Table 5. Adverse Events in Study 1.
| No. (%) of Patientsa | |||
|---|---|---|---|
| Placebo (n = 308) |
Idalopirdine | ||
| 30 mg (n = 313) | 60 mg (n = 309) | ||
| Women | 198 (64.3) | 208 (66.5) | 201 (65.0) |
| Patient-years of exposure | 133 | 136 | 133 |
| Deaths | 1 (0.3) | 1 (0.3) | 3 (1.0) |
| Treatment-emergent adverse eventsb | |||
| Total | 189 (61.4) | 193 (61.7) | 203 (65.7) |
| Seriousc | 12 (3.9) | 18 (5.8) | 20 (6.5) |
| Leading to study withdrawal | 11 (3.6) | 16 (5.1) | 22 (7.1) |
| Common typesd | |||
| Fall | 15 (4.9) | 16 (5.1) | 19 (6.1) |
| Accidental overdosee | 27 (8.8) | 27 (8.6) | 16 (5.2) |
| γ-Glutamyltransferase increasedf | 2 (0.6) | 17 (5.4) | 15 (4.9) |
| Alanine aminotransferase increasedf | 3 (1.0) | 7 (2.2) | 10 (3.2) |
| Nasopharyngitis | 10 (3.2) | 13 (4.2) | 15 (4.9) |
| Headache | 11 (3.6) | 5 (1.6) | 12 (3.9) |
| Diarrhea | 10 (3.2) | 10 (3.2) | 11 (3.6) |
| Urinary tract infection | 5 (1.6) | 7 (2.2) | 11 (3.6) |
| Nausea | 5 (1.6) | 11 (3.5) | 5 (1.6) |
| Cumulative increased levels of liver enzymes, No./total (%)g | 4/304 (1.3) | 4/310 (1.3) | 3/308 (1.0) |
| Suicidal ideation, No./total (%)h | 12/304 (3.9) | 4/310 (1.3) | 8/308 (2.6) |
| Suicidal behavior, No./totalh | 0/304 | 0/310 | 0/308 |
Unless otherwise indicated. Includes patients who received at least 1 dose of treatment.
Defined as an adverse event that starts after the first dose of idalopirdine and prior to the last protocol-specified contact with the patient.
Defined as any adverse event that results in death; is life-threatening (refers to an event in which the patient was at risk of death at the time of the event but does not refer to an event that hypothetically might have caused death had it been more severe); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; and is medically important (refers to an event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require an intervention to prevent any of these other defined events).
Incidence of 3% or greater; Medical Dictionary for Regulatory Activities (MedDRA; version 19.0) preferred terms.
MedDRA term that includes any instance of dosing outside specified regimen for study-specific treatment.
Defined by MedDRA as any increase found to be clinically significant.
Based on single maximal alanine aminotransferase or aspartate aminotransferase level measured as 3 times greater than the upper limit of normal for each patient.
Occurred after study entry.