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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124944303 | 12494430 | 3 | F | 20160824 | 20160623 | 20160831 | EXP | US-JAZZ-2016-US-011226 | JAZZ | 0.00 | M | Y | 0.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124944303 | 12494430 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, FIRST DOSE | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124944303 | 12494430 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, SECOND DOSE | U | 21196 | 1.5 | G | ORAL SOLUTION | ||||||
| 124944303 | 12494430 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 124944303 | 12494430 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, TID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124944303 | 12494430 | 5 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944303 | 12494430 | 6 | C | LORATADINE. | LORATADINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944303 | 12494430 | 7 | C | Multivitamins | VITAMINS | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944303 | 12494430 | 8 | C | Probiotic | PROBIOTICS NOS | 1 | UNK | U | 0 | ||||||||||
| 124944303 | 12494430 | 9 | C | Digestive enzymes | UNSPECIFIED INGREDIENT | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124944303 | 12494430 | 10 | C | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944303 | 12494430 | 11 | C | Amitriptyline hcl | AMITRIPTYLINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944303 | 12494430 | 12 | C | BEPREVE | BEPOTASTINE BESILATE | 1 | UNK | U | 0 | EYE DROPS | |||||||||
| 124944303 | 12494430 | 13 | C | ELMIRON | PENTOSAN POLYSULFATE SODIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124944303 | 12494430 | 14 | C | NEURONTIN | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124944303 | 12494430 | 15 | C | OMNARIS | CICLESONIDE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 124944303 | 12494430 | 16 | C | PENTASA | MESALAMINE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124944303 | 12494430 | 17 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | U | 0 | INHALER | ||||||||||
| 124944303 | 12494430 | 18 | C | TYLENOL | ACETAMINOPHEN | 1 | U | 0 | |||||||||||
| 124944303 | 12494430 | 19 | C | XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124944303 | 12494430 | 1 | Narcolepsy |
| 124944303 | 12494430 | 5 | Product used for unknown indication |
| 124944303 | 12494430 | 6 | Product used for unknown indication |
| 124944303 | 12494430 | 7 | Product used for unknown indication |
| 124944303 | 12494430 | 8 | Product used for unknown indication |
| 124944303 | 12494430 | 9 | Product used for unknown indication |
| 124944303 | 12494430 | 10 | Product used for unknown indication |
| 124944303 | 12494430 | 11 | Product used for unknown indication |
| 124944303 | 12494430 | 12 | Product used for unknown indication |
| 124944303 | 12494430 | 13 | Product used for unknown indication |
| 124944303 | 12494430 | 14 | Product used for unknown indication |
| 124944303 | 12494430 | 15 | Product used for unknown indication |
| 124944303 | 12494430 | 16 | Product used for unknown indication |
| 124944303 | 12494430 | 17 | Product used for unknown indication |
| 124944303 | 12494430 | 18 | Product used for unknown indication |
| 124944303 | 12494430 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124944303 | 12494430 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124944303 | 12494430 | Barrett's oesophagus | |
| 124944303 | 12494430 | Device issue | |
| 124944303 | 12494430 | Headache | |
| 124944303 | 12494430 | Sleep apnoea syndrome |
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 |
|---|---|---|---|---|---|---|
| 124944303 | 12494430 | 1 | 201104 | 201106 | 0 | |
| 124944303 | 12494430 | 2 | 201104 | 201106 | 0 | |
| 124944303 | 12494430 | 3 | 201106 | 201507 | 0 | |
| 124944303 | 12494430 | 4 | 201507 | 0 | ||
| 124944303 | 12494430 | 5 | 201606 | 0 | ||
| 124944303 | 12494430 | 6 | 201401 | 0 | ||
| 124944303 | 12494430 | 7 | 201401 | 0 | ||
| 124944303 | 12494430 | 8 | 201401 | 0 | ||
| 124944303 | 12494430 | 9 | 201301 | 0 | ||
| 124944303 | 12494430 | 10 | 20120702 | 201606 | 0 | |
| 124944303 | 12494430 | 11 | 201606 | 0 | ||
| 124944303 | 12494430 | 12 | 201606 | 0 | ||
| 124944303 | 12494430 | 13 | 201412 | 0 | ||
| 124944303 | 12494430 | 14 | 201412 | 0 | ||
| 124944303 | 12494430 | 15 | 201606 | 0 | ||
| 124944303 | 12494430 | 16 | 201606 | 0 | ||
| 124944303 | 12494430 | 19 | 201606 | 0 |