Trial Outcomes & Findings for Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical Study (NCT NCT02933879)
NCT ID: NCT02933879
Last Updated: 2018-12-20
Results Overview
Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail
COMPLETED
PHASE2
184 participants
Day 365
2018-12-20
Participant Flow
Participant milestones
| Measure |
NVXT Topical Treatment Group A
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
|---|---|---|---|
|
Overall Study
STARTED
|
64
|
62
|
58
|
|
Overall Study
COMPLETED
|
48
|
48
|
41
|
|
Overall Study
NOT COMPLETED
|
16
|
14
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical Study
Baseline characteristics by cohort
| Measure |
NVXT Topical Treatment Group A
n=64 Participants
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
n=62 Participants
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
n=58 Participants
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
53.1 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
50.8 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
51.8 years
STANDARD_DEVIATION 14.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Ethnicity (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
|
|
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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
157 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
|
PRIMARY outcome
Timeframe: Day 365Population: 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.
Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail
Outcome measures
| Measure |
NVXT Topical Treatment Group A
n=52 Participants
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
n=48 Participants
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
n=43 Participants
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
|---|---|---|---|
|
Number of Patients in Each Treatment Group With a Complete Therapeutic Cure
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 141Population: Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.
Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail
Outcome measures
| Measure |
NVXT Topical Treatment Group A
n=107 Participants
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
n=49 Participants
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
|---|---|---|---|
|
Number of Patients in Each Treatment Group With a Complete Therapeutic Cure
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 365Population: 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.
Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail
Outcome measures
| Measure |
NVXT Topical Treatment Group A
n=52 Participants
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
n=48 Participants
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
n=43 Participants
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
|---|---|---|---|
|
Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure
|
2 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 141Population: Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.
Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail
Outcome measures
| Measure |
NVXT Topical Treatment Group A
n=107 Participants
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
n=49 Participants
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
|---|---|---|---|
|
Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: day 365Population: 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.
Mycological cure is defined as a negative KOH test and a negative fungal culture.
Outcome measures
| Measure |
NVXT Topical Treatment Group A
n=52 Participants
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
n=48 Participants
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
n=43 Participants
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
|---|---|---|---|
|
Number of Patients in Each Treatment Group With a Mycological Cure
|
7 Participants
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 141Population: Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 20 subjects from Group A+B and 10 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.
Mycological cure is defined as a negative KOH test and a negative fungal culture.
Outcome measures
| Measure |
NVXT Topical Treatment Group A
n=106 Participants
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
n=48 Participants
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
|---|---|---|---|
|
Number of Patients in Each Treatment Group With a Mycological Cure
|
30 Participants
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: day 365Population: 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.
Complete clinical cure is defined as 0% nail involvement.
Outcome measures
| Measure |
NVXT Topical Treatment Group A
n=52 Participants
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
n=48 Participants
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
n=43 Participants
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
|---|---|---|---|
|
Number of Patients in Each Treatment Group With a Complete Clinical Cure
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 281Population: Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 24 subjects from Group A+B and 15 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.
Complete clinical cure is defined as 0% nail involvement.
Outcome measures
| Measure |
NVXT Topical Treatment Group A
n=102 Participants
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
n=43 Participants
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
|---|---|---|---|
|
Number of Patients in Each Treatment Group With a Complete Clinical Cure
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 141Population: Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.
Complete clinical cure is defined as 0% nail involvement.
Outcome measures
| Measure |
NVXT Topical Treatment Group A
n=107 Participants
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
n=49 Participants
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
|---|---|---|---|
|
Number of Patients in Each Treatment Group With a Complete Clinical Cure
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: day 365Population: 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.
Satisfactory clinical cure is defined as \<5% of the target toenail involvement.
Outcome measures
| Measure |
NVXT Topical Treatment Group A
n=52 Participants
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
n=48 Participants
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
n=43 Participants
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
|---|---|---|---|
|
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
|
7 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 281Population: Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 24 subjects from Group A+B and 15 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.
Satisfactory clinical cure is defined as \<5% of the target toenail involvement.
Outcome measures
| Measure |
NVXT Topical Treatment Group A
n=102 Participants
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
n=43 Participants
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
|---|---|---|---|
|
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
|
2 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 141Population: Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.
