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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126916631 | 12691663 | 1 | I | 20160822 | 20160826 | 20160826 | EXP | US-TEVA-687806USA | TEVA | 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. | 75.00 | YR | M | Y | 73.10000 | KG | 20160827 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126916631 | 12691663 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | U | 65457 | 1000 | MG | BID | |||||||
| 126916631 | 12691663 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 60MG DAILY | U | 80356 | |||||||||
| 126916631 | 12691663 | 3 | SS | nivolumab | NIVOLUMAB | 1 | Unknown | 1 MG/KG | U | 0 | |||||||||
| 126916631 | 12691663 | 4 | SS | ipilimumab | IPILIMUMAB | 1 | Unknown | 3 MG/KG | U | 0 | |||||||||
| 126916631 | 12691663 | 5 | 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 | 0 | |||||||||
| 126916631 | 12691663 | 6 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | U | 0 | 140 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126916631 | 12691663 | 1 | Tubulointerstitial nephritis |
| 126916631 | 12691663 | 2 | Tubulointerstitial nephritis |
| 126916631 | 12691663 | 3 | Metastatic malignant melanoma |
| 126916631 | 12691663 | 4 | Metastatic malignant melanoma |
| 126916631 | 12691663 | 5 | Tubulointerstitial nephritis |
| 126916631 | 12691663 | 6 | Tubulointerstitial nephritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126916631 | 12691663 | OT |
| 126916631 | 12691663 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126916631 | 12691663 | Enterocolitis haemorrhagic | |
| 126916631 | 12691663 | Pseudomonas infection | |
| 126916631 | 12691663 | Septic shock | |
| 126916631 | 12691663 | Tubulointerstitial nephritis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |