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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114039802 | 11403980 | 2 | F | 20150505 | 20150819 | 20150821 | 20160829 | EXP | US-ROCHE-1613360 | ROCHE | 79.45 | YR | M | Y | 80.36000 | KG | 20160829 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114039802 | 11403980 | 1 | PS | ESBRIET | PIRFENIDONE | 1 | Oral | Y | 1402859A | 22535 | 267 | MG | CAPSULE | TID | |||||
| 114039802 | 11403980 | 2 | SS | ESBRIET | PIRFENIDONE | 1 | Oral | Y | 1402859A | 22535 | 801 | MG | CAPSULE | TID | |||||
| 114039802 | 11403980 | 3 | SS | ESBRIET | PIRFENIDONE | 1 | Oral | FOR 3 WEEKS | Y | 1402859A | 22535 | 267 | MG | CAPSULE | TID | ||||
| 114039802 | 11403980 | 4 | SS | ESBRIET | PIRFENIDONE | 1 | Oral | FOR 3 WEEKS | Y | 1402859A | 22535 | 534 | MG | CAPSULE | TID | ||||
| 114039802 | 11403980 | 5 | SS | ESBRIET | PIRFENIDONE | 1 | Oral | 3 CAPSULES THRICE A DAY | Y | 1402859A | 22535 | 801 | MG | CAPSULE | TID | ||||
| 114039802 | 11403980 | 6 | SS | NAPROXEN. | NAPROXEN | 1 | Unknown | U | 17581 | ||||||||||
| 114039802 | 11403980 | 7 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Oral | 0 | 2.5 | MG | QD | ||||||||
| 114039802 | 11403980 | 8 | C | PREVACID | LANSOPRAZOLE | 1 | Oral | 0 | 30 | MG | QD | ||||||||
| 114039802 | 11403980 | 9 | C | NASONEX | MOMETASONE FUROATE | 1 | Nasal | 0 | 50 | UG | QD | ||||||||
| 114039802 | 11403980 | 10 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114039802 | 11403980 | 1 | Idiopathic pulmonary fibrosis |
| 114039802 | 11403980 | 6 | Product used for unknown indication |
| 114039802 | 11403980 | 7 | Hypertension |
| 114039802 | 11403980 | 8 | Gastrooesophageal reflux disease |
| 114039802 | 11403980 | 9 | Rhinitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114039802 | 11403980 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114039802 | 11403980 | Decreased appetite | |
| 114039802 | 11403980 | Drug hypersensitivity | |
| 114039802 | 11403980 | Dysgeusia | |
| 114039802 | 11403980 | Dyspnoea exertional | |
| 114039802 | 11403980 | Fatigue | |
| 114039802 | 11403980 | Mood altered |
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 |
|---|---|---|---|---|---|---|
| 114039802 | 11403980 | 1 | 20150403 | 20150714 | 0 | |
| 114039802 | 11403980 | 2 | 20150508 | 0 | ||
| 114039802 | 11403980 | 5 | 20150714 | 0 |