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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125946292 | 12594629 | 2 | F | 20160729 | 20160726 | 20160803 | EXP | US-JAZZ-2016-US-013530 | JAZZ | 0.00 | F | Y | 0.00000 | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125946292 | 12594629 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 125946292 | 12594629 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 125946292 | 12594629 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, FIRST DOSE | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 125946292 | 12594629 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G, SECOND DOSE | U | 21196 | 3.25 | G | ORAL SOLUTION | ||||||
| 125946292 | 12594629 | 5 | SS | KLONOPIN | CLONAZEPAM | 1 | 1 MG | 0 | 1 | MG | TABLET | ||||||||
| 125946292 | 12594629 | 6 | SS | KLONOPIN | CLONAZEPAM | 1 | 0.25 MG | 0 | .25 | MG | TABLET | ||||||||
| 125946292 | 12594629 | 7 | SS | KLONOPIN | CLONAZEPAM | 1 | 0.5 MG | 0 | .5 | MG | TABLET | ||||||||
| 125946292 | 12594629 | 8 | C | Rabeprazole sodium dr | RABEPRAZOLE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125946292 | 12594629 | 9 | C | Propranolol er | 2 | UNK | U | 0 | CAPSULE | ||||||||||
| 125946292 | 12594629 | 10 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125946292 | 12594629 | 11 | C | Albuterol sulfate hfa | 2 | UNK | U | 0 | INHALER | ||||||||||
| 125946292 | 12594629 | 12 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | U | 0 | TABLET | ||||||||||
| 125946292 | 12594629 | 13 | C | LUNESTA | ESZOPICLONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125946292 | 12594629 | 14 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125946292 | 12594629 | 1 | Insomnia |
| 125946292 | 12594629 | 5 | Sleep disorder |
| 125946292 | 12594629 | 8 | Product used for unknown indication |
| 125946292 | 12594629 | 9 | Product used for unknown indication |
| 125946292 | 12594629 | 10 | Product used for unknown indication |
| 125946292 | 12594629 | 11 | Product used for unknown indication |
| 125946292 | 12594629 | 12 | Product used for unknown indication |
| 125946292 | 12594629 | 13 | Product used for unknown indication |
| 125946292 | 12594629 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125946292 | 12594629 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125946292 | 12594629 | Drug ineffective for unapproved indication | |
| 125946292 | 12594629 | Drug withdrawal syndrome | |
| 125946292 | 12594629 | Gastrooesophageal reflux disease | |
| 125946292 | 12594629 | Pharyngeal disorder | |
| 125946292 | 12594629 | Pre-existing condition improved | |
| 125946292 | 12594629 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 125946292 | 12594629 | 1 | 201205 | 201206 | 0 | |
| 125946292 | 12594629 | 2 | 201206 | 201606 | 0 | |
| 125946292 | 12594629 | 3 | 201606 | 0 | ||
| 125946292 | 12594629 | 4 | 201606 | 0 | ||
| 125946292 | 12594629 | 8 | 201601 | 0 | ||
| 125946292 | 12594629 | 9 | 201510 | 0 | ||
| 125946292 | 12594629 | 10 | 20140905 | 20140919 | 0 | |
| 125946292 | 12594629 | 11 | 201107 | 0 | ||
| 125946292 | 12594629 | 13 | 201205 | 0 | ||
| 125946292 | 12594629 | 14 | 201606 | 0 |