Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8016631 | 8317518 | I | 8016631-6 | 20111223 | 20111231 | EXP | PHHY2011FR112050 | SANDOZ,INC. | 36 | YR | F | Y | 20111231 | OT | FRANCE |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 8016631 | 1018419930 | I | OLANZAPINE | 1 | 10 MG/DAY | ||||||
| 8016631 | 1018419929 | I | VALPROIC ACID | 1 | 1500 MG/DAY | ||||||
| 8016631 | 1018419928 | I | VALPROIC ACID | 1 | 1000 MG/DAY | ||||||
| 8016631 | 1018419927 | PS | DIAZEPAM | 1 | 30 MG/DAY | 070302 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 8016631 | 1018419927 | AGITATION |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 8016631 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 8016631 | DRUG INTERACTION |
| 8016631 | ENCEPHALOPATHY |
| 8016631 | COMA |
| 8016631 | UNRESPONSIVE TO STIMULI |
| 8016631 | SOMNOLENCE |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |