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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115501542 | 11550154 | 2 | F | 20160823 | 20150924 | 20160831 | EXP | US-JAZZ-2013-US-001777 | JAZZ | 0.00 | F | Y | 103.86000 | KG | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115501542 | 11550154 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, SECOND DOSE | Y | 21196 | 2 | G | ORAL SOLUTION | ||||||
| 115501542 | 11550154 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 115501542 | 11550154 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | Y | 21196 | 3.5 | G | ORAL SOLUTION | ||||||
| 115501542 | 11550154 | 4 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 115501542 | 11550154 | 5 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | UNK | U | 0 | ||||||||||
| 115501542 | 11550154 | 6 | C | MELOXICAM. | MELOXICAM | 1 | UNK | U | 0 | ||||||||||
| 115501542 | 11550154 | 7 | C | Baby aspirin | ASPIRIN | 1 | UNK | U | 0 | ||||||||||
| 115501542 | 11550154 | 8 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | U | 0 | ||||||||||
| 115501542 | 11550154 | 9 | C | Hydrocodone | HYDROCODONE | 1 | UNK | U | 0 | ||||||||||
| 115501542 | 11550154 | 10 | C | Atorvastatin | ATORVASTATIN | 1 | UNK | U | 0 | ||||||||||
| 115501542 | 11550154 | 11 | C | FOLIC ACID. | FOLIC ACID | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115501542 | 11550154 | 1 | Narcolepsy |
| 115501542 | 11550154 | 4 | Diabetes mellitus |
| 115501542 | 11550154 | 5 | Asthma |
| 115501542 | 11550154 | 6 | Arthralgia |
| 115501542 | 11550154 | 7 | Product used for unknown indication |
| 115501542 | 11550154 | 8 | Hypothyroidism |
| 115501542 | 11550154 | 9 | Pain |
| 115501542 | 11550154 | 10 | Blood cholesterol increased |
| 115501542 | 11550154 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115501542 | 11550154 | HO |
| 115501542 | 11550154 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115501542 | 11550154 | Blood pressure increased | |
| 115501542 | 11550154 | Drug ineffective | |
| 115501542 | 11550154 | Fatigue | |
| 115501542 | 11550154 | Fibromyalgia | |
| 115501542 | 11550154 | Intervertebral disc protrusion | |
| 115501542 | 11550154 | Lumbar spinal stenosis | |
| 115501542 | 11550154 | Paraesthesia | |
| 115501542 | 11550154 | Pre-existing condition improved | |
| 115501542 | 11550154 | Psoriasis | |
| 115501542 | 11550154 | Psoriatic arthropathy |
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 |
|---|---|---|---|---|---|---|
| 115501542 | 11550154 | 1 | 20061130 | 200701 | 0 | |
| 115501542 | 11550154 | 3 | 201501 | 0 |