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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125381351 | 12538135 | 1 | I | 20160624 | 20160627 | 20160707 | 20160707 | PER | PHHY2016US093538 | SANDOZ | 77.00 | YR | F | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125381351 | 12538135 | 1 | SS | VOLTAREN | DICLOFENAC SODIUM | 1 | Unknown | UNK | U | 0 | EMULGEL | ||||||||
| 125381351 | 12538135 | 2 | PS | LORAZEPAM. | LORAZEPAM | 1 | Unknown | U | 71193 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125381351 | 12538135 | 1 | Musculoskeletal pain |
| 125381351 | 12538135 | 2 | Dyspnoea |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125381351 | 12538135 | Condition aggravated | |
| 125381351 | 12538135 | Drug administered at inappropriate site | |
| 125381351 | 12538135 | Dyspnoea | |
| 125381351 | 12538135 | Feeling abnormal | |
| 125381351 | 12538135 | Incorrect dose administered | |
| 125381351 | 12538135 | Off label use | |
| 125381351 | 12538135 | Somnolence | |
| 125381351 | 12538135 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 125381351 | 12538135 | 1 | 20160624 | 0 |