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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126892023 | 12689202 | 3 | F | 201312 | 20160912 | 20160826 | 20160926 | EXP | GB-AUROBINDO-AUR-APL-2016-10614 | AUROBINDO | 49.00 | YR | F | Y | 0.00000 | 20160926 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126892023 | 12689202 | 1 | SS | Amisulpride 200 mg | AMISULPRIDE | 1 | Oral | 200 MG, QD | 0 | 200 | MG | QD | |||||||
| 126892023 | 12689202 | 2 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 250 MG, QD | 77206 | 250 | MG | QD | |||||||
| 126892023 | 12689202 | 3 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | 550 MG, QD | 0 | 550 | MG | TABLET | QD | ||||||
| 126892023 | 12689202 | 4 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 126892023 | 12689202 | 5 | SS | LITHIUM CARBONATE. | LITHIUM CARBONATE | 1 | Oral | 1200 MG, QD | U | 0 | 1200 | MG | QD | ||||||
| 126892023 | 12689202 | 6 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 126892023 | 12689202 | 7 | C | GTN | NITROGLYCERIN | 1 | Unknown | U | 0 | ||||||||||
| 126892023 | 12689202 | 8 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Unknown | U | 0 | ||||||||||
| 126892023 | 12689202 | 9 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126892023 | 12689202 | 1 | Schizoaffective disorder |
| 126892023 | 12689202 | 2 | Schizoaffective disorder |
| 126892023 | 12689202 | 3 | Schizophrenia |
| 126892023 | 12689202 | 4 | Schizophrenia |
| 126892023 | 12689202 | 5 | Schizoaffective disorder |
| 126892023 | 12689202 | 6 | Product used for unknown indication |
| 126892023 | 12689202 | 7 | Product used for unknown indication |
| 126892023 | 12689202 | 8 | Product used for unknown indication |
| 126892023 | 12689202 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126892023 | 12689202 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126892023 | 12689202 | Electrocardiogram QT prolonged | |
| 126892023 | 12689202 | Electrocardiogram T wave abnormal | |
| 126892023 | 12689202 | Vomiting | |
| 126892023 | 12689202 | White blood cell count abnormal | |
| 126892023 | 12689202 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 126892023 | 12689202 | 4 | 20040529 | 0 |