Trial Outcomes & Findings for Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients (NCT NCT02404389)
NCT ID: NCT02404389
Last Updated: 2021-01-05
Results Overview
Number of participants with at least one AE/SAE in the category up to 20 weeks
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
20 weeks
Results posted on
2021-01-05
Participant Flow
A total of 82 patients, male and female of non-childbearing potential aged 18-75 years, with Actinic Keratosis (AK) on the face or balding scalp were enrolled in the study.
Participant milestones
| Measure |
LFX453 0.1% NMC
LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
|
LFX453 0.15% LCC
LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
|
Vehicle to NMC
Vehicle to nanomedicinal cream (NMC) Twice daily applications
|
Vehicle to LCC
Vehicle to liquid crystal cream (LCC) Twice daily applications
|
Aldara
Aldara cream 3 applications per week
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
11
|
10
|
21
|
|
Overall Study
COMPLETED
|
18
|
20
|
10
|
9
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
LFX453 0.1% NMC
LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
|
LFX453 0.15% LCC
LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
|
Vehicle to NMC
Vehicle to nanomedicinal cream (NMC) Twice daily applications
|
Vehicle to LCC
Vehicle to liquid crystal cream (LCC) Twice daily applications
|
Aldara
Aldara cream 3 applications per week
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
0
|
2
|
|
Overall Study
Subject/guardian decision
|
1
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients
Baseline characteristics by cohort
| Measure |
LFX453 0.1% NMC
n=20 Participants
LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
|
LFX453 0.15% LCC
n=20 Participants
LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
|
Vehicle to NMC
n=11 Participants
Vehicle to nanomedicinal cream (NMC) Twice daily applications
|
Vehicle to LCC
n=10 Participants
Vehicle to liquid crystal cream (LCC) Twice daily applications
|
Aldara
n=21 Participants
Aldara cream 3 applications per week
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 5.23 • n=5 Participants
|
68.6 years
STANDARD_DEVIATION 6.25 • n=7 Participants
|
68.3 years
STANDARD_DEVIATION 6.66 • n=5 Participants
|
70.2 years
STANDARD_DEVIATION 4.32 • n=4 Participants
|
68.6 years
STANDARD_DEVIATION 5.61 • n=21 Participants
|
68.5 years
STANDARD_DEVIATION 5.61 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
73 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 20 weeksPopulation: The safety analysis set included all patients that received any study drug. For Safety \& Tolerability only the 2 vehicles have separate analysis.
Number of participants with at least one AE/SAE in the category up to 20 weeks
Outcome measures
| Measure |
LFX453 0.1% NMC
n=20 Participants
LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
|
LFX453 0.15% LCC
n=20 Participants
LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
|
Vehicle to NMC
n=11 Participants
Vehicle to nanomedicinal cream (NMC) Twice daily applications
|
Vehicle to LCC
n=10 Participants
Vehicle to liquid crystal cream (LCC) Twice daily applications
|
Aldara
n=21 Participants
Aldara cream 3 applications per week
|
|---|---|---|---|---|---|
|
Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 20 Weeks
Serious Adverse Events (SAEs)
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 20 Weeks
Adverse Events (AEs)
|
10 participants
|
15 participants
|
9 participants
|
8 participants
|
18 participants
|
PRIMARY outcome
Timeframe: Week 20Population: Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.
Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined
Outcome measures
| Measure |
LFX453 0.1% NMC
n=20 Participants
LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
|
LFX453 0.15% LCC
n=20 Participants
LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
|
Vehicle to NMC
n=21 Participants
Vehicle to nanomedicinal cream (NMC) Twice daily applications
|
Vehicle to LCC
n=21 Participants
Vehicle to liquid crystal cream (LCC) Twice daily applications
|
Aldara
Aldara cream 3 applications per week
|
|---|---|---|---|---|---|
|
Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined
|
1 participants
|
1 participants
|
1 participants
|
13 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 20Population: Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.
Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined
Outcome measures
| Measure |
LFX453 0.1% NMC
n=20 Participants
LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
|
LFX453 0.15% LCC
n=20 Participants
LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
|
Vehicle to NMC
n=21 Participants
Vehicle to nanomedicinal cream (NMC) Twice daily applications
|
Vehicle to LCC
n=21 Participants
Vehicle to liquid crystal cream (LCC) Twice daily applications
|
Aldara
Aldara cream 3 applications per week
|
|---|---|---|---|---|---|
|
Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined
|
33.2 percent change
Standard Deviation 31.19
|
34.5 percent change
Standard Deviation 33.20
|
34.3 percent change
Standard Deviation 33.31
|
86.7 percent change
Standard Deviation 23.53
|
—
|
SECONDARY outcome
Timeframe: week 8, week 16Population: Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.
Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined
Outcome measures
| Measure |
LFX453 0.1% NMC
n=20 Participants
LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
|
LFX453 0.15% LCC
n=20 Participants
LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
|
Vehicle to NMC
n=21 Participants
Vehicle to nanomedicinal cream (NMC) Twice daily applications
|
Vehicle to LCC
n=21 Participants
Vehicle to liquid crystal cream (LCC) Twice daily applications
|
Aldara
Aldara cream 3 applications per week
|
|---|---|---|---|---|---|
|
Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined
Week 8
|
0 participants
|
0 participants
|
1 participants
|
3 participants
|
—
|
|
Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined
Week 16
|
1 participants
|
1 participants
|
1 participants
|
9 participants
|
—
|
SECONDARY outcome
Timeframe: Week 20Population: Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.
Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at 8 weeks after the end of treatment (Week 20 = EOS visit) for LFX453 compared to vehicle groups combined
Outcome measures
| Measure |
LFX453 0.1% NMC
n=20 Participants
LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
|
LFX453 0.15% LCC
n=20 Participants
LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
|
Vehicle to NMC
n=21 Participants
Vehicle to nanomedicinal cream (NMC) Twice daily applications
|
Vehicle to LCC
n=21 Participants
Vehicle to liquid crystal cream (LCC) Twice daily applications
|
Aldara
Aldara cream 3 applications per week
|
|---|---|---|---|---|---|
|
Number of Participants That Had Partial Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined
|
1 participants
|
2 participants
|
2 participants
|
16 participants
|
—
|
SECONDARY outcome
Timeframe: week 8, week 16Population: Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.
Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined
Outcome measures
| Measure |
LFX453 0.1% NMC
n=20 Participants
LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
|
LFX453 0.15% LCC
n=20 Participants
LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
|
Vehicle to NMC
n=21 Participants
Vehicle to nanomedicinal cream (NMC) Twice daily applications
|
Vehicle to LCC
n=21 Participants
Vehicle to liquid crystal cream (LCC) Twice daily applications
|
Aldara
Aldara cream 3 applications per week
|
|---|---|---|---|---|---|
|
Number of Participants That Partial Clearance of Actinic Keratosis (AK) at at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined
Week 16
|
3 participants
|
4 participants
|
3 participants
|
15 participants
|
—
|
|
Number of Participants That Partial Clearance of Actinic Keratosis (AK) at at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined
Week 8
|
1 participants
|
0 participants
|
3 participants
|
7 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.
