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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125902441 | 12590244 | 1 | I | 2013 | 20160720 | 20160725 | 20160725 | EXP | PL-ABBVIE-16P-129-1684494-00 | ABBVIE | LITWIN T, DZIERZYC K, KARLSINKSI M, ET AL. PSYCHIATRIC DISTURBANCES AS A FIRST CLINICAL SYMPTOM OF WILSON^S DISEASE - CASE REPORT.. PSYCHIATR POL.. 2016;50(2):337-44. | 26.00 | YR | M | Y | 0.00000 | 20160725 | OT | COUNTRY NOT SPECIFIED | PL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125902441 | 12590244 | 1 | PS | VALPROIC ACID. | VALPROIC ACID | 1 | Unknown | UNKNOWN | 18081 | QD | |||||||||
| 125902441 | 12590244 | 2 | SS | MIANSERIN HYDROCHLORIDE | MIANSERIN HYDROCHLORIDE | 1 | Unknown | AT BEDTIME | U | UNKNOWN | 0 | 5 | MG | QD | |||||
| 125902441 | 12590244 | 3 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 125902441 | 12590244 | 4 | SS | QUETIAPINE FUMARATE. | QUETIAPINE FUMARATE | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 125902441 | 12590244 | 5 | SS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | Y | UNKNOWN | 0 | 15 | MG | QD | ||||||
| 125902441 | 12590244 | 6 | C | CLOMIPRAMINE | CLOMIPRAMINE | 1 | 0 | ||||||||||||
| 125902441 | 12590244 | 7 | C | ZINC | ZINCINC CHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125902441 | 12590244 | 1 | Mania |
| 125902441 | 12590244 | 2 | Sleep disorder |
| 125902441 | 12590244 | 3 | Mania |
| 125902441 | 12590244 | 4 | Mania |
| 125902441 | 12590244 | 5 | Mania |
| 125902441 | 12590244 | 6 | Product used for unknown indication |
| 125902441 | 12590244 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125902441 | 12590244 | HO |
| 125902441 | 12590244 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125902441 | 12590244 | Aggression | |
| 125902441 | 12590244 | Agitation | |
| 125902441 | 12590244 | Condition aggravated | |
| 125902441 | 12590244 | Dysarthria | |
| 125902441 | 12590244 | Dyskinesia | |
| 125902441 | 12590244 | Dysphagia | |
| 125902441 | 12590244 | Mania | |
| 125902441 | 12590244 | Nervousness | |
| 125902441 | 12590244 | Neurological decompensation | |
| 125902441 | 12590244 | Postural tremor | |
| 125902441 | 12590244 | Salivary hypersecretion | |
| 125902441 | 12590244 | Therapeutic response decreased |
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 |
|---|---|---|---|---|---|---|
| 125902441 | 12590244 | 1 | 2013 | 0 | ||
| 125902441 | 12590244 | 2 | 201303 | 0 | ||
| 125902441 | 12590244 | 3 | 2013 | 2013 | 0 | |
| 125902441 | 12590244 | 4 | 2013 | 2013 | 0 | |
| 125902441 | 12590244 | 5 | 2013 | 2013 | 0 |