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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5080778 | 6112040 | I | 5080778-7 | 20060501 | 20060725 | 20060809 | EXP | CIP06001773 | PROCTER + GAMBLE PHARMACEUTICALS | 83 | YR | F | N | 20060808 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 5080778 | 1007581250 | PS | ACTONEL | 1 | ORAL | 2.5 MG DAILY, ORAL | Y | D | 20835 | ||
| 5080778 | 1007598308 | SS | STARLIX | 1 | ORAL | 90 MG, ORAL | Y | D | |||
| 5080778 | 1007598312 | SS | PLATIBIT (ALFACALCIDOL) | 2 | ORAL | 15 MCG, ORAL | Y | D | |||
| 5080778 | 1007598315 | SS | VIT K CAP | 1 | ORAL | 15 MG, ORAL | Y | D | |||
| 5080778 | 1007598318 | SS | PRORENAL (LIMAPROST) | 2 | ORAL | 15 MCG, ORAL | Y | D | |||
| 5080778 | 1007598319 | SS | NEUROVITAN (OCTOTIAMINE, CYANOCOBALAMIN, RIBOFLAVIN, PYRIDOXINE HYDROC | 2 | ORAL | ORAL | Y | D | |||
| 5080778 | 1007598320 | SS | DICLOFENAC (DICLOFENAC) | 2 | Y | D | |||||
| 5080778 | 1007598321 | SS | DEPAS (ETIZOLAM) | 2 | ORAL | 0.5 MG, ORAL | Y | D | |||
| 5080778 | 1007598333 | SS | TORSEMIDE | 1 | ORAL | 4 MG, ORAL | Y | D | |||
| 5080778 | 1007598335 | SS | DIAZEPAM | 1 | ORAL | ORAL | Y | D |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 5080778 | 1007581250 | OSTEOPOROSIS |
| 5080778 | 1007598308 | DIABETES MELLITUS |
| 5080778 | 1007598315 | OSTEOPOROSIS |
| 5080778 | 1007598321 | INSOMNIA |
| 5080778 | 1007598333 | CARDIAC FAILURE |
| 5080778 | 1007598335 | INSOMNIA |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 5080778 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 5080778 | ALANINE AMINOTRANSFERASE INCREASED |
| 5080778 | ANOREXIA |
| 5080778 | ASPARTATE AMINOTRANSFERASE INCREASED |
| 5080778 | BILIRUBIN CONJUGATED INCREASED |
| 5080778 | BLOOD ALKALINE PHOSPHATASE INCREASED |
| 5080778 | BLOOD BILIRUBIN INCREASED |
| 5080778 | BLOOD LACTATE DEHYDROGENASE INCREASED |
| 5080778 | GAMMA-GLUTAMYLTRANSFERASE INCREASED |
| 5080778 | GASTRITIS |
| 5080778 | HAEMATOCRIT DECREASED |
| 5080778 | HAEMOGLOBIN DECREASED |
| 5080778 | JAUNDICE |
| 5080778 | LIVER DISORDER |
| 5080778 | PROTEIN TOTAL DECREASED |
| 5080778 | RED BLOOD CELL COUNT DECREASED |
| 5080778 | WHITE BLOOD CELL COUNT DECREASED |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 5080778 | FGN |
| 5080778 | HP |
| 5080778 | OTH |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 5080778 | 1007581250 | 20060522 | |||
| 5080778 | 1007598308 | 20060522 | |||
| 5080778 | 1007598312 | 20060522 | |||
| 5080778 | 1007598315 | 20060522 | |||
| 5080778 | 1007598318 | 20060522 | |||
| 5080778 | 1007598319 | 20060522 | |||
| 5080778 | 1007598321 | 20060522 | |||
| 5080778 | 1007598333 | 20060522 | |||
| 5080778 | 1007598335 | 20060522 |