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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125531344 | 12553134 | 4 | F | 20140818 | 20160921 | 20160713 | 20160927 | EXP | GB-JNJFOC-20160703916 | JANSSEN | 65.84 | YR | A | M | Y | 0.00000 | 20160927 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125531344 | 12553134 | 1 | PS | STELARA | USTEKINUMAB | 1 | Subcutaneous | U | 125261 | 45 | MG | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125531344 | 12553134 | 1 | Psoriasis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125531344 | 12553134 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125531344 | 12553134 | Dyspnoea exertional | |
| 125531344 | 12553134 | Fatigue | |
| 125531344 | 12553134 | Injection related reaction | |
| 125531344 | 12553134 | Laryngotracheal oedema | |
| 125531344 | 12553134 | Lip discolouration | |
| 125531344 | 12553134 | Malaise | |
| 125531344 | 12553134 | Off label use | |
| 125531344 | 12553134 | Oral disorder | |
| 125531344 | 12553134 | Oral infection | |
| 125531344 | 12553134 | Oral mucosal blistering | |
| 125531344 | 12553134 | 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 |
|---|---|---|---|---|---|---|
| 125531344 | 12553134 | 1 | 20140818 | 0 |