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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103714897 | 10371489 | 7 | F | 201405 | 20160719 | 20140808 | 20160725 | PER | US-AMGEN-USASP2014059066 | AMGEN | 56.00 | YR | A | F | Y | 0.00000 | 20160725 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103714897 | 10371489 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, QWK | U | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 103714897 | 10371489 | 2 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 5 MG, BID | 0 | 5 | MG | TABLET | BID | ||||||
| 103714897 | 10371489 | 3 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 5 MG, TAKE 1 TABLET TWICE A DAY | 0 | 5 | MG | TABLET | BID | ||||||
| 103714897 | 10371489 | 4 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | 50 MUG, UNK | 0 | 50 | UG | |||||||||
| 103714897 | 10371489 | 5 | C | NTG | NITROGLYCERIN | 1 | UNK | 0 | |||||||||||
| 103714897 | 10371489 | 6 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | 200 MG, UNK | 0 | 200 | MG | |||||||||
| 103714897 | 10371489 | 7 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | UNK MG, UNK | 0 | |||||||||||
| 103714897 | 10371489 | 8 | C | XANAX | ALPRAZOLAM | 1 | 3 MG, UNK | 0 | 3 | MG | |||||||||
| 103714897 | 10371489 | 9 | C | ZOCOR | SIMVASTATIN | 1 | 80 MG, UNK | 0 | 80 | MG | |||||||||
| 103714897 | 10371489 | 10 | C | LYRICA | PREGABALIN | 1 | 50 MG, UNK | 0 | 50 | MG | |||||||||
| 103714897 | 10371489 | 11 | C | ALBUTEROL. | ALBUTEROL | 1 | 0 | ||||||||||||
| 103714897 | 10371489 | 12 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 103714897 | 10371489 | 13 | C | LIDODERM | LIDOCAINE | 1 | 5 %, UNK | 0 | 5 | PCT | |||||||||
| 103714897 | 10371489 | 14 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 103714897 | 10371489 | 15 | C | NORVASC | AMLODIPINE BESYLATE | 1 | 2.5 MG, UNK | 0 | 2.5 | MG | |||||||||
| 103714897 | 10371489 | 16 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | 10 MG, UNK | 0 | 10 | MG | |||||||||
| 103714897 | 10371489 | 17 | C | O2 | 2 | 0 | |||||||||||||
| 103714897 | 10371489 | 18 | C | PREDNISONE. | PREDNISONE | 1 | 5 MG, UNK | 0 | 5 | MG | |||||||||
| 103714897 | 10371489 | 19 | C | CYCLOBENZAPRINE HCL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | 5 MG, UNK | 0 | 5 | MG | |||||||||
| 103714897 | 10371489 | 20 | C | METFORMIN HCL | METFORMIN HYDROCHLORIDE | 1 | 500 MG, UNK | 0 | 500 | MG | |||||||||
| 103714897 | 10371489 | 21 | C | NITROGLYCERIN. | NITROGLYCERIN | 1 | 400 MUG, UNK | 0 | 400 | UG | |||||||||
| 103714897 | 10371489 | 22 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | UNK | 0 | |||||||||||
| 103714897 | 10371489 | 23 | C | TRAZODONE HYDROCHLORIDE. | TRAZODONE HYDROCHLORIDE | 1 | 300 MG, UNK | 0 | 300 | MG | |||||||||
| 103714897 | 10371489 | 24 | C | POTASSIUM | POTASSIUM | 1 | UNK | 0 | |||||||||||
| 103714897 | 10371489 | 25 | C | VITAMIN D /00107901/ | ERGOCALCIFEROL | 1 | UNK | 0 | |||||||||||
| 103714897 | 10371489 | 26 | C | HYDROCHOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103714897 | 10371489 | 1 | Rheumatoid arthritis |
| 103714897 | 10371489 | 2 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 103714897 | 10371489 | OT |
| 103714897 | 10371489 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103714897 | 10371489 | Abdominal distension | |
| 103714897 | 10371489 | Arthralgia | |
| 103714897 | 10371489 | Back pain | |
| 103714897 | 10371489 | Blood pressure increased | |
| 103714897 | 10371489 | Confusional state | |
| 103714897 | 10371489 | Crying | |
| 103714897 | 10371489 | Fall | |
| 103714897 | 10371489 | Fatigue | |
| 103714897 | 10371489 | Headache | |
| 103714897 | 10371489 | Heart rate increased | |
| 103714897 | 10371489 | Injection site erythema | |
| 103714897 | 10371489 | Injection site pain | |
| 103714897 | 10371489 | Injection site reaction | |
| 103714897 | 10371489 | Injection site swelling | |
| 103714897 | 10371489 | Injection site warmth | |
| 103714897 | 10371489 | Mood altered | |
| 103714897 | 10371489 | Nephrolithiasis | |
| 103714897 | 10371489 | Oesophageal spasm | |
| 103714897 | 10371489 | Pain | |
| 103714897 | 10371489 | Pruritus | |
| 103714897 | 10371489 | Rheumatoid arthritis | |
| 103714897 | 10371489 | Sinusitis | |
| 103714897 | 10371489 | Swelling | |
| 103714897 | 10371489 | Weight increased | |
| 103714897 | 10371489 | Wheelchair user |
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 |
|---|---|---|---|---|---|---|
| 103714897 | 10371489 | 1 | 20140507 | 0 | ||
| 103714897 | 10371489 | 2 | 201503 | 201507 | 0 | |
| 103714897 | 10371489 | 3 | 20160127 | 0 |