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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127779571 | 12777957 | 1 | I | 201605 | 20160607 | 20160924 | 20160924 | PER | US-JAZZ-2016-US-010616 | JAZZ | 52.02 | YR | M | Y | 0.00000 | 20160924 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127779571 | 12777957 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127779571 | 12777957 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127779571 | 12777957 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, FIRST DOSE | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 127779571 | 12777957 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, SECOND DOSE | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 127779571 | 12777957 | 5 | SS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | N | 0 | CAPSULE | ||||||||||
| 127779571 | 12777957 | 6 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | U | 0 | |||||||||||
| 127779571 | 12777957 | 7 | C | BUSPIRONE HCL | BUSPIRONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127779571 | 12777957 | 8 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | U | 0 | |||||||||||
| 127779571 | 12777957 | 9 | C | NUVIGIL | ARMODAFINIL | 1 | U | 0 | |||||||||||
| 127779571 | 12777957 | 10 | C | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127779571 | 12777957 | 11 | C | HORIZANT | GABAPENTIN ENACARBIL | 1 | U | 0 | |||||||||||
| 127779571 | 12777957 | 12 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | U | 0 | |||||||||||
| 127779571 | 12777957 | 13 | C | TRADJENTA | LINAGLIPTIN | 1 | U | 0 | |||||||||||
| 127779571 | 12777957 | 14 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 127779571 | 12777957 | 15 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | |||||||||||
| 127779571 | 12777957 | 16 | C | DIAZEPAM. | DIAZEPAM | 1 | U | 0 | |||||||||||
| 127779571 | 12777957 | 17 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | U | 0 | |||||||||||
| 127779571 | 12777957 | 18 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | U | 0 | |||||||||||
| 127779571 | 12777957 | 19 | C | Multivitamin | VITAMINS | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127779571 | 12777957 | 1 | Somnolence |
| 127779571 | 12777957 | 2 | Narcolepsy |
| 127779571 | 12777957 | 5 | Neuropathy peripheral |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127779571 | 12777957 | Condition aggravated | |
| 127779571 | 12777957 | Feeling abnormal | |
| 127779571 | 12777957 | Neuropathy peripheral | |
| 127779571 | 12777957 | Pain | |
| 127779571 | 12777957 | Restless legs syndrome | |
| 127779571 | 12777957 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 127779571 | 12777957 | 1 | 201201 | 201203 | 0 | |
| 127779571 | 12777957 | 2 | 201203 | 201602 | 0 | |
| 127779571 | 12777957 | 3 | 201602 | 0 | ||
| 127779571 | 12777957 | 4 | 201602 | 0 |