Variable Label (VAR)	Variable Name	Category	N(%)	N(Missing)	Mean(SD)	Median(Q1,Q3)	Range of Values	
A1. Blind_ID	BLIND_ID			1(0)	732.00()	732.00(732.00,732.00)	732.00-732.00	
								
A3. Event number --	EVENTNO			1(0)	2.00()	2.00(2.00,2.00)	2.00-2.00	
								
A4. Patient age (years) at onset of adverse event	PATIENT_AGE_ONSET			1(0)	5.72()	5.72(5.72,5.72)	5.72-5.72	
								
B1. Did the onset of this event occur during or within 24 hours of a study-specific test?	ONSET24	Yes	1(100.0)					
								
B2. Is this AE related to a previously reported AE?	RELATE_PREV	No	1(100.0)					
								
B3. Serious Adverse Event	SAE	No	1(100.0)					
								
B6a. Action taken	STAT_ACTION	Yes	1(100.0)					
								
B6b. Medical therapy	MED_THERAP	Yes	1(100.0)					
								
B6b1. If yes, specify	MED_TH_SP			()	()	(,)	-	
								
B6c. Medication(s) used to treat this event	MEDS_1	Yes	1(100.0)					
								
B6c1. If yes, number of medications	DRUGS			1(0)	1.00()	1.00(1.00,1.00)	1.00-1.00	
								
B6d. Surgeries or procedures used to treat this AE	SURGERY	No	1(100.0)					
								
B7. Narrative	NARRATIVE_1			()	()	(,)	-	
								
B8. Severity of event	SEVERITY	Grade 2	1(100.0)					
								
B9. Expectedness	EXPECT	Expected	1(100.0)					
								
B10. Relationship to study test or procedure	RELAT_TEST	Probably related	1(100.0)					
								
B10a. Specify test or procedure	RELAT_NAME	24 hr ECG holter	1(100.0)					
								
B10b. Patient age (years) at study test or procedure	PATIENT_AGE_RELAT			1(0)	5.72()	5.72(5.72,5.72)	5.72-5.72	
								
B11. Patient age (years) when PHN DCC notified of Adverse Event	PATIENT_AGE_NOTIFIED			1(0)	5.73()	5.73(5.73,5.73)	5.73-5.73