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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126630243 | 12663024 | 3 | F | 20160908 | 20160818 | 20160922 | EXP | NL-AUROBINDO-AUR-APL-2016-10483 | AUROBINDO | 43.00 | YR | M | Y | 0.00000 | 20160922 | OT | NL | NL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126630243 | 12663024 | 1 | SS | OXAZEPAM. | OXAZEPAM | 1 | Oral | 1.1 G, UNK | D | U | 0 | 1.1 | G | ||||||
| 126630243 | 12663024 | 2 | SS | OXAZEPAM. | OXAZEPAM | 1 | Unknown | 1.1 UNK, UNK | D | U | 0 | ||||||||
| 126630243 | 12663024 | 3 | PS | QUETIAPINE. | QUETIAPINE | 1 | Oral | 13 G, UNK | D | U | 91388 | 13 | G | ||||||
| 126630243 | 12663024 | 4 | SS | QUETIAPINE. | QUETIAPINE | 1 | Unknown | 13 UNK, UNK | D | U | 91388 | ||||||||
| 126630243 | 12663024 | 5 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Oral | D | U | 0 | TABLET | ||||||||
| 126630243 | 12663024 | 6 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Oral | D | U | 0 | 45 | G | TABLET | ||||||
| 126630243 | 12663024 | 7 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Oral | D | U | 0 | 45 | G | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126630243 | 12663024 | 1 | Product used for unknown indication |
| 126630243 | 12663024 | 3 | Product used for unknown indication |
| 126630243 | 12663024 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126630243 | 12663024 | OT |
| 126630243 | 12663024 | LT |
| 126630243 | 12663024 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126630243 | 12663024 | Blood creatine phosphokinase increased | |
| 126630243 | 12663024 | Coma | |
| 126630243 | 12663024 | Electrocardiogram QT prolonged | |
| 126630243 | 12663024 | Haemodynamic instability | |
| 126630243 | 12663024 | Hepatic function abnormal | |
| 126630243 | 12663024 | Hyperammonaemia | |
| 126630243 | 12663024 | Intentional overdose | |
| 126630243 | 12663024 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |