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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106743814 | 10674381 | 4 | F | 201410 | 20160921 | 20141224 | 20160927 | PER | US-PFIZER INC-2014351755 | PFIZER | 79.00 | YR | F | Y | 59.00000 | KG | 20160927 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106743814 | 10674381 | 1 | PS | SUTENT | SUNITINIB MALATE | 1 | 25 MG, CYCLIC, 28 DAYS ON 14 DAYS OFF | Y | 21938 | 25 | MG | CAPSULE, HARD | |||||||
| 106743814 | 10674381 | 2 | SS | SUTENT | SUNITINIB MALATE | 1 | Oral | 37.5 MG, 1X/DAY | Y | X731A | 21938 | 37.5 | MG | CAPSULE, HARD | QD | ||||
| 106743814 | 10674381 | 3 | SS | SUTENT | SUNITINIB MALATE | 1 | Oral | 25 MG, 1X/DAY (ALTERNATE 25MG WITH 37.5 MG EVERY OTHER DAY FOR CYCLE #4) | Y | 21938 | 25 | MG | CAPSULE, HARD | QD | |||||
| 106743814 | 10674381 | 4 | SS | SUTENT | SUNITINIB MALATE | 1 | Oral | 37.5 MG, CYCLIC (TAKE 1 CAP BY MOUTH DAILY. DAILY FOR 28 DAYS THEN OFF FOR 14) | Y | 21938 | 37.5 | MG | CAPSULE, HARD | ||||||
| 106743814 | 10674381 | 5 | SS | SUTENT | SUNITINIB MALATE | 1 | Oral | 37.5 MG, CYCLIC [ONCE A DAY FOR 28 DAYS, THEN 2 WEEKS OFF, THEN STARTED CYCLE OVER] | Y | 21938 | 37.5 | MG | CAPSULE, HARD | ||||||
| 106743814 | 10674381 | 6 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 20 MG, 1X/DAY | 0 | 20 | MG | TABLET | QD | ||||||
| 106743814 | 10674381 | 7 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 5 MG, 1X/DAY | 0 | 5 | MG | TABLET | QD | ||||||
| 106743814 | 10674381 | 8 | C | LORAZEPAM. | LORAZEPAM | 1 | Oral | 0.5 MG, AS NEEDED | 0 | .5 | MG | TABLET | |||||||
| 106743814 | 10674381 | 9 | C | BETAMETHASONE VALERATE. | BETAMETHASONE VALERATE | 1 | 0.1 %, AS NEEDED (TWO TIMES A DAY) | 0 | .1 | PCT | CREAM | ||||||||
| 106743814 | 10674381 | 10 | C | CALCIUM VITAMIN D3 | 2 | Oral | 1 DF, 1X/DAY | 0 | 1 | DF | TABLET | QD | |||||||
| 106743814 | 10674381 | 11 | C | ATIVAN | LORAZEPAM | 1 | Oral | 0.5 MG, AS NEEDED (EVERY 6 HOURS AS NEEDED) | 0 | .5 | MG | TABLET | |||||||
| 106743814 | 10674381 | 12 | C | VITAMIN A | VITAMIN A | 1 | Oral | 10000 IU, DAILY | 0 | 10000 | IU | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 106743814 | 10674381 | 1 | Renal cancer metastatic |
| 106743814 | 10674381 | 6 | Blood pressure increased |
| 106743814 | 10674381 | 7 | Blood pressure increased |
| 106743814 | 10674381 | 8 | Anxiety |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106743814 | 10674381 | Alanine aminotransferase increased | |
| 106743814 | 10674381 | Aspartate aminotransferase increased | |
| 106743814 | 10674381 | Blood pressure increased | |
| 106743814 | 10674381 | Hypertension | |
| 106743814 | 10674381 | Liver function test increased | |
| 106743814 | 10674381 | Neoplasm progression | |
| 106743814 | 10674381 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 106743814 | 10674381 | 1 | 20140816 | 0 | ||
| 106743814 | 10674381 | 2 | 20141108 | 20141122 | 0 | |
| 106743814 | 10674381 | 3 | 20140919 | 0 | ||
| 106743814 | 10674381 | 5 | 2014 | 20160907 | 0 | |
| 106743814 | 10674381 | 6 | 201410 | 0 | ||
| 106743814 | 10674381 | 7 | 201410 | 0 |