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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127065602 | 12706560 | 2 | F | 20160715 | 20160908 | 20160901 | 20160921 | EXP | IT-CIPLA LTD.-2016IT17765 | CIPLA | 0.00 | Y | 0.00000 | 20160921 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127065602 | 12706560 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 1000 MG, DAILY | U | U | 0 | 1000 | MG | QD | |||||
| 127065602 | 12706560 | 2 | C | Deursil ^300 MG CAPSULE RIGIDE^ 20 CAPSULE RIGIDE | 2 | Unknown | UNK | U | U | 0 | |||||||||
| 127065602 | 12706560 | 3 | C | Folina ^5 MG CAPSULE MOLLI^ 20 CAPSULE | 2 | Unknown | UNK | U | U | 0 | |||||||||
| 127065602 | 12706560 | 4 | C | Tiklid ^250MG COMPRESSE RIVESTITE^ 30 COMPRESSE | 2 | Unknown | UNK | U | U | 0 | |||||||||
| 127065602 | 12706560 | 5 | C | Tarceva 100 MG 30 COMPRESSE RIVESTITE CON FILM BLISTER PVC/AL | 2 | Unknown | UNK | U | U | 0 | |||||||||
| 127065602 | 12706560 | 6 | C | ESOMEPRAZOLE SODIUM. | ESOMEPRAZOLE SODIUM | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127065602 | 12706560 | 1 | Petit mal epilepsy |
| 127065602 | 12706560 | 2 | Product used for unknown indication |
| 127065602 | 12706560 | 3 | Product used for unknown indication |
| 127065602 | 12706560 | 4 | Product used for unknown indication |
| 127065602 | 12706560 | 5 | Product used for unknown indication |
| 127065602 | 12706560 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127065602 | 12706560 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127065602 | 12706560 | Irritability | |
| 127065602 | 12706560 | Product substitution issue | |
| 127065602 | 12706560 | 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 |
|---|---|---|---|---|---|---|
| 127065602 | 12706560 | 1 | 20160715 | 20160730 | 0 |