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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125063982 | 12506398 | 2 | F | 20160711 | 20160628 | 20160719 | PER | US-AMGEN-USASP2016078569 | AMGEN | 56.00 | YR | A | F | Y | 67.94000 | KG | 20160719 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125063982 | 12506398 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 125063982 | 12506398 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | UNK | 0 | ||||||||||
| 125063982 | 12506398 | 3 | SS | RITUXAN | RITUXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 125063982 | 12506398 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 125063982 | 12506398 | 5 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 125063982 | 12506398 | 6 | SS | TOCILIZUMAB | TOCILIZUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 125063982 | 12506398 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | 1 MG, QD | 0 | 1 | MG | TABLET | QD | |||||||
| 125063982 | 12506398 | 8 | C | DULERA | FORMOTEROL FUMARATE DIHYDRATEMOMETASONE FUROATE | 1 | 5-100 MCG 2 PUFFS BID | 0 | BID | ||||||||||
| 125063982 | 12506398 | 9 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | 50 MG, QD | 0 | 50 | MG | TABLET | QD | |||||||
| 125063982 | 12506398 | 10 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | 25 MG, Q6H PRN | 0 | 25 | MG | TABLET | QID | |||||||
| 125063982 | 12506398 | 11 | C | ALBUTEROL /00139501/ | ALBUTEROL | 1 | 90 MCG 2 PUFFS QID | 0 | QID | ||||||||||
| 125063982 | 12506398 | 12 | C | LIDODERM | LIDOCAINE | 1 | 5% FILM, QD PRN | 0 | QD | ||||||||||
| 125063982 | 12506398 | 13 | C | SECTRAL | ACEBUTOLOL HYDROCHLORIDE | 1 | 200 MG, BID | 0 | 200 | MG | CAPSULE | BID | |||||||
| 125063982 | 12506398 | 14 | C | CALCIUM + VIT D | CALCIUMVITAMIN D | 1 | 600MG -200 UNITS TID | 0 | TID | ||||||||||
| 125063982 | 12506398 | 15 | C | GARLIC /01570501/ | GARLIC | 1 | UNK | 0 | |||||||||||
| 125063982 | 12506398 | 16 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | 60 MG, QD | 0 | 60 | MG | CAPSULE | QD | |||||||
| 125063982 | 12506398 | 17 | C | ARAVA | LEFLUNOMIDE | 1 | 20 MG, QD | 0 | 20 | MG | TABLET | QD | |||||||
| 125063982 | 12506398 | 18 | C | PREDNISONE. | PREDNISONE | 1 | 5 MG TABLET 1..5 TAB QD | 0 | TABLET | QD | |||||||||
| 125063982 | 12506398 | 19 | C | ACTEMRA | TOCILIZUMAB | 1 | 162 MG, QOD | 0 | 162 | MG | QD | ||||||||
| 125063982 | 12506398 | 20 | C | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 5 MG, BID | 0 | 5 | MG | BID | |||||||
| 125063982 | 12506398 | 21 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125063982 | 12506398 | 1 | Rheumatoid arthritis |
| 125063982 | 12506398 | 2 | Product used for unknown indication |
| 125063982 | 12506398 | 3 | Product used for unknown indication |
| 125063982 | 12506398 | 4 | Product used for unknown indication |
| 125063982 | 12506398 | 5 | Product used for unknown indication |
| 125063982 | 12506398 | 6 | Product used for unknown indication |
| 125063982 | 12506398 | 9 | Migraine |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125063982 | 12506398 | Arthralgia | |
| 125063982 | 12506398 | Asthenia | |
| 125063982 | 12506398 | Bronchitis | |
| 125063982 | 12506398 | Conjunctivitis | |
| 125063982 | 12506398 | Drug effect decreased | |
| 125063982 | 12506398 | Dry eye | |
| 125063982 | 12506398 | Dry mouth | |
| 125063982 | 12506398 | Dyspepsia | |
| 125063982 | 12506398 | Dyspnoea | |
| 125063982 | 12506398 | Fatigue | |
| 125063982 | 12506398 | Hypersensitivity | |
| 125063982 | 12506398 | Increased tendency to bruise | |
| 125063982 | 12506398 | Joint swelling | |
| 125063982 | 12506398 | Mean cell haemoglobin concentration decreased | |
| 125063982 | 12506398 | Musculoskeletal pain | |
| 125063982 | 12506398 | Pain in extremity | |
| 125063982 | 12506398 | Palpitations | |
| 125063982 | 12506398 | Periarticular disorder | |
| 125063982 | 12506398 | Peripheral swelling | |
| 125063982 | 12506398 | Pharyngitis streptococcal | |
| 125063982 | 12506398 | Sleep disorder | |
| 125063982 | 12506398 | Stomatitis |
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 |
|---|---|---|---|---|---|---|
| 125063982 | 12506398 | 2 | 1998 | 2014 | 0 |