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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125509012 | 12550901 | 2 | F | 20160629 | 20160729 | 20160712 | 20160801 | EXP | US-ROCHE-1792102 | ROCHE | 86.31 | YR | M | Y | 84.90000 | KG | 20160801 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125509012 | 12550901 | 1 | PS | ESBRIET | PIRFENIDONE | 1 | Oral | 3 CAPSULES 3 TIMES A DAY; 1 CAPSULES BY MOUTH 3 TIMES A DAY FOR THE FIRST WEEK, THE MOST RECENT DOSE | Y | 22535 | 267 | MG | CAPSULE | TID | |||||
| 125509012 | 12550901 | 2 | SS | ESBRIET | PIRFENIDONE | 1 | Oral | 2 CAPSULES BY MOUTH 3 TIMES A DAY | Y | 22535 | 267 | MG | CAPSULE | TID | |||||
| 125509012 | 12550901 | 3 | SS | NAPROXEN. | NAPROXEN | 1 | Unknown | U | 17581 | ||||||||||
| 125509012 | 12550901 | 4 | C | COUMADIN | WARFARIN SODIUM | 1 | Unknown | 0 | |||||||||||
| 125509012 | 12550901 | 5 | C | ELIQUIS | APIXABAN | 1 | Unknown | TWICE A DAY | 0 | 10 | MG | BID | |||||||
| 125509012 | 12550901 | 6 | C | CARVEDILOL. | CARVEDILOL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125509012 | 12550901 | 1 | Idiopathic pulmonary fibrosis |
| 125509012 | 12550901 | 3 | Product used for unknown indication |
| 125509012 | 12550901 | 4 | Vascular graft |
| 125509012 | 12550901 | 5 | Pulmonary thrombosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125509012 | 12550901 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125509012 | 12550901 | Abdominal discomfort | |
| 125509012 | 12550901 | Abdominal pain | |
| 125509012 | 12550901 | Abdominal pain lower | |
| 125509012 | 12550901 | Abdominal pain upper | |
| 125509012 | 12550901 | Blood pressure decreased | |
| 125509012 | 12550901 | Chills | |
| 125509012 | 12550901 | Drug dose omission | |
| 125509012 | 12550901 | Drug hypersensitivity | |
| 125509012 | 12550901 | Pulmonary thrombosis | |
| 125509012 | 12550901 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 125509012 | 12550901 | 1 | 20160617 | 20160705 | 0 | |
| 125509012 | 12550901 | 4 | 201607 | 0 | ||
| 125509012 | 12550901 | 5 | 20160707 | 0 |