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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123509172 | 12350917 | 2 | F | 2015 | 20160916 | 20160510 | 20160926 | EXP | CA-CELGENEUS-CAN-2016047593 | CELGENE | 0.00 | M | Y | 90.70000 | KG | 20160926 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123509172 | 12350917 | 1 | PS | OTEZLA | APREMILAST | 1 | Oral | 60 MILLIGRAM | U | U | UNKNOWN | 205437 | 30 | MG | TABLETS | BID | |||
| 123509172 | 12350917 | 2 | SS | OTEZLA | APREMILAST | 1 | U | U | UNKNOWN | 205437 | |||||||||
| 123509172 | 12350917 | 3 | SS | OTEZLA | APREMILAST | 1 | U | U | UNKNOWN | 205437 | |||||||||
| 123509172 | 12350917 | 4 | SS | Ciclosporin | CYCLOSPORINE | 1 | Unknown | U | U | 0 | UNKNOWN | ||||||||
| 123509172 | 12350917 | 5 | SS | Certolizumab pegol | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | U | U | 205437 | INJECTION | ||||||||
| 123509172 | 12350917 | 6 | SS | Etanercept | ETANERCEPT | 1 | Subcutaneous | .6 MILLIGRAM | U | U | UNKNOWN | 0 | INJECTION | ||||||
| 123509172 | 12350917 | 7 | SS | Etanercept | ETANERCEPT | 1 | U | U | UNKNOWN | 0 | |||||||||
| 123509172 | 12350917 | 8 | SS | Adalimumab | ADALIMUMAB | 1 | Subcutaneous | U | U | 0 | INJECTION | ||||||||
| 123509172 | 12350917 | 9 | SS | IBUPROFEN. | IBUPROFEN | 1 | Oral | U | U | 0 | 600 | MG | UNKNOWN | ||||||
| 123509172 | 12350917 | 10 | SS | Infliximab | INFLIXIMAB | 1 | Unknown | U | U | 0 | UNKNOWN | ||||||||
| 123509172 | 12350917 | 11 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 123509172 | 12350917 | 12 | SS | Abatacept | ABATACEPT | 1 | Subcutaneous | 5 MILLIGRAM | U | U | 0 | INJECTION | |||||||
| 123509172 | 12350917 | 13 | SS | Golimumab | GOLIMUMAB | 1 | Subcutaneous | U | U | 0 | INJECTION | ||||||||
| 123509172 | 12350917 | 14 | SS | Ustekinumab | USTEKINUMAB | 1 | Subcutaneous | U | U | 0 | INJECTION | ||||||||
| 123509172 | 12350917 | 15 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | U | U | 0 | UNKNOWN | ||||||||
| 123509172 | 12350917 | 16 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 123509172 | 12350917 | 17 | C | COLCHICINE. | COLCHICINE | 1 | Oral | 0 | .6 | MG | TABLETS | ||||||||
| 123509172 | 12350917 | 18 | C | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Oral | 0 | 4 | DF | TABLETS | /wk | |||||||
| 123509172 | 12350917 | 19 | C | Nitrazepam | NITRAZEPAM | 1 | Unknown | 4 TABLET | 0 | 5 | MG | UNKNOWN | |||||||
| 123509172 | 12350917 | 20 | C | ULORIC | FEBUXOSTAT | 1 | Oral | 0 | 80 | MG | TABLETS | BID | |||||||
| 123509172 | 12350917 | 21 | C | OXYCODONE HYDROCHLORIDE. | OXYCODONE HYDROCHLORIDE | 1 | Unknown | 160 MILLIGRAM | 0 | 40 | MG | UNKNOWN | |||||||
| 123509172 | 12350917 | 22 | C | OXYCODONE HYDROCHLORIDE. | OXYCODONE HYDROCHLORIDE | 1 | Unknown | 0 | 10 | MG | UNKNOWN | ||||||||
| 123509172 | 12350917 | 23 | C | DEXILANT | DEXLANSOPRAZOLE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 123509172 | 12350917 | 24 | C | GRAVOL | DIMENHYDRINATE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 123509172 | 12350917 | 25 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123509172 | 12350917 | 1 | Psoriatic arthropathy |
| 123509172 | 12350917 | 2 | Psoriasis |
| 123509172 | 12350917 | 3 | Rheumatoid arthritis |
| 123509172 | 12350917 | 4 | Product used for unknown indication |
| 123509172 | 12350917 | 5 | Psoriatic arthropathy |
| 123509172 | 12350917 | 6 | Psoriatic arthropathy |
| 123509172 | 12350917 | 7 | Rheumatoid arthritis |
| 123509172 | 12350917 | 8 | Psoriatic arthropathy |
| 123509172 | 12350917 | 9 | Product used for unknown indication |
| 123509172 | 12350917 | 10 | Psoriatic arthropathy |
| 123509172 | 12350917 | 11 | Product used for unknown indication |
| 123509172 | 12350917 | 12 | Psoriatic arthropathy |
| 123509172 | 12350917 | 13 | Psoriatic arthropathy |
| 123509172 | 12350917 | 14 | Psoriatic arthropathy |
| 123509172 | 12350917 | 15 | Product used for unknown indication |
| 123509172 | 12350917 | 16 | Product used for unknown indication |
| 123509172 | 12350917 | 17 | Product used for unknown indication |
| 123509172 | 12350917 | 18 | Product used for unknown indication |
| 123509172 | 12350917 | 19 | Product used for unknown indication |
| 123509172 | 12350917 | 20 | Product used for unknown indication |
| 123509172 | 12350917 | 21 | Product used for unknown indication |
| 123509172 | 12350917 | 23 | Product used for unknown indication |
| 123509172 | 12350917 | 24 | Product used for unknown indication |
| 123509172 | 12350917 | 25 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123509172 | 12350917 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123509172 | 12350917 | Activities of daily living impaired | |
| 123509172 | 12350917 | Alanine aminotransferase increased | |
| 123509172 | 12350917 | Aspartate aminotransferase increased | |
| 123509172 | 12350917 | C-reactive protein abnormal | |
| 123509172 | 12350917 | Drug hypersensitivity | |
| 123509172 | 12350917 | Enthesopathy | |
| 123509172 | 12350917 | Headache | |
| 123509172 | 12350917 | Nausea | |
| 123509172 | 12350917 | Synovitis | |
| 123509172 | 12350917 | Tenosynovitis | |
| 123509172 | 12350917 | Treatment failure |
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 |
|---|---|---|---|---|---|---|
| 123509172 | 12350917 | 1 | 20150318 | 20150902 | 0 |