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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127360691 | 12736069 | 1 | I | 20121227 | 20130205 | 20160913 | 20160913 | EXP | US-ROCHE-1188075 | ROCHE | 64.00 | YR | M | Y | 113.40000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127360691 | 12736069 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE: 21/DEC/2012 | 125085 | 15 | MG/KG | ||||||||
| 127360691 | 12736069 | 2 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 125085 | 1370 | MG | |||||||||
| 127360691 | 12736069 | 3 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 125085 | 1460 | MG | |||||||||
| 127360691 | 12736069 | 4 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 125085 | 1260 | MG | |||||||||
| 127360691 | 12736069 | 5 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 125085 | 1700 | MG | |||||||||
| 127360691 | 12736069 | 6 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 125085 | 1550 | MG | |||||||||
| 127360691 | 12736069 | 7 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 125085 | 1430 | MG | |||||||||
| 127360691 | 12736069 | 8 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 125085 | 1400 | MG | |||||||||
| 127360691 | 12736069 | 9 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE: 21/DEC/2012 | 0 | 75 | MG/M**2 | ||||||||
| 127360691 | 12736069 | 10 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 0 | 154 | MG | |||||||||
| 127360691 | 12736069 | 11 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 0 | 149 | MG | |||||||||
| 127360691 | 12736069 | 12 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 0 | 169 | MG | |||||||||
| 127360691 | 12736069 | 13 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 0 | 162 | MG | |||||||||
| 127360691 | 12736069 | 14 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 0 | 157 | MG | |||||||||
| 127360691 | 12736069 | 15 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 0 | 155 | MG | |||||||||
| 127360691 | 12736069 | 16 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | LAST DOSE PRIOR TO SAE: 08/JAN/2013 | 0 | 5 | MG | BID | |||||||
| 127360691 | 12736069 | 17 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 105 | MG | |||||||||
| 127360691 | 12736069 | 18 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 210 | MG | |||||||||
| 127360691 | 12736069 | 19 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 105 | MG | |||||||||
| 127360691 | 12736069 | 20 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 220 | MG | |||||||||
| 127360691 | 12736069 | 21 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 180 | MG | |||||||||
| 127360691 | 12736069 | 22 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 210 | MG | |||||||||
| 127360691 | 12736069 | 23 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 240 | MG | |||||||||
| 127360691 | 12736069 | 24 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Oral | LAST DOSE PRIOR TO SAE:03/JAN/2013 | Y | 0 | 25 | MG | |||||||
| 127360691 | 12736069 | 25 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Unknown | Y | 0 | ||||||||||
| 127360691 | 12736069 | 26 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Oral | Y | 0 | 350 | MG | ||||||||
| 127360691 | 12736069 | 27 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Oral | Y | 0 | 350 | MG | ||||||||
| 127360691 | 12736069 | 28 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Oral | Y | 0 | 350 | MG | ||||||||
| 127360691 | 12736069 | 29 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Oral | Y | 0 | 350 | MG | ||||||||
| 127360691 | 12736069 | 30 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Oral | Y | 0 | 200 | MG | ||||||||
| 127360691 | 12736069 | 31 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Oral | Y | 0 | 325 | MG | ||||||||
| 127360691 | 12736069 | 32 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Oral | Y | 0 | 275 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127360691 | 12736069 | 1 | Prostate cancer |
| 127360691 | 12736069 | 9 | Prostate cancer |
| 127360691 | 12736069 | 16 | Prostate cancer |
| 127360691 | 12736069 | 24 | Prostate cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127360691 | 12736069 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127360691 | 12736069 | Cataract | |
| 127360691 | 12736069 | Decreased appetite | |
| 127360691 | 12736069 | Dental caries | |
| 127360691 | 12736069 | Diarrhoea | |
| 127360691 | 12736069 | Hypertension | |
| 127360691 | 12736069 | Neutrophil count decreased | |
| 127360691 | 12736069 | Weight 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 |
|---|---|---|---|---|---|---|
| 127360691 | 12736069 | 1 | 20101221 | 0 | ||
| 127360691 | 12736069 | 2 | 20130204 | 0 | ||
| 127360691 | 12736069 | 3 | 20121001 | 0 | ||
| 127360691 | 12736069 | 4 | 20130520 | 0 | ||
| 127360691 | 12736069 | 5 | 20110131 | 0 | ||
| 127360691 | 12736069 | 6 | 20110718 | 0 | ||
| 127360691 | 12736069 | 7 | 20120326 | 0 | ||
| 127360691 | 12736069 | 8 | 20121221 | 0 | ||
| 127360691 | 12736069 | 9 | 20101221 | 0 | ||
| 127360691 | 12736069 | 10 | 20130204 | 0 | ||
| 127360691 | 12736069 | 11 | 20130520 | 0 | ||
| 127360691 | 12736069 | 12 | 20110131 | 0 | ||
| 127360691 | 12736069 | 13 | 20110718 | 0 | ||
| 127360691 | 12736069 | 14 | 20120326 | 0 | ||
| 127360691 | 12736069 | 15 | 20121221 | 0 | ||
| 127360691 | 12736069 | 16 | 20101221 | 0 | ||
| 127360691 | 12736069 | 17 | 20130204 | 0 | ||
| 127360691 | 12736069 | 18 | 20121001 | 0 | ||
| 127360691 | 12736069 | 19 | 20130520 | 0 | ||
| 127360691 | 12736069 | 20 | 20110131 | 0 | ||
| 127360691 | 12736069 | 21 | 20110718 | 0 | ||
| 127360691 | 12736069 | 22 | 20120326 | 0 | ||
| 127360691 | 12736069 | 23 | 20121221 | 0 | ||
| 127360691 | 12736069 | 24 | 20101221 | 20101227 | 0 | |
| 127360691 | 12736069 | 25 | 20121229 | 0 | ||
| 127360691 | 12736069 | 26 | 20130204 | 0 | ||
| 127360691 | 12736069 | 27 | 20121001 | 0 | ||
| 127360691 | 12736069 | 28 | 20130520 | 0 | ||
| 127360691 | 12736069 | 29 | 20110131 | 0 | ||
| 127360691 | 12736069 | 30 | 20110718 | 0 | ||
| 127360691 | 12736069 | 31 | 20120326 | 0 | ||
| 127360691 | 12736069 | 32 | 20121221 | 0 |