Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126549511 | 12654951 | 1 | I | 201607 | 20160809 | 20160816 | 20160816 | EXP | US-GLAXOSMITHKLINE-US2016116487 | GLAXOSMITHKLINE | 83.00 | YR | F | Y | 0.00000 | 20160816 | CN | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126549511 | 12654951 | 1 | PS | VOLTAREN | DICLOFENAC SODIUM | 1 | Topical | UNK UNK, BID | W5770 | 22122 | GEL | BID | |||||||
| 126549511 | 12654951 | 2 | SS | VOLTAREN | DICLOFENAC SODIUM | 1 | 22122 | GEL | |||||||||||
| 126549511 | 12654951 | 3 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | UNK | U | UNK | 0 | TABLET | |||||||
| 126549511 | 12654951 | 4 | C | Alendronate Tablet | 2 | Oral | UNK | U | UNK | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126549511 | 12654951 | 1 | Foot fracture |
| 126549511 | 12654951 | 2 | Sciatica |
| 126549511 | 12654951 | 3 | Osteoporosis |
| 126549511 | 12654951 | 4 | Osteoporosis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126549511 | 12654951 | Drug administered at inappropriate site | |
| 126549511 | 12654951 | Fall | |
| 126549511 | 12654951 | Gastrooesophageal reflux disease | |
| 126549511 | 12654951 | Incorrect dosage administered | |
| 126549511 | 12654951 | Intentional product misuse | |
| 126549511 | 12654951 | Nausea | |
| 126549511 | 12654951 | Sciatica | |
| 126549511 | 12654951 | Therapeutic response unexpected | |
| 126549511 | 12654951 | Wrist fracture | |
| 126549511 | 12654951 | Wrong technique in product usage process |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126549511 | 12654951 | 1 | 201603 | 0 |