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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126114321 | 12611432 | 1 | I | 20160702 | 20160725 | 20160801 | 20160801 | EXP | AU-PFIZER INC-2016361117 | PFIZER | 63.00 | YR | F | Y | 0.00000 | 20160801 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126114321 | 12611432 | 1 | PS | IRINOTECAN HCL | IRINOTECAN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | DAY 1 OF 14-DAY CYCLES (180 MG/M2,1 IN 14 D) | 20571 | 180 | MG/M**2 | ||||||||
| 126114321 | 12611432 | 2 | SS | IRINOTECAN HCL | IRINOTECAN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | DAY 1 OF 14-DAY CYCL ES (150 MG/M2,1 IN 14 D) | 20571 | 150 | MG/M**2 | ||||||||
| 126114321 | 12611432 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | DAY 1 OF 14-DAY CYCLES, OVER 46 HOURS (2400 MG/M2,1 IN 14 D) | 0 | 2400 | MG/M**2 | ||||||||
| 126114321 | 12611432 | 4 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | DAY 1 OF 14-DAY CYCLES, OVER 46 HOURS (1920 MG/M2,1 IN 14 D) | 0 | 1920 | MG/M**2 | ||||||||
| 126114321 | 12611432 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | DAY 1 OF 14-DAY CYCLES (400 MG/M2, 1 IN 14 D) | 0 | 400 | MG/M**2 | ||||||||
| 126114321 | 12611432 | 6 | SS | ABT-888 | VELIPARIB | 1 | Oral | DAYS -2 THROUGH 5 OF 14-DAY CYCLES (2 IN 1 D) | 0 | ||||||||||
| 126114321 | 12611432 | 7 | SS | BEVACIZUMAB | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 5 MG/KG, IMMEDIATELY PRECEDING FOLFIRI | 0 | 5 | MG/KG | ||||||||
| 126114321 | 12611432 | 8 | C | FOLINIC ACID /00566702/ | LEUCOVORIN CALCIUM | 1 | Intravenous (not otherwise specified) | DAY 1 OF 14-DAY CYCLES (400 MG/M2,1 IN 14 D) | 0 | 400 | MG/M**2 | ||||||||
| 126114321 | 12611432 | 9 | C | GLIPIZIDE. | GLIPIZIDE | 1 | Oral | 15 MG (5 MG, 3 IN 1 D) | 0 | 5 | MG | TID | |||||||
| 126114321 | 12611432 | 10 | C | GLIPIZIDE. | GLIPIZIDE | 1 | Oral | 6 MG (2 MG, 3 IN 1 D) | 0 | 2 | MG | TID | |||||||
| 126114321 | 12611432 | 11 | C | ATORVASTATIN /01326102/ | ATORVASTATIN | 1 | Oral | 80 MG, 1 IN 1 D | 0 | 80 | MG | QD | |||||||
| 126114321 | 12611432 | 12 | C | ATORVASTATIN /01326102/ | ATORVASTATIN | 1 | Oral | 40 MG, 1 IN 1 D | 0 | 40 | MG | QD | |||||||
| 126114321 | 12611432 | 13 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | Oral | 100 MG, 1 IN 1 D | 0 | 100 | MG | QD | |||||||
| 126114321 | 12611432 | 14 | C | DAPAGLIFLOZIN | DAPAGLIFLOZIN | 1 | Oral | 10 MCG, 1 IN 1 D | 0 | 100 | UG | QD | |||||||
| 126114321 | 12611432 | 15 | C | ESOMEPRAZOLE /01479302/ | ESOMEPRAZOLE | 1 | Oral | 20 MG, 1 IN 1 D | 0 | 20 | MG | QD | |||||||
| 126114321 | 12611432 | 16 | C | ENDONE | OXYCODONE HYDROCHLORIDE | 1 | Oral | 5-10 MG (AS REQUIRED) | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126114321 | 12611432 | 1 | Colorectal cancer |
| 126114321 | 12611432 | 3 | Colorectal cancer |
| 126114321 | 12611432 | 6 | Colorectal cancer |
| 126114321 | 12611432 | 7 | Colorectal cancer |
| 126114321 | 12611432 | 8 | Colorectal cancer |
| 126114321 | 12611432 | 9 | Diabetes mellitus |
| 126114321 | 12611432 | 11 | Hypercholesterolaemia |
| 126114321 | 12611432 | 13 | Prophylaxis |
| 126114321 | 12611432 | 14 | Diabetes mellitus |
| 126114321 | 12611432 | 15 | Gastrooesophageal reflux disease |
| 126114321 | 12611432 | 16 | Abdominal pain upper |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126114321 | 12611432 | DE |
| 126114321 | 12611432 | HO |
| 126114321 | 12611432 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126114321 | 12611432 | General physical health deterioration | |
| 126114321 | 12611432 | Pain |
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 |
|---|---|---|---|---|---|---|
| 126114321 | 12611432 | 1 | 20150916 | 20151111 | 0 | |
| 126114321 | 12611432 | 2 | 20151204 | 20160329 | 0 | |
| 126114321 | 12611432 | 3 | 20150916 | 20151113 | 0 | |
| 126114321 | 12611432 | 4 | 20151204 | 20160331 | 0 | |
| 126114321 | 12611432 | 5 | 20150916 | 20151111 | 0 | |
| 126114321 | 12611432 | 6 | 20150914 | 20160411 | 0 | |
| 126114321 | 12611432 | 7 | 20150930 | 20160329 | 0 | |
| 126114321 | 12611432 | 8 | 20150916 | 20160329 | 0 | |
| 126114321 | 12611432 | 9 | 201510 | 0 | ||
| 126114321 | 12611432 | 10 | 2001 | 201510 | 0 | |
| 126114321 | 12611432 | 11 | 201510 | 0 | ||
| 126114321 | 12611432 | 12 | 2001 | 201510 | 0 | |
| 126114321 | 12611432 | 13 | 2001 | 0 | ||
| 126114321 | 12611432 | 14 | 201507 | 0 | ||
| 126114321 | 12611432 | 15 | 20160203 | 0 | ||
| 126114321 | 12611432 | 16 | 20160426 | 0 |