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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125242461 | 12524246 | 1 | I | 20160620 | 20160704 | 20160704 | EXP | GR-AUROBINDO-AUR-APL-2016-08660 | AUROBINDO | 57.00 | YR | F | Y | 0.00000 | 20160704 | OT | GR | GR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125242461 | 12524246 | 1 | PS | CLOPIDOGREL | CLOPIDOGREL BISULFATE | 1 | Unknown | 75 MG, DAILY | U | 90540 | 75 | MG | |||||||
| 125242461 | 12524246 | 2 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 125242461 | 12524246 | 3 | C | BOSENTAN. | BOSENTAN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125242461 | 12524246 | 1 | Systemic scleroderma |
| 125242461 | 12524246 | 2 | Product used for unknown indication |
| 125242461 | 12524246 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125242461 | 12524246 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125242461 | 12524246 | Condition aggravated | |
| 125242461 | 12524246 | Endothelial dysfunction | |
| 125242461 | 12524246 | Rash | |
| 125242461 | 12524246 | Skin ulcer |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |