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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127079781 | 12707978 | 1 | I | 20160729 | 20160825 | 20160901 | 20160901 | EXP | US-INDIVIOR LIMITED-INDV-094401-2016 | INDIVIOR | 47.28 | YR | F | Y | 0.00000 | 20160901 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127079781 | 12707978 | 1 | PS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Sublingual | 8MG ON DAY 1 | UNKNOWN | 22410 | |||||||||
| 127079781 | 12707978 | 2 | SS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Sublingual | 16 MG ON DAY 2 | UNKNOWN | 22410 | |||||||||
| 127079781 | 12707978 | 3 | SS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Sublingual | UNK DOSE ON DAY 3 | UNKNOWN | 22410 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127079781 | 12707978 | 1 | Drug dependence |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127079781 | 12707978 | OT |
| 127079781 | 12707978 | LT |
| 127079781 | 12707978 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127079781 | 12707978 | Brain oedema | |
| 127079781 | 12707978 | Confusional state | |
| 127079781 | 12707978 | Lethargy | |
| 127079781 | 12707978 | Myoclonus | |
| 127079781 | 12707978 | Respiratory failure | |
| 127079781 | 12707978 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 127079781 | 12707978 | 1 | 20160727 | 20160727 | 0 | |
| 127079781 | 12707978 | 2 | 20160728 | 20160728 | 0 | |
| 127079781 | 12707978 | 3 | 20160729 | 20160729 | 0 |