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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123234853 | 12323485 | 3 | F | 201603 | 20160620 | 20160502 | 20160704 | EXP | US-JNJFOC-20160426045 | JANSSEN | 31.59 | YR | A | F | Y | 101.15000 | KG | 20160704 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123234853 | 12323485 | 1 | PS | INVEGA TRINZA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | U | UNKNOWN | 207946 | 410 | MG | SUSPENSION FOR INJECTION | |||||
| 123234853 | 12323485 | 2 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | U | UNKNOWN | 0 | 234 | MG | INJECTION | |||||
| 123234853 | 12323485 | 3 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | U | UNKNOWN | 0 | 117 | MG | INJECTION | /month | ||||
| 123234853 | 12323485 | 4 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | U | UNKNOWN | 22264 | 156 | MG | INJECTION | |||||
| 123234853 | 12323485 | 5 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Unknown | 0 | 88 | UG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123234853 | 12323485 | 1 | Bipolar disorder |
| 123234853 | 12323485 | 2 | Product used for unknown indication |
| 123234853 | 12323485 | 3 | Product used for unknown indication |
| 123234853 | 12323485 | 4 | Product used for unknown indication |
| 123234853 | 12323485 | 5 | Hypothyroidism |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123234853 | 12323485 | HO |
| 123234853 | 12323485 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123234853 | 12323485 | Bipolar I disorder | |
| 123234853 | 12323485 | Drug ineffective | |
| 123234853 | 12323485 | Off label use | |
| 123234853 | 12323485 | Product use issue | |
| 123234853 | 12323485 | Sedation |
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 |
|---|---|---|---|---|---|---|
| 123234853 | 12323485 | 1 | 20160211 | 20160622 | 0 | |
| 123234853 | 12323485 | 2 | 201604 | 201604 | 0 | |
| 123234853 | 12323485 | 3 | 201207 | 201601 | 0 | |
| 123234853 | 12323485 | 4 | 201604 | 0 | ||
| 123234853 | 12323485 | 5 | 2012 | 0 |