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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127471271 | 12747127 | 1 | I | 20011015 | 20160907 | 20160915 | 20160915 | EXP | US-JNJFOC-20160909064 | JANSSEN | 16.49 | YR | T | M | Y | 0.00000 | 20160915 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127471271 | 12747127 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | N | 0 | UNSPECIFIED | ||||||||
| 127471271 | 12747127 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | N | 0 | 1 | MG | UNSPECIFIED | BID | |||||
| 127471271 | 12747127 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | N | 0 | .5 | MG | UNSPECIFIED | BID | |||||
| 127471271 | 12747127 | 4 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | N | 0 | .5 | MG | UNSPECIFIED | BID | |||||
| 127471271 | 12747127 | 5 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | N | 20272 | .5 | MG | UNSPECIFIED | BID | |||||
| 127471271 | 12747127 | 6 | SS | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 60 | Y | 0 | 50 | MG | UNSPECIFIED | BID | |||||
| 127471271 | 12747127 | 7 | SS | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | Y | 0 | 100 | MG | UNSPECIFIED | QD | ||||||
| 127471271 | 12747127 | 8 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Unknown | 90 | 0 | 250 | MG | UNSPECIFIED | |||||||
| 127471271 | 12747127 | 9 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | Unknown | 0 | 800 | IU | UNSPECIFIED | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127471271 | 12747127 | 1 | Product used for unknown indication |
| 127471271 | 12747127 | 2 | Product used for unknown indication |
| 127471271 | 12747127 | 3 | Product used for unknown indication |
| 127471271 | 12747127 | 4 | Product used for unknown indication |
| 127471271 | 12747127 | 5 | Product used for unknown indication |
| 127471271 | 12747127 | 6 | Product used for unknown indication |
| 127471271 | 12747127 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127471271 | 12747127 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127471271 | 12747127 | Abnormal behaviour | |
| 127471271 | 12747127 | Bipolar disorder | |
| 127471271 | 12747127 | Gynaecomastia | |
| 127471271 | 12747127 | Hypersomnia | |
| 127471271 | 12747127 | Impulse-control disorder | |
| 127471271 | 12747127 | Increased appetite | |
| 127471271 | 12747127 | Weight 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 |
|---|---|---|---|---|---|---|
| 127471271 | 12747127 | 1 | 19980414 | 0 | ||
| 127471271 | 12747127 | 2 | 19980204 | 0 | ||
| 127471271 | 12747127 | 3 | 19990623 | 0 | ||
| 127471271 | 12747127 | 4 | 19991022 | 0 | ||
| 127471271 | 12747127 | 5 | 20000313 | 0 |