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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127401011 | 12740101 | 1 | I | 20160907 | 20160913 | 20160913 | EXP | PHHY2016VE125361 | NOVARTIS | 0.00 | M | Y | 0.00000 | 20160913 | CN | COUNTRY NOT SPECIFIED | VE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127401011 | 12740101 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, UNK | Y | 22334 | 10 | MG | |||||||
| 127401011 | 12740101 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | Y | 22334 | 5 | MG | QD | ||||||
| 127401011 | 12740101 | 3 | SS | DIOVAN HCT | HYDROCHLOROTHIAZIDEVALSARTAN | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | QD | ||||||
| 127401011 | 12740101 | 4 | C | CONCOR | BISOPROLOL FUMARATE | 1 | Unknown | 1.25 MG, QD | U | 0 | 1.25 | MG | QD | ||||||
| 127401011 | 12740101 | 5 | C | VITAMIN C | ASCORBIC ACID | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127401011 | 12740101 | 1 | Renal cancer |
| 127401011 | 12740101 | 3 | Hypertension |
| 127401011 | 12740101 | 4 | Hypertension |
| 127401011 | 12740101 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127401011 | 12740101 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127401011 | 12740101 | Cough | |
| 127401011 | 12740101 | Lung neoplasm malignant | |
| 127401011 | 12740101 | Pulmonary fibrosis | |
| 127401011 | 12740101 | Pyrexia | |
| 127401011 | 12740101 | Second primary malignancy |
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 |
|---|---|---|---|---|---|---|
| 127401011 | 12740101 | 1 | 201111 | 0 |