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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 128004401 | 12800440 | 1 | I | 2014 | 20160922 | 20160930 | 20160930 | EXP | US-JAZZ-2016-US-018638 | JAZZ | 0.00 | F | Y | 0.00000 | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 128004401 | 12800440 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 128004401 | 12800440 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 128004401 | 12800440 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 128004401 | 12800440 | 4 | SS | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 128004401 | 12800440 | 5 | C | MELOXICAM. | MELOXICAM | 1 | U | 0 | TABLET | ||||||||||
| 128004401 | 12800440 | 6 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 128004401 | 12800440 | 7 | C | NORTRIPTYLINE | NORTRIPTYLINE | 1 | U | 0 | |||||||||||
| 128004401 | 12800440 | 8 | C | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 128004401 | 12800440 | 9 | C | SIMVASTATIN. | SIMVASTATIN | 1 | U | 0 | |||||||||||
| 128004401 | 12800440 | 10 | C | VITAMIN D /00107901/ | ERGOCALCIFEROL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 128004401 | 12800440 | 1 | Chronic fatigue syndrome |
| 128004401 | 12800440 | 4 | Depression |
| 128004401 | 12800440 | 5 | Product used for unknown indication |
| 128004401 | 12800440 | 6 | Product used for unknown indication |
| 128004401 | 12800440 | 7 | Product used for unknown indication |
| 128004401 | 12800440 | 8 | Product used for unknown indication |
| 128004401 | 12800440 | 9 | Product used for unknown indication |
| 128004401 | 12800440 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 128004401 | 12800440 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 128004401 | 12800440 | Blood pressure increased | |
| 128004401 | 12800440 | Depression | |
| 128004401 | 12800440 | Fatigue | |
| 128004401 | 12800440 | Limb operation | |
| 128004401 | 12800440 | Nerve injury | |
| 128004401 | 12800440 | Pain | |
| 128004401 | 12800440 | Sleep 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 |
|---|---|---|---|---|---|---|
| 128004401 | 12800440 | 1 | 200907 | 200907 | 0 | |
| 128004401 | 12800440 | 2 | 200907 | 201305 | 0 | |
| 128004401 | 12800440 | 3 | 201305 | 0 |