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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125003195 | 12500319 | 5 | F | 2016 | 20160811 | 20160627 | 20160817 | PER | US-PFIZER INC-2016249951 | PFIZER | 60.00 | YR | M | Y | 94.00000 | KG | 20160817 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125003195 | 12500319 | 1 | PS | SUTENT | SUNITINIB MALATE | 1 | 50 MG, CYCLIC(2 WEEKS ON/1 WEEK OFF) | N | 21938 | 50 | MG | CAPSULE, HARD | |||||||
| 125003195 | 12500319 | 2 | SS | SUTENT | SUNITINIB MALATE | 1 | 50 MG, CYCLIC (28 DAYS ON/14DAYS OFF) | N | 21938 | 50 | MG | CAPSULE, HARD | |||||||
| 125003195 | 12500319 | 3 | SS | SUTENT | SUNITINIB MALATE | 1 | 50 MG, CYCLIC (2 WEEKS ON / 1WEEK OFF) | N | 21938 | 50 | MG | CAPSULE, HARD | |||||||
| 125003195 | 12500319 | 4 | C | SOTALOL. | SOTALOL | 1 | UNK | 0 | |||||||||||
| 125003195 | 12500319 | 5 | C | COZAAR | LOSARTAN POTASSIUM | 1 | UNK | 0 | |||||||||||
| 125003195 | 12500319 | 6 | C | FENOFIBRATE. | FENOFIBRATE | 1 | UNK | 0 | |||||||||||
| 125003195 | 12500319 | 7 | C | VYTORIN | EZETIMIBESIMVASTATIN | 1 | UNK | 0 | |||||||||||
| 125003195 | 12500319 | 8 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | UNK | 0 | |||||||||||
| 125003195 | 12500319 | 9 | C | WARFARIN | WARFARIN | 1 | UNK | 0 | |||||||||||
| 125003195 | 12500319 | 10 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | UNK | 0 | |||||||||||
| 125003195 | 12500319 | 11 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | UNK | 0 | |||||||||||
| 125003195 | 12500319 | 12 | C | TUSSIN CF | DEXTROMETHORPHAN HYDROBROMIDEGUAIFENESINPHENYLEPHRINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 125003195 | 12500319 | 13 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125003195 | 12500319 | 1 | Metastatic renal cell carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125003195 | 12500319 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125003195 | 12500319 | Abdominal discomfort | |
| 125003195 | 12500319 | Abdominal pain upper | |
| 125003195 | 12500319 | Blood pressure increased | |
| 125003195 | 12500319 | Blood urine present | |
| 125003195 | 12500319 | Cough | |
| 125003195 | 12500319 | Disease progression | |
| 125003195 | 12500319 | Dry skin | |
| 125003195 | 12500319 | Dyspnoea | |
| 125003195 | 12500319 | Fatigue | |
| 125003195 | 12500319 | Feeling abnormal | |
| 125003195 | 12500319 | Frequent bowel movements | |
| 125003195 | 12500319 | Haematochezia | |
| 125003195 | 12500319 | Haemoglobin decreased | |
| 125003195 | 12500319 | Haemorrhoids | |
| 125003195 | 12500319 | Headache | |
| 125003195 | 12500319 | Metastatic renal cell carcinoma | |
| 125003195 | 12500319 | Muscle spasms | |
| 125003195 | 12500319 | Nausea | |
| 125003195 | 12500319 | Neuralgia | |
| 125003195 | 12500319 | Pain | |
| 125003195 | 12500319 | Pain in extremity | |
| 125003195 | 12500319 | Palmar-plantar erythrodysaesthesia syndrome | |
| 125003195 | 12500319 | Platelet count decreased | |
| 125003195 | 12500319 | Rash macular | |
| 125003195 | 12500319 | Skin exfoliation |
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 |
|---|---|---|---|---|---|---|
| 125003195 | 12500319 | 1 | 20160506 | 201605 | 0 | |
| 125003195 | 12500319 | 2 | 20160527 | 0 | ||
| 125003195 | 12500319 | 3 | 20160624 | 0 |