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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115392768 | 11539276 | 8 | F | 201502 | 20160817 | 20150923 | 20160826 | EXP | US-PFIZER INC-2015302339 | PFIZER | 71.00 | YR | M | Y | 0.00000 | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115392768 | 11539276 | 1 | PS | SUTENT | SUNITINIB MALATE | 1 | 50 MG, CYCLIC (28 DAYS ON/14 DAYS OFF) | Y | B422BA | 21938 | 50 | MG | CAPSULE, HARD | ||||||
| 115392768 | 11539276 | 2 | SS | SUTENT | SUNITINIB MALATE | 1 | 37.5 MG, DAILY | Y | 21938 | 37.5 | MG | CAPSULE, HARD | |||||||
| 115392768 | 11539276 | 3 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | UNK | 0 | |||||||||||
| 115392768 | 11539276 | 4 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | 1000 UG, MONTHLY | 0 | 1000 | UG | /month | ||||||||
| 115392768 | 11539276 | 5 | C | DUTASTERIDE. | DUTASTERIDE | 1 | UNK | 0 | |||||||||||
| 115392768 | 11539276 | 6 | C | BENICAR | OLMESARTAN MEDOXOMIL | 1 | UNK (40) | 0 | |||||||||||
| 115392768 | 11539276 | 7 | C | BENICAR | OLMESARTAN MEDOXOMIL | 1 | UNK (20) | 0 | |||||||||||
| 115392768 | 11539276 | 8 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | UNK | 0 | |||||||||||
| 115392768 | 11539276 | 9 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 20 MG, DAILY | 0 | 20 | MG | |||||||||
| 115392768 | 11539276 | 10 | C | CHLORHEXIDINE GLUCONATE. | CHLORHEXIDINE GLUCONATE | 1 | 0.12 %, UNK | 0 | .12 | PCT | |||||||||
| 115392768 | 11539276 | 11 | C | ZINC OXIDE. | ZINC OXIDE | 1 | Rectal | UNK | 0 | CREAM | |||||||||
| 115392768 | 11539276 | 12 | C | CLOTRIMAZOLE. | CLOTRIMAZOLE | 1 | Topical | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115392768 | 11539276 | 1 | Metastatic renal cell carcinoma |
| 115392768 | 11539276 | 5 | Prostatomegaly |
| 115392768 | 11539276 | 6 | Hypertension |
| 115392768 | 11539276 | 8 | Hypertension |
| 115392768 | 11539276 | 10 | Mouth ulceration |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115392768 | 11539276 | HO |
| 115392768 | 11539276 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115392768 | 11539276 | Abdominal distension | |
| 115392768 | 11539276 | Asthenia | |
| 115392768 | 11539276 | Blood pressure decreased | |
| 115392768 | 11539276 | Blood urine present | |
| 115392768 | 11539276 | Decreased appetite | |
| 115392768 | 11539276 | Dehydration | |
| 115392768 | 11539276 | Diarrhoea | |
| 115392768 | 11539276 | Dry eye | |
| 115392768 | 11539276 | Dry mouth | |
| 115392768 | 11539276 | Dry skin | |
| 115392768 | 11539276 | Dysgeusia | |
| 115392768 | 11539276 | Dyspepsia | |
| 115392768 | 11539276 | Epistaxis | |
| 115392768 | 11539276 | Fatigue | |
| 115392768 | 11539276 | Gastrooesophageal reflux disease | |
| 115392768 | 11539276 | Haemoglobin decreased | |
| 115392768 | 11539276 | Haemorrhage | |
| 115392768 | 11539276 | Hair texture abnormal | |
| 115392768 | 11539276 | Hypertension | |
| 115392768 | 11539276 | Hypothyroidism | |
| 115392768 | 11539276 | Oral discomfort | |
| 115392768 | 11539276 | Oral pain | |
| 115392768 | 11539276 | Oropharyngeal plaque | |
| 115392768 | 11539276 | Platelet count abnormal | |
| 115392768 | 11539276 | Pruritus | |
| 115392768 | 11539276 | Rash | |
| 115392768 | 11539276 | Sunburn | |
| 115392768 | 11539276 | Syncope | |
| 115392768 | 11539276 | Temperature intolerance | |
| 115392768 | 11539276 | Thrombocytopenia | |
| 115392768 | 11539276 | Vitamin B12 decreased | |
| 115392768 | 11539276 | Weight decreased | |
| 115392768 | 11539276 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 115392768 | 11539276 | 1 | 20150120 | 0 | ||
| 115392768 | 11539276 | 3 | 20150512 | 0 | ||
| 115392768 | 11539276 | 4 | 20150727 | 0 |