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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125861071 | 12586107 | 1 | I | 20160204 | 20160725 | 20160725 | PER | US-JAZZ-2016-US-002196 | JAZZ | 0.00 | F | Y | 0.00000 | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125861071 | 12586107 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125861071 | 12586107 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125861071 | 12586107 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, FIRST DOSE | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125861071 | 12586107 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, SECOND DOSE | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125861071 | 12586107 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, THIRD DOSE | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125861071 | 12586107 | 6 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 125861071 | 12586107 | 7 | C | ABILIFY | ARIPIPRAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861071 | 12586107 | 8 | C | AEROSPAN | FLUNISOLIDE | 1 | UNK | U | 0 | INHALER | |||||||||
| 125861071 | 12586107 | 9 | C | Cyclobenzaprine | CYCLOBENZAPRINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861071 | 12586107 | 10 | C | Flonase allergy rlf | 2 | UNK | U | 0 | SPRAY | ||||||||||
| 125861071 | 12586107 | 11 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125861071 | 12586107 | 12 | C | NAPROXEN. | NAPROXEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861071 | 12586107 | 13 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861071 | 12586107 | 14 | C | Cal mag | 2 | UNK | U | 0 | POWDER | ||||||||||
| 125861071 | 12586107 | 15 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125861071 | 12586107 | 16 | C | Naltrexone | NALTREXONE | 1 | UNK | U | 0 | ||||||||||
| 125861071 | 12586107 | 17 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | ||||||||||
| 125861071 | 12586107 | 18 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861071 | 12586107 | 19 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861071 | 12586107 | 20 | C | VIRTUSSIN AC | CODEINE PHOSPHATEGUAIFENESIN | 1 | UNK | U | 0 | LIQUID | |||||||||
| 125861071 | 12586107 | 21 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125861071 | 12586107 | 1 | Narcolepsy |
| 125861071 | 12586107 | 6 | Product used for unknown indication |
| 125861071 | 12586107 | 7 | Product used for unknown indication |
| 125861071 | 12586107 | 8 | Product used for unknown indication |
| 125861071 | 12586107 | 9 | Product used for unknown indication |
| 125861071 | 12586107 | 10 | Product used for unknown indication |
| 125861071 | 12586107 | 11 | Product used for unknown indication |
| 125861071 | 12586107 | 12 | Product used for unknown indication |
| 125861071 | 12586107 | 13 | Product used for unknown indication |
| 125861071 | 12586107 | 14 | Product used for unknown indication |
| 125861071 | 12586107 | 15 | Product used for unknown indication |
| 125861071 | 12586107 | 16 | Product used for unknown indication |
| 125861071 | 12586107 | 17 | Product used for unknown indication |
| 125861071 | 12586107 | 18 | Product used for unknown indication |
| 125861071 | 12586107 | 19 | Product used for unknown indication |
| 125861071 | 12586107 | 20 | Product used for unknown indication |
| 125861071 | 12586107 | 21 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125861071 | 12586107 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 125861071 | 12586107 | 1 | 200904 | 200904 | 0 | |
| 125861071 | 12586107 | 3 | 201601 | 0 | ||
| 125861071 | 12586107 | 4 | 201601 | 0 | ||
| 125861071 | 12586107 | 5 | 201601 | 0 | ||
| 125861071 | 12586107 | 7 | 20160104 | 0 | ||
| 125861071 | 12586107 | 8 | 20151223 | 0 | ||
| 125861071 | 12586107 | 9 | 20151223 | 20151223 | 0 | |
| 125861071 | 12586107 | 10 | 20151223 | 0 | ||
| 125861071 | 12586107 | 11 | 20151223 | 0 | ||
| 125861071 | 12586107 | 12 | 20151223 | 0 | ||
| 125861071 | 12586107 | 13 | 20151223 | 20160104 | 0 | |
| 125861071 | 12586107 | 14 | 20151023 | 20151223 | 0 | |
| 125861071 | 12586107 | 15 | 20151023 | 20151023 | 0 | |
| 125861071 | 12586107 | 16 | 20151023 | 20151223 | 0 | |
| 125861071 | 12586107 | 17 | 20151023 | 20151023 | 0 | |
| 125861071 | 12586107 | 18 | 20151023 | 20151223 | 0 | |
| 125861071 | 12586107 | 19 | 20151023 | 0 | ||
| 125861071 | 12586107 | 20 | 20151023 | 20151025 | 0 | |
| 125861071 | 12586107 | 21 | 20151023 | 0 |