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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121604282 | 12160428 | 2 | F | 20160131 | 20160304 | 20160308 | 20160909 | PER | US-APOTEX-2016AP006300 | APOTEX | 0.00 | F | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121604282 | 12160428 | 1 | PS | DILTIAZEM HYDROCHLORIDE. | DILTIAZEM HYDROCHLORIDE | 1 | Oral | 240 MG, UNKNOWN | 74943 | 240 | MG | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121604282 | 12160428 | 1 | Hypertension |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121604282 | 12160428 | Condition aggravated | |
| 121604282 | 12160428 | Drug ineffective | |
| 121604282 | 12160428 | Joint swelling | |
| 121604282 | 12160428 | Peripheral swelling | |
| 121604282 | 12160428 | Product substitution 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 |
|---|---|---|---|---|---|---|
| 121604282 | 12160428 | 1 | 20160131 | 0 |