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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127995211 | 12799521 | 1 | I | 20160820 | 20160926 | 20160930 | 20160930 | EXP | FR-JNJFOC-20160925869 | JANSSEN | 21.46 | YR | A | M | Y | 0.00000 | 20160930 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127995211 | 12799521 | 1 | SS | XEPLION | PALIPERIDONE PALMITATE | 1 | Intramuscular | DELTOID MUSCLE | U | U | 0 | 150 | MG | INJECTION | |||||
| 127995211 | 12799521 | 2 | PS | XEPLION | PALIPERIDONE PALMITATE | 1 | Intramuscular | U | U | 22264 | 100 | MG | INJECTION | ||||||
| 127995211 | 12799521 | 3 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | Y | 0 | 2 | MG | TABLETS | QD | ||||||
| 127995211 | 12799521 | 4 | SS | TERCIAN | CYAMEMAZINE | 1 | Unknown | 40MG/ML25 DROPS 3TIMES A DAY (IN THE MORNING, THE MIDDAY AND THE EVENING) | Y | 0 | ORAL SOLUTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127995211 | 12799521 | 1 | Delusional disorder, unspecified type |
| 127995211 | 12799521 | 2 | Delusional disorder, unspecified type |
| 127995211 | 12799521 | 3 | Delusional disorder, unspecified type |
| 127995211 | 12799521 | 4 | Anxiety |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127995211 | 12799521 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127995211 | 12799521 | Depressed level of consciousness | |
| 127995211 | 12799521 | Dysuria | |
| 127995211 | 12799521 | Extrapyramidal disorder | |
| 127995211 | 12799521 | Malaise | |
| 127995211 | 12799521 | Off label use | |
| 127995211 | 12799521 | Palpitations | |
| 127995211 | 12799521 | Product use issue | |
| 127995211 | 12799521 | Psychomotor retardation | |
| 127995211 | 12799521 | Sedation | |
| 127995211 | 12799521 | Tachycardia | |
| 127995211 | 12799521 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 127995211 | 12799521 | 1 | 20160809 | 20160809 | 0 | |
| 127995211 | 12799521 | 2 | 20160816 | 0 | ||
| 127995211 | 12799521 | 3 | 20160726 | 20160826 | 0 | |
| 127995211 | 12799521 | 4 | 20160726 | 20160810 | 0 |