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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127794221 | 12779422 | 1 | I | 20160622 | 20160912 | 20160926 | 20160926 | EXP | FR-AUROBINDO-AUR-APL-2016-11703 | AUROBINDO | 40.56 | YR | M | Y | 75.00000 | KG | 20160926 | CN | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127794221 | 12779422 | 1 | PS | VALPROIC | VALPROIC ACID | 1 | Oral | 600 MG, 3 TIMES A DAY | 1800 | MG | Y | U | 90554 | 600 | MG | TID | |||
| 127794221 | 12779422 | 2 | SS | DEPAKOTE | DIVALPROEX SODIUM | 1 | Oral | 500 MG, 3 TIMES A DAY | 7500 | MG | Y | U | 0 | 500 | MG | TABLET | TID | ||
| 127794221 | 12779422 | 3 | C | HALDOL | HALOPERIDOL | 1 | Oral | 25 MG, UNK | U | 0 | 25 | MG | |||||||
| 127794221 | 12779422 | 4 | C | NOZINAN /00038601/ | LEVOMEPROMAZINE | 1 | Oral | 400 MG, UNK | U | 0 | 400 | MG | |||||||
| 127794221 | 12779422 | 5 | C | VALIUM | DIAZEPAM | 1 | Unknown | 40 MG, DAILY | U | 0 | 40 | MG | |||||||
| 127794221 | 12779422 | 6 | C | VALIUM | DIAZEPAM | 1 | Intravenous (not otherwise specified) | 100 MG, UNK | U | 0 | 100 | MG | |||||||
| 127794221 | 12779422 | 7 | C | LYSANXIA | PRAZEPAM | 1 | Unknown | UNK | U | 0 | |||||||||
| 127794221 | 12779422 | 8 | C | LARGACTIL /00011901/ | CHLORPROMAZINE | 1 | Unknown | 350 MG, DAILY | U | 0 | 350 | MG | DROP | ||||||
| 127794221 | 12779422 | 9 | C | OLANZAPINE. | OLANZAPINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 127794221 | 12779422 | 10 | C | LOXAPAC /00401801/ | LOXAPINE SUCCINATE | 1 | Intravenous (not otherwise specified) | 100 MG, UNK | U | 0 | 100 | MG | |||||||
| 127794221 | 12779422 | 11 | C | NICOTINE. | NICOTINE | 1 | Unknown | UNK | U | 0 | PATCH |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127794221 | 12779422 | 1 | Bipolar disorder |
| 127794221 | 12779422 | 2 | Bipolar disorder |
| 127794221 | 12779422 | 3 | Product used for unknown indication |
| 127794221 | 12779422 | 4 | Product used for unknown indication |
| 127794221 | 12779422 | 5 | Product used for unknown indication |
| 127794221 | 12779422 | 7 | Product used for unknown indication |
| 127794221 | 12779422 | 8 | Product used for unknown indication |
| 127794221 | 12779422 | 9 | Product used for unknown indication |
| 127794221 | 12779422 | 10 | Product used for unknown indication |
| 127794221 | 12779422 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127794221 | 12779422 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127794221 | 12779422 | Coma | |
| 127794221 | 12779422 | Fall | |
| 127794221 | 12779422 | Sedation |
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 |
|---|---|---|---|---|---|---|
| 127794221 | 12779422 | 1 | 20160621 | 20160623 | 0 | |
| 127794221 | 12779422 | 2 | 20160617 | 20160623 | 0 | |
| 127794221 | 12779422 | 3 | 20160620 | 0 | ||
| 127794221 | 12779422 | 4 | 20160620 | 0 | ||
| 127794221 | 12779422 | 5 | 20160613 | 0 | ||
| 127794221 | 12779422 | 6 | 20160619 | 0 | ||
| 127794221 | 12779422 | 7 | 20160621 | 0 | ||
| 127794221 | 12779422 | 8 | 20160617 | 20160620 | 0 | |
| 127794221 | 12779422 | 9 | 20160618 | 20160620 | 0 | |
| 127794221 | 12779422 | 10 | 20160619 | 0 | ||
| 127794221 | 12779422 | 11 | 20160606 | 0 |