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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6840109 | 7840731 | F | 1 | 6840109-6 | 20100616 | 20100709 | EXP | AUR-APL-2010-00452 | AUROBINDO PHARMA USA | 69 | YR | F | N | 20100708 | CN | UNITED STATES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 6840109 | 1014122231 | PS | HYDROCHLOROTHIAZIDE | 1 | ORAL | 12.5MG - DAILY - ORAL | D | D | 078164 | ||
| 6840109 | 1014221286 | SS | BENICAR | 1 | ORAL | 20-40MG - DAILY - ORAL | D | D | |||
| 6840109 | 1014221287 | SS | BENICAR HCT | 1 | ORAL | 40/12.5MG - DAILY - ORAL | D | D | |||
| 6840109 | 1014221288 | C | INSULIN | 1 | |||||||
| 6840109 | 1014221289 | C | ASPIRIN | 1 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 6840109 | 1014122231 | HYPERTENSION |
| 6840109 | 1014221286 | HYPERTENSION |
| 6840109 | 1014221287 | HYPERTENSION |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 6840109 | HO |
| 6840109 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 6840109 | ABDOMINAL PAIN UPPER |
| 6840109 | CAROTID ARTERY OCCLUSION |
| 6840109 | DIARRHOEA |
| 6840109 | HEART RATE DECREASED |
| 6840109 | HYPERSENSITIVITY |
| 6840109 | HYPERTENSION |
| 6840109 | HYPOTENSION |
| 6840109 | TRANSIENT ISCHAEMIC ATTACK |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 6840109 | CSM |
| 6840109 | OTH |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 6840109 | 1014122231 | 20050101 | |||
| 6840109 | 1014221286 | 20050101 | |||
| 6840109 | 1014221287 | 20020101 | 20050101 |