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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126702541 | 12670254 | 1 | I | 20160708 | 20160821 | 20160821 | EXP | GB-MYLANLABS-2016M1034744 | MYLAN | 0.00 | Y | 0.00000 | 20160819 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126702541 | 12670254 | 1 | PS | CLOZAPINE. | CLOZAPINE | 1 | Oral | UNK | 75417 | TABLET | |||||||||
| 126702541 | 12670254 | 2 | SS | CLOZAPINE. | CLOZAPINE | 1 | Oral | 600 MG, UNK | 75417 | 600 | MG | TABLET | |||||||
| 126702541 | 12670254 | 3 | SS | CLOZAPINE. | CLOZAPINE | 1 | Oral | 550 MG, UNK | 75417 | 550 | MG | TABLET | |||||||
| 126702541 | 12670254 | 4 | SS | CLOZAPINE. | CLOZAPINE | 1 | Oral | 500 MG, QD | 75417 | 500 | MG | TABLET | QD | ||||||
| 126702541 | 12670254 | 5 | C | SODIUM VALPROATE | VALPROATE SODIUM | 1 | Oral | 500 MG, HS | 0 | 500 | MG | QD | |||||||
| 126702541 | 12670254 | 6 | C | HYOSCINE HYDROBROMIDE | SCOPOLAMINE | 1 | Oral | 200 ?G, HS | 0 | 200 | UG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126702541 | 12670254 | 1 | Schizophrenia |
| 126702541 | 12670254 | 5 | Product used for unknown indication |
| 126702541 | 12670254 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126702541 | 12670254 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126702541 | 12670254 | Aggression | |
| 126702541 | 12670254 | Salivary hypersecretion | |
| 126702541 | 12670254 | Schizophrenia | |
| 126702541 | 12670254 | Sedation | |
| 126702541 | 12670254 | Treatment noncompliance |
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 |
|---|---|---|---|---|---|---|
| 126702541 | 12670254 | 1 | 20010720 | 0 | ||
| 126702541 | 12670254 | 3 | 201501 | 0 |