT | DEXLANSOPRAZOLE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 117587556 | 11758755 | 7 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | AS NEEDED. | 0 | 2.5 | MG | UNSPECIFIED | QD | ||||||
| 117587556 | 11758755 | 8 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | AS NEEDED. | 0 | UNSPECIFIED | |||||||||
| 117587556 | 11758755 | 9 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | 2 PUFFS. | 0 | UNSPECIFIED | |||||||||
| 117587556 | 11758755 | 10 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intravenous (not otherwise specified) | 0 | 200 | MG | UNSPECIFIED | ||||||||
| 117587556 | 11758755 | 11 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG | UNSPECIFIED | ||||||||
| 117587556 | 11758755 | 12 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117587556 | 11758755 | 1 | Crohn's disease |
| 117587556 | 11758755 | 2 | Crohn's disease |
| 117587556 | 11758755 | 3 | Crohn's disease |
| 117587556 | 11758755 | 4 | Crohn's disease |
| 117587556 | 11758755 | 5 | Crohn's disease |
| 117587556 | 11758755 | 7 | Adjuvant therapy |
| 117587556 | 11758755 | 10 | Premedication |
| 117587556 | 11758755 | 11 | Premedication |
| 117587556 | 11758755 | 12 | Premedication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117587556 | 11758755 | Crohn's disease | |
| 117587556 | 11758755 | Drug ineffective | |
| 117587556 | 11758755 | Food intolerance | |
| 117587556 | 11758755 | General physical health deterioration | |
| 117587556 | 11758755 | Nausea | |
| 117587556 | 11758755 | Neoplasm skin | |
| 117587556 | 11758755 | Off label use | |
| 117587556 | 11758755 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 117587556 | 11758755 | 1 | 20080304 | 0 | ||
| 117587556 | 11758755 | 2 | 20160513 | 0 | ||
| 117587556 | 11758755 | 3 | 20160624 | 0 | ||
| 117587556 | 11758755 | 4 | 201110 | 0 | ||
| 117587556 | 11758755 | 5 | 2004 | 0 |