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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127975691 | 12797569 | 1 | I | 20100915 | 20110607 | 20160930 | 20160930 | EXP | US-ROCHE-784723 | ROCHE | 75.04 | YR | F | Y | 71.40000 | KG | 20160930 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127975691 | 12797569 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | CYCLE 21 DAYS: OVER 30-90 MINUTES ON DAY 1.?COURSE ID 1 | U | 125085 | 15 | MG/KG | SOLUTION FOR INFUSION | ||||||
| 127975691 | 12797569 | 2 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | CYCLE 7 PLUS: OVER 30-90 MINUTE ON DAY 1 | U | 125085 | 15 | MG/KG | |||||||
| 127975691 | 12797569 | 3 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | OVER 30-90 MINUTES ON DAY 1.?COURSE ID 2 | U | 125085 | 1193 | MG | SOLUTION FOR INFUSION | ||||||
| 127975691 | 12797569 | 4 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | OVER 30-90 MINUTES ON DAY 1.?COURSE ID 3 | U | 125085 | 1193 | MG | SOLUTION FOR INFUSION | ||||||
| 127975691 | 12797569 | 5 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | OVER 30-90 MINUTES ON DAY 1.?COURSE ID 4 | U | 125085 | 1193 | MG | SOLUTION FOR INFUSION | ||||||
| 127975691 | 12797569 | 6 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | OVER 30-90 MINUTES ON DAY 1.?COURSE ID 5 | U | 125085 | 1193 | MG | SOLUTION FOR INFUSION | ||||||
| 127975691 | 12797569 | 7 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | OVER 30-90 MINUTES ON DAY 1.?COURSE ID 6 | U | 125085 | 1070 | MG | SOLUTION FOR INFUSION | ||||||
| 127975691 | 12797569 | 8 | SS | IXABEPILONE | IXABEPILONE | 1 | Intravenous (not otherwise specified) | OVER 1 HOUR ON DAY 1 TO 6 CYCLES.?COURSE ID 1 | U | 0 | 57 | MG | |||||||
| 127975691 | 12797569 | 9 | SS | IXABEPILONE | IXABEPILONE | 1 | Intravenous (not otherwise specified) | OVER 1 HOUR ON DAY 1 TO 6 CYCLES.?COURSE ID 2 | U | 0 | 57 | MG | |||||||
| 127975691 | 12797569 | 10 | SS | IXABEPILONE | IXABEPILONE | 1 | Intravenous (not otherwise specified) | OVER 1 HOUR ON DAY 1 TO 6 CYCLES.?COURSE ID 3 | U | 0 | 57 | MG | |||||||
| 127975691 | 12797569 | 11 | SS | IXABEPILONE | IXABEPILONE | 1 | Intravenous (not otherwise specified) | OVER 1 HOUR ON DAY 1 TO 6 CYCLES.?COURSE ID 4 | U | 0 | 57 | MG | |||||||
| 127975691 | 12797569 | 12 | SS | IXABEPILONE | IXABEPILONE | 1 | Intravenous (not otherwise specified) | OVER 1 HOUR ON DAY 1 TO 6 CYCLES.?COURSE ID 5 | U | 0 | 57 | MG | |||||||
| 127975691 | 12797569 | 13 | SS | IXABEPILONE | IXABEPILONE | 1 | Intravenous (not otherwise specified) | OVER 1 HOUR ON DAY 1 TO 6 CYCLES.?COURSE ID 6 | U | 0 | 55 | MG | |||||||
| 127975691 | 12797569 | 14 | SS | LOVENOX | ENOXAPARIN SODIUM | 1 | Unknown | U | 0 | 80 | MG | BID | |||||||
| 127975691 | 12797569 | 15 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | DOSE: AUC-6 OVER 30 MINUTES ON DAY 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127975691 | 12797569 | 1 | Endometrial cancer |
| 127975691 | 12797569 | 8 | Endometrial cancer |
| 127975691 | 12797569 | 14 | Product used for unknown indication |
| 127975691 | 12797569 | 15 | Endometrial cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127975691 | 12797569 | HO |
| 127975691 | 12797569 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127975691 | 12797569 | Acidosis | |
| 127975691 | 12797569 | Anaemia | |
| 127975691 | 12797569 | Blood bilirubin increased | |
| 127975691 | 12797569 | Hypoalbuminaemia | |
| 127975691 | 12797569 | Hypocalcaemia | |
| 127975691 | 12797569 | Hypokalaemia | |
| 127975691 | 12797569 | Hyponatraemia | |
| 127975691 | 12797569 | Hypophosphataemia | |
| 127975691 | 12797569 | Neutrophil count decreased | |
| 127975691 | 12797569 | Pelvic infection | |
| 127975691 | 12797569 | Platelet count decreased | |
| 127975691 | 12797569 | Rectal haemorrhage | |
| 127975691 | 12797569 | Sepsis | |
| 127975691 | 12797569 | 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 |
|---|---|---|---|---|---|---|
| 127975691 | 12797569 | 7 | 20100824 | 20100824 | 0 | |
| 127975691 | 12797569 | 13 | 20100824 | 20100824 | 0 | |
| 127975691 | 12797569 | 15 | 20100504 | 0 |