Trial Outcomes & Findings for A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease (NCT NCT00838110)
NCT ID: NCT00838110
Last Updated: 2018-12-06
Results Overview
Abnormal clinically significant vital signs included absolute systolic blood pressure (BP) values: less than (\<) 90 millimeter of mercury (mmHg), maximum increase or decrease of greater than or equal to (\>=) 30 mmHg from baseline; absolute diastolic BP value: \<50 mmHg, maximum increase or decrease of \>=20 mmHg from baseline; absolute heart rate values: \>120 beats per minute (bpm).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
742 participants
Primary outcome timeframe
Baseline up to Week 30 (follow-up)
Results posted on
2018-12-06
Participant Flow
Participant milestones
| Measure |
Dimebon (Cohort 1)
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
|
Placebo (Cohort 1)
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
|
Dimebon (Cohort 2)
Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
|
Placebo (Cohort 2)
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
127
|
128
|
243
|
244
|
|
Overall Study
Treated
|
127
|
127
|
243
|
244
|
|
Overall Study
COMPLETED
|
105
|
106
|
226
|
226
|
|
Overall Study
NOT COMPLETED
|
22
|
22
|
17
|
18
|
Reasons for withdrawal
| Measure |
Dimebon (Cohort 1)
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
|
Placebo (Cohort 1)
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
|
Dimebon (Cohort 2)
Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
|
Placebo (Cohort 2)
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
2
|
|
Overall Study
Adverse Event
|
11
|
10
|
8
|
7
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
3
|
4
|
|
Overall Study
Other
|
3
|
3
|
3
|
2
|
|
Overall Study
Protocol Violation
|
0
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
0
|
0
|
|
Overall Study
Did not meet eligibility criteria
|
0
|
0
|
1
|
2
|
|
Overall Study
Randomized but not treated
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Dimebon
n=370 Participants
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
|
Placebo
n=371 Participants
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
|
Total
n=741 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
50 to 59 years
|
24 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Customized
60 to 69 years
|
50 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Age, Customized
70 to 79 years
|
155 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
309 Participants
n=5 Participants
|
|
Age, Customized
80 to 85 years
|
109 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Age, Customized
Greater than 85 years
|
32 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
192 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
390 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
178 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
351 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 30 (follow-up)Population: Cohort 1 analysis set included all those participants in the safety analysis set (SAS) (all participants who receive at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.
Abnormal clinically significant vital signs included absolute systolic blood pressure (BP) values: less than (\<) 90 millimeter of mercury (mmHg), maximum increase or decrease of greater than or equal to (\>=) 30 mmHg from baseline; absolute diastolic BP value: \<50 mmHg, maximum increase or decrease of \>=20 mmHg from baseline; absolute heart rate values: \>120 beats per minute (bpm).
Outcome measures
| Measure |
Dimebon (Cohort 1)
n=127 Participants
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
|
Placebo (Cohort 1)
n=127 Participants
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
|
|---|---|---|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1
Systolic BP (<90 mmHg) (n=127,127)
|
0.8 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1
Increase in systolic BP (>=30 mmHg) (n=126,124)
|
9.5 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1
Decrease in systolic BP (>=30 mmHg) (n=126,124)
|
16.7 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1
Diastolic BP (<50 mmHg) (n=127,127)
|
0.8 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1
Increase in diastolic BP (>=20 mmHg) (n=126,124)
|
7.1 percentage of participants
|
7.3 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1
Decrease in diastolic BP (>=20 mmHg) (n=126,124)
|
15.9 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1
Heart rate (>120 bpm) (n=127,127)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 16 (follow-up)Population: Cohort 2 analysis set included all those participants in the SAS (all participants who receive at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.
Abnormal clinically significant vital signs included absolute systolic BP values: \<90 mmHg, maximum increase or decrease of \>=30 mmHg from baseline; absolute diastolic BP values: \<50 mmHg, maximum increase or decrease of \>=20 mmHg from baseline; absolute heart rate values: \>120 bpm.
Outcome measures
| Measure |
Dimebon (Cohort 1)
n=243 Participants
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
|
Placebo (Cohort 1)
n=244 Participants
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
|
|---|---|---|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2
Systolic BP (<90 mmHg) (n=243,244)
|
0.8 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2
Increase in systolic BP (>=30 mmHg) (n=240,240)
|
3.8 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2
Decrease in systolic BP (>=30 mmHg) (n=240,240)
|
9.6 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2
Diastolic BP (<50 mmHg) (n=243,244)
|
1.2 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2
Increase in diastolic BP (>=20 mmHg) (n=240,240)
|
6.3 percentage of participants
|
5.4 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2
Decrease in diastolic BP (>=20 mmHg) (n=240,240)
|
6.7 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2
Heart rate (>120 bpm) (n=243,244)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 30 (follow-up)Population: Cohort 1 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.
