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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123991615 | 12399161 | 5 | F | 201511 | 20160728 | 20160524 | 20160809 | EXP | HU-PFIZER INC-2015408441 | PFIZER | 55.00 | YR | M | Y | 0.00000 | 20160809 | OT | HU | HU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123991615 | 12399161 | 1 | PS | SUTENT | SUNITINIB MALATE | 1 | Oral | 50 MG, CYCLIC (1ST CYCLE, 50 MG, 1X/DAY, 4/2 SCHEMA) | Y | 21938 | 50 | MG | CAPSULE, HARD | ||||||
| 123991615 | 12399161 | 2 | SS | SUTENT | SUNITINIB MALATE | 1 | Oral | 50 MG, CYCLIC (50 MG, 1X/DAY, 2/1 SCHEMA) | Y | 21938 | 50 | MG | CAPSULE, HARD | ||||||
| 123991615 | 12399161 | 3 | SS | SUTENT | SUNITINIB MALATE | 1 | Oral | 50 MG, CYCLIC (3RD CYCLE, 50 MG 1X/DAY, 2/1 SCHEMA) | Y | 21938 | 50 | MG | CAPSULE, HARD | ||||||
| 123991615 | 12399161 | 4 | SS | SUTENT | SUNITINIB MALATE | 1 | Oral | 50 MG, CYCLIC (4RD CYCLE, 50 MG 1X/DAY, 2/1 SCHEMA) | Y | 21938 | 50 | MG | CAPSULE, HARD | ||||||
| 123991615 | 12399161 | 5 | SS | SUTENT | SUNITINIB MALATE | 1 | Oral | 37.5 MG DAILY CYCLIC (5TH CYCLE, 4/2 SCHEMA) | Y | 21938 | 37.5 | MG | CAPSULE, HARD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123991615 | 12399161 | 1 | Renal cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123991615 | 12399161 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123991615 | 12399161 | Anaemia | |
| 123991615 | 12399161 | Asthenia | |
| 123991615 | 12399161 | Back pain | |
| 123991615 | 12399161 | Disease progression | |
| 123991615 | 12399161 | Eating disorder | |
| 123991615 | 12399161 | Epistaxis | |
| 123991615 | 12399161 | Fatigue | |
| 123991615 | 12399161 | Glossodynia | |
| 123991615 | 12399161 | Headache | |
| 123991615 | 12399161 | Lip blister | |
| 123991615 | 12399161 | Mucosal inflammation | |
| 123991615 | 12399161 | Musculoskeletal pain | |
| 123991615 | 12399161 | Nausea | |
| 123991615 | 12399161 | Neck pain | |
| 123991615 | 12399161 | Oral mucosal blistering | |
| 123991615 | 12399161 | Oral mucosal eruption | |
| 123991615 | 12399161 | Oral pain | |
| 123991615 | 12399161 | Palmar-plantar erythrodysaesthesia syndrome | |
| 123991615 | 12399161 | Pathological fracture | |
| 123991615 | 12399161 | Rash | |
| 123991615 | 12399161 | Renal cancer | |
| 123991615 | 12399161 | Tongue blistering | |
| 123991615 | 12399161 | Tongue discolouration | |
| 123991615 | 12399161 | Tongue eruption | |
| 123991615 | 12399161 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 123991615 | 12399161 | 1 | 20151102 | 0 | ||
| 123991615 | 12399161 | 2 | 20151214 | 20160110 | 0 | |
| 123991615 | 12399161 | 3 | 20160125 | 0 | ||
| 123991615 | 12399161 | 4 | 20160307 | 0 | ||
| 123991615 | 12399161 | 5 | 20160418 | 20160509 | 0 |