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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123712792 | 12371279 | 2 | F | 2013 | 20160825 | 20160516 | 20160902 | PER | US-JAZZ-2015-US-014172 | JAZZ | 75.00 | YR | F | Y | 85.71000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123712792 | 12371279 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, FIRST DOSE | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 123712792 | 12371279 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, SECOND DOSE | 21196 | 2 | G | ORAL SOLUTION | |||||||
| 123712792 | 12371279 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 123712792 | 12371279 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G, BID | 21196 | 3.25 | G | ORAL SOLUTION | |||||||
| 123712792 | 12371279 | 5 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123712792 | 12371279 | 6 | C | METHOTREXATE. | METHOTREXATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123712792 | 12371279 | 7 | C | METHOTREXATE. | METHOTREXATE | 1 | U | 0 | TABLET | ||||||||||
| 123712792 | 12371279 | 8 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 123712792 | 12371279 | 9 | C | VERELAN | VERAPAMIL HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123712792 | 12371279 | 10 | C | MELOXICAM. | MELOXICAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 123712792 | 12371279 | 11 | C | IRBESARTAN. | IRBESARTAN | 1 | UNK | U | 0 | TABLET | |||||||||
| 123712792 | 12371279 | 12 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 123712792 | 12371279 | 13 | C | HUMIRA | ADALIMUMAB | 1 | UNK | U | 0 | ||||||||||
| 123712792 | 12371279 | 14 | C | HUMIRA | ADALIMUMAB | 1 | U | 0 | |||||||||||
| 123712792 | 12371279 | 15 | C | Hydrocodone | HYDROCODONE | 1 | UNK | U | 0 | ||||||||||
| 123712792 | 12371279 | 16 | C | Atorvastatin | ATORVASTATIN | 1 | UNK | U | 0 | ||||||||||
| 123712792 | 12371279 | 17 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123712792 | 12371279 | 18 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123712792 | 12371279 | 19 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 123712792 | 12371279 | 20 | C | FOLIC ACID. | FOLIC ACID | 1 | UNK | U | 0 | ||||||||||
| 123712792 | 12371279 | 21 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | UNK | U | 0 | ||||||||||
| 123712792 | 12371279 | 22 | C | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | ||||||||||
| 123712792 | 12371279 | 23 | C | VYTORIN | EZETIMIBESIMVASTATIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 123712792 | 12371279 | 24 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123712792 | 12371279 | 1 | Narcolepsy |
| 123712792 | 12371279 | 5 | Diabetes mellitus |
| 123712792 | 12371279 | 6 | Psoriatic arthropathy |
| 123712792 | 12371279 | 7 | Psoriasis |
| 123712792 | 12371279 | 8 | Asthma |
| 123712792 | 12371279 | 9 | Hypertension |
| 123712792 | 12371279 | 10 | Arthralgia |
| 123712792 | 12371279 | 11 | Hypertension |
| 123712792 | 12371279 | 12 | Hypothyroidism |
| 123712792 | 12371279 | 13 | Psoriatic arthropathy |
| 123712792 | 12371279 | 14 | Psoriasis |
| 123712792 | 12371279 | 15 | Pain |
| 123712792 | 12371279 | 16 | Blood cholesterol increased |
| 123712792 | 12371279 | 17 | Hypertension |
| 123712792 | 12371279 | 18 | Gastrooesophageal reflux disease |
| 123712792 | 12371279 | 19 | Product used for unknown indication |
| 123712792 | 12371279 | 20 | Product used for unknown indication |
| 123712792 | 12371279 | 21 | Product used for unknown indication |
| 123712792 | 12371279 | 22 | Product used for unknown indication |
| 123712792 | 12371279 | 23 | Product used for unknown indication |
| 123712792 | 12371279 | 24 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123712792 | 12371279 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123712792 | 12371279 | Urinary tract infection | |
| 123712792 | 12371279 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 123712792 | 12371279 | 1 | 200611 | 2006 | 0 | |
| 123712792 | 12371279 | 2 | 200611 | 2006 | 0 | |
| 123712792 | 12371279 | 4 | 201501 | 0 | ||
| 123712792 | 12371279 | 5 | 20150101 | 0 | ||
| 123712792 | 12371279 | 6 | 20150101 | 0 | ||
| 123712792 | 12371279 | 8 | 20150101 | 0 | ||
| 123712792 | 12371279 | 9 | 20150101 | 0 | ||
| 123712792 | 12371279 | 10 | 20150101 | 0 | ||
| 123712792 | 12371279 | 12 | 20150101 | 0 | ||
| 123712792 | 12371279 | 13 | 20150101 | 0 | ||
| 123712792 | 12371279 | 17 | 20010101 | 0 | ||
| 123712792 | 12371279 | 18 | 20150101 | 0 | ||
| 123712792 | 12371279 | 19 | 20150623 | 0 | ||
| 123712792 | 12371279 | 21 | 20150101 | 0 | ||
| 123712792 | 12371279 | 22 | 20150101 | 0 | ||
| 123712792 | 12371279 | 23 | 20150101 | 20150916 | 0 | |
| 123712792 | 12371279 | 24 | 20131111 | 20150601 | 0 |