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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127127043 | 12712704 | 3 | F | 20160715 | 20160909 | 20160902 | 20160921 | EXP | IT-MINISAL02-371844 | IT-TEVA-688651ACC | TEVA | 86.98 | YR | M | Y | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127127043 | 12712704 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 1000 MILLIGRAM DAILY; | Y | U | 78101 | 1000 | MG | TABLET | |||||
| 127127043 | 12712704 | 2 | C | DEURSIL - 300 MG CAPSULE RIGIDE | 2 | U | 0 | ||||||||||||
| 127127043 | 12712704 | 3 | C | FOLINA - 5 MG CAPSULE MOLLI | 2 | U | 0 | ||||||||||||
| 127127043 | 12712704 | 4 | C | TIKLID - 250 MG COMPRESSE RIVESTITE | 2 | U | 0 | ||||||||||||
| 127127043 | 12712704 | 5 | C | TARCEVA - 100 MG COMPRESSE RIVESTITE CON FILM | 2 | U | 0 | ||||||||||||
| 127127043 | 12712704 | 6 | C | ESOMEPRAZOLE SODIUM. | ESOMEPRAZOLE SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127127043 | 12712704 | 1 | Petit mal epilepsy |
| 127127043 | 12712704 | 2 | Product used for unknown indication |
| 127127043 | 12712704 | 3 | Product used for unknown indication |
| 127127043 | 12712704 | 4 | Product used for unknown indication |
| 127127043 | 12712704 | 5 | Product used for unknown indication |
| 127127043 | 12712704 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127127043 | 12712704 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127127043 | 12712704 | Irritability | |
| 127127043 | 12712704 | Product substitution issue | |
| 127127043 | 12712704 | 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 |
|---|---|---|---|---|---|---|
| 127127043 | 12712704 | 1 | 20160715 | 20160730 | 0 |