Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4431339 | 4197031 | I | 4431339-1 | 20040604 | 20040802 | 20040818 | EXP | DSA_24585_2004 | BIOVAIL PHARMACEUTICALS INC. | 74 | YR | M | N | 171 | LBS | 20040817 | OT |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 4431339 | 1005138175 | PS | CARDIZEM | 1 | DF | Y | D | 18602 | |||
| 4431339 | 1005147581 | SS | DILTIAZEM | 1 | ORAL | 30 MG BID PO | Y | D | |||
| 4431339 | 1005147583 | SS | DILTIAZEM (PUREPAK BAND) | 2 | 120 MG Q DAY | D | D | PUREPAK | |||
| 4431339 | 1005147584 | C | LASIX | 1 | |||||||
| 4431339 | 1005147585 | C | LEXAPRO | 1 | |||||||
| 4431339 | 1005147590 | C | PROTONIX | 1 | |||||||
| 4431339 | 1005147591 | C | DIGITEK | 2 | |||||||
| 4431339 | 1005147592 | C | COUMADIN | 1 | |||||||
| 4431339 | 1005147593 | C | ENALARPIL | 2 | |||||||
| 4431339 | 1005147595 | C | GLIPIZIDE | 1 | |||||||
| 4431339 | 1005147596 | C | ADVAIR DISKUS 100/50 | 1 | |||||||
| 4431339 | 1005147598 | C | IRON | 2 | |||||||
| 4431339 | 1005147599 | C | COLCHICINE | 2 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 4431339 | 1005147581 | BLOOD PRESSURE |
| 4431339 | 1005147583 | HYPERTENSION |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 4431339 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 4431339 | BLOOD POTASSIUM DECREASED |
| 4431339 | BRADYCARDIA |
| 4431339 | CARDIAC FAILURE CONGESTIVE |
| 4431339 | CONDITION AGGRAVATED |
| 4431339 | TOOTH DISCOLOURATION |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 4431339 | HP |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 4431339 | 1005138175 | 20040701 | |||
| 4431339 | 1005147581 | 20040601 | 20040701 | ||
| 4431339 | 1005147583 | 20030730 | 20040501 |