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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126850631 | 12685063 | 1 | I | 201301 | 20160816 | 20160825 | 20160825 | EXP | US-INDIVIOR LIMITED-INDV-093908-2016 | INDIVIOR | 63.00 | YR | F | Y | 0.00000 | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126850631 | 12685063 | 1 | PS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Sublingual | UNK FOR ABOUT 11 MONTHS | Y | UNKNOWN | 22410 | ||||||||
| 126850631 | 12685063 | 2 | SS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Sublingual | 16 MG DAILY | Y | UNKNOWN | 0 | ||||||||
| 126850631 | 12685063 | 3 | SS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Sublingual | 8MG DAILY BUT OCCASIONALLY TOOK MORE THAN PRESCRIBED | Y | UNKNOWN | 0 | ||||||||
| 126850631 | 12685063 | 4 | SS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Sublingual | 12 MG, QD | UNKNOWN | 0 | 12 | MG | QD | ||||||
| 126850631 | 12685063 | 5 | SS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Sublingual | TAKING MORE THAN 12 MG DAILY | UNKNOWN | 0 | |||||||||
| 126850631 | 12685063 | 6 | SS | METHADONE | METHADONE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126850631 | 12685063 | 7 | SS | HEROIN | DIACETYLMORPHINE | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126850631 | 12685063 | 1 | Drug dependence |
| 126850631 | 12685063 | 2 | Drug dependence |
| 126850631 | 12685063 | 4 | Drug dependence |
| 126850631 | 12685063 | 6 | Product used for unknown indication |
| 126850631 | 12685063 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126850631 | 12685063 | OT |
| 126850631 | 12685063 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126850631 | 12685063 | Chest pain | |
| 126850631 | 12685063 | Drug abuse | |
| 126850631 | 12685063 | Drug dependence | |
| 126850631 | 12685063 | Drug withdrawal syndrome | |
| 126850631 | 12685063 | Dyspnoea | |
| 126850631 | 12685063 | Dysuria | |
| 126850631 | 12685063 | Intentional product use issue | |
| 126850631 | 12685063 | Myocardial infarction |
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 |
|---|---|---|---|---|---|---|
| 126850631 | 12685063 | 1 | 201301 | 201311 | 0 | |
| 126850631 | 12685063 | 2 | 201603 | 2016 | 0 | |
| 126850631 | 12685063 | 3 | 2016 | 2016 | 0 | |
| 126850631 | 12685063 | 4 | 201608 | 201608 | 0 | |
| 126850631 | 12685063 | 5 | 201608 | 0 |