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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126223951 | 12622395 | 1 | I | 20160720 | 20160804 | 20160804 | EXP | PL-MLMSERVICE-20160711-0321782-1 | PL-ALKEM LABORATORIES LIMITED-PL-ALKEM-2016-00086 | ALKEM | 26.00 | YR | M | Y | 0.00000 | 20160804 | MD | PL | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126223951 | 12622395 | 1 | SS | OLANZAPINE. | OLANZAPINE | 1 | 15 MG, QD | Y | 0 | 15 | MG | QD | |||||||
| 126223951 | 12622395 | 2 | PS | QUETIAPINE FUMARATE. | QUETIAPINE FUMARATE | 1 | UNKNOWN | Y | 201504 | ||||||||||
| 126223951 | 12622395 | 3 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | 1500 MG, QD | 0 | 1500 | MG | QD | ||||||||
| 126223951 | 12622395 | 4 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | UNKNOWN | Y | 0 | ||||||||||
| 126223951 | 12622395 | 5 | C | CLORAZEPATE POTASSIUM | CLORAZEPATE DIPOTASSIUM | 1 | UNKNOWN | 0 | |||||||||||
| 126223951 | 12622395 | 6 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | UNKNOWN | 0 | |||||||||||
| 126223951 | 12622395 | 7 | C | MIANSERIN | MIANSERIN | 1 | 5 MG, QD, PER NIGHT | 0 | 5 | MG | QD | ||||||||
| 126223951 | 12622395 | 8 | C | ZINC | ZINCINC CHLORIDE | 1 | 180 MG, QD | 0 | 180 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126223951 | 12622395 | 1 | Mania |
| 126223951 | 12622395 | 2 | Mania |
| 126223951 | 12622395 | 3 | Mania |
| 126223951 | 12622395 | 4 | Mania |
| 126223951 | 12622395 | 5 | Product used for unknown indication |
| 126223951 | 12622395 | 6 | Product used for unknown indication |
| 126223951 | 12622395 | 7 | Sleep disorder |
| 126223951 | 12622395 | 8 | Hepato-lenticular degeneration |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126223951 | 12622395 | HO |
| 126223951 | 12622395 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126223951 | 12622395 | Drug ineffective | |
| 126223951 | 12622395 | Dysarthria | |
| 126223951 | 12622395 | Dyskinesia | |
| 126223951 | 12622395 | Dysphagia | |
| 126223951 | 12622395 | Neurological decompensation | |
| 126223951 | 12622395 | Postural tremor | |
| 126223951 | 12622395 | Salivary hypersecretion | |
| 126223951 | 12622395 | Speech disorder |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |