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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118113084 | 11811308 | 4 | F | 20160722 | 20151208 | 20160728 | EXP | PHEH2015US025119 | NOVARTIS | 0.00 | M | Y | 83.00000 | KG | 20160728 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118113084 | 11811308 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Unknown | 10 MG, QD | Y | 22334 | 10 | MG | QD | ||||||
| 118113084 | 11811308 | 2 | C | INLYTA | AXITINIB | 1 | Unknown | 5 MG, BID | U | 0 | 5 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118113084 | 11811308 | 1 | Renal cell carcinoma |
| 118113084 | 11811308 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118113084 | 11811308 | OT |
| 118113084 | 11811308 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118113084 | 11811308 | Anaemia | |
| 118113084 | 11811308 | Anxiety | |
| 118113084 | 11811308 | Asthenia | |
| 118113084 | 11811308 | Atelectasis | |
| 118113084 | 11811308 | Blood pressure decreased | |
| 118113084 | 11811308 | Cardiac disorder | |
| 118113084 | 11811308 | Cardiac failure congestive | |
| 118113084 | 11811308 | Cardiomegaly | |
| 118113084 | 11811308 | Diarrhoea | |
| 118113084 | 11811308 | Dyspnoea | |
| 118113084 | 11811308 | Dyspnoea exertional | |
| 118113084 | 11811308 | Epistaxis | |
| 118113084 | 11811308 | Fatigue | |
| 118113084 | 11811308 | Gingival recession | |
| 118113084 | 11811308 | Heart rate decreased | |
| 118113084 | 11811308 | Hyperhidrosis | |
| 118113084 | 11811308 | Lymph node calcification | |
| 118113084 | 11811308 | Metastases to abdominal cavity | |
| 118113084 | 11811308 | Nervousness | |
| 118113084 | 11811308 | Oedema | |
| 118113084 | 11811308 | Oedema peripheral | |
| 118113084 | 11811308 | Peripheral swelling | |
| 118113084 | 11811308 | Pleural effusion | |
| 118113084 | 11811308 | Pulmonary mass | |
| 118113084 | 11811308 | Pyrexia | |
| 118113084 | 11811308 | Rash pruritic | |
| 118113084 | 11811308 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 118113084 | 11811308 | 1 | 201505 | 201508 | 0 | |
| 118113084 | 11811308 | 2 | 20150508 | 0 |