Trial Outcomes & Findings for Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for TLC599 in OA Patients (NCT NCT03005873)
NCT ID: NCT03005873
Last Updated: 2024-04-22
Results Overview
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale consist of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. The total score of the pain subscale for each patient is normalized and expressed on a 0 to 4 scale. Higher scores represent higher levels of pain (worse outcome), whereas lower scores represent lower levels of pain (better outcome). Missing data were imputed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2024-04-22
Participant Flow
Participant milestones
| Measure |
TLC599 LD Group
12 mg DSP with 100 µmol PL (1.0 mL)
TLC599 LD group: Single dose via intra-articular injection
|
TLC599 HD Group
18 mg DSP with 150 µmol PL (1.5 mL)
TLC599 HD group: Single dose via intra-articular injection
|
Placebo Group
1.5 mL normal saline
Normal Saline: Single dose via intra-articular injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
26
|
|
Overall Study
COMPLETED
|
25
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
4
|
Reasons for withdrawal
| Measure |
TLC599 LD Group
12 mg DSP with 100 µmol PL (1.0 mL)
TLC599 LD group: Single dose via intra-articular injection
|
TLC599 HD Group
18 mg DSP with 150 µmol PL (1.5 mL)
TLC599 HD group: Single dose via intra-articular injection
|
Placebo Group
1.5 mL normal saline
Normal Saline: Single dose via intra-articular injection
|
|---|---|---|---|
|
Overall Study
Prohibited medication use post radnomization
|
1
|
1
|
1
|
|
Overall Study
Withdrew consent
|
0
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Ineligible post randomization
|
0
|
0
|
1
|
Baseline Characteristics
Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for TLC599 in OA Patients
Baseline characteristics by cohort
| Measure |
TLC599 LD Group
n=26 Participants
12 mg DSP with 100 µmol PL (1.0 mL)
TLC599 LD group: Single dose via intra-articular injection
|
TLC599 HD Group
n=24 Participants
18 mg DSP with 150 µmol PL (1.5 mL)
TLC599 HD group: Single dose via intra-articular injection
|
Placebo Group
n=25 Participants
1.5 mL normal saline
Normal Saline: Single dose via intra-articular injection
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 9.07 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 8.80 • n=7 Participants
|
64.8 years
STANDARD_DEVIATION 8.45 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 8.69 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
37 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
13 participants
n=5 Participants
|
38 participants
n=4 Participants
|
|
VAS score (Study Knee)
|
6.45 units on a scale
STANDARD_DEVIATION 1.113 • n=5 Participants
|
6.87 units on a scale
STANDARD_DEVIATION 1.215 • n=7 Participants
|
6.56 units on a scale
STANDARD_DEVIATION 1.049 • n=5 Participants
|
6.62 units on a scale
STANDARD_DEVIATION 1.125 • n=4 Participants
|
|
WOMAC Pain score (0-4)
|
1.49 units on a scale
STANDARD_DEVIATION 0.558 • n=5 Participants
|
1.74 units on a scale
STANDARD_DEVIATION 0.631 • n=7 Participants
|
1.62 units on a scale
STANDARD_DEVIATION 0.609 • n=5 Participants
|
1.62 units on a scale
STANDARD_DEVIATION 0.600 • n=4 Participants
|
|
WOMAC Function score (0-4)
|
1.53 units on a scale
STANDARD_DEVIATION 0.531 • n=5 Participants
|
1.82 units on a scale
STANDARD_DEVIATION 0.742 • n=7 Participants
|
1.48 units on a scale
STANDARD_DEVIATION 0.652 • n=5 Participants
|
1.61 units on a scale
STANDARD_DEVIATION 0.653 • n=4 Participants
|
|
Kellgren-Lawrence grades
Grade 0
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Kellgren-Lawrence grades
Grade 1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Kellgren-Lawrence grades
Grade 2
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Kellgren-Lawrence grades
Grade 3
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Kellgren-Lawrence grades
Grade 4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale consist of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. The total score of the pain subscale for each patient is normalized and expressed on a 0 to 4 scale. Higher scores represent higher levels of pain (worse outcome), whereas lower scores represent lower levels of pain (better outcome). Missing data were imputed.
