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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125210581 | 12521058 | 1 | I | 201509 | 20160623 | 20160701 | 20160701 | EXP | CA-JNJFOC-20160623272 | JOHNSON AND JOHNSON | 69.85 | YR | E | F | Y | 68.00000 | KG | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125210581 | 12521058 | 1 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | GAM08013 | 103772 | 400 | MG | LYOPHILIZED POWDER | |||||
| 125210581 | 12521058 | 2 | SS | TYLENOL | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | UNSPECIFIED | ||||||||
| 125210581 | 12521058 | 3 | SS | TYLENOL | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | UNSPECIFIED | ||||||||
| 125210581 | 12521058 | 4 | C | ENTOCORT | BUDESONIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125210581 | 12521058 | 5 | C | RESTORALAX | POLYETHYLENE GLYCOL 3350 | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125210581 | 12521058 | 6 | C | MOTRIN | IBUPROFEN | 1 | Unknown | PRN (AS REQUIRED) | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125210581 | 12521058 | 1 | Crohn's disease |
| 125210581 | 12521058 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125210581 | 12521058 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125210581 | 12521058 | Arthralgia | |
| 125210581 | 12521058 | Blood pressure increased | |
| 125210581 | 12521058 | Chills | |
| 125210581 | 12521058 | Infusion related reaction | |
| 125210581 | 12521058 | Off label use | |
| 125210581 | 12521058 | Peripheral swelling | |
| 125210581 | 12521058 | 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 |
|---|---|---|---|---|---|---|
| 125210581 | 12521058 | 1 | 201509 | 0 | ||
| 125210581 | 12521058 | 3 | 20160623 | 0 |