Trial Outcomes & Findings for Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202) (NCT NCT02079909)
NCT ID: NCT02079909
Last Updated: 2019-02-26
Results Overview
The ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) is a structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Scores can range from 0 (best) to 70 (worse).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
482 participants
Primary outcome timeframe
Baseline and 52 weeks
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
T-817MA-H
224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.
T-817MA-H: 224 mg or 448 mg T-817 MA once daily
|
T-817MA-L
224 mg T-817MA once daily
T-817MA-L: 224 mg T-817 MA once daily
|
Placebo
Placebo once daily
Placebo: Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
158
|
166
|
158
|
|
Overall Study
COMPLETED
|
120
|
117
|
140
|
|
Overall Study
NOT COMPLETED
|
38
|
49
|
18
|
Reasons for withdrawal
| Measure |
T-817MA-H
224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.
T-817MA-H: 224 mg or 448 mg T-817 MA once daily
|
T-817MA-L
224 mg T-817MA once daily
T-817MA-L: 224 mg T-817 MA once daily
|
Placebo
Placebo once daily
Placebo: Placebo
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
23
|
23
|
7
|
|
Overall Study
Withdrawal by Subject
|
9
|
17
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
1
|
|
Overall Study
Death
|
2
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
|
Overall Study
Relocation etc.
|
2
|
2
|
3
|
Baseline Characteristics
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)
Baseline characteristics by cohort
| Measure |
T-817MA-H
n=154 Participants
224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.
T-817MA-H: 224 mg or 448 mg T-817 MA once daily
|
T-817MA-L
n=159 Participants
224 mg T-817MA once daily
T-817MA-L: 224 mg T-817 MA once daily
|
Placebo
n=156 Participants
Placebo once daily
Placebo: Placebo
|
Total
n=469 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.8 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
71.9 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
71.8 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
71.9 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
252 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
217 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
140 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
428 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
ApoE4 genotype
Non-carriers
|
54 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
ApoE4 genotype
Heterozygotes
|
55 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
ApoE4 genotype
Homozygotes
|
32 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
ApoE4 genotype
Unknown
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
MMSE
|
18.4 units on a scale
STANDARD_DEVIATION 3.9 • n=5 Participants
|
18.2 units on a scale
STANDARD_DEVIATION 3.8 • n=7 Participants
|
18.2 units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
18.3 units on a scale
STANDARD_DEVIATION 3.8 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 52 weeksPopulation: The overall number of participants display the numbers of patients who were included in the mITT population and had baseline and at least one post-baseline ADAS-cog evaluation.
The ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) is a structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Scores can range from 0 (best) to 70 (worse).
Outcome measures
| Measure |
T-817MA-H
n=117 Participants
224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.
T-817MA-H: 224 mg or 448 mg T-817 MA once daily
|
T-817MA-L
n=115 Participants
224 mg T-817MA once daily
T-817MA-L: 224 mg T-817 MA once daily
|
Placebo
n=137 Participants
Placebo once daily
Placebo: Placebo
|
|---|---|---|---|
|
ADAS-cog Change From Baseline to Week 52
|
7.08 units on a scale
Standard Error 0.756
|
7.45 units on a scale
Standard Error 0.756
|
7.91 units on a scale
Standard Error 0.727
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: The overall number of participants display the numbers of patients who were included in the mITT population and had at least one post-baseline CGIC evaluation.
The ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change) is a validated categorical measure of change in the patient's clinical condition between baseline and follow-up visits. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). It is suggested that the instrument has distinct clinical utility in assessing change in AD clinical trials.
Outcome measures
| Measure |
T-817MA-H
n=118 Participants
224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.
T-817MA-H: 224 mg or 448 mg T-817 MA once daily
|
T-817MA-L
n=116 Participants
224 mg T-817MA once daily
T-817MA-L: 224 mg T-817 MA once daily
|
Placebo
n=138 Participants
Placebo once daily
Placebo: Placebo
|
|---|---|---|---|
|
CGIC
|
5.25 units on a scale
Standard Error 0.1
|
5.24 units on a scale
Standard Error 0.1
|
5.22 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: The overall number of participants display the numbers of patients who were included in the mITT population and had baseline and at least one post-baseline ADCS-ADL evaluation.
The ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) is a validated tool for assessing instrumental and basic activities of daily living based on a 23-item structured interview of the study partner. The scale has a range of 0 to 78, with lower scores indicating greater impairment.
Outcome measures
| Measure |
T-817MA-H
n=118 Participants
224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.
T-817MA-H: 224 mg or 448 mg T-817 MA once daily
|
T-817MA-L
n=118 Participants
224 mg T-817MA once daily
T-817MA-L: 224 mg T-817 MA once daily
|
Placebo
n=140 Participants
Placebo once daily
Placebo: Placebo
|
|---|---|---|---|
|
ADCS-ADL Change From Baseline to Week 52
|
-10.01 units on a scale
Standard Error 0.991
|
-11.07 units on a scale
Standard Error 0.992
|
-11.29 units on a scale
Standard Error 0.957
|
Adverse Events
T-817MA-H
Serious events: 26 serious events
Other events: 132 other events
Deaths: 2 deaths
T-817MA-L
Serious events: 25 serious events
Other events: 133 other events
Deaths: 2 deaths
Placebo
Serious events: 20 serious events
Other events: 119 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
T-817MA-H
n=158 participants at risk
224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.
