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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126523501 | 12652350 | 1 | I | 20160711 | 20160803 | 20160815 | 20160815 | EXP | AU-TEVA-683040ISR | TEVA | 52.00 | YR | M | Y | 0.00000 | 20160815 | OT | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126523501 | 12652350 | 1 | PS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | DAY 1 OF EACH 14-DAY CYCLE | 78122 | 180 | MG/M**2 | ||||||||
| 126523501 | 12652350 | 2 | SS | ABT-888 | VELIPARIB | 1 | Oral | DAYN -2 THRU 5 OF EACH 14 DAY CYCLE (2 IN 1 D) | 0 | ||||||||||
| 126523501 | 12652350 | 3 | SS | 5-FLUOROURACIL | FLUOROURACIL | 1 | Intravenous bolus | OVER I5 MINUTES;BAY 1 OF EACH 14-DAY CYCLE | 0 | 400 | MG/M**2 | ||||||||
| 126523501 | 12652350 | 4 | SS | 5-FLUOROURACIL | FLUOROURACIL | 1 | Intravenous drip | OVER 46 HRS DAY 1 OF EACH 14-DAY CYCLE | 0 | 2400 | MG/M**2 | ||||||||
| 126523501 | 12652350 | 5 | SS | BEVACIZUMAB | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | DAY 1 OF EACH 14-DAY CYCLE | 0 | 5 | MG/KG | ||||||||
| 126523501 | 12652350 | 6 | C | LEUCOVORIN. | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | DAY 1 OF EACH 14 DAYS CYCLE | 0 | 400 | MG/M**2 | ||||||||
| 126523501 | 12652350 | 7 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | DAY 1 OF CHEMOTHERAPY | 0 | 8 | MG | ||||||||
| 126523501 | 12652350 | 8 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | TWICE/DAY FOR 2 DAYS POST CHEMOTHERAPY | 0 | 8 | MG | ||||||||
| 126523501 | 12652350 | 9 | C | ATROPINE. | ATROPINE | 1 | Intravenous bolus | DAY 1 OF CHEMOTHERAPY | 0 | .4 | MG | ||||||||
| 126523501 | 12652350 | 10 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Oral | 30 MILLIGRAM DAILY; | 0 | 10 | MG | TID | |||||||
| 126523501 | 12652350 | 11 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | 0 | ||||||||||||
| 126523501 | 12652350 | 12 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 225 MILLIGRAM DAILY; | 0 | 225 | MG | QD | |||||||
| 126523501 | 12652350 | 13 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 150 MILLIGRAM DAILY; | 0 | 150 | MG | QD | |||||||
| 126523501 | 12652350 | 14 | C | ENDONE | OXYCODONE HYDROCHLORIDE | 1 | Oral | 10 MILLIEQUIVALENTS DAILY; | 0 | 5 | MEQ | BID | |||||||
| 126523501 | 12652350 | 15 | C | PANAD0L | 2 | 1200 MILLIGRAM DAILY; AS REQUIRED | 0 | ||||||||||||
| 126523501 | 12652350 | 16 | C | TEMAZEPAM. | TEMAZEPAM | 1 | Oral | 10-20 MG DAILY (AN REQUIRED) | 0 | ||||||||||
| 126523501 | 12652350 | 17 | C | FENTANYL TRANSDERMAL SYSTEM | FENTANYL | 1 | Transdermal | 28.5714 MILLIGRAM DAILY; | 0 | 100 | MG | TRANSDERMAL PATCH | BIW | ||||||
| 126523501 | 12652350 | 18 | C | DICLOFENAC | DICLOFENAC | 1 | Oral | AS REQUIRED | 0 | 50 | MG | ||||||||
| 126523501 | 12652350 | 19 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Subcutaneous | 70 MILLIGRAM DAILY; | 0 | ||||||||||
| 126523501 | 12652350 | 20 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Subcutaneous | 80 MILLIGRAM DAILY; | 0 | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126523501 | 12652350 | 1 | Colorectal cancer |
| 126523501 | 12652350 | 2 | Colorectal cancer |
| 126523501 | 12652350 | 3 | Colorectal cancer |
| 126523501 | 12652350 | 5 | Colorectal cancer |
| 126523501 | 12652350 | 6 | Colorectal cancer |
| 126523501 | 12652350 | 7 | Chemotherapy |
| 126523501 | 12652350 | 8 | Prophylaxis of nausea and vomiting |
| 126523501 | 12652350 | 9 | Chemotherapy |
| 126523501 | 12652350 | 10 | Nausea |
| 126523501 | 12652350 | 11 | Vomiting |
| 126523501 | 12652350 | 12 | Anxiety |
| 126523501 | 12652350 | 13 | Depression |
| 126523501 | 12652350 | 14 | Abdominal pain |
| 126523501 | 12652350 | 15 | Abdominal pain |
| 126523501 | 12652350 | 16 | Insomnia |
| 126523501 | 12652350 | 17 | Abdominal pain |
| 126523501 | 12652350 | 18 | Back pain |
| 126523501 | 12652350 | 19 | Pulmonary embolism |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126523501 | 12652350 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126523501 | 12652350 | Hypokalaemia |
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 |
|---|---|---|---|---|---|---|
| 126523501 | 12652350 | 1 | 20150805 | 0 | ||
| 126523501 | 12652350 | 2 | 20150803 | 0 | ||
| 126523501 | 12652350 | 3 | 20150805 | 0 | ||
| 126523501 | 12652350 | 4 | 20150805 | 0 | ||
| 126523501 | 12652350 | 5 | 20150805 | 0 | ||
| 126523501 | 12652350 | 7 | 20150705 | 0 | ||
| 126523501 | 12652350 | 8 | 20150806 | 0 | ||
| 126523501 | 12652350 | 9 | 20150705 | 0 | ||
| 126523501 | 12652350 | 10 | 20150722 | 0 | ||
| 126523501 | 12652350 | 12 | 20151125 | 20160712 | 0 | |
| 126523501 | 12652350 | 13 | 20160712 | 0 | ||
| 126523501 | 12652350 | 14 | 20150703 | 0 | ||
| 126523501 | 12652350 | 15 | 20151230 | 0 | ||
| 126523501 | 12652350 | 16 | 20150907 | 0 | ||
| 126523501 | 12652350 | 17 | 20151230 | 0 | ||
| 126523501 | 12652350 | 18 | 20150828 | 0 | ||
| 126523501 | 12652350 | 19 | 20160208 | 20160627 | 0 | |
| 126523501 | 12652350 | 20 | 20160627 | 0 |