Table 1.

Event counts for conditional and nonconditional patient-reported safety incidents (class I) and actionable safety findings (class II)

EventEvent Count (Nonconditional), n (%)Patients (n)Adjusted Ratea (per 100 Patients) (95% CI)Event Count (Conditional), n (%)Patients (n)Adjusted Ratea (per 100 Patients) (95% CI)
Class I
 Hypoglycemiab90 (33.7)26733.4 (27.9 to 39.4)87 (58.0)15057.6 (49.5 to 65.3)
 Falling or severe dizzinessc63 (23.6)26723.2 (18.5 to 28.7)61 (23.6)25923.1 (18.3 to 28.7)
 Hyperkalemia requiring a changed53 (19.9)26719.7 (15.3 to 24.9)38 (18.0)21118.1 (13.4 to 23.8)
 Nausea, vomiting, and/or diarrheae42 (15.7)26715.7 (11.8 to 20.6)17 (20.5)8321.1 (13.5 to 31.5)
 Muscle weakness or crampsf29 (10.9)26710.8 (7.6 to 15.1)25 (12.7)19712.7 (8.7 to 18.1)
 Lower-extremity edemag22 (8.2)2678.2 (5.5 to 12.2)19 (11.4)16712.7 (8.7 to 18.1)
 Bleedingh19 (7.1)2676.0 (3.6 to 9.9)15 (8.2)1836.4 (3.5 to 11.6)
 Confusioni19 (7.1)2677.0 (4.5 to 10.8)12 (16.7)7216.9 (9.8 to 27.5)
 Angioedemaj14 (5.2)2675.2 (3.1 to 8.6)6 (4.6)1314.6 (2.1 to 9.8)
 Skin rashk8 (3.0)2672.9 (1.4 to 5.8)8 (3.0)2672.9 (1.4 to 5.8)
Class II
 High hemoglobinl (>13.5 g/dl)60 (22.5)26721.8 (17.2 to 27.3)0 (0.0)11
 Hyperkalemiam (potassium>5.5 mEq/L)21 (7.9)2677.0 (4.4 to 11.1)19 (9.0)2118.3 (5.1 to 13.2)
 Low hemoglobinn (<10 g/dl)20 (7.5)2675.1 (2.7 to 9.3)14 (5.5)2564.0 (2.0 to 7.9)
 Change in systolic BPo (>20 mmHg)18 (6.9)262p6.9 (4.4 to 10.6)17 (6.7)2546.7 (4.2 to 10.5)
 Low pulseq (<50 beats/min)15 (5.7)264p5.7 (3.4 to 9.2)12 (7.3)1646.4 (3.5 to 11.6)
 Hypoglycemiar (glucose<70 mg/dl)10 (3.8)2673.7 (2.0 to 6.8)9 (6.0)1508.3 (5.1 to 13.2)
 Hypokalemias (potassium<3.5 mEq/L)8 (3.0)2673.0 (1.5 to 5.9)7 (3.9)1813.9 (1.9 to 7.9)
 Hyperglycemiat (glucose>250 mg/dl)7 (2.6)2672.2 (1.0 to 5.1)7 (2.6)2672.2 (1.0 to 5.1)
 Low systolic BPu (<90 mmHg)6 (2.3)264p2.1 (0.9 to 4.9)6 (2.3)2562.2 (0.9 to 5.1)
  • 95% CI, 95% confidence interval.

  • a Adjusted for first principal component of a principal component analysis of study participants characteristics based on age, sex, African American race, diabetes, cancer, cardiovascular disease, GFR, annual household income, education level, marital status, and number of medications.

  • b Insulin and all other diabetic therapies.

  • c Renin-angiotensin-aldosterone system, potassium-sparing diuretic, and nonpotassium-sparing diuretic, calcium-channel blocker, central-acting antihypertensive, β-blocker, other antihypertensive, and antianginal.

  • d Renin-angiotensin-aldosterone system blocker, potassium-sparing diuretic, nonsteroidal anti-inflammatory drug.

  • e Nonsteroidal anti-inflammatory drug, colchicine, iron preparation.

  • f Hydroxymethylglutaryl coenzyme A reductase inhibitors (statins).

  • g Calcium-channel blocker, thiazolidinedione, other antihypertensive.

  • h Aspirin, warfarin, or clopidogrel.

  • i Opioid analgesic, tramadol.

  • j Angiotensin-converting enzyme inhibitor.

  • k Any drug.

  • l Erythropoietic stimulating agent.

  • m Renin-angiotensin-aldosterone system blocker, potassium-sparing diuretic, nonsteroidal anti-inflammatory drug.

  • n No treatment with an erythropoietic stimulating agent.

  • o Renin-angiotensin-aldosterone system blocker, β-blocker, nonpotassium-sparing and potassium-sparing diuretic, calcium-channel blocker, central-acting antihypertensive, other antihypertensive, and antianginal.

  • p Missing values due to atrial fibrillation or inability to stand for vital sign measurements.

  • q β-Blocker.

  • r Insulin and all other diabetic therapies.

  • s Nonpotassium-sparing diuretic.

  • t No medication required.

  • u Renin-angiotensin-aldosterone system blocker, β-blocker, nonpotassium-sparing and potassium-sparing diuretic, calcium-channel blocker, central-acting antihypertensive, other antihypertensive, and antianginal.