Outcome measures
| Measure |
TLC599 LD Group
n=26 Participants
12 mg DSP with 100 µmol PL (1.0 mL)
TLC599 LD group: Single dose via intra-articular injection
|
TLC599 HD Group
n=24 Participants
18 mg DSP with 150 µmol PL (1.5 mL)
TLC599 HD group: Single dose via intra-articular injection
|
Placebo Group
n=25 Participants
1.5 mL normal saline
Normal Saline: Single dose via intra-articular injection
|
|---|---|---|---|
|
Change From Baseline in WOMAC Pain Subscale at Week 12
|
-0.83 score on a scale
Standard Error 0.090
|
-0.64 score on a scale
Standard Error 0.094
|
-0.47 score on a scale
Standard Error 0.092
|
Adverse Events
TLC599 LD Group
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
TLC599 HD Group
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TLC599 LD Group
n=26 participants at risk
12 mg DSP with 100 µmol PL (1.0 mL)
TLC599 LD group: Single dose via intra-articular injection
|
TLC599 HD Group
n=24 participants at risk
18 mg DSP with 150 µmol PL (1.5 mL)
TLC599 HD group: Single dose via intra-articular injection
|
Placebo Group
n=25 participants at risk
1.5 mL normal saline
Normal Saline: Single dose via intra-articular injection
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
Other adverse events
| Measure |
TLC599 LD Group
n=26 participants at risk
12 mg DSP with 100 µmol PL (1.0 mL)
TLC599 LD group: Single dose via intra-articular injection
|
TLC599 HD Group
n=24 participants at risk
18 mg DSP with 150 µmol PL (1.5 mL)
TLC599 HD group: Single dose via intra-articular injection
|
Placebo Group
n=25 participants at risk
1.5 mL normal saline
Normal Saline: Single dose via intra-articular injection
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
15.4%
4/26 • 6 months
|
4.2%
1/24 • 6 months
|
12.0%
3/25 • 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
1/26 • 6 months
|
16.7%
4/24 • 6 months
|
8.0%
2/25 • 6 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
12.0%
3/25 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
7.7%
2/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Infections and infestations
Fungal skin infection
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Infections and infestations
Gastrointestinal infection
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Infections and infestations
Respiratory tract infection viral
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
1/26 • 6 months
|
8.3%
2/24 • 6 months
|
12.0%
3/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.8%
1/26 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/26 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/26 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Nervous system disorders
Headache
|
11.5%
3/26 • 6 months
|
25.0%
6/24 • 6 months
|
16.0%
4/25 • 6 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/26 • 6 months
|
4.2%
1/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/26 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Nervous system disorders
Migraine
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Nervous system disorders
Piriformis syndrome
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Nervous system disorders
Tension headache
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Investigations
Cortisol decreased
|
7.7%
2/26 • 6 months
|
25.0%
6/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Investigations
Lipase increased
|
0.00%
0/26 • 6 months
|
4.2%
1/24 • 6 months
|
8.0%
2/25 • 6 months
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Investigations
Amylase increased
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Investigations
Blood calcium increased
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Investigations
Blood glucose increased
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/26 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Investigations
Heart rate irregular
|
0.00%
0/26 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Investigations
Hepatitis C virus test positive
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Investigations
Liver function test abnormal
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Investigations
White blood cells urine positive
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
11.5%
3/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/26 • 6 months
|
8.3%
2/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
2/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
8.0%
2/25 • 6 months
|
|
Injury, poisoning and procedural complications
Joint injury
|
3.8%
1/26 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/26 • 6 months
|
8.3%
2/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Endocrine disorders
Glucocorticoid deficiency
|
11.5%
3/26 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
General disorders
Feeling hot
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
General disorders
Influenza like illness
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
General disorders
Mass
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
General disorders
Peripheral swelling
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Psychiatric disorders
Insomnia
|
3.8%
1/26 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
8.0%
2/25 • 6 months
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
|
Cardiac disorders
Coronary artery stenosis
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/26 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/26 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/26 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
0.00%
0/26 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
3.8%
1/26 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Surgical and medical procedures
Skin lesion removal
|
0.00%
0/26 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/25 • 6 months
|
|
Vascular disorders
Varicose vein
|
0.00%
0/26 • 6 months
|
0.00%
0/24 • 6 months
|
4.0%
1/25 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place