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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114427704 | 11442770 | 4 | F | 20160707 | 20150901 | 20160713 | PER | US-CELGENEUS-USA-2015074514 | CELGENE | 0.00 | F | Y | 0.00000 | 20160713 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114427704 | 11442770 | 1 | PS | OTEZLA | APREMILAST | 1 | Oral | U | U | TXNW | 205437 | 30 | MG | TABLETS | BID | ||||
| 114427704 | 11442770 | 2 | SS | OTEZLA | APREMILAST | 1 | Oral | U | U | TXNW | 205437 | 30 | MG | TABLETS | BID | ||||
| 114427704 | 11442770 | 3 | SS | Amitriptyline | AMITRIPTYLINE | 1 | Unknown | U | U | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114427704 | 11442770 | 1 | Psoriatic arthropathy |
| 114427704 | 11442770 | 2 | Psoriasis |
| 114427704 | 11442770 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114427704 | 11442770 | Abdominal pain | |
| 114427704 | 11442770 | Diarrhoea | |
| 114427704 | 11442770 | Disease recurrence | |
| 114427704 | 11442770 | Inflammation | |
| 114427704 | 11442770 | Pain |
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 |
|---|---|---|---|---|---|---|
| 114427704 | 11442770 | 1 | 201412 | 0 | ||
| 114427704 | 11442770 | 2 | 201502 | 0 |