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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126791842 | 12679184 | 2 | F | 20160817 | 20160824 | 20160831 | EXP | JP-MLMSERVICE-20160804-0381404-1 | JP-ACCORD-043334 | ACCORD | YAMADA T, KAN H, MATSUMOTO S, KOIZUMI M, SHINJI S, MATSUDA A ET AL. RECHALLENGE WITH 5-FLUOROURACIL IN A PATIENT WHO DEVELOPED ENCEPHALOPATHY CAUSED BY 5-FLUOROURACIL FOR COLON CANCER. INTERNATIONAL CANCER CONFERENCE JOURNAL. 2016; 5(3):131-135 | 61.00 | YR | M | Y | 0.00000 | 20160831 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126791842 | 12679184 | 1 | PS | FLUOROURACIL. | FLUOROURACIL | 1 | MFOLFOX6: 400 MG/M2 BOLUS ON DAY 1 FOLLOWED BY 2400 MG/M2 CONTINUOUS INFUSION OVER THE NEXT 46 H | Y | N | 40743 | 2400 | MG/M**2 | INFUSION | ||||||
| 126791842 | 12679184 | 2 | C | OXALIPLATIN. | OXALIPLATIN | 1 | MFOLFOX6 ADJUVANT THERAPY | Y | 0 | 85 | MG/M**2 | ||||||||
| 126791842 | 12679184 | 3 | C | FOLINIC ACID | LEUCOVORIN | 1 | 3 CYCLES | 0 | 400 | MG/M**2 | |||||||||
| 126791842 | 12679184 | 4 | C | IRINOTECAN | IRINOTECAN | 1 | 3 CYCLES | 0 | 150 | MG/M**2 | |||||||||
| 126791842 | 12679184 | 5 | C | SALMETEROL | SALMETEROL | 1 | Oral | 0 | |||||||||||
| 126791842 | 12679184 | 6 | C | TIOTROPIUM | TIOTROPIUM | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126791842 | 12679184 | 1 | Adenocarcinoma of colon |
| 126791842 | 12679184 | 2 | Adenocarcinoma of colon |
| 126791842 | 12679184 | 3 | Adenocarcinoma of colon |
| 126791842 | 12679184 | 4 | Adenocarcinoma of colon |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126791842 | 12679184 | DS |
| 126791842 | 12679184 | OT |
| 126791842 | 12679184 | LT |
| 126791842 | 12679184 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126791842 | 12679184 | Coma | Coma |
| 126791842 | 12679184 | Hyperammonaemia | Hyperammonaemia |
| 126791842 | 12679184 | Neuropathy peripheral | |
| 126791842 | 12679184 | Toxic encephalopathy | Toxic encephalopathy |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |