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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104009286 | 10400928 | 6 | F | 20160912 | 20140821 | 20160916 | EXP | DE-ROCHE-1452727 | ROCHE | , STINTZING S, FISCHER VON WEIKERSTHAL L, DECKER T, KIANI A, VEHLING-KAISER U, AL BATRAN S, HEINTGES T, LERCHENMULLER C, KAHL C, SEIPELT G, KULLMANN F, STAUCH M, SCHEITHAUER W, HELD S, GIESSEN C, JUNG A, KIRCHNER R AND HEINEMANN V 2ND-LINE THERAPIES AFTER 1ST-LINE THERAPY WITH FOLFIRI IN COMBINATION WITH CETUXIMAB OR BEVACIZUMAB IN PATIENTS WITH KRAS WILD-TYPE METASTATIC COLORECTAL CANCER (MCRC)-ANALYSIS OF THE AIO KRK 0306 (FIRE 3)-TRIAL. ANNALS OF ONCOLOGY 2014 JUN;25 (SUPP2):II112-. | 0.00 | Y | 0.00000 | 20160916 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104009286 | 10400928 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | OVER 90 MIN | U | 125085 | 5 | MG/KG | SOLUTION FOR INFUSION | BIW | |||||
| 104009286 | 10400928 | 2 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125085 | 5 | MG/KG | ||||||||
| 104009286 | 10400928 | 3 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125085 | 5 | MG/KG | INFUSION | QOW | ||||||
| 104009286 | 10400928 | 4 | SS | FOLINIC ACID | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | U | 0 | 400 | MG/M**2 | INFUSION | |||||||
| 104009286 | 10400928 | 5 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | U | 0 | 180 | MG/M**2 | INFUSION | |||||||
| 104009286 | 10400928 | 6 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | U | 0 | 400 | MG/M**2 | ||||||||
| 104009286 | 10400928 | 7 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous drip | U | 0 | 2400 | MG/M**2 | INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104009286 | 10400928 | 1 | Colorectal cancer metastatic |
| 104009286 | 10400928 | 4 | Colorectal cancer metastatic |
| 104009286 | 10400928 | 5 | Colorectal cancer metastatic |
| 104009286 | 10400928 | 6 | Colorectal cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104009286 | 10400928 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104009286 | 10400928 | Abdominal wall haematoma | |
| 104009286 | 10400928 | Activated partial thromboplastin time prolonged | |
| 104009286 | 10400928 | Amenorrhoea | |
| 104009286 | 10400928 | Cardiac failure | |
| 104009286 | 10400928 | Cerebral ischaemia | |
| 104009286 | 10400928 | Cholangitis | |
| 104009286 | 10400928 | Dehydration | |
| 104009286 | 10400928 | Device related infection | |
| 104009286 | 10400928 | Dyspnoea exertional | |
| 104009286 | 10400928 | Febrile neutropenia | |
| 104009286 | 10400928 | Flatulence | |
| 104009286 | 10400928 | Gamma-glutamyltransferase increased | |
| 104009286 | 10400928 | Gastrointestinal perforation | |
| 104009286 | 10400928 | Hemiparesis | |
| 104009286 | 10400928 | Hyperhidrosis | |
| 104009286 | 10400928 | Hypermagnesaemia | |
| 104009286 | 10400928 | Hypernatraemia | |
| 104009286 | 10400928 | Hyponatraemia | |
| 104009286 | 10400928 | Hypotension | |
| 104009286 | 10400928 | Ileus | |
| 104009286 | 10400928 | Impaired healing | |
| 104009286 | 10400928 | Infected fistula | |
| 104009286 | 10400928 | Inflammatory marker increased | |
| 104009286 | 10400928 | Ligament rupture | |
| 104009286 | 10400928 | Mental disorder | |
| 104009286 | 10400928 | Metastasis | |
| 104009286 | 10400928 | Myocardial ischaemia | |
| 104009286 | 10400928 | Neurotoxicity | |
| 104009286 | 10400928 | Proteinuria | |
| 104009286 | 10400928 | Sepsis | |
| 104009286 | 10400928 | Speech disorder | |
| 104009286 | 10400928 | Subileus | |
| 104009286 | 10400928 | Tumour perforation | |
| 104009286 | 10400928 | VIth nerve paralysis | |
| 104009286 | 10400928 | Weight increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |