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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1174922511 | 11749225 | 11 | F | 20150902 | 20160908 | 20151118 | 20160919 | EXP | CA-ROCHE-ITM201506IM018071 | ROCHE | 69.01 | YR | M | Y | 0.00000 | 20160919 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1174922511 | 11749225 | 1 | PS | ESBRIET | PIRFENIDONE | 1 | Oral | 22535 | 267 | MG | CAPSULE | TID | |||||||
| 1174922511 | 11749225 | 2 | SS | ESBRIET | PIRFENIDONE | 1 | Oral | 22535 | 534 | MG | CAPSULE | TID | |||||||
| 1174922511 | 11749225 | 3 | SS | ESBRIET | PIRFENIDONE | 1 | Oral | 22535 | 801 | MG | CAPSULE | TID | |||||||
| 1174922511 | 11749225 | 4 | SS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | D | 0 | 50 | MG | QD | |||||||
| 1174922511 | 11749225 | 5 | C | ATIVAN | LORAZEPAM | 1 | 0 | ||||||||||||
| 1174922511 | 11749225 | 6 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 0 | ||||||||||||
| 1174922511 | 11749225 | 7 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1174922511 | 11749225 | 1 | Idiopathic pulmonary fibrosis |
| 1174922511 | 11749225 | 4 | Anxiety |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1174922511 | 11749225 | HO |
| 1174922511 | 11749225 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1174922511 | 11749225 | Anxiety | |
| 1174922511 | 11749225 | Depression | |
| 1174922511 | 11749225 | Diarrhoea | |
| 1174922511 | 11749225 | Dyspnoea | |
| 1174922511 | 11749225 | Dyspnoea exertional | |
| 1174922511 | 11749225 | Fatigue | |
| 1174922511 | 11749225 | Lung neoplasm malignant | |
| 1174922511 | 11749225 | Myocardial infarction | |
| 1174922511 | 11749225 | Nausea | |
| 1174922511 | 11749225 | Pulmonary function test decreased | |
| 1174922511 | 11749225 | Thrombosis |
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 |
|---|---|---|---|---|---|---|
| 1174922511 | 11749225 | 1 | 20150522 | 0 | ||
| 1174922511 | 11749225 | 2 | 20150529 | 0 | ||
| 1174922511 | 11749225 | 3 | 20150605 | 0 | ||
| 1174922511 | 11749225 | 4 | 20160218 | 0 |