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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126486652 | 12648665 | 2 | F | 2005 | 20160812 | 20160812 | 20160818 | EXP | JP-SA-2016SA145272 | AVENTIS | SAMESHIMA S, KOKETSU S, OKUYAMA T, KUBOTA Y, ONO Y, NOIE T, ET AL. ULCERATIVE COLITIS ASSOCIATED WITH NEPHROTIC SYNDROME AFTER TREATMENT WITH MESALAZINE DEVELOPED INTO RECTAL CARCINOMA: A CASE STUDY. WORLD JOURNAL OF SURGICAL ONCOLOGY 2016;14(1):ARTICLE NUMBER 192. DOI: 10.1186/S12957-016-0950-1. ACCESSED: 2016 JUL 22. | 22.00 | YR | A | M | Y | 0.00000 | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126486652 | 12648665 | 1 | SS | MESALAZINE | MESALAMINE | 1 | Unknown | U | UNK | 0 | 2250 | MG | QD | ||||||
| 126486652 | 12648665 | 2 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | UNK | 0 | 35 | MG | QD | |||||||
| 126486652 | 12648665 | 3 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | UNK | 0 | 12.5 | MG | ||||||||
| 126486652 | 12648665 | 4 | PS | OXALIPLATIN. | OXALIPLATIN | 1 | Unknown | MODIFIED FOLFOX6 | UNK | 21759 | |||||||||
| 126486652 | 12648665 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | MODIFIED FOLFOX6 | UNK | 0 | |||||||||
| 126486652 | 12648665 | 6 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | UNK | 0 | 250 | MG | QD | |||||||
| 126486652 | 12648665 | 7 | SS | MIZORIBINE | MIZORIBINE | 1 | Unknown | UNK | 0 | 150 | MG | QD | |||||||
| 126486652 | 12648665 | 8 | SS | PANITUMUMAB | PANITUMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 126486652 | 12648665 | 9 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | MODIFIED FOLFOX6 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126486652 | 12648665 | 1 | Colitis ulcerative |
| 126486652 | 12648665 | 2 | Nephrotic syndrome |
| 126486652 | 12648665 | 3 | Nephrotic syndrome |
| 126486652 | 12648665 | 4 | Rectal adenocarcinoma |
| 126486652 | 12648665 | 5 | Rectal adenocarcinoma |
| 126486652 | 12648665 | 6 | Nephrotic syndrome |
| 126486652 | 12648665 | 7 | Nephrotic syndrome |
| 126486652 | 12648665 | 8 | Rectal adenocarcinoma |
| 126486652 | 12648665 | 9 | Rectal adenocarcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126486652 | 12648665 | OT |
| 126486652 | 12648665 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126486652 | 12648665 | Abdominal distension | |
| 126486652 | 12648665 | Abdominal pain | |
| 126486652 | 12648665 | Biopsy kidney abnormal | |
| 126486652 | 12648665 | Blood albumin decreased | |
| 126486652 | 12648665 | Blood creatinine increased | |
| 126486652 | 12648665 | Blood urea increased | |
| 126486652 | 12648665 | Carbohydrate antigen 19-9 increased | |
| 126486652 | 12648665 | Carcinoembryonic antigen increased | |
| 126486652 | 12648665 | Drug resistance | |
| 126486652 | 12648665 | Dyspnoea | |
| 126486652 | 12648665 | Generalised oedema | |
| 126486652 | 12648665 | Lymphadenopathy | |
| 126486652 | 12648665 | Metastases to lymph nodes | |
| 126486652 | 12648665 | Nephrotic syndrome | |
| 126486652 | 12648665 | Neuropathy peripheral | |
| 126486652 | 12648665 | Protein total decreased | |
| 126486652 | 12648665 | Proteinuria | |
| 126486652 | 12648665 | Rash | |
| 126486652 | 12648665 | Rectal adenocarcinoma | |
| 126486652 | 12648665 | Rectal lesion | |
| 126486652 | 12648665 | Rectal stenosis | |
| 126486652 | 12648665 | Weight 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 |
|---|---|---|---|---|---|---|
| 126486652 | 12648665 | 1 | 2000 | 0 | ||
| 126486652 | 12648665 | 2 | 2005 | 0 | ||
| 126486652 | 12648665 | 4 | 2014 | 0 | ||
| 126486652 | 12648665 | 5 | 2014 | 0 | ||
| 126486652 | 12648665 | 6 | 2005 | 0 | ||
| 126486652 | 12648665 | 7 | 2005 | 0 | ||
| 126486652 | 12648665 | 8 | 2014 | 0 | ||
| 126486652 | 12648665 | 9 | 2014 | 0 |