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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125885871 | 12588587 | 1 | I | 2016 | 20160623 | 20160725 | 20160725 | PER | US-JNJFOC-20160711685 | JANSSEN | 58.00 | YR | A | M | Y | 0.00000 | 20160725 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125885871 | 12588587 | 1 | PS | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | UNSPECIFIED | ||||||||
| 125885871 | 12588587 | 2 | SS | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | UNSPECIFIED | ||||||||
| 125885871 | 12588587 | 3 | SS | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Unknown | U | U | 999999 | UNSPECIFIED | ||||||||
| 125885871 | 12588587 | 4 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 0 | UNSPECIFIED | ||||||||||
| 125885871 | 12588587 | 5 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 0 | UNSPECIFIED | ||||||||||
| 125885871 | 12588587 | 6 | C | ATENOLOL. | ATENOLOL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125885871 | 12588587 | 7 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125885871 | 12588587 | 8 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 0 | 40 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125885871 | 12588587 | 2 | Premedication |
| 125885871 | 12588587 | 3 | Premedication |
| 125885871 | 12588587 | 4 | Crohn's disease |
| 125885871 | 12588587 | 5 | Crohn's disease |
| 125885871 | 12588587 | 6 | Product used for unknown indication |
| 125885871 | 12588587 | 7 | Product used for unknown indication |
| 125885871 | 12588587 | 8 | Premedication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125885871 | 12588587 | Off label use | |
| 125885871 | 12588587 | 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 |
|---|---|---|---|---|---|---|
| 125885871 | 12588587 | 2 | 2016 | 0 | ||
| 125885871 | 12588587 | 3 | 2016 | 0 | ||
| 125885871 | 12588587 | 4 | 20160520 | 0 | ||
| 125885871 | 12588587 | 5 | 2016 | 0 |