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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124756973 | 12475697 | 3 | F | 201605 | 20160706 | 20160617 | 20160720 | EXP | CO-JNJFOC-20160609455 | JANSSEN | 36.35 | YR | A | M | Y | 78.00000 | KG | 20160720 | OT | CO | CO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124756973 | 12475697 | 1 | SS | STELARA | USTEKINUMAB | 1 | Subcutaneous | Y | N | 0 | 45 | MG | SOLUTION FOR INJECTION | ||||||
| 124756973 | 12475697 | 2 | PS | STELARA | USTEKINUMAB | 1 | Subcutaneous | Y | N | 125261 | 45 | MG | SOLUTION FOR INJECTION | ||||||
| 124756973 | 12475697 | 3 | SS | ISONIAZID. | ISONIAZID | 1 | Unknown | 0 | 300 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124756973 | 12475697 | 1 | Psoriasis |
| 124756973 | 12475697 | 2 | Psoriasis |
| 124756973 | 12475697 | 3 | Tuberculin test positive |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124756973 | 12475697 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124756973 | 12475697 | Arthralgia | |
| 124756973 | 12475697 | Feeling hot | |
| 124756973 | 12475697 | Flushing | |
| 124756973 | 12475697 | Headache | |
| 124756973 | 12475697 | Mycobacterium tuberculosis complex test positive | |
| 124756973 | 12475697 | Tachycardia |
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 |
|---|---|---|---|---|---|---|
| 124756973 | 12475697 | 2 | 20130326 | 20160426 | 0 | |
| 124756973 | 12475697 | 3 | 20160621 | 0 |