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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93613552 | 9361355 | 2 | F | 20160824 | 20130621 | 20160826 | EXP | DE-JNJFOC-20130608952 | JANSSEN | GAEBEL W, ANDREAS S, PAUL B, ROSARIO AD, FREDERIC R, JOACHIM C, ET AL. RELAPSE PREVENTION IN SCHIZOPHRENIA AND SCHIZOAFFECTIVE DISORDER WITH RISPERIDONE LONG-ACTING INJECTABLE VS QUETIAPINE: RESULTS OF A LONG-TERM, OPEN-LABEL, RANDOMIZED CLINICAL TRIAL. NEUROPSYCHOPHARMACOLOGY 2010;35:2367-2377. GAEBEL W. RELAPSE PREVENTION WITH RISPERIDONE LONG-ACTING INJECTABLE VS. ORAL QUETIAPINE. RESULTS OF AN OPEN-LABEL RCT. SCHIZOPHRENIA RESEARCH 2012;136:S5. | 0.00 | Y | 0.00000 | 20160826 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93613552 | 9361355 | 1 | SS | RISPERIDONE. | RISPERIDONE | 1 | Intramuscular | U | U | UNKNOWN | 0 | 25 | MG | MICROSPHERES | QOW | ||||
| 93613552 | 9361355 | 2 | PS | RISPERIDONE. | RISPERIDONE | 1 | Intramuscular | U | U | UNKNOWN | 21346 | 25 | MG | MICROSPHERES | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 93613552 | 9361355 | 1 | Schizoaffective disorder |
| 93613552 | 9361355 | 2 | Schizophrenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 93613552 | 9361355 | DE |
| 93613552 | 9361355 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 93613552 | 9361355 | Aggression | |
| 93613552 | 9361355 | Completed suicide | |
| 93613552 | 9361355 | Drug ineffective | |
| 93613552 | 9361355 | Extrapyramidal disorder | |
| 93613552 | 9361355 | Headache | |
| 93613552 | 9361355 | Homicidal ideation | |
| 93613552 | 9361355 | Hyperkinesia | |
| 93613552 | 9361355 | Hyperprolactinaemia | |
| 93613552 | 9361355 | Intentional self-injury | |
| 93613552 | 9361355 | Mental disorder | |
| 93613552 | 9361355 | Parkinsonism | |
| 93613552 | 9361355 | Psychotic disorder | |
| 93613552 | 9361355 | Somnolence | |
| 93613552 | 9361355 | Suicidal ideation | |
| 93613552 | 9361355 | Tremor | |
| 93613552 | 9361355 | Weight increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |