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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 82373662 | 8237366 | 2 | F | 20110626 | 20160823 | 20111109 | 20160919 | EXP | US-ROCHE-798074 | ROCHE | 71.70 | YR | M | Y | 66.40000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 82373662 | 8237366 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE:14 JUN 2011, IV OVER 30-90 MINUTES ON DAY 1. | 125085 | 15 | MG/KG | SOLUTION FOR INFUSION | |||||||
| 82373662 | 8237366 | 2 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Oral | QD, ON DAYS 1-14. LAST DOSE PRIOR TO SAE ON 27 JUN 2011. | 0 | ||||||||||
| 82373662 | 8237366 | 3 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Oral | DELAYED FOR 7 DAYS. TOTAL DOSE 275 MG | 0 | ||||||||||
| 82373662 | 8237366 | 4 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | OVER 60 MINUTES ON DAY 1. LAST DOSE PRIOR TO SAE ON 14 JUN 2011. | 0 | 125 | MG | ||||||||
| 82373662 | 8237366 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | LAST DOSE 11/JUL/2011 | 0 | BID | |||||||||
| 82373662 | 8237366 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | TOTAL DOSE 27.5 MG, DELAYED 7 DAYS | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 82373662 | 8237366 | 1 | Prostate cancer metastatic |
| 82373662 | 8237366 | 2 | Prostate cancer metastatic |
| 82373662 | 8237366 | 4 | Prostate cancer metastatic |
| 82373662 | 8237366 | 5 | Prostate cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 82373662 | 8237366 | LT |
| 82373662 | 8237366 | HO |
| 82373662 | 8237366 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 82373662 | 8237366 | Acute kidney injury | |
| 82373662 | 8237366 | Anaemia | |
| 82373662 | 8237366 | Blood creatinine increased | |
| 82373662 | 8237366 | Haematuria | |
| 82373662 | 8237366 | Hypoalbuminaemia | |
| 82373662 | 8237366 | Neutrophil count decreased | |
| 82373662 | 8237366 | Sepsis | |
| 82373662 | 8237366 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 82373662 | 8237366 | 4 | 20100712 | 0 | ||
| 82373662 | 8237366 | 5 | 20100712 | 0 | ||
| 82373662 | 8237366 | 6 | 20110722 | 0 |