Satisfactory clinical cure is defined as \<5% of the target toenail involvement.
Outcome measures
| Measure |
NVXT Topical Treatment Group A
n=107 Participants
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
n=49 Participants
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
|---|---|---|---|
|
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
|
2 Participants
|
2 Participants
|
—
|
Adverse Events
NVXT Topical Treatment Group A
NVXT Topical Treatment Group B
Placebo (Vehicle) Topical Treatment Group C
Serious adverse events
| Measure |
NVXT Topical Treatment Group A
n=64 participants at risk
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
n=62 participants at risk
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
n=58 participants at risk
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
Other adverse events
| Measure |
NVXT Topical Treatment Group A
n=64 participants at risk
daily dosing for one 8-week treatment period
NVXT topical: topical treatment
|
NVXT Topical Treatment Group B
n=62 participants at risk
daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment
|
Placebo (Vehicle) Topical Treatment Group C
n=58 participants at risk
two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical
|
|---|---|---|---|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Ear and labyrinth disorders
Vertigo
|
1.6%
1/64 • Number of events 1 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/64 • 1 year, 1 month
|
1.6%
1/62 • Number of events 1 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Gastrointestinal disorders
Vomiting projectile
|
1.6%
1/64 • Number of events 1 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
General disorders
Chest pain
|
0.00%
0/64 • 1 year, 1 month
|
1.6%
1/62 • Number of events 1 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
General disorders
Chills
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Immune system disorders
Seasonal allergy
|
3.1%
2/64 • Number of events 2 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Infections and infestations
Cystitis
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Infections and infestations
Influenza
|
0.00%
0/64 • 1 year, 1 month
|
1.6%
1/62 • Number of events 1 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
5/64 • Number of events 6 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
3.4%
2/58 • Number of events 2 • 1 year, 1 month
|
|
Infections and infestations
Orchitis
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Infections and infestations
Otitis externa
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Infections and infestations
Otitis media
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/64 • 1 year, 1 month
|
1.6%
1/62 • Number of events 1 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Infections and infestations
Upper respiratory tract infection
|
4.7%
3/64 • Number of events 5 • 1 year, 1 month
|
6.5%
4/62 • Number of events 5 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/64 • 1 year, 1 month
|
1.6%
1/62 • Number of events 1 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Injury, poisoning and procedural complications
Contusion
|
3.1%
2/64 • Number of events 2 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.6%
1/64 • Number of events 1 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.6%
1/64 • Number of events 1 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.6%
1/64 • Number of events 1 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
5.2%
3/58 • Number of events 3 • 1 year, 1 month
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Investigations
Eosinophil count increased
|
0.00%
0/64 • 1 year, 1 month
|
3.2%
2/62 • Number of events 2 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
6.9%
4/58 • Number of events 4 • 1 year, 1 month
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
4/64 • Number of events 4 • 1 year, 1 month
|
1.6%
1/62 • Number of events 1 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
1.6%
1/64 • Number of events 1 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/64 • 1 year, 1 month
|
1.6%
1/62 • Number of events 1 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/64 • 1 year, 1 month
|
1.6%
1/62 • Number of events 1 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Nervous system disorders
Headache
|
3.1%
2/64 • Number of events 2 • 1 year, 1 month
|
3.2%
2/62 • Number of events 2 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Scrotal varicose veins
|
0.00%
0/64 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/64 • 1 year, 1 month
|
3.2%
2/62 • Number of events 2 • 1 year, 1 month
|
1.7%
1/58 • Number of events 1 • 1 year, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.6%
1/64 • Number of events 1 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.6%
1/64 • Number of events 1 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.6%
1/64 • Number of events 2 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
1.6%
1/64 • Number of events 1 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
1.6%
1/64 • Number of events 2 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
1.6%
1/64 • Number of events 1 • 1 year, 1 month
|
1.6%
1/62 • Number of events 2 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.6%
1/64 • Number of events 1 • 1 year, 1 month
|
0.00%
0/62 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/64 • 1 year, 1 month
|
1.6%
1/62 • Number of events 1 • 1 year, 1 month
|
0.00%
0/58 • 1 year, 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place