T-817MA-H: 224 mg or 448 mg T-817 MA once daily
|
T-817MA-L
n=166 participants at risk
224 mg T-817MA once daily
T-817MA-L: 224 mg T-817 MA once daily
|
Placebo
n=158 participants at risk
Placebo once daily
Placebo: Placebo
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia Macrocytic
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.00%
0/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Cardiac disorders
Bradycardia
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Cardiac disorders
Cardiac Arrest
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Cardiac disorders
Myocardial Infarction
|
0.63%
1/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Gastrointestinal disorders
Megacolon
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
General disorders
Asthenia
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
General disorders
Chest Pain
|
0.00%
0/158 • 52weeks
|
1.2%
2/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Hepatobiliary disorders
Hepatitis
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Infections and infestations
Cellulitis
|
1.3%
2/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Infections and infestations
Diverticulitis
|
0.63%
1/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Infections and infestations
Gastroenteritis
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Infections and infestations
Pneumonia Influenzal
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/158 • 52weeks
|
1.2%
2/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Infections and infestations
Urinary Tract Infection
|
1.3%
2/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.63%
1/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
2/158 • 52weeks
|
1.2%
2/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis Pyrophosphate
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of Colon
|
0.00%
0/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Nervous system disorders
Altered State of Consciousness
|
0.00%
0/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Nervous system disorders
Cerebral Haematoma
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Nervous system disorders
Loss of Consciousness
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/158 • 52weeks
|
1.2%
2/166 • 52weeks
|
1.9%
3/158 • 52weeks
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Psychiatric disorders
Abnormal Behaviour
|
0.00%
0/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Psychiatric disorders
Agitation
|
0.00%
0/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Psychiatric disorders
Completed Suicide
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Psychiatric disorders
Confusional State
|
0.63%
1/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Psychiatric disorders
Delirium
|
1.9%
3/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Psychiatric disorders
Mental Status Changes
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Psychiatric disorders
Paranoia
|
0.63%
1/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/158 • 52weeks
|
0.60%
1/166 • 52weeks
|
0.00%
0/158 • 52weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/158 • 52weeks
|
0.00%
0/166 • 52weeks
|
0.63%
1/158 • 52weeks
|
Other adverse events
| Measure |
T-817MA-H
n=158 participants at risk
224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.
T-817MA-H: 224 mg or 448 mg T-817 MA once daily
|
T-817MA-L
n=166 participants at risk
224 mg T-817MA once daily
T-817MA-L: 224 mg T-817 MA once daily
|
Placebo
n=158 participants at risk
Placebo once daily
Placebo: Placebo
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.5%
4/158 • 52weeks
|
2.4%
4/166 • 52weeks
|
5.7%
9/158 • 52weeks
|
|
Infections and infestations
Urinary tract infection
|
13.3%
21/158 • 52weeks
|
10.2%
17/166 • 52weeks
|
13.9%
22/158 • 52weeks
|
|
Psychiatric disorders
Agitation
|
2.5%
4/158 • 52weeks
|
3.0%
5/166 • 52weeks
|
8.9%
14/158 • 52weeks
|
|
Psychiatric disorders
Anxiety
|
4.4%
7/158 • 52weeks
|
5.4%
9/166 • 52weeks
|
7.6%
12/158 • 52weeks
|
|
Psychiatric disorders
Depression
|
5.1%
8/158 • 52weeks
|
3.6%
6/166 • 52weeks
|
4.4%
7/158 • 52weeks
|
|
Nervous system disorders
Dizziness
|
7.0%
11/158 • 52weeks
|
4.2%
7/166 • 52weeks
|
1.9%
3/158 • 52weeks
|
|
Nervous system disorders
Headache
|
5.7%
9/158 • 52weeks
|
9.6%
16/166 • 52weeks
|
6.3%
10/158 • 52weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
31.0%
49/158 • 52weeks
|
20.5%
34/166 • 52weeks
|
12.7%
20/158 • 52weeks
|
|
Gastrointestinal disorders
Nausea
|
5.7%
9/158 • 52weeks
|
7.8%
13/166 • 52weeks
|
3.8%
6/158 • 52weeks
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
9/158 • 52weeks
|
4.8%
8/166 • 52weeks
|
4.4%
7/158 • 52weeks
|
|
Investigations
Weight decreased
|
5.1%
8/158 • 52weeks
|
2.4%
4/166 • 52weeks
|
1.9%
3/158 • 52weeks
|
|
Injury, poisoning and procedural complications
Fall
|
7.6%
12/158 • 52weeks
|
8.4%
14/166 • 52weeks
|
10.8%
17/158 • 52weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place