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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118169782 | 11816978 | 2 | F | 2007 | 20160804 | 20151210 | 20160929 | PER | US-JNJFOC-20151008453 | JANSSEN | 0.00 | M | Y | 0.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118169782 | 11816978 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | 1MG, 3MG AND 4MG | U | U | 0 | UNSPECIFIED | |||||||
| 118169782 | 11816978 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | 1MG AND 3MG | U | U | 0 | UNSPECIFIED | |||||||
| 118169782 | 11816978 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | UNSPECIFIED | ||||||||
| 118169782 | 11816978 | 4 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | UNSPECIFIED | ||||||
| 118169782 | 11816978 | 5 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 20272 | 2 | MG | UNSPECIFIED | ||||||
| 118169782 | 11816978 | 6 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 21999 | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118169782 | 11816978 | 1 | Post-traumatic stress disorder |
| 118169782 | 11816978 | 2 | Post-traumatic stress disorder |
| 118169782 | 11816978 | 3 | Post-traumatic stress disorder |
| 118169782 | 11816978 | 4 | Post-traumatic stress disorder |
| 118169782 | 11816978 | 5 | Post-traumatic stress disorder |
| 118169782 | 11816978 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118169782 | 11816978 | Abnormal weight gain | |
| 118169782 | 11816978 | Galactorrhoea | |
| 118169782 | 11816978 | Gynaecomastia | |
| 118169782 | 11816978 | Off label use | |
| 118169782 | 11816978 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 118169782 | 11816978 | 1 | 20110304 | 20130103 | 0 | |
| 118169782 | 11816978 | 2 | 20101207 | 20120920 | 0 | |
| 118169782 | 11816978 | 4 | 20100111 | 0 | ||
| 118169782 | 11816978 | 5 | 20100222 | 0 |