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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127098981 | 12709898 | 1 | I | 2010 | 20141106 | 20160902 | 20160902 | EXP | CHPA2014US014985 | GLAXOSMITHKLINE | 0.00 | Y | 0.00000 | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127098981 | 12709898 | 1 | PS | VOLTAREN | DICLOFENAC SODIUM | 1 | Topical | UNK (VERY LITTLE, ONCE OR TWICE DAILY) | Y | W3176 | 22122 | GEL | |||||||
| 127098981 | 12709898 | 2 | SS | VOLTAREN | DICLOFENAC SODIUM | 1 | Topical | UNK (VERY LITTLE, ONCE OR TWICE DAILY) | Y | UNKNOWN | 22122 | GEL | |||||||
| 127098981 | 12709898 | 3 | SS | VOLTAREN | DICLOFENAC SODIUM | 1 | Y | 22122 | GEL | ||||||||||
| 127098981 | 12709898 | 4 | SS | VOLTAREN | DICLOFENAC SODIUM | 1 | Y | 22122 | GEL |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127098981 | 12709898 | 1 | Arthritis |
| 127098981 | 12709898 | 2 | Off label use |
| 127098981 | 12709898 | 3 | Pain in extremity |
| 127098981 | 12709898 | 4 | Musculoskeletal stiffness |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127098981 | 12709898 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127098981 | 12709898 | Blood pressure increased | |
| 127098981 | 12709898 | Drug administered at inappropriate site | |
| 127098981 | 12709898 | Feeling abnormal | |
| 127098981 | 12709898 | Incorrect dosage administered | |
| 127098981 | 12709898 | Off label use | |
| 127098981 | 12709898 | Palpitations | |
| 127098981 | 12709898 | Therapeutic response unexpected | |
| 127098981 | 12709898 | Underdose | |
| 127098981 | 12709898 | 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 |
|---|---|---|---|---|---|---|
| 127098981 | 12709898 | 2 | 2010 | 0 |