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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126011041 | 12601104 | 1 | I | 201606 | 20160718 | 20160728 | 20160728 | EXP | FR-AMGEN-FRASP2016096973 | AMGEN | 59.00 | YR | A | F | Y | 0.00000 | 20160728 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126011041 | 12601104 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | N | 103795 | 50 | MG | UNKNOWN FORMULATION | /wk | |||||
| 126011041 | 12601104 | 2 | SS | METOJECT | METHOTREXATE SODIUM | 1 | Subcutaneous | 10 MG, WEEKLY | 0 | 10 | MG | /wk | |||||||
| 126011041 | 12601104 | 3 | SS | FLUOXETINE HYDROCHLORIDE. | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, 1X/DAY | 0 | 20 | MG | QD | |||||||
| 126011041 | 12601104 | 4 | SS | SERESTA | OXAZEPAM | 1 | Oral | 10 MG, 2X/DAY | 0 | 10 | MG | BID | |||||||
| 126011041 | 12601104 | 5 | SS | IXPRIM | ACETAMINOPHENTRAMADOL HYDROCHLORIDE | 1 | Oral | 1 DF, 6X/AY | 0 | 1 | DF | ||||||||
| 126011041 | 12601104 | 6 | SS | ZOPICLONE | ZOPICLONE | 1 | Oral | 7.5 MG, 1X/DAY | 0 | 7.5 | MG | QD | |||||||
| 126011041 | 12601104 | 7 | SS | PARIET | RABEPRAZOLE SODIUM | 1 | Oral | 0 | |||||||||||
| 126011041 | 12601104 | 8 | C | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Oral | 1 G, 3X/DAY | 0 | 1 | G | TID | |||||||
| 126011041 | 12601104 | 9 | C | SPECIAFOLDINE | FOLIC ACID | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126011041 | 12601104 | 1 | Psoriatic arthropathy |
| 126011041 | 12601104 | 2 | Psoriatic arthropathy |
| 126011041 | 12601104 | 3 | Depression |
| 126011041 | 12601104 | 4 | Depression |
| 126011041 | 12601104 | 5 | Depression |
| 126011041 | 12601104 | 6 | Depression |
| 126011041 | 12601104 | 7 | Depression |
| 126011041 | 12601104 | 8 | Dyspnoea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126011041 | 12601104 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126011041 | 12601104 | Dyspnoea | |
| 126011041 | 12601104 | Interstitial lung disease | |
| 126011041 | 12601104 | Sinus tachycardia |
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 |
|---|---|---|---|---|---|---|
| 126011041 | 12601104 | 1 | 20140626 | 20160614 | 0 | |
| 126011041 | 12601104 | 2 | 20151209 | 20160614 | 0 |