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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118834362 | 11883436 | 2 | F | 2015 | 20160729 | 20151231 | 20160808 | EXP | US-JAZZ-2015-US-022597 | JAZZ | 0.00 | M | Y | 105.00000 | KG | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118834362 | 11883436 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 118834362 | 11883436 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 118834362 | 11883436 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 118834362 | 11883436 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 118834362 | 11883436 | 5 | C | DIAZEPAM. | DIAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 118834362 | 11883436 | 6 | C | LEVOXYL | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 118834362 | 11883436 | 7 | C | NIASPAN | NIACIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 118834362 | 11883436 | 8 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118834362 | 11883436 | 9 | C | PROVIGIL | MODAFINIL | 1 | UNK UNK, QD | U | 0 | TABLET | |||||||||
| 118834362 | 11883436 | 10 | C | TEKTURNA | ALISKIREN HEMIFUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118834362 | 11883436 | 11 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 118834362 | 11883436 | 12 | C | LASIX | FUROSEMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118834362 | 11883436 | 13 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | UNK | U | 0 | POWDER | |||||||||
| 118834362 | 11883436 | 14 | C | NORVASC | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118834362 | 11883436 | 15 | C | Omega 3 | OMEGA-3 FATTY ACIDS | 1 | UNK UNK, QD | U | 0 | ||||||||||
| 118834362 | 11883436 | 16 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 2000 U | U | 0 | ||||||||||
| 118834362 | 11883436 | 17 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 5000 U | U | 0 | ||||||||||
| 118834362 | 11883436 | 18 | C | LOTREL | AMLODIPINE BESYLATEBENAZEPRIL HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 118834362 | 11883436 | 19 | C | VALIUM | DIAZEPAM | 1 | UNK | U | 0 | ||||||||||
| 118834362 | 11883436 | 20 | C | VALIUM | DIAZEPAM | 1 | U | 0 | |||||||||||
| 118834362 | 11883436 | 21 | C | FAMOTIDINE. | FAMOTIDINE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118834362 | 11883436 | 1 | Narcolepsy |
| 118834362 | 11883436 | 5 | Product used for unknown indication |
| 118834362 | 11883436 | 6 | Product used for unknown indication |
| 118834362 | 11883436 | 7 | Product used for unknown indication |
| 118834362 | 11883436 | 8 | Polycythaemia |
| 118834362 | 11883436 | 9 | Narcolepsy |
| 118834362 | 11883436 | 10 | Product used for unknown indication |
| 118834362 | 11883436 | 11 | Prostatic disorder |
| 118834362 | 11883436 | 12 | Product used for unknown indication |
| 118834362 | 11883436 | 13 | Functional gastrointestinal disorder |
| 118834362 | 11883436 | 14 | Blood pressure measurement |
| 118834362 | 11883436 | 15 | Product used for unknown indication |
| 118834362 | 11883436 | 16 | Product used for unknown indication |
| 118834362 | 11883436 | 18 | Blood pressure measurement |
| 118834362 | 11883436 | 19 | Depression |
| 118834362 | 11883436 | 20 | Anxiety |
| 118834362 | 11883436 | 21 | Gastrointestinal disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118834362 | 11883436 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118834362 | 11883436 | Arthralgia | |
| 118834362 | 11883436 | Fall | |
| 118834362 | 11883436 | Musculoskeletal pain | |
| 118834362 | 11883436 | Neoplasm malignant | |
| 118834362 | 11883436 | Non-alcoholic fatty liver |
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 |
|---|---|---|---|---|---|---|
| 118834362 | 11883436 | 1 | 201008 | 201009 | 0 | |
| 118834362 | 11883436 | 3 | 201211 | 201512 | 0 | |
| 118834362 | 11883436 | 5 | 20120913 | 0 | ||
| 118834362 | 11883436 | 11 | 20151228 | 0 | ||
| 118834362 | 11883436 | 12 | 20151228 | 0 | ||
| 118834362 | 11883436 | 13 | 20151228 | 0 | ||
| 118834362 | 11883436 | 14 | 20151228 | 0 | ||
| 118834362 | 11883436 | 15 | 20151228 | 0 | ||
| 118834362 | 11883436 | 16 | 20151228 | 0 |