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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124537534 | 12453753 | 4 | F | 2010 | 20160711 | 20160609 | 20160718 | EXP | BR-ABBVIE-16P-020-1648137-00 | ABBVIE | 0.00 | M | Y | 0.00000 | 20160718 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124537534 | 12453753 | 1 | PS | DEPAKENE | VALPROIC ACID | 1 | Unknown | UNKNOWN | 18081 | CAPSULE | |||||||||
| 124537534 | 12453753 | 2 | SS | DEPAKENE | VALPROIC ACID | 1 | Oral | UNKNOWN | 18081 | 500 | MG | Q12H | |||||||
| 124537534 | 12453753 | 3 | C | RISPERIDONE. | RISPERIDONE | 1 | Oral | 0 | 2 | MG | Q12H | ||||||||
| 124537534 | 12453753 | 4 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | UNIT DAOSE: 1 TABLET; FASTING | 0 | 1 | DF | ||||||||
| 124537534 | 12453753 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 124537534 | 12453753 | 6 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 124537534 | 12453753 | 7 | C | DEPRAX | TRAZODONE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124537534 | 12453753 | 1 | Schizophrenia |
| 124537534 | 12453753 | 2 | Schizophrenia |
| 124537534 | 12453753 | 3 | Schizophrenia |
| 124537534 | 12453753 | 4 | Gastric disorder |
| 124537534 | 12453753 | 5 | Prophylaxis |
| 124537534 | 12453753 | 6 | Depression |
| 124537534 | 12453753 | 7 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124537534 | 12453753 | HO |
| 124537534 | 12453753 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124537534 | 12453753 | Back pain | |
| 124537534 | 12453753 | Chest pain | |
| 124537534 | 12453753 | Chills | |
| 124537534 | 12453753 | Dementia | |
| 124537534 | 12453753 | Drug ineffective | |
| 124537534 | 12453753 | Feeling abnormal | |
| 124537534 | 12453753 | Gastritis | |
| 124537534 | 12453753 | Head discomfort | |
| 124537534 | 12453753 | Headache | |
| 124537534 | 12453753 | Hypertension | |
| 124537534 | 12453753 | Insomnia | |
| 124537534 | 12453753 | Nausea | |
| 124537534 | 12453753 | Nervousness | |
| 124537534 | 12453753 | Off label use | |
| 124537534 | 12453753 | Product quality issue | |
| 124537534 | 12453753 | Product use issue | |
| 124537534 | 12453753 | Schizophrenia | |
| 124537534 | 12453753 | Sedation | |
| 124537534 | 12453753 | Therapy cessation | |
| 124537534 | 12453753 | Vision blurred | |
| 124537534 | 12453753 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 124537534 | 12453753 | 1 | 2010 | 0 | ||
| 124537534 | 12453753 | 3 | 2010 | 0 |