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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6797390 | 7448490 | I | 6797390-1 | 20100413 | 20100607 | 20100623 | EXP | TCI2010A01603 | TAKEDA PHARMACEUTICALS NORTH AMERICA. | 75 | YR | M | N | 20100622 | JAPAN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 6797390 | 1013964918 | PS | ACTOS | 1 | ORAL | 15 MG (15 MG, 1 IN 1 D) PER ORAL; 30 MG (15 MG, 2 IN 1 D) PER ORAL | D | 21073 | |||
| 6797390 | 1014004216 | SS | MEPIVACAINE HCL | 1 | INJECTION | ||||||
| 6797390 | 1014004217 | SS | BOTULINUM TOXIN TYPE A | 1 | INJECTION | ||||||
| 6797390 | 1014004219 | C | SEIBULE (MIGLITOL) | 2 | |||||||
| 6797390 | 1014004221 | C | AMARYL | 1 | |||||||
| 6797390 | 1014004224 | C | ADALAT CC | 1 | |||||||
| 6797390 | 1014004235 | C | ASPIRIN | 1 | |||||||
| 6797390 | 1014004236 | C | DIOVAN | 1 | |||||||
| 6797390 | 1014004237 | C | LOXONIN (LOXOPROFEN SODIUM) | 2 | |||||||
| 6797390 | 1014004238 | C | TIZANIDINE HCL | 1 | |||||||
| 6797390 | 1014004239 | C | CORTICOSTEROIDS | 2 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 6797390 | 1013964918 | DIABETES MELLITUS |
| 6797390 | 1014004216 | BACK PAIN |
| 6797390 | 1014004217 | BACK PAIN |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 6797390 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 6797390 | BACK PAIN |
| 6797390 | BRAIN NATRIURETIC PEPTIDE INCREASED |
| 6797390 | CARDIAC FAILURE |
| 6797390 | CARDIAC MURMUR |
| 6797390 | CARDIOTHORACIC RATIO INCREASED |
| 6797390 | DIABETES MELLITUS INADEQUATE CONTROL |
| 6797390 | DYSGEUSIA |
| 6797390 | DYSPNOEA |
| 6797390 | GASTRITIS EROSIVE |
| 6797390 | GASTROOESOPHAGEAL REFLUX DISEASE |
| 6797390 | GENERALISED OEDEMA |
| 6797390 | OXYGEN SATURATION DECREASED |
| 6797390 | PLEURAL EFFUSION |
| 6797390 | WEIGHT INCREASED |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 6797390 | FGN |
| 6797390 | HP |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 6797390 | 1013964918 | 20070507 | 20090829 | 845 | DAY |
| 6797390 | 1013964918 | 20090830 | 20100413 | 226 | DAY |
| 6797390 | 1014004216 | 20100406 | 20100411 | 5 | DAY |
| 6797390 | 1014004217 | 20100406 | 20100411 | 5 | DAY |