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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125215251 | 12521525 | 1 | I | 201606 | 20160624 | 20160701 | 20160701 | EXP | US-JAZZ-2016-US-011889 | JAZZ | 51.00 | YR | M | Y | 0.00000 | 20160701 | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125215251 | 12521525 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125215251 | 12521525 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125215251 | 12521525 | 3 | SS | Amantadine | AMANTADINE | 1 | UNK | 0 | CAPSULE | ||||||||||
| 125215251 | 12521525 | 4 | C | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | UNK | U | 0 | ||||||||||
| 125215251 | 12521525 | 5 | C | KLONOPIN | CLONAZEPAM | 1 | U | 0 | TABLET | ||||||||||
| 125215251 | 12521525 | 6 | C | LITHIUM. | LITHIUM | 1 | U | 0 | |||||||||||
| 125215251 | 12521525 | 7 | C | LUNESTA | ESZOPICLONE | 1 | U | 0 | TABLET | ||||||||||
| 125215251 | 12521525 | 8 | C | REMERON | MIRTAZAPINE | 1 | U | 0 | |||||||||||
| 125215251 | 12521525 | 9 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | U | 0 | |||||||||||
| 125215251 | 12521525 | 10 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | U | 0 | TABLET | ||||||||||
| 125215251 | 12521525 | 11 | C | ZYPREXA | OLANZAPINE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125215251 | 12521525 | 1 | Sleep disorder |
| 125215251 | 12521525 | 3 | Parkinson's disease |
| 125215251 | 12521525 | 4 | Product used for unknown indication |
| 125215251 | 12521525 | 5 | Product used for unknown indication |
| 125215251 | 12521525 | 6 | Product used for unknown indication |
| 125215251 | 12521525 | 7 | Product used for unknown indication |
| 125215251 | 12521525 | 8 | Product used for unknown indication |
| 125215251 | 12521525 | 9 | Product used for unknown indication |
| 125215251 | 12521525 | 10 | Product used for unknown indication |
| 125215251 | 12521525 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125215251 | 12521525 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125215251 | 12521525 | Dizziness | |
| 125215251 | 12521525 | Feeling abnormal | |
| 125215251 | 12521525 | Parkinson's disease | |
| 125215251 | 12521525 | Speech disorder |
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 |
|---|---|---|---|---|---|---|
| 125215251 | 12521525 | 1 | 200902 | 200911 | 0 | |
| 125215251 | 12521525 | 2 | 200911 | 0 | ||
| 125215251 | 12521525 | 3 | 201606 | 0 | ||
| 125215251 | 12521525 | 4 | 20140826 | 0 |