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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126491563 | 12649156 | 3 | F | 20160711 | 20160926 | 20160812 | 20160929 | EXP | AU-PFIZER INC-2016372924 | PFIZER | 52.00 | YR | M | Y | 0.00000 | 20160929 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126491563 | 12649156 | 1 | PS | IRINOTECAN HCL | IRINOTECAN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 180 MG/M2, CYCLIC, DAY 1 OF EACH 14-DAY CYCLE | 20571 | 180 | MG/M**2 | ||||||||
| 126491563 | 12649156 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M2, CYCLIC, OVER 15 MINUTES; DAY 1 OF EACH 14-DAY CYCLE | 0 | 400 | MG/M**2 | ||||||||
| 126491563 | 12649156 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous drip | 2400 MG/M2, CYCLIC, OVER 46 HRS DAY 1 OF EACH 14-DAY CYCLE | 0 | 2400 | MG/M**2 | ||||||||
| 126491563 | 12649156 | 4 | SS | BEVACIZUMAB | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 5 MG/KG, CYCLIC, OVER 46 HRS DAY 1 OF EACH 14-DAY CYCLE | 0 | 5 | MG/KG | ||||||||
| 126491563 | 12649156 | 5 | SS | BLINDED THERAPY | INVESTIGATIONAL PRODUCT | 1 | Oral | UNK | 0 | ||||||||||
| 126491563 | 12649156 | 6 | C | LEUCOVORIN. | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 400 MG/M2, CYCLIC, DAY 1 OF EACH 14-DAY CYCLE | 0 | 400 | MG/M**2 | ||||||||
| 126491563 | 12649156 | 7 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous bolus | DAY 1 OF CHEMOTHERAPY (8 MG) | 0 | 8 | MG | ||||||||
| 126491563 | 12649156 | 8 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | TWICE / DAY FOR 2 DAYS POST CHEMOTHERAPY (8 MG) | 0 | 8 | MG | BID | |||||||
| 126491563 | 12649156 | 9 | C | ATROPINE. | ATROPINE | 1 | Intravenous bolus | (DAY 1 OF CHEMOTHERAPY 0.4 MG) | 0 | .4 | MG | ||||||||
| 126491563 | 12649156 | 10 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Oral | 30 MG (10 MG, 3 IN 1 D) | 0 | 30 | MG | ||||||||
| 126491563 | 12649156 | 11 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Oral | 30 MG (10 MG, 3 IN 1 D) | 0 | 30 | MG | ||||||||
| 126491563 | 12649156 | 12 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 225 MG, (225 MG, 1 IN 1 D) | 0 | 225 | MG | ||||||||
| 126491563 | 12649156 | 13 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 150 MG, (150 MG, 1 IN 1 D) | 0 | 150 | MG | ||||||||
| 126491563 | 12649156 | 14 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126491563 | 12649156 | 15 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126491563 | 12649156 | 16 | C | ENDONE | OXYCODONE HYDROCHLORIDE | 1 | Oral | 10 MG (5 MG,2 IN 1 D) | 0 | 10 | MG | ||||||||
| 126491563 | 12649156 | 17 | C | PANADOL | ACETAMINOPHEN | 1 | Oral | (1000 MG,AS REQUIRED) | 0 | 1000 | MG | ||||||||
| 126491563 | 12649156 | 18 | C | TEMAZEPAM. | TEMAZEPAM | 1 | Oral | 10-20 MG (AS REQUIRED) | 0 | ||||||||||
| 126491563 | 12649156 | 19 | C | FENTANYL TRANSDERMAL SYSTEM | FENTANYL | 1 | Transdermal | (100 MG,2 IN 1 WK) | 0 | 100 | MG | ||||||||
| 126491563 | 12649156 | 20 | C | DICLOFENAC | DICLOFENAC | 1 | Oral | (50 MG,AS REQUIRED) | 0 | 50 | MG | ||||||||
| 126491563 | 12649156 | 21 | C | DICLOFENAC | DICLOFENAC | 1 | 0 | ||||||||||||
| 126491563 | 12649156 | 22 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Subcutaneous | 70 MG, UNK | 0 | 70 | MG | ||||||||
| 126491563 | 12649156 | 23 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Subcutaneous | (80 MG,2 IN 1 D) | 0 | 80 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126491563 | 12649156 | 1 | Colorectal cancer |
| 126491563 | 12649156 | 2 | Colorectal cancer |
| 126491563 | 12649156 | 4 | Colorectal cancer |
| 126491563 | 12649156 | 5 | Colorectal cancer |
| 126491563 | 12649156 | 6 | Colorectal cancer |
| 126491563 | 12649156 | 7 | Chemotherapy |
| 126491563 | 12649156 | 8 | Prophylaxis of nausea and vomiting |
| 126491563 | 12649156 | 9 | Chemotherapy |
| 126491563 | 12649156 | 10 | Nausea |
| 126491563 | 12649156 | 11 | Vomiting |
| 126491563 | 12649156 | 12 | Anxiety |
| 126491563 | 12649156 | 13 | Hiccups |
| 126491563 | 12649156 | 14 | Depression |
| 126491563 | 12649156 | 15 | Electrocardiogram QT prolonged |
| 126491563 | 12649156 | 16 | Abdominal pain |
| 126491563 | 12649156 | 17 | Abdominal pain |
| 126491563 | 12649156 | 18 | Insomnia |
| 126491563 | 12649156 | 19 | Abdominal pain |
| 126491563 | 12649156 | 20 | Analgesic therapy |
| 126491563 | 12649156 | 21 | Back pain |
| 126491563 | 12649156 | 22 | Pulmonary embolism |
| 126491563 | 12649156 | 23 | Pulmonary embolism |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126491563 | 12649156 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126491563 | 12649156 | 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 |
|---|---|---|---|---|---|---|
| 126491563 | 12649156 | 1 | 20150805 | 0 | ||
| 126491563 | 12649156 | 2 | 20150805 | 0 | ||
| 126491563 | 12649156 | 3 | 20150805 | 0 | ||
| 126491563 | 12649156 | 4 | 20150805 | 0 | ||
| 126491563 | 12649156 | 5 | 20150803 | 0 | ||
| 126491563 | 12649156 | 6 | 20150805 | 0 | ||
| 126491563 | 12649156 | 7 | 20150705 | 0 | ||
| 126491563 | 12649156 | 8 | 20150806 | 0 | ||
| 126491563 | 12649156 | 9 | 20150705 | 0 | ||
| 126491563 | 12649156 | 10 | 20150722 | 0 | ||
| 126491563 | 12649156 | 11 | 20150722 | 0 | ||
| 126491563 | 12649156 | 12 | 20151125 | 20160712 | 0 | |
| 126491563 | 12649156 | 13 | 20160712 | 0 | ||
| 126491563 | 12649156 | 16 | 20150703 | 0 | ||
| 126491563 | 12649156 | 17 | 20151230 | 0 | ||
| 126491563 | 12649156 | 18 | 20150907 | 0 | ||
| 126491563 | 12649156 | 19 | 20151230 | 0 | ||
| 126491563 | 12649156 | 20 | 20150828 | 0 | ||
| 126491563 | 12649156 | 22 | 20160208 | 20160627 | 0 | |
| 126491563 | 12649156 | 23 | 20160321 | 0 |