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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117159255 | 11715925 | 5 | F | 2004 | 20160913 | 20151109 | 20160923 | EXP | US-INDIVIOR-INDV-085086-2015 | INDIVIOR | 59.00 | YR | M | Y | 89.98000 | KG | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117159255 | 11715925 | 1 | PS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Oral | 8MG, DAILY | Y | UNKNOWN | 20733 | TABLET | |||||||
| 117159255 | 11715925 | 2 | SS | CELECOXIB. | CELECOXIB | 1 | Oral | UNK, THREE TIMES DAILY | Y | 0 | |||||||||
| 117159255 | 11715925 | 3 | SS | CELECOXIB. | CELECOXIB | 1 | Y | 0 | |||||||||||
| 117159255 | 11715925 | 4 | SS | IBUPROFEN. | IBUPROFEN | 1 | Oral | UNK, THREE TIMES DAILY | Y | 0 | |||||||||
| 117159255 | 11715925 | 5 | SS | IBUPROFEN. | IBUPROFEN | 1 | Y | 0 | |||||||||||
| 117159255 | 11715925 | 6 | SS | NAPROXEN. | NAPROXEN | 1 | Oral | UNK, THREE TIMES DAILY | Y | 0 | |||||||||
| 117159255 | 11715925 | 7 | SS | NAPROXEN. | NAPROXEN | 1 | Y | 0 | |||||||||||
| 117159255 | 11715925 | 8 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 117159255 | 11715925 | 9 | C | COREG | CARVEDILOL | 1 | Unknown | UNK | 0 | ||||||||||
| 117159255 | 11715925 | 10 | C | ENALAPRIL | ENALAPRIL | 1 | Unknown | UNK | 0 | ||||||||||
| 117159255 | 11715925 | 11 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | UNK | 0 | ||||||||||
| 117159255 | 11715925 | 12 | C | HUMIRA | ADALIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 117159255 | 11715925 | 13 | C | BRINTELLIX | VORTIOXETINE HYDROBROMIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 117159255 | 11715925 | 14 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Unknown | UNK | 0 | ||||||||||
| 117159255 | 11715925 | 15 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | Unknown | UNK | 0 | ||||||||||
| 117159255 | 11715925 | 16 | C | XANAX | ALPRAZOLAM | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117159255 | 11715925 | 1 | Rheumatoid arthritis |
| 117159255 | 11715925 | 2 | Osteoarthritis |
| 117159255 | 11715925 | 3 | Rheumatoid arthritis |
| 117159255 | 11715925 | 4 | Osteoarthritis |
| 117159255 | 11715925 | 5 | Rheumatoid arthritis |
| 117159255 | 11715925 | 6 | Osteoarthritis |
| 117159255 | 11715925 | 7 | Rheumatoid arthritis |
| 117159255 | 11715925 | 8 | Gastrointestinal disorder |
| 117159255 | 11715925 | 9 | Product used for unknown indication |
| 117159255 | 11715925 | 10 | Product used for unknown indication |
| 117159255 | 11715925 | 11 | Product used for unknown indication |
| 117159255 | 11715925 | 12 | Product used for unknown indication |
| 117159255 | 11715925 | 13 | Product used for unknown indication |
| 117159255 | 11715925 | 14 | Product used for unknown indication |
| 117159255 | 11715925 | 15 | Product used for unknown indication |
| 117159255 | 11715925 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117159255 | 11715925 | HO |
| 117159255 | 11715925 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117159255 | 11715925 | Generalised tonic-clonic seizure | |
| 117159255 | 11715925 | Insomnia | |
| 117159255 | 11715925 | Off label use | |
| 117159255 | 11715925 | Seizure |
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 |
|---|---|---|---|---|---|---|
| 117159255 | 11715925 | 1 | 2004 | 20150607 | 0 | |
| 117159255 | 11715925 | 2 | 20120926 | 20160224 | 0 | |
| 117159255 | 11715925 | 4 | 20120926 | 20150607 | 0 | |
| 117159255 | 11715925 | 6 | 20120926 | 20150607 | 0 | |
| 117159255 | 11715925 | 8 | 20120926 | 20150607 | 0 | |
| 117159255 | 11715925 | 9 | 2004 | 0 | ||
| 117159255 | 11715925 | 10 | 2004 | 0 | ||
| 117159255 | 11715925 | 11 | 2004 | 0 | ||
| 117159255 | 11715925 | 12 | 20140724 | 0 | ||
| 117159255 | 11715925 | 13 | 20150401 | 0 | ||
| 117159255 | 11715925 | 14 | 2006 | 0 | ||
| 117159255 | 11715925 | 15 | 2004 | 0 |