Table 3.

Association analysis of study participants who had two or more class I or II adverse safety events (n=102) from the at-risk sample of participants with at least one event (n=185)

Event (a)Count (a)Event (b)Count (b)Co-occurrence (n)Support (%)Confidence (a→b) (%)Confidence (b→a) (%)Lift RatioP Value
PatientsPatients with GFR<45 ml/min per 1.73 m2Patients with GFR≥45 ml/min per 1.73 m2
Class I only
 Falling or severe dizziness61Confusion129364.914.875.02.30.001
 Muscle weakness or cramps25Edema197613.828.036.82.70.002
 Muscle weakness or cramps25Nausea, vomiting, and/or diarrhea176423.224.035.32.60.01
 Muscle weakness or cramps25Confusion124042.216.033.32.50.04
 Nausea, vomiting and/or diarrhea17Rash83301.617.737.54.10.01
 Bleeding15Angioedema62111.113.333.34.10.02
 Rash8Confusion122111.125.016.73.90.03
Class II only
 None
Class I and class II
 Hypoglycemia (class I)87Hypoglycemia (class II)98264.39.288.91.90.01
 Hypoglycemia (class I)87Hyperglycemia (class II)76153.26.985.71.80.04
 Muscle weakness or cramps (class I)25Hypokalemia (class II)74222.216.057.14.2<0.001
 Edema (class I)19Low hemoglobin (class II)144312.221.128.62.80.02
 Confusion (class I)12Hypokalemia (class II)72021.116.728.64.40.02
  • Support: participants with a co-occurrence of the named events divided by the at-risk sample with at least one event (n=185). Confidence: frequency of participants with co-occurrence of events (a and b) divided by the frequency of participants with the designated antecedent event. Expected confidence: frequency of participants with the consequent event divided by the at-risk sample (not shown). Lift ratio: confidence divided by the expected confidence for the at-risk sample (note: lift ratio is identical regardless of the choice of antecedent and consequent designation in a pair).