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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114476635 | 11447663 | 5 | F | 1999 | 20160829 | 20150902 | 20160929 | PER | US-JNJFOC-20150808966 | JANSSEN | 0.00 | C | M | Y | 74.84000 | KG | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114476635 | 11447663 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 2 | MG | TABLETS | ||||||
| 114476635 | 11447663 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | DOSE-1 TO 3MG | U | U | 0 | TABLETS | |||||||
| 114476635 | 11447663 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | .25 | MG | TABLETS | ||||||
| 114476635 | 11447663 | 4 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 114476635 | 11447663 | 5 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 114476635 | 11447663 | 6 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | .25 | MG | TABLETS | ||||||
| 114476635 | 11447663 | 7 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | DOSE-1 TO 3MG | U | U | 0 | TABLETS | |||||||
| 114476635 | 11447663 | 8 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 20272 | 2 | MG | TABLETS | ||||||
| 114476635 | 11447663 | 9 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 0 | 1 | MG | UNSPECIFIED | |||||||
| 114476635 | 11447663 | 10 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 20272 | 1 | MG | UNSPECIFIED | |||||||
| 114476635 | 11447663 | 11 | SS | INVEGA | PALIPERIDONE | 1 | Oral | DOSE-6 TO 9MG | U | 21999 | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||||
| 114476635 | 11447663 | 12 | C | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Unknown | D | 0 | 18 | MG | UNSPECIFIED | |||||||
| 114476635 | 11447663 | 13 | C | ABILIFY | ARIPIPRAZOLE | 1 | Unknown | DOSE-5 TO 30MG | D | 0 | UNSPECIFIED | ||||||||
| 114476635 | 11447663 | 14 | C | LAMICTAL | LAMOTRIGINE | 1 | Unknown | D | 0 | 25 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114476635 | 11447663 | 1 | Aggression |
| 114476635 | 11447663 | 2 | Aggression |
| 114476635 | 11447663 | 3 | Aggression |
| 114476635 | 11447663 | 4 | Aggression |
| 114476635 | 11447663 | 5 | Bipolar disorder |
| 114476635 | 11447663 | 6 | Bipolar disorder |
| 114476635 | 11447663 | 7 | Bipolar disorder |
| 114476635 | 11447663 | 8 | Bipolar disorder |
| 114476635 | 11447663 | 9 | Aggression |
| 114476635 | 11447663 | 10 | Bipolar disorder |
| 114476635 | 11447663 | 11 | Bipolar disorder |
| 114476635 | 11447663 | 13 | Product used for unknown indication |
| 114476635 | 11447663 | 14 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114476635 | 11447663 | Abdominal pain upper | |
| 114476635 | 11447663 | Emotional disorder | |
| 114476635 | 11447663 | Gynaecomastia | |
| 114476635 | 11447663 | Tremor | |
| 114476635 | 11447663 | Vomiting | |
| 114476635 | 11447663 | 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 |
|---|---|---|---|---|---|---|
| 114476635 | 11447663 | 1 | 2006 | 2008 | 0 | |
| 114476635 | 11447663 | 2 | 2004 | 2006 | 0 | |
| 114476635 | 11447663 | 3 | 1999 | 2002 | 0 | |
| 114476635 | 11447663 | 4 | 2003 | 2006 | 0 | |
| 114476635 | 11447663 | 5 | 2003 | 2006 | 0 | |
| 114476635 | 11447663 | 6 | 1999 | 2002 | 0 | |
| 114476635 | 11447663 | 7 | 2004 | 2006 | 0 | |
| 114476635 | 11447663 | 8 | 2006 | 2008 | 0 | |
| 114476635 | 11447663 | 9 | 2008 | 2008 | 0 | |
| 114476635 | 11447663 | 10 | 2008 | 2008 | 0 | |
| 114476635 | 11447663 | 11 | 2008 | 2009 | 0 | |
| 114476635 | 11447663 | 12 | 2008 | 0 | ||
| 114476635 | 11447663 | 13 | 2005 | 2007 | 0 | |
| 114476635 | 11447663 | 14 | 2005 | 2006 | 0 |