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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123780362 | 12378036 | 2 | F | 20160502 | 20160502 | 20160517 | 20160725 | PER | US-JNJFOC-20160503871 | JANSSEN | 69.84 | YR | E | F | Y | 58.97000 | KG | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123780362 | 12378036 | 1 | PS | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | UNSPECIFIED | ||||||||
| 123780362 | 12378036 | 2 | SS | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | 650 | MG | UNSPECIFIED | ||||||
| 123780362 | 12378036 | 3 | C | CLARITIN | LORATADINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123780362 | 12378036 | 4 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 0 | 40 | MG | UNSPECIFIED | ||||||||
| 123780362 | 12378036 | 5 | C | VITAMIN B | VITAMIN B | 1 | Unknown | 0 | INJECTION | ||||||||||
| 123780362 | 12378036 | 6 | C | PENTASA | MESALAMINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123780362 | 12378036 | 7 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123780362 | 12378036 | 8 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123780362 | 12378036 | 9 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | FJL84013P1 | 0 | LYOPHILIZED POWDER | |||||||||
| 123780362 | 12378036 | 10 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | FJL84013P1 | 0 | LYOPHILIZED POWDER | |||||||||
| 123780362 | 12378036 | 11 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | FJL84013P1 | 0 | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123780362 | 12378036 | 2 | Premedication |
| 123780362 | 12378036 | 3 | Premedication |
| 123780362 | 12378036 | 4 | Premedication |
| 123780362 | 12378036 | 5 | Product used for unknown indication |
| 123780362 | 12378036 | 6 | Product used for unknown indication |
| 123780362 | 12378036 | 7 | Product used for unknown indication |
| 123780362 | 12378036 | 8 | Product used for unknown indication |
| 123780362 | 12378036 | 9 | Crohn's disease |
| 123780362 | 12378036 | 10 | Crohn's disease |
| 123780362 | 12378036 | 11 | Crohn's disease |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123780362 | 12378036 | Off label use | |
| 123780362 | 12378036 | 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 |
|---|---|---|---|---|---|---|
| 123780362 | 12378036 | 2 | 20160502 | 0 | ||
| 123780362 | 12378036 | 3 | 20160502 | 0 | ||
| 123780362 | 12378036 | 4 | 20160502 | 0 | ||
| 123780362 | 12378036 | 10 | 20160404 | 0 | ||
| 123780362 | 12378036 | 11 | 20160502 | 0 |