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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127035761 | 12703576 | 1 | I | 201311 | 20160825 | 20160831 | 20160831 | EXP | PHHY2016BR118679 | NOVARTIS | 29.74 | YR | F | Y | 0.00000 | 20160831 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127035761 | 12703576 | 1 | PS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 2 DF, QD | U | 21014 | 2 | DF | TABLET | QD | |||||
| 127035761 | 12703576 | 2 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 2 DF, QD | U | 21014 | 2 | DF | TABLET | QD | |||||
| 127035761 | 12703576 | 3 | SS | RIVOTRIL | CLONAZEPAM | 1 | Unknown | U | 0 | ||||||||||
| 127035761 | 12703576 | 4 | C | HALDOL | HALOPERIDOL | 1 | Unknown | 10 GTT, QD (10 AT BREAKFAST, 10 DROPS AT LUNCH, 10 DROPS AT DINNER) | 0 | 30 | GTT | DROPS | QD | ||||||
| 127035761 | 12703576 | 5 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127035761 | 12703576 | 1 | Insomnia |
| 127035761 | 12703576 | 2 | Mood altered |
| 127035761 | 12703576 | 3 | Product used for unknown indication |
| 127035761 | 12703576 | 4 | Product used for unknown indication |
| 127035761 | 12703576 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127035761 | 12703576 | OT |
| 127035761 | 12703576 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127035761 | 12703576 | Coma | |
| 127035761 | 12703576 | Dizziness | |
| 127035761 | 12703576 | Drug dependence | |
| 127035761 | 12703576 | Erythema | |
| 127035761 | 12703576 | Euphoric mood | |
| 127035761 | 12703576 | Hypercoagulation | |
| 127035761 | 12703576 | Incorrect dose administered | |
| 127035761 | 12703576 | Mood altered | |
| 127035761 | 12703576 | Pain | |
| 127035761 | 12703576 | Peripheral swelling | |
| 127035761 | 12703576 | Pneumonia | |
| 127035761 | 12703576 | Product use issue | |
| 127035761 | 12703576 | Sleep disorder | |
| 127035761 | 12703576 | Somnolence | |
| 127035761 | 12703576 | Thrombosis | |
| 127035761 | 12703576 | Vein disorder |
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 |
|---|---|---|---|---|---|---|
| 127035761 | 12703576 | 2 | 2015 | 0 |