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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127361991 | 12736199 | 1 | I | 20160823 | 20160913 | 20160913 | EXP | US-ROCHE-1828605 | ROCHE | 72.00 | YR | M | Y | 71.60000 | KG | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127361991 | 12736199 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 15 MG/KG CYCLE 1 DAY 1, REPEATED EVERY 21 DAYS (AS PER PROTOCOL)?COURSE ID 2 | U | 125085 | SOLUTION FOR INFUSION | ||||||||
| 127361991 | 12736199 | 2 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | COURSE ID 2 | U | 125085 | 1070 | MG | |||||||
| 127361991 | 12736199 | 3 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | COURSE ID 3 | U | 125085 | 1070 | MG | |||||||
| 127361991 | 12736199 | 4 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | COURSE ID 4 | U | 125085 | 1070 | MG | |||||||
| 127361991 | 12736199 | 5 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | COURSE ID 5 | U | 125085 | 1070 | MG | |||||||
| 127361991 | 12736199 | 6 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | COURSE ID 6 | U | 125085 | 1070 | MG | |||||||
| 127361991 | 12736199 | 7 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 75 MG/M2 IV OVER 60 MINUTES ON CYCLE 1 DAY 1, REPEATED EVERY 21 DAYS (AS PER PROTOCOL)?COURSE ID 1 | U | 0 | 136 | MG | |||||||
| 127361991 | 12736199 | 8 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | COURSE ID 2 | U | 0 | 136 | MG | |||||||
| 127361991 | 12736199 | 9 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | COURSE ID 3 | U | 0 | 136 | MG | |||||||
| 127361991 | 12736199 | 10 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | COURSE ID 4 | U | 0 | 136 | MG | |||||||
| 127361991 | 12736199 | 11 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | COURSE ID 5 | U | 0 | 136 | MG | |||||||
| 127361991 | 12736199 | 12 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | COURSE ID 6 | U | 0 | 137 | MG | |||||||
| 127361991 | 12736199 | 13 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 10 MG ORALLY EVERY DAY (AS PER PROTOCOL) | U | 0 | 270 | MG | QD | ||||||
| 127361991 | 12736199 | 14 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | COURSE ID 2 | U | 0 | 210 | MG | |||||||
| 127361991 | 12736199 | 15 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | COURSE ID 3 | U | 0 | 210 | MG | |||||||
| 127361991 | 12736199 | 16 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | COURSE ID 4 | U | 0 | 210 | MG | |||||||
| 127361991 | 12736199 | 17 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | COURSE ID 5 | U | 0 | 210 | MG | |||||||
| 127361991 | 12736199 | 18 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | COURSE ID 6 | U | 0 | 220 | MG | |||||||
| 127361991 | 12736199 | 19 | SS | Lenalidomide | LENALIDOMIDE | 1 | Oral | ONCE DAILY DAYS 1-14 OF EVERY 21 (AS PER PROTOCOL)?COURSE ID 1 | U | 0 | 325 | MG | |||||||
| 127361991 | 12736199 | 20 | SS | Lenalidomide | LENALIDOMIDE | 1 | Oral | COURSE ID 3 | U | 0 | 280 | MG | |||||||
| 127361991 | 12736199 | 21 | SS | Lenalidomide | LENALIDOMIDE | 1 | Oral | COURSE ID 4 | U | 0 | 280 | MG | |||||||
| 127361991 | 12736199 | 22 | SS | Lenalidomide | LENALIDOMIDE | 1 | Oral | COURSE ID 5 | U | 0 | 280 | MG | |||||||
| 127361991 | 12736199 | 23 | SS | Lenalidomide | LENALIDOMIDE | 1 | Oral | COURSE ID 6 | U | 0 | 280 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127361991 | 12736199 | 1 | Prostate cancer |
| 127361991 | 12736199 | 7 | Prostate cancer |
| 127361991 | 12736199 | 13 | Prostate cancer |
| 127361991 | 12736199 | 19 | Prostate cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127361991 | 12736199 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127361991 | 12736199 | Alanine aminotransferase increased |
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 |
|---|---|---|---|---|---|---|
| 127361991 | 12736199 | 1 | 20110222 | 0 | ||
| 127361991 | 12736199 | 2 | 20110321 | 0 | ||
| 127361991 | 12736199 | 3 | 20110411 | 0 | ||
| 127361991 | 12736199 | 4 | 20110502 | 0 | ||
| 127361991 | 12736199 | 5 | 20110523 | 0 | ||
| 127361991 | 12736199 | 6 | 20110613 | 20110707 | 0 | |
| 127361991 | 12736199 | 7 | 20110222 | 0 | ||
| 127361991 | 12736199 | 8 | 20110321 | 0 | ||
| 127361991 | 12736199 | 9 | 20110411 | 0 | ||
| 127361991 | 12736199 | 10 | 20110502 | 0 | ||
| 127361991 | 12736199 | 11 | 20110523 | 0 | ||
| 127361991 | 12736199 | 12 | 20110313 | 20110707 | 0 | |
| 127361991 | 12736199 | 13 | 20110222 | 0 | ||
| 127361991 | 12736199 | 15 | 20110411 | 0 | ||
| 127361991 | 12736199 | 16 | 20110502 | 0 | ||
| 127361991 | 12736199 | 17 | 20110523 | 0 | ||
| 127361991 | 12736199 | 18 | 20110613 | 20110707 | 0 | |
| 127361991 | 12736199 | 19 | 20110222 | 0 | ||
| 127361991 | 12736199 | 20 | 20110411 | 0 | ||
| 127361991 | 12736199 | 21 | 20110502 | 0 | ||
| 127361991 | 12736199 | 22 | 20110523 | 0 | ||
| 127361991 | 12736199 | 23 | 20110613 | 20110707 | 0 |