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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127112723 | 12711272 | 3 | F | 20160715 | 20160909 | 20160902 | 20160919 | EXP | 371844 | IT-ACCORD-043599 | ACCORD | 87.00 | YR | M | Y | 0.00000 | 20160919 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127112723 | 12711272 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | Y | 90843 | 1000 | MG | TABLET | |||||||
| 127112723 | 12711272 | 2 | C | DEURSIL | URSODIOL | 1 | STRENGTH: 300 MG | 0 | CAPSULE, HARD | ||||||||||
| 127112723 | 12711272 | 3 | C | FOLINA | FOLIC ACID | 1 | STRENGTH: 5 MG, SOFT CAPSULES | 0 | |||||||||||
| 127112723 | 12711272 | 4 | C | TIKLID | TICLOPIDINE HYDROCHLORIDE | 1 | STRENGTH: 250 MG | 0 | COATED TABLET | ||||||||||
| 127112723 | 12711272 | 5 | C | TARCEVA | ERLOTINIB HYDROCHLORIDE | 1 | STRENGTH: 100 MG | 0 | FILM-COATED TABLET | ||||||||||
| 127112723 | 12711272 | 6 | C | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127112723 | 12711272 | 1 | Petit mal epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127112723 | 12711272 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127112723 | 12711272 | Irritability | |
| 127112723 | 12711272 | Product substitution issue | |
| 127112723 | 12711272 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 127112723 | 12711272 | 1 | 20160715 | 20160730 | 0 |