Abnormal ECG findings included maximum value of \>=300 millisecond (msec), maximum increase of \>=25% for baseline value of \>200 msec and maximum increase of \>=50% for baseline value of \<=200 msec for PR interval (int); maximum value of \>=200 msec, maximum increase of \>=25% for baseline value of \>100 msec and maximum increase of \>=50% for baseline value of \<=100 msec for QRS interval; maximum value of \>=500 msec for QT interval; maximum value of 450 to \<480, 480 to \<500 and \>=500 msec, increase of \>=30 to \<60 and \>=60 msec for QT interval corrected using Fridericia's formula (QTcF interval).
Outcome measures
| Measure |
Dimebon (Cohort 1)
n=127 Participants
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
|
Placebo (Cohort 1)
n=127 Participants
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
|
|---|---|---|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1
PR int (>=300 msec) (n=123,113)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1
Increase in PR int (>=25/50%) (n=122,112)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1
QRS int (>=200 msec) (n=127,127)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1
Increase in QRS int (>=25/50%) (n=126,126)
|
1.6 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1
QT int (>=500 msec) (n=127,127)
|
0.0 percentage of participants
|
2.4 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1
QTcF int (450 to <480 msec) (n=127,127)
|
15.7 percentage of participants
|
13.4 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1
QTcF int (480 to <500 msec) (n=127,127)
|
1.6 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1
QTcF int (>=500 msec) (n=127,127)
|
0.0 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1
Increase in QTcF int (>=30 to <60msec )(n=126,126)
|
9.5 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1
Increase in QTcF int (>=60 msec) (n=126,126)
|
0.8 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 16 (follow-up)Population: Cohort 2 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.
Abnormal ECG findings included maximum value of \>=300 msec, maximum increase of \>=25% for baseline value of \>200 msec and maximum increase of \>=50% for baseline value of \<=200 msec for PR interval; maximum value of \>=200 msec, maximum increase of \>=25% for baseline value of \>100 msec and maximum increase of \>=50% for baseline value of \<=100 msec for QRS interval; maximum value of \>=500 msec for QT interval; maximum value of 450 to \<480, 480 to \<500 and \>=500 msec, increase of \>=30 to \<60 and \>=60 msec for QT interval corrected using Fridericia's formula (QTcF interval).
Outcome measures
| Measure |
Dimebon (Cohort 1)
n=243 Participants
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
|
Placebo (Cohort 1)
n=244 Participants
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
|
|---|---|---|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2
PR int (>=300 msec) (n=232,232)
|
0.9 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2
Increase in PR int (>=25/50%) (n=231,229)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2
QRS int (>=200 msec) (n=243,244)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2
Increase in QRS int (>=25/50%) (n=242,243)
|
0.8 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2
QT int (>=500 msec) (n=243,244)
|
0.8 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2
QTcF int (450 to <480 msec) (n=243,244)
|
15.6 percentage of participants
|
19.3 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2
QTcF int (480 to <500 msec) (n=243,244)
|
2.1 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2
QTcF int (>=500 msec) (n=243,244)
|
1.2 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2
Increase in QTcF int (>=30 to <60 msec)(n=242,243)
|
6.6 percentage of participants
|
5.8 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2
Increase in QTcF int (>=60 msec) (n=242,243)
|
0.4 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 30 (follow-up)Population: Cohort 1 analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.
For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the upper limit of normal (ULN) or lower limit of normal (LLN) respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was \>=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH \>8 and specific gravity \<1.003 or \>1.030.
Outcome measures
| Measure |
Dimebon (Cohort 1)
n=126 Participants
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
|
Placebo (Cohort 1)
n=124 Participants
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
|
|---|---|---|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Hemoglobin (<0.8*LLN) (n=126,123)
|
1 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Red blood cell count (<0.8*LLN) (n=126,123)
|
2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Mean corpuscular volume (<0.9*LLN) (n=126,123)
|
0 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Mean corpuscular volume (>1.1*ULN) (n=126,123)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
White blood cell count (<0.6*LLN) (n=126,123)
|
0 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
White blood cell count (>1.5*ULN) (n=126,123)
|
1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Lymphocytes (<0.8*LLN) (n=126,123)
|
2 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Lymphocytes (>1.2*ULN) (n=126,123)
|
1 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Total Neutrophils (<0.8*LLN) (n=126,123)
|
0 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Total Neutrophils (>1.2*ULN) (n=126,123)
|
4 percentage of participants
|
3 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Monocytes (>1.2*ULN) (n=126,123)
|
0 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Total bilirubin (>1.5*ULN) (n=125,123)
|
1 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Aspartate aminotransferase (>3.0*ULN) (n=125,123)
|
1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Alanine aminotransferase (>3.0*ULN) (n=125,123)
|
1 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Blood urea nitrogen (>1.3*ULN) (n=125,123)
|
1 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Creatinine (>1.3*ULN) (n=125,123)
|
2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Sodium (<0.95*LLN) (n=125,123)
|
0 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Sodium (>1.05*ULN) (n=125,123)
|
0 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Potassium (<0.9*LLN) (n=125,123)
|
0 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Potassium (>1.1*ULN) (n=125,123)
|
2 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Calcium (>1.1*ULN) (n=125,123)
|
1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Magnesium (<0.9*LLN) (n=125,123)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Magnesium (>1.1*ULN) (n=125,123)
|
20 percentage of participants
|
24 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Phosphate (<0.8*LLN) (n=125,123)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Phosphate (>1.2*ULN) (n=125,123)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Bicarbonate (<0.9*LLN) (n=125,123)
|
2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Bicarbonate (>1.1*ULN) (n=125,123)
|
0 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Glucose (>1.5*ULN) (n=125,123)
|
9 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Creatine kinase (>2.0*ULN) (n=125,123)
|
3 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Urine specific gravity (<1.003) (n=125,123)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Urine specific gravity (>1.030) (n=125,123)
|
2 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Urine pH (>8) (n=125,123)
|
0 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Urine glucose (>=1) (n=125,123)
|
4 percentage of participants
|
3 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Urine ketones (>=1) (n=125,123)
|
1 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Urine blood (>=1) (n=125,123)
|
32 percentage of participants
|
7 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Urine protein (>=1) (n=125,123)
|
4 percentage of participants
|
2 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 16 (follow-up)Population: Cohort 2 analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.
