Trial Outcomes & Findings for An Efficacy, Safety, and Tolerability Study for TA-7284 in Patients With Type 2 Diabetes (NCT NCT01022112)
NCT ID: NCT01022112
Last Updated: 2026-01-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
383 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-01-08
Participant Flow
Participant milestones
| Measure |
TA-7284-Low
TA-7284 50 mg, once daily for 12 weeks
|
TA-7284-Low-middle
TA-7284 100 mg, once daily for 12 weeks
|
TA-7284-High-middle
TA-7284 200 mg, once daily for 12 weeks
|
TA-7284-High
TA-7284 300 mg, once daily for 12 weeks
|
Placebo
TA-7284 Placebo, once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
82
|
74
|
77
|
75
|
75
|
|
Overall Study
COMPLETED
|
79
|
71
|
74
|
72
|
65
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
3
|
10
|
Reasons for withdrawal
| Measure |
TA-7284-Low
TA-7284 50 mg, once daily for 12 weeks
|
TA-7284-Low-middle
TA-7284 100 mg, once daily for 12 weeks
|
TA-7284-High-middle
TA-7284 200 mg, once daily for 12 weeks
|
TA-7284-High
TA-7284 300 mg, once daily for 12 weeks
|
Placebo
TA-7284 Placebo, once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
2
|
1
|
|
Overall Study
Fasting plasma glucose level increased
|
1
|
0
|
0
|
0
|
7
|
Baseline Characteristics
An Efficacy, Safety, and Tolerability Study for TA-7284 in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
TA-7284-Low
n=82 Participants
TA-7284 50 mg, once daily for 12 weeks
|
TA-7284-Low-middle
n=74 Participants
TA-7284 100 mg, once daily for 12 weeks
|
TA-7284-High-middle
n=77 Participants
TA-7284 200 mg, once daily for 12 weeks
|
TA-7284-High
n=75 Participants
TA-7284 300 mg, once daily for 12 weeks
|
Placebo
n=75 Participants
TA-7284 Placebo, once daily for 12 weeks
|
Total
n=383 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 10.8 • n=18 Participants
|
57.7 years
STANDARD_DEVIATION 10.5 • n=17 Participants
|
57 years
STANDARD_DEVIATION 10.6 • n=35 Participants
|
57.1 years
STANDARD_DEVIATION 10.1 • n=42 Participants
|
57.7 years
STANDARD_DEVIATION 11.0 • n=217 Participants
|
57.4 years
STANDARD_DEVIATION 10.6 • n=1518 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=18 Participants
|
22 Participants
n=17 Participants
|
27 Participants
n=35 Participants
|
20 Participants
n=42 Participants
|
21 Participants
n=217 Participants
|
122 Participants
n=1518 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=18 Participants
|
52 Participants
n=17 Participants
|
50 Participants
n=35 Participants
|
55 Participants
n=42 Participants
|
54 Participants
n=217 Participants
|
261 Participants
n=1518 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Full analysis set, last observation carried forward
Outcome measures
| Measure |
TA-7284-Low
n=82 Participants
TA-7284 50 mg, once daily for 12 weeks
|
TA-7284-Low-middle
n=74 Participants
TA-7284 100 mg, once daily for 12 weeks
|
TA-7284-High-middle
n=75 Participants
TA-7284 200 mg, once daily for 12 weeks
|
TA-7284-High
n=75 Participants
TA-7284 300 mg, once daily for 12 weeks
|
Placebo
n=75 Participants
TA-7284 Placebo, once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)
|
-0.61 percent HbA1C
Standard Error 0.06
|
-0.80 percent HbA1C
Standard Error 0.06
|
-0.79 percent HbA1C
Standard Error 0.06
|
-0.88 percent HbA1C
Standard Error 0.06
|
0.11 percent HbA1C
Standard Error 0.06
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 weeksOutcome measures
Outcome data not reported
Adverse Events
TA-7284-Low
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
TA-7284-Low-middle
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
TA-7284-High-middle
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
TA-7284-High
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TA-7284-Low
n=82 participants at risk
TA-7284 50 mg, once daily for 12 weeks
|
TA-7284-Low-middle
n=74 participants at risk
TA-7284 100 mg, once daily for 12 weeks
|
TA-7284-High-middle
n=77 participants at risk
TA-7284 200 mg, once daily for 12 weeks
|
TA-7284-High
n=75 participants at risk
TA-7284 300 mg, once daily for 12 weeks
|
Placebo
n=75 participants at risk
TA-7284 Placebo, once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
Other adverse events
| Measure |
TA-7284-Low
n=82 participants at risk
TA-7284 50 mg, once daily for 12 weeks
|
TA-7284-Low-middle
n=74 participants at risk
TA-7284 100 mg, once daily for 12 weeks
|
TA-7284-High-middle
n=77 participants at risk
TA-7284 200 mg, once daily for 12 weeks
|
TA-7284-High
n=75 participants at risk
TA-7284 300 mg, once daily for 12 weeks
|
Placebo
n=75 participants at risk
TA-7284 Placebo, once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Infections and infestations
Gastroenteritis
|
2.4%
2/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Infections and infestations
Hordeolum
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Infections and infestations
Localised infection
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
8/82 • 14 weeks
|
13.5%
10/74 • 14 weeks
|
10.4%
8/77 • 14 weeks
|
12.0%
9/75 • 14 weeks
|
13.3%
10/75 • 14 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Infections and infestations
Stitch abscess
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Infections and infestations
Vulvitis
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.7%
3/82 • 14 weeks
|
2.7%
2/74 • 14 weeks
|
2.6%
2/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia unawareness
|
1.2%
1/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
3.9%
3/77 • 14 weeks
|
2.7%
2/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
2.6%
2/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/82 • 14 weeks
|
2.7%
2/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Eye disorders
Glaucoma
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Cardiac disorders
Palpitations
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
2/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/82 • 14 weeks
|
6.8%
5/74 • 14 weeks
|
3.9%
3/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
2/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
2.6%
2/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
4.0%
3/75 • 14 weeks
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Gastrointestinal disorders
Periodontitis
|
3.7%
3/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/82 • 14 weeks
|
2.7%
2/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
2.7%
2/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
2.6%
2/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
2.7%
2/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/82 • 14 weeks
|
2.7%
2/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
1.2%
1/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Reproductive system and breast disorders
Vulvar erosion
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
General disorders
Chest discomfort
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
General disorders
Chest pain
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
2.7%
2/75 • 14 weeks
|
|
General disorders
Hunger
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
General disorders
Malaise
|
3.7%
3/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
General disorders
Thirst
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Investigations
Blood ketone body increased
|
4.9%
4/82 • 14 weeks
|
6.8%
5/74 • 14 weeks
|
11.7%
9/77 • 14 weeks
|
8.0%
6/75 • 14 weeks
|
2.7%
2/75 • 14 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Investigations
Blood urine present
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
2.6%
2/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Investigations
Electrocardiogram abnormal
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Investigations
Platelet count decreased
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Investigations
Protein urine present
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Investigations
Urine output increased
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Investigations
White blood cell count decreased
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
1.3%
1/75 • 14 weeks
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
1.3%
1/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.2%
1/82 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/82 • 14 weeks
|
1.4%
1/74 • 14 weeks
|
0.00%
0/77 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
0.00%
0/75 • 14 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER