DEFINITIONS.csv

DEFINITION_ID	DEFINITION	CITATION
TABLE_OUTCOME_SUMMARY_RESULTS	Outcome Summary Result tables review at risk patients (i.e. [AT_RISK]) and how many go on to become cases (i.e. [CASES]) either under a per protocol approach (i.e. [PER_PROTOCOL]) or under the intent to treat approach (i.e. [ITT]).  It additionally provides incidence (i.e. [INCIDENCE_PROPORTION]) proportions for each approach.	
AT_RISK	The count of people with a non-zero chance of developing the outcome.	
CASES	Subjects who developed the event of interest.	
PER_PROTOCOL	A study type where the event of interest is valid if it occurs any time after the index date and before the study end  / defined time at risk.	
ITT	A study type where the event of interest is valid if it occurs any time after the index date.	
INCIDENCE_PROPORTION	The number of subjects that convert from non-cases to cases as a proportion of the total population during a given time period.	
NEGATIVE_CONTROLS	"Negative controls are either different drugs that are known not to cause the outcome of interest or outcomes that are known not to be caused by the drug of interest [1,2].   In other words, drug–outcome pairs for which we have confidence that there is no causal relationship."	"[1] Lipsitch M, Tchetgen Tchetgen E, Cohen T. Negative controls: a tool for detecting confounding and bias in observational studies. Epidemiology. 2010 May;21(3):383-8. doi: 10.1097/EDE.0b013e3181d61eeb. Erratum in: Epidemiology. 2010 Jul;21(4):589. PubMed PMID: 20335814; PubMed Central PMCID: PMC3053408.  [2]  Schuemie MJ, Ryan PB, DuMouchel W, Suchard MA, Madigan D. Interpreting observational studies: why empirical calibration is needed to correct p-values. Stat Med. 2014 Jan 30;33(2):209-18. doi: 10.1002/sim.5925. Epub 2013 Jul 30. PubMed PMID: 23900808; PubMed Central PMCID: PMC4285234."