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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117682965 | 11768296 | 5 | F | 2015 | 20160713 | 20151123 | 20160727 | EXP | BR-PFIZER INC-2015010233 | PFIZER | 58.00 | YR | M | Y | 74.00000 | KG | 20160727 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117682965 | 11768296 | 1 | PS | SUTENT | SUNITINIB MALATE | 1 | Oral | 50 MG, CYCLIC (4 WEEKS ON/2 WEEKS OFF) | Y | V4768 | 21938 | 50 | MG | CAPSULE, HARD | |||||
| 117682965 | 11768296 | 2 | SS | SUTENT | SUNITINIB MALATE | 1 | 37.5 MG, UNK | Y | 21938 | 37.5 | MG | CAPSULE, HARD | |||||||
| 117682965 | 11768296 | 3 | SS | SUTENT | SUNITINIB MALATE | 1 | 50 MG, ALTERNATE DAY | Y | 21938 | 50 | MG | CAPSULE, HARD | QOD | ||||||
| 117682965 | 11768296 | 4 | SS | SUTENT | SUNITINIB MALATE | 1 | Oral | 25 MG, (COMBINED WITH 12.5 MG FOR TOTAL 37.5MG) CONTINUOUS USE | Y | Z583A | 21938 | 25 | MG | CAPSULE, HARD | |||||
| 117682965 | 11768296 | 5 | SS | SUTENT | SUNITINIB MALATE | 1 | Oral | 12.5 MG, (COMBINED WITH 25MG FOR TOTAL 37.5MG) CONTINUOUS USE | Y | 289AA | 21938 | 12.5 | MG | CAPSULE, HARD | |||||
| 117682965 | 11768296 | 6 | SS | SUTENT | SUNITINIB MALATE | 1 | 50 MG, UNK | Y | 21938 | 50 | MG | CAPSULE, HARD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117682965 | 11768296 | 1 | Metastatic renal cell carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117682965 | 11768296 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117682965 | 11768296 | Asthenia | |
| 117682965 | 11768296 | Back pain | |
| 117682965 | 11768296 | Depressed mood | |
| 117682965 | 11768296 | Disease progression | |
| 117682965 | 11768296 | Dyspnoea | |
| 117682965 | 11768296 | Erythema | |
| 117682965 | 11768296 | Eye pain | |
| 117682965 | 11768296 | Gait disturbance | |
| 117682965 | 11768296 | Headache | |
| 117682965 | 11768296 | Hiccups | |
| 117682965 | 11768296 | Metastatic renal cell carcinoma | |
| 117682965 | 11768296 | Nail bed bleeding | |
| 117682965 | 11768296 | Nail bed disorder | |
| 117682965 | 11768296 | Nasal injury | |
| 117682965 | 11768296 | Nausea | |
| 117682965 | 11768296 | Oral pain | |
| 117682965 | 11768296 | Pain in extremity | |
| 117682965 | 11768296 | Pruritus genital | |
| 117682965 | 11768296 | Skin irritation | |
| 117682965 | 11768296 | Testicular injury | |
| 117682965 | 11768296 | Thermal burn | |
| 117682965 | 11768296 | Vascular neoplasm |
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 |
|---|---|---|---|---|---|---|
| 117682965 | 11768296 | 1 | 20141220 | 0 | ||
| 117682965 | 11768296 | 4 | 201503 | 0 | ||
| 117682965 | 11768296 | 5 | 201503 | 0 | ||
| 117682965 | 11768296 | 6 | 201501 | 0 |