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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126604851 | 12660485 | 1 | I | 20160811 | 20160817 | 20160817 | EXP | US-MYLANLABS-2016M1034349 | MYLAN | MURAKAMI N, BORGES TJ, YAMASHITA M, RIELLA LV. SEVERE ACUTE INTERSTITIAL NEPHRITIS AFTER COMBINATION IMMUNE-CHECKPOINT INHIBITOR THERAPY FOR METASTATIC MELANOMA. CLIN-KIDNEY-J 2016;9(3):411-417. | 0.00 | Y | 0.00000 | 20160817 | OT | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126604851 | 12660485 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 1000 MG, BID | U | U | 65520 | 1000 | MG | BID | |||||
126604851 | 12660485 | 2 | SS | NIVOLUMAB | NIVOLUMAB | 1 | Unknown | 1 MG/KG | U | U | 0 | ||||||||
126604851 | 12660485 | 3 | SS | IPILIMUMAB | IPILIMUMAB | 1 | Unknown | 3 MG/KG | U | U | 0 | ||||||||
126604851 | 12660485 | 4 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 500MG FOR 3 DAYS; LATER DOSE WAS INCREASED TO 140MG TWICE A DAY | U | U | 0 | ||||||||
126604851 | 12660485 | 5 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 140 MG, BID | U | U | 0 | 140 | MG | BID | |||||
126604851 | 12660485 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 60 MG, QD | U | U | 0 | 60 | MG | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126604851 | 12660485 | 1 | Tubulointerstitial nephritis |
126604851 | 12660485 | 2 | Metastatic malignant melanoma |
126604851 | 12660485 | 3 | Metastatic malignant melanoma |
126604851 | 12660485 | 4 | Tubulointerstitial nephritis |
126604851 | 12660485 | 6 | Tubulointerstitial nephritis |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126604851 | 12660485 | HO |
126604851 | 12660485 | DE |
126604851 | 12660485 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126604851 | 12660485 | Enterocolitis haemorrhagic | |
126604851 | 12660485 | Pseudomonas infection | |
126604851 | 12660485 | Septic shock | |
126604851 | 12660485 | Tubulointerstitial nephritis |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |