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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125880011 | 12588001 | 1 | I | 2016 | 20160706 | 20160725 | 20160725 | EXP | CA-JNJFOC-20160705729 | JANSSEN | 60.76 | YR | A | F | Y | 40.00000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125880011 | 12588001 | 1 | SS | STELARA | USTEKINUMAB | 1 | Subcutaneous | Y | U | FKS06MA | 0 | 180 | MG | SOLUTION FOR INJECTION | /wk | ||||
| 125880011 | 12588001 | 2 | PS | STELARA | USTEKINUMAB | 1 | Subcutaneous | Y | U | FKS06MA | 125261 | 270 | MG | SOLUTION FOR INJECTION | /wk | ||||
| 125880011 | 12588001 | 3 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Oral | 0 | 75 | MG | CAPSULE | QD | |||||||
| 125880011 | 12588001 | 4 | C | ASA | ASPIRIN | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 125880011 | 12588001 | 5 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125880011 | 12588001 | 1 | Crohn's disease |
| 125880011 | 12588001 | 2 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125880011 | 12588001 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125880011 | 12588001 | Contusion | |
| 125880011 | 12588001 | Dyspnoea | |
| 125880011 | 12588001 | Fatigue | |
| 125880011 | 12588001 | Headache | |
| 125880011 | 12588001 | Nausea | |
| 125880011 | 12588001 | Off label use | |
| 125880011 | 12588001 | Palpitations | |
| 125880011 | 12588001 | 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 |
|---|---|---|---|---|---|---|
| 125880011 | 12588001 | 1 | 20160627 | 0 | ||
| 125880011 | 12588001 | 2 | 20160627 | 0 |