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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124944373 | 12494437 | 3 | F | 2015 | 20160823 | 20160623 | 20160830 | EXP | US-JAZZ-2016-US-011202 | JAZZ | 0.00 | F | Y | 95.00000 | KG | 20160830 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124944373 | 12494437 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 124944373 | 12494437 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 124944373 | 12494437 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 6 G, BID | U | 21196 | 6 | G | ORAL SOLUTION | ||||||
| 124944373 | 12494437 | 4 | C | AVAPRO | IRBESARTAN | 1 | U | 0 | TABLET | ||||||||||
| 124944373 | 12494437 | 5 | C | CHLORTHALIDONE. | CHLORTHALIDONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944373 | 12494437 | 6 | C | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 124944373 | 12494437 | 7 | C | Ferrex | 2 | U | 0 | CAPSULE | |||||||||||
| 124944373 | 12494437 | 8 | C | Iron | IRON | 1 | UNK | U | 0 | ||||||||||
| 124944373 | 12494437 | 9 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | U | 0 | TABLET | ||||||||||
| 124944373 | 12494437 | 10 | C | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | 0.25 MG | U | 0 | TABLET | |||||||||
| 124944373 | 12494437 | 11 | C | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | 0.25 MG | U | 0 | TABLET | |||||||||
| 124944373 | 12494437 | 12 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | U | 0 | CAPSULE | ||||||||||
| 124944373 | 12494437 | 13 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 124944373 | 12494437 | 14 | C | Vitamin b-1 | THIAMINE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124944373 | 12494437 | 1 | Insomnia |
| 124944373 | 12494437 | 4 | Product used for unknown indication |
| 124944373 | 12494437 | 5 | Product used for unknown indication |
| 124944373 | 12494437 | 6 | Product used for unknown indication |
| 124944373 | 12494437 | 7 | Product used for unknown indication |
| 124944373 | 12494437 | 8 | Product used for unknown indication |
| 124944373 | 12494437 | 9 | Product used for unknown indication |
| 124944373 | 12494437 | 10 | Product used for unknown indication |
| 124944373 | 12494437 | 12 | Product used for unknown indication |
| 124944373 | 12494437 | 13 | Product used for unknown indication |
| 124944373 | 12494437 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124944373 | 12494437 | HO |
| 124944373 | 12494437 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124944373 | 12494437 | Asthenia | |
| 124944373 | 12494437 | Gait disturbance | |
| 124944373 | 12494437 | Hypertension | |
| 124944373 | 12494437 | Pain | |
| 124944373 | 12494437 | Unevaluable event | |
| 124944373 | 12494437 | Viral myositis | |
| 124944373 | 12494437 | Weight 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 |
|---|---|---|---|---|---|---|
| 124944373 | 12494437 | 1 | 201004 | 2010 | 0 | |
| 124944373 | 12494437 | 2 | 201005 | 201508 | 0 | |
| 124944373 | 12494437 | 3 | 201508 | 0 | ||
| 124944373 | 12494437 | 6 | 201601 | 0 | ||
| 124944373 | 12494437 | 8 | 201101 | 0 | ||
| 124944373 | 12494437 | 10 | 201601 | 0 | ||
| 124944373 | 12494437 | 11 | 201612 | 0 |