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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119484653 | 11948465 | 3 | F | 201511 | 20160624 | 20160125 | 20160705 | EXP | CA-JNJFOC-20151200789 | JANSSEN | 25.54 | YR | A | F | Y | 47.00000 | KG | 20160705 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119484653 | 11948465 | 1 | PS | STELARA | USTEKINUMAB | 1 | Subcutaneous | WK0, 1, 2 AND THEN Q8WKS; | Y | N | FAS3MND;FHS4KMJ | 125261 | 90 | MG | SOLUTION FOR INJECTION | ||||
| 119484653 | 11948465 | 2 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 20 | MG | UNSPECIFIED | QD | |||||||
| 119484653 | 11948465 | 3 | C | CODEINE | CODEINE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119484653 | 11948465 | 1 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119484653 | 11948465 | HO |
| 119484653 | 11948465 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119484653 | 11948465 | Abdominal distension | |
| 119484653 | 11948465 | Abdominal pain | |
| 119484653 | 11948465 | Arthralgia | |
| 119484653 | 11948465 | Asthenia | |
| 119484653 | 11948465 | Bacterial infection | |
| 119484653 | 11948465 | Decreased appetite | |
| 119484653 | 11948465 | Dehydration | |
| 119484653 | 11948465 | Dyspnoea | |
| 119484653 | 11948465 | Heart rate increased | |
| 119484653 | 11948465 | Hypotension | |
| 119484653 | 11948465 | Ileostomy | |
| 119484653 | 11948465 | Ileostomy closure | |
| 119484653 | 11948465 | Influenza like illness | |
| 119484653 | 11948465 | Joint swelling | |
| 119484653 | 11948465 | Nausea | |
| 119484653 | 11948465 | Off label use | |
| 119484653 | 11948465 | Pallor | |
| 119484653 | 11948465 | Product use issue | |
| 119484653 | 11948465 | Stoma complication | |
| 119484653 | 11948465 | Vomiting | |
| 119484653 | 11948465 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 119484653 | 11948465 | 1 | 20151120 | 0 |