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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127581781 | 12758178 | 1 | I | 2014 | 20160907 | 20160919 | 20160919 | EXP | JP-MYLANLABS-2016M1039401 | MYLAN | 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-J-SURG-ONCOL 2016;14:NO. 192. | 0.00 | Y | 0.00000 | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127581781 | 12758178 | 1 | PS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | UNK | Y | U | 202179 | TABLET | |||||||
| 127581781 | 12758178 | 2 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | UNK | Y | U | 202179 | TABLET | |||||||
| 127581781 | 12758178 | 3 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | Unknown | 250 MG/DAY | U | U | 0 | CAPSULE | |||||||
| 127581781 | 12758178 | 4 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Unknown | UNK | 0 | ||||||||||
| 127581781 | 12758178 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | UNK | 0 | ||||||||||
| 127581781 | 12758178 | 6 | SS | MESALAZINE | MESALAMINE | 1 | Unknown | 2250 MG/DAY | U | U | 0 | ||||||||
| 127581781 | 12758178 | 7 | SS | MIZORIBINE | MIZORIBINE | 1 | Unknown | 150 MG/DAY | U | U | 0 | ||||||||
| 127581781 | 12758178 | 8 | SS | PANITUMUMAB | PANITUMUMAB | 1 | Unknown | U | U | 0 | |||||||||
| 127581781 | 12758178 | 9 | SS | FOLINIC ACID | LEUCOVORIN | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127581781 | 12758178 | 1 | Nephrotic syndrome |
| 127581781 | 12758178 | 3 | Nephrotic syndrome |
| 127581781 | 12758178 | 4 | Rectal adenocarcinoma |
| 127581781 | 12758178 | 5 | Rectal adenocarcinoma |
| 127581781 | 12758178 | 6 | Colitis ulcerative |
| 127581781 | 12758178 | 7 | Nephrotic syndrome |
| 127581781 | 12758178 | 8 | Rectal adenocarcinoma |
| 127581781 | 12758178 | 9 | Rectal adenocarcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127581781 | 12758178 | OT |
| 127581781 | 12758178 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127581781 | 12758178 | Metastases to lymph nodes | |
| 127581781 | 12758178 | Neuropathy peripheral | |
| 127581781 | 12758178 | Rash | |
| 127581781 | 12758178 | Rectal adenocarcinoma |
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 |
|---|---|---|---|---|---|---|
| 127581781 | 12758178 | 1 | 200506 | 0 | ||
| 127581781 | 12758178 | 3 | 200506 | 0 | ||
| 127581781 | 12758178 | 4 | 200506 | 0 |