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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122119119 | 12211911 | 9 | F | 201512 | 20160727 | 20160325 | 20160809 | EXP | US-CELGENEUS-USA-2016035559 | CELGENE | 54.64 | YR | F | Y | 0.00000 | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122119119 | 12211911 | 1 | PS | OTEZLA | APREMILAST | 1 | Oral | Y | U | TGFY,F2083A,F2081A | 205437 | 30 | MG | TABLETS | BID | ||||
| 122119119 | 12211911 | 2 | SS | OTEZLA | APREMILAST | 1 | Oral | Y | U | TGFY,F2083A,F2081A | 205437 | 30 | MG | TABLETS | QD | ||||
| 122119119 | 12211911 | 3 | SS | OTEZLA | APREMILAST | 1 | Oral | Y | U | TGFY,F2083A,F2081A | 205437 | 30 | MG | TABLETS | BID | ||||
| 122119119 | 12211911 | 4 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | Y | U | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122119119 | 12211911 | 1 | Psoriatic arthropathy |
| 122119119 | 12211911 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122119119 | 12211911 | HO |
| 122119119 | 12211911 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122119119 | 12211911 | Arthralgia | |
| 122119119 | 12211911 | Drug ineffective | |
| 122119119 | 12211911 | Hypersensitivity | |
| 122119119 | 12211911 | Joint swelling | |
| 122119119 | 12211911 | Nausea | |
| 122119119 | 12211911 | Sinusitis | |
| 122119119 | 12211911 | Thrombosis |
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 |
|---|---|---|---|---|---|---|
| 122119119 | 12211911 | 1 | 201508 | 0 | ||
| 122119119 | 12211911 | 2 | 20160107 | 20160119 | 0 | |
| 122119119 | 12211911 | 3 | 2016 | 0 |