Table 3. Adverse Events During the Trial.
| Verapamil (n = 47) | Placebo (n = 41) | |
|---|---|---|
| Adverse eventsa | ||
| No. of events | 134 | 91 |
| Participants with ≥1 event, No. (%) | 39 (83) | 30 (73) |
| Incidence per 100 person-yearsb | 307.5 | 245.9 |
| Severe hypoglycemiac | ||
| No. of events | 1 | 1 |
| Participants with ≥1 event, No. (%) | 1 (2) | 1 (2) |
| Incidence per 100 person-yearsb | 2.3 | 2.7 |
| Diabetic ketoacidosisd | ||
| No. of events | 0 | 1 |
| Participants with ≥1 event, No. (%) | 0 | 1 (2) |
| Incidence per 100 person-yearsb | 0 | 2.7 |
| Other serious adverse eventse | ||
| No. of events | 7 | 3 |
| Participants with ≥1 event, No. (%) | 3 (6) | 3 (7) |
| Incidence per 100 person-yearsb | 16.0 | 8.1 |
| Specific serious adverse events among participants with ≥1 event, No. (%) | ||
| Depression or suicidal ideation | 3 (6) | 1 (2) |
| Asthma | 0 | 1 (2) |
| Dehydration and ketosis | 0 | 1 (2) |
| Nonserious adverse events of special interest among participants with ≥1 event, No. (%) | ||
| Nausea or vomiting | 5 (11) | 0 |
| Headache | 4 (9) | 7 (17) |
| Constipation | 3 (6) | 1 (2) |
| Electrocardiogram abnormalityf | 3 (6) | 0 |
| Elevated level of liver enzymesg | 2 (4) | 2 (5) |
| Hypotensionh | 1 (2) | 0 |
| Bradycardiah | 0 | 1 (2) |
| Dizziness | 0 | 0 |
Eight participants in each group experienced an adverse event considered to be related to treatment. In the verapamil group, there were 10 events in 8 participants (2 with constipation, 2 with hypotension, 1 with headache, 1 with fatigue, 1 with both a prolonged PR interval on electrocardiogram and elevated levels of liver enzymes, 1 with elevated levels of liver enzymes [alanine transaminase and aspartate aminotransferase], 1 with second-degree heart block and a prolonged PR interval, and 1 with first-degree heart block). In the placebo group, there were 8 events in 8 participants (4 with headache, 2 with elevated levels of liver enzymes, 1 with constipation, and 1 with fatigue).
Calculated as the number of events in the numerator and the total amount of study time across all participants in the group in years in the denominator multiplied by 100.
Defined as hypoglycemia that required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions due to the participant being impaired cognitively to the point that they were unable to treat themselves, were unable to verbalize their needs, were incoherent, disoriented, combative, or a combination of these, or experienced seizure or loss of consciousness.
Defined as hyperglycemia associated with serum level of ketones greater than 1.5 mmol/L or large or moderate urine ketones; arterial blood pH less than 7.30, venous pH less than 7.24, or serum bicarbonate less than 15; and treatment provided in a health care facility.
Defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity, is a congenital abnormality or birth defect, or requires a medical or surgical intervention to prevent permanent impairment. In the verapamil group, 1 participant had 2 hospitalizations reported for suicidal ideation and depression, 1 participant had 1 hospitalization for suicidal ideation, and 1 participant had 1 hospitalization for depression and 3 hospitalizations for suicidal ideation. In the placebo group, 3 participants each had 1 hospitalization for suicidal ideation, exacerbation of asthma, and dehydration with ketosis.
Included prolonged PR interval in 1 participant, second-degree heart block and prolonged PR interval in 1 participant, and first-degree heart block in 1 participant.
Reported as an adverse event when the laboratory normal range was exceeded for alanine transaminase and aspartate aminotransferase.
Pulse was considered abnormal if less than second percentile for age and sex. Blood pressure (either systolic or diastolic) was considered to be abnormal if less than the fifth percentile for age, sex, and height.