For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the ULN or LLN respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was \>=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH \>8 and specific gravity \<1.003 or \>1.030.
Outcome measures
| Measure |
Dimebon (Cohort 1)
n=239 Participants
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
|
Placebo (Cohort 1)
n=241 Participants
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
|
|---|---|---|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Hemoglobin (<0.8*LLN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Red blood cell count (<0.8*LLN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Mean corpuscular volume (<0.9*LLN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Mean corpuscular volume (>1.1*ULN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
White blood cell count (<0.6*LLN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
White blood cell count (>1.5*ULN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Lymphocytes (<0.8*LLN) (n=239,241)
|
1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Lymphocytes (>1.2*ULN) (n=239,241)
|
3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Total Neutrophils (<0.8*LLN) (n=239,241)
|
0 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Total Neutrophils (>1.2*ULN) (n=239,241)
|
2 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Monocytes (>1.2*ULN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Total bilirubin (>1.5*ULN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Aspartate aminotransferase (>3.0*ULN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Alanine aminotransferase (>3.0*ULN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Blood urea nitrogen (>1.3*ULN) ((n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Creatinine (>1.3*ULN) (n=239,241)
|
0 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Sodium (<0.95*LLN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Sodium (>1.05*ULN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Potassium (<0.9*LLN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Potassium (>1.1*ULN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Calcium (>1.1*ULN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Magnesium (<0.9*LLN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Magnesium (>1.1*ULN) (n=239,241)
|
18 percentage of participants
|
17 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Phosphate (<0.8*LLN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Phosphate (>1.2*ULN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Bicarbonate (<0.9*LLN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Bicarbonate (>1.1*ULN) (n=239,241)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Glucose (>1.5*ULN) (n=239,241)
|
6 percentage of participants
|
4 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Creatine kinase (>2.0*ULN) (n=239,241)
|
3 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Urine specific gravity (<1.003) (n=237,240)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Urine specific gravity (>1.030) (n=237,240)
|
2 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Urine pH (>8) (n=237,240)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Urine glucose (>=1) (n=237,240)
|
3 percentage of participants
|
3 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Urine ketones (>=1) (n=237,240)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Urine blood (>=1) (n=237,240)
|
26 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Urine protein (>=1) (n=237,240)
|
1 percentage of participants
|
3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 30 (follow-up)Population: Cohort 1 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Outcome measures
| Measure |
Dimebon (Cohort 1)
n=127 Participants
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
|
Placebo (Cohort 1)
n=127 Participants
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) in Cohort 1
|
64.6 percentage of participants
|
64.6 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 16 (follow-up)Population: Cohort 2 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Outcome measures
| Measure |
Dimebon (Cohort 1)
n=243 Participants
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
|
Placebo (Cohort 1)
n=244 Participants
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) in Cohort 2
|
55.1 percentage of participants
|
53.3 percentage of participants
|
Adverse Events
Dimebon
Serious events: 26 serious events
Other events: 107 other events
Deaths: 0 deaths
Placebo
Serious events: 28 serious events
Other events: 110 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dimebon
n=370 participants at risk
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
|
Placebo
n=371 participants at risk
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
|
|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.54%
2/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest discomfort
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.81%
3/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.54%
2/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Uterine rupture
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood magnesium decreased
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.81%
3/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma recurrent
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebral infarction
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.54%
2/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Grand mal convulsion
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Agitation
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Belligerence
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Major depression
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Bladder irritation
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure acute
|
0.54%
2/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.27%
1/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.54%
2/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.27%
1/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Dimebon
n=370 participants at risk
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
|
Placebo
n=371 participants at risk
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.54%
2/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
9/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
13/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
9/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
8/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
9/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
5.1%
19/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
9/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
3.0%
11/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
9/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
7.0%
26/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.3%
27/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
4.1%
15/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.9%
18/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
5/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.7%
10/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
2.4%
9/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
9/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
3.8%
14/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.7%
10/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
5.1%
19/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.9%
7/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Agitation
|
2.2%
8/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
5/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.81%
3/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
9/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Confusional state
|
1.1%
4/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
9/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
1.4%
5/370
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
9/371
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER