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 Ratio | P Value | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Patients | Patients with GFR<45 ml/min per 1.73 m2 | Patients with GFR≥45 ml/min per 1.73 m2 | |||||||||
| Class I only | |||||||||||
| Falling or severe dizziness | 61 | Confusion | 12 | 9 | 3 | 6 | 4.9 | 14.8 | 75.0 | 2.3 | 0.001 |
| Muscle weakness or cramps | 25 | Edema | 19 | 7 | 6 | 1 | 3.8 | 28.0 | 36.8 | 2.7 | 0.002 |
| Muscle weakness or cramps | 25 | Nausea, vomiting, and/or diarrhea | 17 | 6 | 4 | 2 | 3.2 | 24.0 | 35.3 | 2.6 | 0.01 |
| Muscle weakness or cramps | 25 | Confusion | 12 | 4 | 0 | 4 | 2.2 | 16.0 | 33.3 | 2.5 | 0.04 |
| Nausea, vomiting and/or diarrhea | 17 | Rash | 8 | 3 | 3 | 0 | 1.6 | 17.7 | 37.5 | 4.1 | 0.01 |
| Bleeding | 15 | Angioedema | 6 | 2 | 1 | 1 | 1.1 | 13.3 | 33.3 | 4.1 | 0.02 |
| Rash | 8 | Confusion | 12 | 2 | 1 | 1 | 1.1 | 25.0 | 16.7 | 3.9 | 0.03 |
| Class II only | |||||||||||
| None | |||||||||||
| Class I and class II | |||||||||||
| Hypoglycemia (class I) | 87 | Hypoglycemia (class II) | 9 | 8 | 2 | 6 | 4.3 | 9.2 | 88.9 | 1.9 | 0.01 |
| Hypoglycemia (class I) | 87 | Hyperglycemia (class II) | 7 | 6 | 1 | 5 | 3.2 | 6.9 | 85.7 | 1.8 | 0.04 |
| Muscle weakness or cramps (class I) | 25 | Hypokalemia (class II) | 7 | 4 | 2 | 2 | 2.2 | 16.0 | 57.1 | 4.2 | <0.001 |
| Edema (class I) | 19 | Low hemoglobin (class II) | 14 | 4 | 3 | 1 | 2.2 | 21.1 | 28.6 | 2.8 | 0.02 |
| Confusion (class I) | 12 | Hypokalemia (class II) | 7 | 2 | 0 | 2 | 1.1 | 16.7 | 28.6 | 4.4 | 0.02 |
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).