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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125669491 | 12566949 | 1 | I | 201606 | 20160713 | 20160718 | 20160718 | PER | FR-EISAI MEDICAL RESEARCH-EC-2016-018561 | EISAI | 59.30 | YR | F | Y | 0.00000 | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125669491 | 12566949 | 1 | PS | PARIET | RABEPRAZOLE SODIUM | 1 | Oral | UNKNOWN | U | 20973 | TABLET | ||||||||
| 125669491 | 12566949 | 2 | SS | METOJECT | METHOTREXATE SODIUM | 1 | Subcutaneous | N | 0 | 10 | MG | /wk | |||||||
| 125669491 | 12566949 | 3 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | N | 0 | 50 | MG | /wk | |||||||
| 125669491 | 12566949 | 4 | SS | FLUOXETIN | FLUOXETINE HYDROCHLORIDE | 1 | Oral | U | 0 | 20 | MG | QD | |||||||
| 125669491 | 12566949 | 5 | SS | SERESTA | OXAZEPAM | 1 | Oral | U | 0 | 10 | MG | BID | |||||||
| 125669491 | 12566949 | 6 | SS | IXPRIM | ACETAMINOPHENTRAMADOL HYDROCHLORIDE | 1 | U | 0 | 1 | DF | TABLET | ||||||||
| 125669491 | 12566949 | 7 | SS | ZOPICLONE | ZOPICLONE | 1 | Oral | U | 0 | 7.5 | MG | QD | |||||||
| 125669491 | 12566949 | 8 | C | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | 0 | 1 | G | TID | |||||||||
| 125669491 | 12566949 | 9 | C | SPECIAFOLDINE | FOLIC ACID | 1 | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125669491 | 12566949 | 1 | Product used for unknown indication |
| 125669491 | 12566949 | 2 | Psoriatic arthropathy |
| 125669491 | 12566949 | 3 | Psoriatic arthropathy |
| 125669491 | 12566949 | 4 | Product used for unknown indication |
| 125669491 | 12566949 | 5 | Product used for unknown indication |
| 125669491 | 12566949 | 6 | Product used for unknown indication |
| 125669491 | 12566949 | 7 | Product used for unknown indication |
| 125669491 | 12566949 | 8 | Product used for unknown indication |
| 125669491 | 12566949 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125669491 | 12566949 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125669491 | 12566949 | Dyspnoea | |
| 125669491 | 12566949 | Interstitial lung disease |
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 |
|---|---|---|---|---|---|---|
| 125669491 | 12566949 | 2 | 20151209 | 2016 | 0 | |
| 125669491 | 12566949 | 3 | 20140626 | 2016 | 0 |