Reduction rate (percent) of Actinic keratosis (AK) lesion count at Week 8 for LFX453 compared to vehicle groups combined
Outcome measures
| Measure |
LFX453 0.1% NMC
n=20 Participants
LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
|
LFX453 0.15% LCC
n=20 Participants
LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
|
Vehicle to NMC
n=21 Participants
Vehicle to nanomedicinal cream (NMC) Twice daily applications
|
Vehicle to LCC
n=21 Participants
Vehicle to liquid crystal cream (LCC) Twice daily applications
|
Aldara
Aldara cream 3 applications per week
|
|---|---|---|---|---|---|
|
Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at Week 8 for LFX453 Compared to Vehicle Groups Combined
|
21.9 percent change
Standard Deviation 36.18
|
21.9 percent change
Standard Deviation 28.91
|
32.3 percent change
Standard Deviation 33.55
|
55.8 percent change
Standard Deviation 36.54
|
—
|
Adverse Events
LFX453 0.1% NMC
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
LFX453 0.15% LCC
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Vehicle to NMC
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Vehicle to LCC
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Aldara
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LFX453 0.1% NMC
n=20 participants at risk
LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
|
LFX453 0.15% LCC
n=20 participants at risk
LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
|
Vehicle to NMC
n=11 participants at risk
Vehicle to nanomedicinal cream (NMC) Twice daily applications
|
Vehicle to LCC
n=10 participants at risk
Vehicle to liquid crystal cream (LCC) Twice daily applications
|
Aldara
n=21 participants at risk
Aldara cream 3 applications per week
|
|---|---|---|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Psychiatric disorders
DEPRESSION
|
5.0%
1/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
Other adverse events
| Measure |
LFX453 0.1% NMC
n=20 participants at risk
LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
|
LFX453 0.15% LCC
n=20 participants at risk
LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
|
Vehicle to NMC
n=11 participants at risk
Vehicle to nanomedicinal cream (NMC) Twice daily applications
|
Vehicle to LCC
n=10 participants at risk
Vehicle to liquid crystal cream (LCC) Twice daily applications
|
Aldara
n=21 participants at risk
Aldara cream 3 applications per week
|
|---|---|---|---|---|---|
|
Infections and infestations
TINEA PEDIS
|
5.0%
1/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Injury, poisoning and procedural complications
CORNEAL ABRASION
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Injury, poisoning and procedural complications
EYELID INJURY
|
5.0%
1/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Blood and lymphatic system disorders
HAEMOLYTIC ANAEMIA
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Blood and lymphatic system disorders
INCREASED TENDENCY TO BRUISE
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Ear and labyrinth disorders
VESTIBULAR DISORDER
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Eye disorders
BLEPHARITIS
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Gastrointestinal disorders
APHTHOUS ULCER
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Gastrointestinal disorders
APICAL GRANULOMA
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/20 • 24 weeks
|
15.0%
3/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
General disorders
APPLICATION SITE COLDNESS
|
5.0%
1/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
General disorders
APPLICATION SITE ERYTHEMA
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
23.8%
5/21 • 24 weeks
|
|
General disorders
APPLICATION SITE PRURITUS
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
9.5%
2/21 • 24 weeks
|
|
General disorders
APPLICATION SITE SCAB
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
9.5%
2/21 • 24 weeks
|
|
General disorders
CHILLS
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
General disorders
FATIGUE
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
9.5%
2/21 • 24 weeks
|
|
General disorders
HYPOTHERMIA
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
5.0%
1/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
14.3%
3/21 • 24 weeks
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Infections and infestations
EYE INFECTION
|
5.0%
1/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Infections and infestations
INFLUENZA
|
5.0%
1/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.0%
1/20 • 24 weeks
|
25.0%
5/20 • 24 weeks
|
27.3%
3/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Infections and infestations
RELAPSING FEVER
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Injury, poisoning and procedural complications
MUSCLE RUPTURE
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Injury, poisoning and procedural complications
PERIORBITAL HAEMATOMA
|
5.0%
1/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Investigations
ANTIPSYCHOTIC DRUG LEVEL INCREASED
|
5.0%
1/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
5.0%
1/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
5.0%
1/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
5.0%
1/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
MYOSCLEROSIS
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.0%
1/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
PERIARTHRITIS
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
5.0%
1/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEBORRHOEIC KERATOSIS
|
5.0%
1/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Nervous system disorders
AUTONOMIC NERVOUS SYSTEM IMBALANCE
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Nervous system disorders
BURNING SENSATION
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
18.2%
2/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Nervous system disorders
POLYNEUROPATHY
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Nervous system disorders
POOR QUALITY SLEEP
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Psychiatric disorders
AGITATION
|
5.0%
1/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Psychiatric disorders
BURNOUT SYNDROME
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Renal and urinary disorders
RENAL CYST
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
5.0%
1/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
5.0%
1/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
0.00%
0/20 • 24 weeks
|
0.00%
0/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
10.0%
1/10 • 24 weeks
|
4.8%
1/21 • 24 weeks
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
9.1%
1/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/10 • 24 weeks
|
0.00%
0/21 • 24 weeks
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER