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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127090931 | 12709093 | 1 | I | 20160502 | 20160502 | 20160901 | 20160901 | PER | US-JAZZ-2016-US-008290 | JAZZ | 66.58 | YR | F | Y | 69.00000 | KG | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127090931 | 12709093 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127090931 | 12709093 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, BID | Y | 21196 | 2.5 | G | ORAL SOLUTION | ||||||
| 127090931 | 12709093 | 3 | SS | TOPAMAX | TOPIRAMATE | 1 | U | 0 | TABLET | ||||||||||
| 127090931 | 12709093 | 4 | SS | TOPAMAX | TOPIRAMATE | 1 | U | 0 | TABLET | ||||||||||
| 127090931 | 12709093 | 5 | C | PROVIGIL | MODAFINIL | 1 | U | 0 | TABLET | ||||||||||
| 127090931 | 12709093 | 6 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 127090931 | 12709093 | 7 | C | DIOVAN | VALSARTAN | 1 | UNK | U | 0 | TABLET | |||||||||
| 127090931 | 12709093 | 8 | C | VITAMIN C | ASCORBIC ACID | 1 | U | 0 | TABLET | ||||||||||
| 127090931 | 12709093 | 9 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 127090931 | 12709093 | 10 | C | Fish oil | FISH OIL | 1 | U | 0 | |||||||||||
| 127090931 | 12709093 | 11 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | U | 0 | TABLET | ||||||||||
| 127090931 | 12709093 | 12 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | U | 0 | TABLET | ||||||||||
| 127090931 | 12709093 | 13 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127090931 | 12709093 | 14 | C | ADVIL | IBUPROFEN | 1 | U | 0 | TABLET | ||||||||||
| 127090931 | 12709093 | 15 | C | ALPHA LIPOIC ACID | .ALPHA.-LIPOIC ACID | 1 | U | 0 | CAPSULE | ||||||||||
| 127090931 | 12709093 | 16 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | U | 0 | SPRAY | ||||||||||
| 127090931 | 12709093 | 17 | C | KEFLEX | CEPHALEXIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127090931 | 12709093 | 18 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | U | 0 | TABLET | ||||||||||
| 127090931 | 12709093 | 19 | C | MEDROL | METHYLPREDNISOLONE | 1 | UNK | U | 0 | ||||||||||
| 127090931 | 12709093 | 20 | C | Multivitamin | VITAMINS | 1 | U | 0 | TABLET | ||||||||||
| 127090931 | 12709093 | 21 | C | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127090931 | 12709093 | 22 | C | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | U | 0 | CAPSULE | ||||||||||
| 127090931 | 12709093 | 23 | C | Probiotic | PROBIOTICS NOS | 1 | U | 0 | CAPSULE | ||||||||||
| 127090931 | 12709093 | 24 | C | VICODIN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | U | 0 | TABLET | ||||||||||
| 127090931 | 12709093 | 25 | C | WELCHOL | COLESEVELAM HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127090931 | 12709093 | 26 | C | ZANAFLEX | TIZANIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127090931 | 12709093 | 27 | C | ZOCOR | SIMVASTATIN | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127090931 | 12709093 | 1 | Narcolepsy |
| 127090931 | 12709093 | 2 | Somnolence |
| 127090931 | 12709093 | 3 | Pain |
| 127090931 | 12709093 | 4 | Migraine |
| 127090931 | 12709093 | 5 | Narcolepsy |
| 127090931 | 12709093 | 6 | Narcolepsy |
| 127090931 | 12709093 | 7 | Hypertension |
| 127090931 | 12709093 | 8 | Product used for unknown indication |
| 127090931 | 12709093 | 9 | Product used for unknown indication |
| 127090931 | 12709093 | 10 | Product used for unknown indication |
| 127090931 | 12709093 | 11 | Deep vein thrombosis |
| 127090931 | 12709093 | 12 | Pulmonary embolism |
| 127090931 | 12709093 | 13 | Product used for unknown indication |
| 127090931 | 12709093 | 14 | Product used for unknown indication |
| 127090931 | 12709093 | 15 | Product used for unknown indication |
| 127090931 | 12709093 | 16 | Product used for unknown indication |
| 127090931 | 12709093 | 17 | Product used for unknown indication |
| 127090931 | 12709093 | 18 | Product used for unknown indication |
| 127090931 | 12709093 | 19 | Product used for unknown indication |
| 127090931 | 12709093 | 20 | Product used for unknown indication |
| 127090931 | 12709093 | 21 | Deep vein thrombosis |
| 127090931 | 12709093 | 22 | Pulmonary embolism |
| 127090931 | 12709093 | 23 | Product used for unknown indication |
| 127090931 | 12709093 | 24 | Product used for unknown indication |
| 127090931 | 12709093 | 25 | Product used for unknown indication |
| 127090931 | 12709093 | 26 | Product used for unknown indication |
| 127090931 | 12709093 | 27 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127090931 | 12709093 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127090931 | 12709093 | Dizziness | |
| 127090931 | 12709093 | Drug interaction | |
| 127090931 | 12709093 | Hypertension | |
| 127090931 | 12709093 | Hypoaesthesia oral | |
| 127090931 | 12709093 | Paraesthesia oral |
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 |
|---|---|---|---|---|---|---|
| 127090931 | 12709093 | 1 | 20160428 | 2016 | 0 | |
| 127090931 | 12709093 | 2 | 2016 | 20160505 | 0 | |
| 127090931 | 12709093 | 7 | 201404 | 0 | ||
| 127090931 | 12709093 | 13 | 200001 | 0 | ||
| 127090931 | 12709093 | 17 | 201504 | 0 | ||
| 127090931 | 12709093 | 19 | 201504 | 0 | ||
| 127090931 | 12709093 | 21 | 201604 | 0 | ||
| 127090931 | 12709093 | 26 | 201501 | 0 | ||
| 127090931 | 12709093 | 27 | 201601 | 0 |