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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127474981 | 12747498 | 1 | I | 20140103 | 20160915 | 20160915 | PER | US-JAZZ-2014-US-000090 | JAZZ | 0.00 | F | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127474981 | 12747498 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 3081801 | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127474981 | 12747498 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127474981 | 12747498 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 3113962 | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 127474981 | 12747498 | 4 | SS | FENTANYL. | FENTANYL | 1 | UNK | Y | 0 | PATCH | |||||||||
| 127474981 | 12747498 | 5 | SS | Hydrocodone | HYDROCODONE | 1 | Y | 0 | |||||||||||
| 127474981 | 12747498 | 6 | C | Oxycodone hcl cr | 2 | UNK | U | 0 | TABLET | ||||||||||
| 127474981 | 12747498 | 7 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127474981 | 12747498 | 8 | C | ALPRAZOLAM ER | ALPRAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127474981 | 12747498 | 9 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127474981 | 12747498 | 10 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | U | 0 | CAPSULE | ||||||||||
| 127474981 | 12747498 | 11 | C | DOXYCYCLINE HYCLATE. | DOXYCYCLINE HYCLATE | 1 | U | 0 | CAPSULE | ||||||||||
| 127474981 | 12747498 | 12 | C | FOLIC ACID. | FOLIC ACID | 1 | U | 0 | TABLET | ||||||||||
| 127474981 | 12747498 | 13 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127474981 | 12747498 | 14 | C | METHOTREXATE. | METHOTREXATE | 1 | U | 0 | TABLET | ||||||||||
| 127474981 | 12747498 | 15 | C | OMEPRAZOLE DR | OMEPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127474981 | 12747498 | 16 | C | Oxybutynin | OXYBUTYNIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 127474981 | 12747498 | 17 | C | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127474981 | 12747498 | 18 | C | REMICADE | INFLIXIMAB | 1 | UNK | U | 0 | ||||||||||
| 127474981 | 12747498 | 19 | C | SOMA | CARISOPRODOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127474981 | 12747498 | 20 | C | TRIAZOLAM. | TRIAZOLAM | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127474981 | 12747498 | 1 | Apnoea |
| 127474981 | 12747498 | 2 | Narcolepsy |
| 127474981 | 12747498 | 4 | Product used for unknown indication |
| 127474981 | 12747498 | 5 | Product used for unknown indication |
| 127474981 | 12747498 | 6 | Product used for unknown indication |
| 127474981 | 12747498 | 7 | Product used for unknown indication |
| 127474981 | 12747498 | 8 | Product used for unknown indication |
| 127474981 | 12747498 | 9 | Product used for unknown indication |
| 127474981 | 12747498 | 10 | Product used for unknown indication |
| 127474981 | 12747498 | 11 | Product used for unknown indication |
| 127474981 | 12747498 | 12 | Product used for unknown indication |
| 127474981 | 12747498 | 13 | Product used for unknown indication |
| 127474981 | 12747498 | 14 | Product used for unknown indication |
| 127474981 | 12747498 | 15 | Product used for unknown indication |
| 127474981 | 12747498 | 16 | Product used for unknown indication |
| 127474981 | 12747498 | 17 | Product used for unknown indication |
| 127474981 | 12747498 | 18 | Product used for unknown indication |
| 127474981 | 12747498 | 19 | Product used for unknown indication |
| 127474981 | 12747498 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127474981 | 12747498 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127474981 | 12747498 | Activities of daily living impaired | |
| 127474981 | 12747498 | Anxiety | |
| 127474981 | 12747498 | Asthenia | |
| 127474981 | 12747498 | Depression | |
| 127474981 | 12747498 | Pain |
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 |
|---|---|---|---|---|---|---|
| 127474981 | 12747498 | 1 | 201011 | 201012 | 0 | |
| 127474981 | 12747498 | 3 | 201306 | 0 | ||
| 127474981 | 12747498 | 4 | 20131118 | 20140103 | 0 | |
| 127474981 | 12747498 | 6 | 20131231 | 201605 | 0 | |
| 127474981 | 12747498 | 7 | 20121204 | 0 | ||
| 127474981 | 12747498 | 8 | 201601 | 0 | ||
| 127474981 | 12747498 | 9 | 201605 | 0 | ||
| 127474981 | 12747498 | 13 | 201505 | 0 | ||
| 127474981 | 12747498 | 15 | 201405 | 0 | ||
| 127474981 | 12747498 | 16 | 201305 | 0 | ||
| 127474981 | 12747498 | 19 | 201605 | 0 | ||
| 127474981 | 12747498 | 20 | 201605 | 0 |