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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125465211 | 12546521 | 1 | I | 20160628 | 20160711 | 20160711 | EXP | GB-WATSON-2016-14742 | WATSON | 39.00 | YR | M | Y | 0.00000 | 20160711 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125465211 | 12546521 | 1 | PS | Diazepam (Unknown) | DIAZEPAM | 1 | Unknown | UNK | U | UNCONFIRMED | 70296 | UNK | |||||||
| 125465211 | 12546521 | 2 | SS | Lorazepam (Unknown) | LORAZEPAM | 1 | Unknown | UNK | U | UNCONFIRMED | 0 | UNK | |||||||
| 125465211 | 12546521 | 3 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | 400 MG, QD | 0 | 400 | MG | TABLET | QD | ||||||
| 125465211 | 12546521 | 4 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | UNK | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125465211 | 12546521 | 1 | Product used for unknown indication |
| 125465211 | 12546521 | 2 | Product used for unknown indication |
| 125465211 | 12546521 | 3 | Schizophrenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125465211 | 12546521 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125465211 | 12546521 | Antipsychotic drug level above therapeutic | |
| 125465211 | 12546521 | Cold sweat | |
| 125465211 | 12546521 | Dysarthria | |
| 125465211 | 12546521 | Head discomfort | |
| 125465211 | 12546521 | Salivary hypersecretion | |
| 125465211 | 12546521 | Sedation | |
| 125465211 | 12546521 | 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 |
|---|---|---|---|---|---|---|
| 125465211 | 12546521 | 4 | 20070201 | 0 |