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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121727694 | 12172769 | 4 | F | 200901 | 20160704 | 20160311 | 20160708 | EXP | CA-AMGEN-CANSP2016029473 | AMGEN | 75.00 | YR | E | F | Y | 0.00000 | 20160708 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121727694 | 12172769 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, QWK | 103795 | 50 | MG | UNKNOWN FORMULATION | /wk | ||||||
| 121727694 | 12172769 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 488 MG, Q4WK | 0 | 488 | MG | ||||||||
| 121727694 | 12172769 | 3 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | UNK | 0 | ||||||||||
| 121727694 | 12172769 | 4 | SS | ORENCIA | ABATACEPT | 1 | Intravenous (not otherwise specified) | 750 MG, Q4WK | 0 | 750 | MG | ||||||||
| 121727694 | 12172769 | 5 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | 2.5 G, QD | 0 | 2.5 | G | QD | |||||||
| 121727694 | 12172769 | 6 | SS | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 121727694 | 12172769 | 7 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 7.5-12.5 MG, WEEKLY | 0 | /wk | |||||||||
| 121727694 | 12172769 | 8 | SS | CELEBREX | CELECOXIB | 1 | Oral | UNK | 0 | ||||||||||
| 121727694 | 12172769 | 9 | SS | FENTANYL. | FENTANYL | 1 | Unknown | UNK | 0 | ||||||||||
| 121727694 | 12172769 | 10 | C | OMEGA-3 FATTY ACIDS | OMEGA-3 FATTY ACIDS | 1 | 1200 MG, BID | 0 | 1200 | MG | BID | ||||||||
| 121727694 | 12172769 | 11 | C | DIPHENOXYLATE | DIPHENOXYLATE | 1 | 2.5/0.25 MG, QD | 0 | QD | ||||||||||
| 121727694 | 12172769 | 12 | C | VITAMIN D /00107901/ | ERGOCALCIFEROL | 1 | 400 UNIT, QD | 0 | QD | ||||||||||
| 121727694 | 12172769 | 13 | C | ACTONEL | RISEDRONATE SODIUM | 1 | 36 MG, QWK | 0 | 36 | MG | /wk | ||||||||
| 121727694 | 12172769 | 14 | C | PREDNISONE. | PREDNISONE | 1 | 5 MG, QD | 0 | 5 | MG | QD | ||||||||
| 121727694 | 12172769 | 15 | C | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 750 MG, (EVERY FOUR WEEKS) | 0 | 750 | MG | INFUSION | |||||||
| 121727694 | 12172769 | 16 | C | CALCIUM | CALCIUM | 1 | UNK | 0 | |||||||||||
| 121727694 | 12172769 | 17 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 100 MG, BID | 0 | 100 | MG | BID | |||||||
| 121727694 | 12172769 | 18 | C | FERROUS GLUCONATE | FERROUS GLUCONATE | 1 | 300 MG, ONE DAILY | 0 | 300 | MG | QD | ||||||||
| 121727694 | 12172769 | 19 | C | GENTEAL /00445101/ | HYPROMELLOSE 2910 (4000 MPA.S) | 1 | 3M USE AS DIRECTED | 0 | |||||||||||
| 121727694 | 12172769 | 20 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 500 MG 2 TABS, OD | 0 | 1000 | MG | TABLET | QD | ||||||
| 121727694 | 12172769 | 21 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | 40 MG ONE TAB, BID | 0 | 40 | MG | TABLET | BID | |||||||
| 121727694 | 12172769 | 22 | C | TRAZODONE HYDROCHLORIDE. | TRAZODONE HYDROCHLORIDE | 1 | Oral | 50 MG, QHS | 0 | 50 | MG | /hr | |||||||
| 121727694 | 12172769 | 23 | C | NASONEX | MOMETASONE FUROATE | 1 | 2 SPRAYS PER NOSTRILS, BID | 0 | BID | ||||||||||
| 121727694 | 12172769 | 24 | C | NORTRIPTYLINE HYDROCHLORIDE. | NORTRIPTYLINE HYDROCHLORIDE | 1 | Oral | 10 MG 1-3 TABS | 0 | 10 | MG | TABLET | /hr | ||||||
| 121727694 | 12172769 | 25 | C | PERCOCET /00446701/ | ACETAMINOPHENOXYCODONE HYDROCHLORIDEOXYCODONE TEREPHTHALATE | 1 | 1 TAB, 4-6H PRN FOR PAIN | 0 | TABLET | ||||||||||
| 121727694 | 12172769 | 26 | C | LOMOTIL | ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE | 1 | 2.5 MG, 3-4 TIMES/DAY | 0 | 2.5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121727694 | 12172769 | 1 | Rheumatoid arthritis |
| 121727694 | 12172769 | 2 | Product used for unknown indication |
| 121727694 | 12172769 | 3 | Product used for unknown indication |
| 121727694 | 12172769 | 4 | Product used for unknown indication |
| 121727694 | 12172769 | 5 | Rheumatoid arthritis |
| 121727694 | 12172769 | 6 | Product used for unknown indication |
| 121727694 | 12172769 | 7 | Rheumatoid arthritis |
| 121727694 | 12172769 | 8 | Product used for unknown indication |
| 121727694 | 12172769 | 9 | Product used for unknown indication |
| 121727694 | 12172769 | 19 | Dry eye |
| 121727694 | 12172769 | 25 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121727694 | 12172769 | HO |
| 121727694 | 12172769 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121727694 | 12172769 | Arthralgia | |
| 121727694 | 12172769 | Arthropathy | |
| 121727694 | 12172769 | Bone cyst | |
| 121727694 | 12172769 | Crohn's disease | |
| 121727694 | 12172769 | Deafness neurosensory | |
| 121727694 | 12172769 | Deformity | |
| 121727694 | 12172769 | Diarrhoea | |
| 121727694 | 12172769 | Drug effect decreased | |
| 121727694 | 12172769 | Dry eye | |
| 121727694 | 12172769 | Exostosis | |
| 121727694 | 12172769 | Fatigue | |
| 121727694 | 12172769 | Hypersensitivity | |
| 121727694 | 12172769 | Joint swelling | |
| 121727694 | 12172769 | Mobility decreased | |
| 121727694 | 12172769 | Musculoskeletal stiffness | |
| 121727694 | 12172769 | Myocardial infarction | |
| 121727694 | 12172769 | Osteoarthritis | |
| 121727694 | 12172769 | Osteopenia | |
| 121727694 | 12172769 | Osteosclerosis | |
| 121727694 | 12172769 | Pain | |
| 121727694 | 12172769 | Pain in extremity | |
| 121727694 | 12172769 | Pleural thickening | |
| 121727694 | 12172769 | Presbyacusis | |
| 121727694 | 12172769 | Renal impairment | |
| 121727694 | 12172769 | Rheumatoid arthritis | |
| 121727694 | 12172769 | Skin lesion | |
| 121727694 | 12172769 | Sleep disorder |
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 |
|---|---|---|---|---|---|---|
| 121727694 | 12172769 | 1 | 200804 | 201310 | 0 | |
| 121727694 | 12172769 | 2 | 201310 | 20150303 | 0 | |
| 121727694 | 12172769 | 3 | 2008 | 2008 | 0 | |
| 121727694 | 12172769 | 4 | 20150331 | 20160223 | 0 | |
| 121727694 | 12172769 | 5 | 200404 | 2008 | 0 | |
| 121727694 | 12172769 | 7 | 2008 | 20110913 | 0 |