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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127381831 | 12738183 | 1 | I | 201606 | 20160908 | 20160913 | 20160913 | EXP | CH-JNJFOC-20160907359 | JANSSEN | 69.00 | YR | E | F | Y | 0.00000 | 20160913 | MD | CH | CH |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127381831 | 12738183 | 1 | SS | HALDOL | HALOPERIDOL | 1 | Oral | Y | N | UNKNOWN | 0 | UNSPECIFIED | |||||||
| 127381831 | 12738183 | 2 | PS | HALDOL | HALOPERIDOL | 1 | Oral | Y | N | UNKNOWN | 15923 | UNSPECIFIED | |||||||
| 127381831 | 12738183 | 3 | SS | ZYPREXA | OLANZAPINE | 1 | Oral | Y | 0 | UNSPECIFIED | |||||||||
| 127381831 | 12738183 | 4 | SS | TEMESTA | LORAZEPAM | 1 | Oral | Y | 0 | UNSPECIFIED | |||||||||
| 127381831 | 12738183 | 5 | SS | SEROQUEL | QUETIAPINE FUMARATE | 1 | Oral | 12.5-25-25 | Y | 0 | 62.5 | MG | UNSPECIFIED | QD | |||||
| 127381831 | 12738183 | 6 | C | EBIXA | MEMANTINE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | FILM COATED TABLET | BID | |||||||
| 127381831 | 12738183 | 7 | C | REMERON | MIRTAZAPINE | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 127381831 | 12738183 | 8 | C | TRITTICO | TRAZODONE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | UNSPECIFIED | QD | |||||||
| 127381831 | 12738183 | 9 | C | LYRICA | PREGABALIN | 1 | Oral | 0 | 75 | MG | UNSPECIFIED | BID | |||||||
| 127381831 | 12738183 | 10 | C | ORFIRIL | VALPROIC ACID | 1 | Oral | 550-0-825 | 0 | 1375 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127381831 | 12738183 | 1 | Hallucination, visual |
| 127381831 | 12738183 | 2 | Psychomotor hyperactivity |
| 127381831 | 12738183 | 3 | Agitation |
| 127381831 | 12738183 | 4 | Agitation |
| 127381831 | 12738183 | 5 | Agitation |
| 127381831 | 12738183 | 6 | Dementia Alzheimer's type |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127381831 | 12738183 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127381831 | 12738183 | Agitation | |
| 127381831 | 12738183 | Akathisia | |
| 127381831 | 12738183 | Condition aggravated | |
| 127381831 | 12738183 | Dysphagia | |
| 127381831 | 12738183 | Hallucinations, mixed | |
| 127381831 | 12738183 | Muscle rigidity | |
| 127381831 | 12738183 | Restlessness |
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 |
|---|---|---|---|---|---|---|
| 127381831 | 12738183 | 1 | 201512 | 20160706 | 0 | |
| 127381831 | 12738183 | 2 | 201512 | 20160706 | 0 | |
| 127381831 | 12738183 | 3 | 20160707 | 20160718 | 0 | |
| 127381831 | 12738183 | 4 | 20160707 | 20160718 | 0 | |
| 127381831 | 12738183 | 5 | 20160727 | 20160819 | 0 | |
| 127381831 | 12738183 | 6 | 201405 | 0 | ||
| 127381831 | 12738183 | 7 | 20160808 | 20160815 | 0 | |
| 127381831 | 12738183 | 8 | 20160816 | 20160819 | 0 | |
| 127381831 | 12738183 | 9 | 20160817 | 20160819 | 0 | |
| 127381831 | 12738183 | 10 | 20160809 | 20160819 | 0 |