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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127686511 | 12768651 | 1 | I | 201605 | 20160530 | 20160921 | 20160921 | PER | US-JAZZ-2016-US-010064 | JAZZ | 38.92 | YR | F | Y | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127686511 | 12768651 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127686511 | 12768651 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127686511 | 12768651 | 3 | SS | ROCEPHIN | CEFTRIAXONE SODIUM | 1 | U | 0 | |||||||||||
| 127686511 | 12768651 | 4 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | U | 0 | |||||||||||
| 127686511 | 12768651 | 5 | C | Alosetron hcl | ALOSETRON HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127686511 | 12768651 | 6 | C | DICYCLOMINE | DICYCLOMINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127686511 | 12768651 | 7 | C | Diphenoxylate/atropine | ATROPINEDIPHENOXYLATE | 1 | U | 0 | |||||||||||
| 127686511 | 12768651 | 8 | C | EXCEDRIN EXTRA STRENGTH | ACETAMINOPHENASPIRINCAFFEINE | 1 | U | 0 | |||||||||||
| 127686511 | 12768651 | 9 | C | Multivitamins | VITAMINS | 1 | U | 0 | |||||||||||
| 127686511 | 12768651 | 10 | C | NUVIGIL | ARMODAFINIL | 1 | U | 0 | |||||||||||
| 127686511 | 12768651 | 11 | C | TYLENOL | ACETAMINOPHEN | 1 | U | 0 | |||||||||||
| 127686511 | 12768651 | 12 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127686511 | 12768651 | 13 | C | Alka Seltzer Plus Cold +Cough Formula | 2 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127686511 | 12768651 | 1 | Narcolepsy |
| 127686511 | 12768651 | 2 | Cataplexy |
| 127686511 | 12768651 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127686511 | 12768651 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127686511 | 12768651 | Ear infection | |
| 127686511 | 12768651 | Feeling abnormal | |
| 127686511 | 12768651 | Insomnia | |
| 127686511 | 12768651 | Nasopharyngitis | |
| 127686511 | 12768651 | Pulmonary congestion | |
| 127686511 | 12768651 | Sinusitis | |
| 127686511 | 12768651 | Syncope | |
| 127686511 | 12768651 | Upper respiratory tract infection |
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 |
|---|---|---|---|---|---|---|
| 127686511 | 12768651 | 1 | 201605 | 201605 | 0 | |
| 127686511 | 12768651 | 2 | 201605 | 0 |