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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125480272 | 12548027 | 2 | F | 20160628 | 20160712 | 20160712 | EXP | US-CIPLA LTD.-2016US09476 | CIPLA | EDEN EVINS A, DEMOPULOS C, NIERENBERG A, CULHANE MA, EISNER L, SACHS G. A DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ADJUNCTIVE DONEPEZIL IN TREATMENT-RESISTANT MANIA. BIPOLAR DISORDERS. 2006;8:75 TO 80 | 0.00 | Y | 0.00000 | 20160712 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125480272 | 12548027 | 1 | SS | DONEPEZIL. | DONEPEZIL | 1 | Unknown | 5 MG/DAY | U | 0 | 5 | MG | |||||||
| 125480272 | 12548027 | 2 | PS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | 20 MG/DAY | U | U | 203333 | 20 | MG | ||||||
| 125480272 | 12548027 | 3 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Unknown | 3000 MG/DAY | U | U | 0 | 3000 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125480272 | 12548027 | 1 | Mania |
| 125480272 | 12548027 | 2 | Psychotherapy |
| 125480272 | 12548027 | 3 | Mood swings |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125480272 | 12548027 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125480272 | 12548027 | Adverse event | |
| 125480272 | 12548027 | Drug ineffective |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |