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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118254533 | 11825453 | 3 | F | 20100107 | 20160915 | 20151211 | 20160927 | EXP | CA-PFIZER INC-2015420985 | PFIZER | 62.00 | YR | F | Y | 0.00000 | 20160927 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118254533 | 11825453 | 1 | PS | SUNITINIB MALATE. | SUNITINIB MALATE | 1 | 50 MG DAILY, CYCLIC FOR 4 WEEKS ON AND 2 WEEKS OFF | Y | 21938 | 50 | MG | ||||||||
| 118254533 | 11825453 | 2 | SS | SUNITINIB MALATE. | SUNITINIB MALATE | 1 | 50 MG DAILY, CYCLIC FOR 4 WEEKS ON AND 2 WEEKS OFF | Y | 21938 | 50 | MG | ||||||||
| 118254533 | 11825453 | 3 | SS | SUNITINIB MALATE. | SUNITINIB MALATE | 1 | 37.5 MG DAILY CONTINUOUS AFTER A 3 WEEK BREAK | Y | 21938 | 37.5 | MG | ||||||||
| 118254533 | 11825453 | 4 | SS | SUNITINIB MALATE. | SUNITINIB MALATE | 1 | 25 MG DAILY, CYCLIC FOR 2 WEEKS ON, 7-10 DAYS OFF | Y | 21938 | 25 | MG | ||||||||
| 118254533 | 11825453 | 5 | SS | SUNITINIB MALATE. | SUNITINIB MALATE | 1 | 25 MG DAILY, CYCLIC FOR 2 WEEKS ON, 7-10 DAYS OFF | Y | 21938 | 25 | MG | ||||||||
| 118254533 | 11825453 | 6 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118254533 | 11825453 | 1 | Metastatic renal cell carcinoma |
| 118254533 | 11825453 | 6 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118254533 | 11825453 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118254533 | 11825453 | Bone marrow failure | |
| 118254533 | 11825453 | Bone marrow toxicity | |
| 118254533 | 11825453 | Diarrhoea | |
| 118254533 | 11825453 | Diplopia | |
| 118254533 | 11825453 | Disease progression | |
| 118254533 | 11825453 | Epistaxis | |
| 118254533 | 11825453 | Fatigue | |
| 118254533 | 11825453 | Headache | |
| 118254533 | 11825453 | Hypertension | |
| 118254533 | 11825453 | Hypothyroidism | |
| 118254533 | 11825453 | Metastatic renal cell carcinoma | |
| 118254533 | 11825453 | Nausea | |
| 118254533 | 11825453 | Neutropenia | |
| 118254533 | 11825453 | Palmar-plantar erythrodysaesthesia syndrome | |
| 118254533 | 11825453 | Petechiae | |
| 118254533 | 11825453 | Stomatitis | |
| 118254533 | 11825453 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 118254533 | 11825453 | 1 | 20100101 | 201001 | 0 | |
| 118254533 | 11825453 | 2 | 201001 | 20100125 | 0 | |
| 118254533 | 11825453 | 3 | 201002 | 201003 | 0 | |
| 118254533 | 11825453 | 4 | 201003 | 201301 | 0 | |
| 118254533 | 11825453 | 5 | 201310 | 0 |