Capture-6.jpgRecently, Advera Health released a comparative safety report of the HER2+ Antagonists. In this drug review, we analyzed FDA Adverse Event Reporting System (FAERS) and clinical trial data to better understand how the drugs in this class stacked up.

Based on Advera’s analysis of FAERS data, Kadcyla (ado- trastuzumab emtansine) and Perjeta (pertuzumab) have multiple serious unlabeled adverse events that appear on Herceptin's (trastuzumab) label, with the following four events triggering serious Active RxSignals in our system:

  • Pulmonary fibrosis for Kadcyla and Perjeta
  • Pulmonary hypertension and Cardiac failure for Kadcyla 
  • Interstitial lung disease for Perjeta 

FAERS data show that Kadcyla had the highest reporting rates for six out of seven serious patient outcomes, and clinical trial data show that Kadcyla was also found to have the greatest number of serious adverse events where the treatment rate was higher than the control rate.

You can access the full report here.


What I'd like to do in this blog post however, is walk through a demonstration with screen shots showing how to obtain the data on Kadcyla within our Evidex platform.

First, by searching for Kadcyla the Overview tab of the drug page will show key points for the drug, and how the data are matched. Note at the top left, the ability to navigate between the Clinical Evidence (our proprietary database of clinical trial outcomes) and Real-World Evidence (standardized data from FAERS).


The Adverse Events tab brings us to all of the AEs reported to FAERS for Kadcyla. The default sort lists the Active and Watchlist signals first -- Our proprietary RxSignal analytic predicts FDA regulatory action by flagging serious risks that have been reported at an elevated rate, but which are not yet listed in the drug's package insert or labeling info. Our methodolgoy has been peer-reviewed and published in Drug Safety. Note how the platform designates Labeled and Important Medical Event (IME) Seriousness status, and also links to any literature references that are associated with the drug-AE combo.



Out of the Active signals that are showing up for Kadcyla for AEs that are on Herceptin’s label, you can see by going into the detailed Drug-AE analysis report, that Pulmonary Hypertension also showed up in 1 out of 2,397 patients in clinical trials of Kadcyla. Obviously a low incidence rate, but interesting that the AE was not seen in any of the control arms.




Looking further into the clinical evidence, we can see that the aggregated, pooled analysis shows several AEs that fall under the Cardiac Disorder SOC that have higher FAERS reporting rates than what was seen in clinical trials. Specifically, cardiac arrest, cardiac failure, tachycardia, cardiomyopathy, and pericardial effusion. You can also clearly see any signals being picked up post-market in the RxSignal column. For the most part, reporting odds ratios remain non-elevated, but it bares further attention as more data continue to be reported.



This is just a small sub-set of the types of analyses that can be conducted using Evidex. Learn more. 


Andrea R. Demakas, Product Specialist


Topics: FAERS, Clinical Evidence, Drug / Indication Information

Andrea Demakas

Written by Andrea Demakas