1. Version 1 Version 2 Review Published
Vital Signs, Labs, ECG – Central Tendency
Oct 2013
Non-Compartmental PK
March 2014
Demographics, Disposition, Medications
Oct 2014
Q4 2017
Q1 2018
Vital Signs, Labs, ECG – Outliers / Shifts
Sept 2015
Labs (Wei)
Q32019
Vital Signs
Q42019
ECG
Q32020
QT/QTc Studies
March 2016
Adverse Events
Feb 2017
Treatment-Emergent Definitions (Data Collection)
Q1 2020
Hepatotoxicity (Terry)
Q4 2019
Questionnaires (Karin)
Safety Topics of Interest (Brenda)
Q2 2019
General Output Tips and Considerations (Karin)
Interactive Displays for Clinical Safety Data (Wei)
Q2 2020