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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127590251 | 12759025 | 1 | I | 20151208 | 20160919 | 20160919 | PER | US-BAUSCH-BL-2015-029854 | BAUSCH AND LOMB | 0.00 | F | Y | 0.00000 | 20160919 | OT | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127590251 | 12759025 | 1 | PS | DIAZEPAM. | DIAZEPAM | 1 | Unknown | D | 20648 | RECTAL GEL | |||||||||
127590251 | 12759025 | 2 | SS | DIAZEPAM. | DIAZEPAM | 1 | D | 20648 | |||||||||||
127590251 | 12759025 | 3 | SS | DIASTAT | DIAZEPAM | 1 | Unknown | 0 | |||||||||||
127590251 | 12759025 | 4 | SS | DIASTAT | DIAZEPAM | 1 | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127590251 | 12759025 | 1 | Severe myoclonic epilepsy of infancy |
127590251 | 12759025 | 2 | Epilepsy |
127590251 | 12759025 | 3 | Severe myoclonic epilepsy of infancy |
127590251 | 12759025 | 4 | Epilepsy |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127590251 | 12759025 | Drug ineffective | |
127590251 | 12759025 | Product formulation issue |
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 |
---|---|---|---|---|---|---|
127590251 | 12759025 | 3 | 201506 | 0 |