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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126284342 | 12628434 | 2 | F | 20160915 | 20160808 | 20160922 | PER | US-JAZZ-2016-US-003910 | JAZZ | 0.00 | F | Y | 0.00000 | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126284342 | 12628434 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126284342 | 12628434 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 126284342 | 12628434 | 3 | SS | REQUIP | ROPINIROLE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126284342 | 12628434 | 4 | C | NEURONTIN | GABAPENTIN | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 5 | C | BACLOFEN. | BACLOFEN | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 6 | C | METHOCARBAMOL. | METHOCARBAMOL | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 7 | C | VESICARE | SOLIFENACIN SUCCINATE | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 8 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 9 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 10 | C | BETAMETHASONE. | BETAMETHASONE | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 11 | C | CALTRATE WITH VITAMIN D | CALCIUM CARBONATECHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 12 | C | CLARITIN | LORATADINE | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 13 | C | MYRBETRIQ | MIRABEGRON | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 14 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 15 | C | RESTASIS | CYCLOSPORINE | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 16 | C | TYLENOL ARTHRITIS PAIN | ACETAMINOPHEN | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 17 | C | VECTICAL | CALCITRIOL | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 18 | C | CELEBREX | CELECOXIB | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 19 | C | Doxepin | DOXEPIN | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 20 | C | FOLIC ACID. | FOLIC ACID | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 21 | C | LUNESTA | ESZOPICLONE | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 22 | C | MODAFINIL. | MODAFINIL | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 23 | C | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126284342 | 12628434 | 24 | C | REMICADE | INFLIXIMAB | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126284342 | 12628434 | 1 | Somnolence |
| 126284342 | 12628434 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126284342 | 12628434 | Drug ineffective | |
| 126284342 | 12628434 | Pre-existing condition improved | |
| 126284342 | 12628434 | 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 |
|---|---|---|---|---|---|---|
| 126284342 | 12628434 | 1 | 201512 | 201512 | 0 | |
| 126284342 | 12628434 | 2 | 201512 | 0 |