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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125483152 | 12548315 | 2 | F | 20160715 | 20160712 | 20160728 | EXP | US-AUROBINDO-AUR-APL-2016-08209 | AUROBINDO | 58.00 | YR | M | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125483152 | 12548315 | 1 | PS | METHADONE | METHADONE HYDROCHLORIDE | 1 | Oral | 80 MG, UNK | U | U | 203502 | 80 | MG | ||||||
| 125483152 | 12548315 | 2 | SS | ONDANSETRON | ONDANSETRON | 1 | Intravenous (not otherwise specified) | 4 MG, UNK | U | U | 0 | 4 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125483152 | 12548315 | 1 | Product used for unknown indication |
| 125483152 | 12548315 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125483152 | 12548315 | HO |
| 125483152 | 12548315 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125483152 | 12548315 | Hyperhidrosis | |
| 125483152 | 12548315 | Malaise | |
| 125483152 | 12548315 | Nausea | |
| 125483152 | 12548315 | Torsade de pointes | |
| 125483152 | 12548315 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |