The Safety Rates Drug Report

Member Login
2004.Q1    2004.Q2    2004.Q3    2004.Q4    2005.Q1    2005.Q2    2005.Q3    2005.Q4    2006.Q1    2006.Q2    2006.Q3    2006.Q4    2007.Q1    2007.Q2    2007.Q3    2007.Q4    2008.Q1    2008.Q2    2008.Q3    2008.Q4    2009.Q1    2009.Q2    2009.Q3    2009.Q4    2010.Q1    2010.Q2    2010.Q3    2010.Q4    2011.Q1    2011.Q2    2011.Q3    2011.Q4    2012.Q1    2012.Q2    2012.Q3    2012.Q4    2013.Q1    2013.Q2    2013.Q3    2013.Q4    2014.Q1    2014.Q2    2014.Q3    2014.Q4    2015.Q1    2015.Q2    2015.Q3    2015.Q4    2016.Q1    2016.Q2    2016.Q3   

Drug     Injury     Quarter    

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