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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6768751 | 7255984 | F | 1 | 6768751-1 | 20050614 | 20100527 | 20100611 | EXP | TPA2009A03974 | TAKEDA PHARMACEUTICALS NORTH AMERICA | 81 | YR | M | N | 200 | LBS | 20100610 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 6768751 | 1013862901 | PS | ACTOS | 1 | ORAL | 15 MG, 1 IN 1 D, PER ORAL | N | D | 21073 | ||
| 6768751 | 1013895568 | SS | KETOCONAZOLE | 1 | |||||||
| 6768751 | 1013895577 | SS | CORTISONE (CORTISONE) | 2 | ORAL | 25 MG, PER ORAL | |||||
| 6768751 | 1013895578 | C | ALDACTONE | 1 | |||||||
| 6768751 | 1013895581 | C | RISPERDAL | 1 | |||||||
| 6768751 | 1013895586 | C | ARICEPT | 1 | |||||||
| 6768751 | 1013895587 | C | SINGULAIR | 1 | |||||||
| 6768751 | 1013895588 | C | ASPIRIN | 1 | |||||||
| 6768751 | 1013895590 | C | NASONEX | 1 | |||||||
| 6768751 | 1013895591 | C | PINDOLOL | 1 | |||||||
| 6768751 | 1013895592 | C | PLAVIX | 1 | |||||||
| 6768751 | 1013895593 | C | INSULIN (INSULIN) | 2 | |||||||
| 6768751 | 1013895594 | C | FLUOXETINE | 1 | |||||||
| 6768751 | 1013895595 | C | LASIX | 1 | |||||||
| 6768751 | 1013895596 | C | NIASPAN | 1 | |||||||
| 6768751 | 1013895597 | C | ACETAMINOPHEN | 1 | |||||||
| 6768751 | 1013895599 | C | PROTONIX | 1 | |||||||
| 6768751 | 1013895601 | C | VISKEN | 1 | |||||||
| 6768751 | 1013895603 | C | PROZAC | 1 | |||||||
| 6768751 | 1013895606 | C | NIACIN | 1 | |||||||
| 6768751 | 1013895622 | C | NAMENDA | 1 | |||||||
| 6768751 | 1013895623 | C | HORMONAL THERAPY (HORMONES AND RELATED AGENTS) | 2 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 6768751 | 1013862901 | DIABETES MELLITUS |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 6768751 | HO |
| 6768751 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 6768751 | BACK PAIN |
| 6768751 | CARDIAC DISORDER |
| 6768751 | DEFORMITY |
| 6768751 | DEHYDRATION |
| 6768751 | GAIT DISTURBANCE |
| 6768751 | HEPATITIS CHOLESTATIC |
| 6768751 | HYPOAESTHESIA |
| 6768751 | INTERVERTEBRAL DISC PROTRUSION |
| 6768751 | LUMBAR SPINAL STENOSIS |
| 6768751 | MENTAL STATUS CHANGES |
| 6768751 | MUSCULAR WEAKNESS |
| 6768751 | NEUROPATHY PERIPHERAL |
| 6768751 | PERIPHERAL SENSORY NEUROPATHY |
| 6768751 | POLYNEUROPATHY |
| 6768751 | PROSTATE CANCER |
| 6768751 | SPINAL COMPRESSION FRACTURE |
| 6768751 | URINARY INCONTINENCE |
| 6768751 | WEIGHT DECREASED |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 6768751 | CR |
| 6768751 | CSM |
| 6768751 | HP |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 6768751 | 1013862901 | 20041015 | 20050707 | ||
| 6768751 | 1013895568 | 20050614 |