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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127051152 | 12705115 | 2 | F | 20160914 | 20160831 | 20160921 | EXP | US-JAZZ-2016-US-016126 | JAZZ | 0.00 | F | Y | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127051152 | 12705115 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127051152 | 12705115 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 127051152 | 12705115 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 127051152 | 12705115 | 4 | SS | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127051152 | 12705115 | 5 | SS | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 127051152 | 12705115 | 6 | C | SAVELLA | MILNACIPRAN HYDROCHLORIDE | 1 | 50 MG, UNK | U | 0 | 50 | MG | TABLET | |||||||
| 127051152 | 12705115 | 7 | C | SAVELLA | MILNACIPRAN HYDROCHLORIDE | 1 | 50 MG, UNK | U | 0 | 50 | MG | TABLET | |||||||
| 127051152 | 12705115 | 8 | C | DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 127051152 | 12705115 | 9 | C | DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 1 | 5 MG, UNK | U | 0 | 5 | MG | ||||||||
| 127051152 | 12705115 | 10 | C | DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 1 | 15 MG, UNK | U | 0 | 15 | MG | ||||||||
| 127051152 | 12705115 | 11 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127051152 | 12705115 | 12 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127051152 | 12705115 | 13 | C | Cyclobenzaprine hcl | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | UNK | U | 0 | POWDER | |||||||||
| 127051152 | 12705115 | 14 | C | LASIX | FUROSEMIDE | 1 | U | 0 | TABLET | ||||||||||
| 127051152 | 12705115 | 15 | C | LORTAB | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127051152 | 12705115 | 16 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127051152 | 12705115 | 1 | Narcolepsy |
| 127051152 | 12705115 | 2 | Cataplexy |
| 127051152 | 12705115 | 4 | Foot operation |
| 127051152 | 12705115 | 5 | Product used for unknown indication |
| 127051152 | 12705115 | 6 | Product used for unknown indication |
| 127051152 | 12705115 | 8 | Product used for unknown indication |
| 127051152 | 12705115 | 11 | Product used for unknown indication |
| 127051152 | 12705115 | 12 | Product used for unknown indication |
| 127051152 | 12705115 | 13 | Product used for unknown indication |
| 127051152 | 12705115 | 14 | Product used for unknown indication |
| 127051152 | 12705115 | 15 | Product used for unknown indication |
| 127051152 | 12705115 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127051152 | 12705115 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127051152 | 12705115 | Drug ineffective | |
| 127051152 | 12705115 | Fatigue | |
| 127051152 | 12705115 | Foot operation | |
| 127051152 | 12705115 | Insomnia | |
| 127051152 | 12705115 | Psoriasis | |
| 127051152 | 12705115 | Tarsal tunnel syndrome | |
| 127051152 | 12705115 | 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 |
|---|---|---|---|---|---|---|
| 127051152 | 12705115 | 1 | 201111 | 201112 | 0 | |
| 127051152 | 12705115 | 2 | 201112 | 201503 | 0 | |
| 127051152 | 12705115 | 3 | 201503 | 0 | ||
| 127051152 | 12705115 | 4 | 20160816 | 0 | ||
| 127051152 | 12705115 | 5 | 20140831 | 0 | ||
| 127051152 | 12705115 | 6 | 201512 | 0 | ||
| 127051152 | 12705115 | 7 | 201512 | 0 | ||
| 127051152 | 12705115 | 8 | 201508 | 0 | ||
| 127051152 | 12705115 | 9 | 201508 | 0 | ||
| 127051152 | 12705115 | 10 | 201508 | 0 | ||
| 127051152 | 12705115 | 11 | 201501 | 0 | ||
| 127051152 | 12705115 | 12 | 201408 | 0 | ||
| 127051152 | 12705115 | 13 | 201408 | 0 | ||
| 127051152 | 12705115 | 15 | 201501 | 0 | ||
| 127051152 | 12705115 | 16 | 201408 | 0 |