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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125629851 | 12562985 | 1 | I | 20160712 | 20160715 | 20160715 | EXP | NL-JNJFOC-20160712768 | JANSSEN | HEINTJES EM, OVERBEEK JA, PENNING-VAN BEEST FJ, BROBERT G, HERINGS RM. POST AUTHORIZATION SAFETY STUDY COMPARING QUETIAPINE TO RISPERIDONE AND OLANZAPINE. HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL 2016;31 (4):304-312. | 0.00 | Y | 0.00000 | 20160715 | MD | NL | NL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125629851 | 12562985 | 1 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | MEAN DOSE: MORE THAN OR EQUAL TO 0.125 MG TO MORE THAN 0.75 MG | U | U | 0 | UNSPECIFIED | |||||||
| 125629851 | 12562985 | 2 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | MEAN DOSE: MORE THAN OR EQUAL TO 0.125 MG TO MORE THAN 0.75 MG | U | U | 0 | UNSPECIFIED | |||||||
| 125629851 | 12562985 | 3 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | MEAN DOSE: MORE THAN OR EQUAL TO 0.125 MG TO MORE THAN 0.75 MG | U | U | 0 | UNSPECIFIED | |||||||
| 125629851 | 12562985 | 4 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | MEAN DOSE: MORE THAN OR EQUAL TO 0.125 MG TO MORE THAN 0.75 MG | U | U | 0 | UNSPECIFIED | |||||||
| 125629851 | 12562985 | 5 | PS | RISPERIDONE. | RISPERIDONE | 1 | Oral | MEAN DOSE: MORE THAN OR EQUAL TO 0.125 MG TO MORE THAN 0.75 MG | U | U | 20272 | UNSPECIFIED | |||||||
| 125629851 | 12562985 | 6 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Other | U | U | 0 | MICROSPHERES | ||||||||
| 125629851 | 12562985 | 7 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Other | U | U | 0 | MICROSPHERES | ||||||||
| 125629851 | 12562985 | 8 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Other | U | U | 0 | MICROSPHERES | ||||||||
| 125629851 | 12562985 | 9 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Other | U | U | 0 | MICROSPHERES | ||||||||
| 125629851 | 12562985 | 10 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Other | U | U | 21346 | MICROSPHERES | ||||||||
| 125629851 | 12562985 | 11 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125629851 | 12562985 | 1 | Mental disorder |
| 125629851 | 12562985 | 2 | Generalised anxiety disorder |
| 125629851 | 12562985 | 3 | Bipolar disorder |
| 125629851 | 12562985 | 4 | Major depression |
| 125629851 | 12562985 | 5 | Schizophrenia |
| 125629851 | 12562985 | 6 | Mental disorder |
| 125629851 | 12562985 | 7 | Generalised anxiety disorder |
| 125629851 | 12562985 | 8 | Bipolar disorder |
| 125629851 | 12562985 | 9 | Major depression |
| 125629851 | 12562985 | 10 | Schizophrenia |
| 125629851 | 12562985 | 11 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125629851 | 12562985 | HO |
| 125629851 | 12562985 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125629851 | 12562985 | Acute myocardial infarction | |
| 125629851 | 12562985 | Cerebrovascular accident | |
| 125629851 | 12562985 | Death | |
| 125629851 | 12562985 | Diabetes mellitus | |
| 125629851 | 12562985 | Extrapyramidal disorder | |
| 125629851 | 12562985 | Hypothyroidism | |
| 125629851 | 12562985 | Off label use | |
| 125629851 | 12562985 | Product use issue | |
| 125629851 | 12562985 | Suicide attempt |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |