Trial Outcomes & Findings for Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy (PDN) (NCT NCT03297294)
NCT ID: NCT03297294
Last Updated: 2021-10-08
Results Overview
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The following parameters were evaluated using the 11-point NRS: 24-hour Average Pain Score and 24-hour Worst Pain Score Patients evaluated their "average pain" and "worst pain" during the past 24 hours in the evening prior to sleep by touching the appropriate corresponding number between zero and ten on a eDiary device.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
142 participants
Primary outcome timeframe
Baseline up to Week 12
Results posted on
2021-10-08
Participant Flow
Three hundred six patients were screened and 137 randomized
Participant milestones
| Measure |
EMA401 100mg BID DB
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID -> EMA401 100mg BID TW
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of DB treatment period (week 12)
|
EMA401 100mg BID -> Placebo BID TW
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of DB treatment period (week 12)
|
Placebo BID -> Placebo BID TW
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|---|---|
|
Double-Blind Treatment Period (DB)
STARTED
|
70
|
67
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (DB)
COMPLETED
|
32
|
30
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (DB)
NOT COMPLETED
|
38
|
37
|
0
|
0
|
0
|
|
Treatment Withdrawal Period (TW)
STARTED
|
0
|
0
|
14
|
12
|
27
|
|
Treatment Withdrawal Period (TW)
COMPLETED
|
0
|
0
|
14
|
11
|
27
|
|
Treatment Withdrawal Period (TW)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
EMA401 100mg BID DB
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID -> EMA401 100mg BID TW
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of DB treatment period (week 12)
|
EMA401 100mg BID -> Placebo BID TW
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of DB treatment period (week 12)
|
Placebo BID -> Placebo BID TW
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|---|---|
|
Double-Blind Treatment Period (DB)
Study terminated by sponsor
|
30
|
31
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (DB)
Withdrawal by Subject
|
4
|
4
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (DB)
Adverse Event
|
3
|
1
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (DB)
Physician Decision
|
1
|
1
|
0
|
0
|
0
|
|
Treatment Withdrawal Period (TW)
Study terminated by sponsor
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy (PDN)
Baseline characteristics by cohort
| Measure |
EMA401 100mg BID DB
n=70 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=67 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 - 64 years
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Customized
65 - 84 years
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Age, Customized
≥ 85 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
70 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Body mass index
|
30.8 kg/m^2
n=5 Participants
|
30.2 kg/m^2
n=7 Participants
|
30.6 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 12Population: Full analysis set
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The following parameters were evaluated using the 11-point NRS: 24-hour Average Pain Score and 24-hour Worst Pain Score Patients evaluated their "average pain" and "worst pain" during the past 24 hours in the evening prior to sleep by touching the appropriate corresponding number between zero and ten on a eDiary device.
Outcome measures
| Measure |
EMA401 100mg BID DB
n=70 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=67 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
Placebo BID -> Placebo BID TW
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|
|
Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12
Week 4
|
-1.0 scores on a scale
Standard Error 0.21
|
-0.8 scores on a scale
Standard Error 0.18
|
—
|
|
Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12
Week 8
|
-1.7 scores on a scale
Standard Error 0.29
|
-1.1 scores on a scale
Standard Error 0.26
|
—
|
|
Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12
Week 12
|
-1.9 scores on a scale
Standard Error 0.31
|
-1.3 scores on a scale
Standard Error 0.27
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12The Neuropathic Pain Symptom Inventory (NPSI) is a 12 item patient reported outcome measure that contains 10 descriptors representing 5 dimensions of pain (burning pain, deep/pressing pain, paroxysmal pain, evoked pain and paraesthesia/dysesthesia) and 2 temporal items designed to assess pain duration and the number of pain paroxysms. The sum of the responses to the 10 questions (all except temporal questions) was regarded as the total score and was divided by 10 (10 questions). The range of the total score and of the 5 dimensional scores is 0 to 10. Lower values represent better outcomes.
Outcome measures
| Measure |
EMA401 100mg BID DB
n=70 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=67 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
Placebo BID -> Placebo BID TW
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|
|
Change in Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 12
Week 4
|
-1.2 scores on a scale
Standard Error 0.19
|
-1.0 scores on a scale
Standard Error 0.18
|
—
|
|
Change in Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 12
Week 8
|
-1.3 scores on a scale
Standard Error 0.25
|
-0.9 scores on a scale
Standard Error 0.22
|
—
|
|
Change in Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 12
Week 12
|
-1.6 scores on a scale
Standard Error 0.32
|
-1.1 scores on a scale
Standard Error 0.26
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12The BPI-SF is a validated, self-administered (at clinic) questionnaire that assesses pain severity and its mpact on daily functions. Patients were asked to complete the 7-item pain interference scale that assessed the degree to which pain interfered with walking and other physical activity, work, mood, relations with others and sleep using a zero to ten scale with zero being "does not interfere" and ten being "completely interferes". The BPI total score is the sum of the 7 items. Each item ranges from 0 to 10, thus the total score ranges from 0 to 70. Lower values indicate a better outcome.
Outcome measures
| Measure |
EMA401 100mg BID DB
n=70 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=67 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
Placebo BID -> Placebo BID TW
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|
|
Change in Brief Pain Inventory-Short Form Interference (BPI-SF) Mean Total Score From Baseline to Week 12
|
-12.03 scores on a scale
Standard Deviation 13.336
|
-10.83 scores on a scale
Standard Deviation 14.602
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The following parameters were evaluated using the 11-point NRS: 24-hour Average Pain Score and 24-hour Worst Pain Score Patients evaluated their "average pain" and "worst pain" during the past 24 hours in the evening prior to sleep by touching the appropriate corresponding number between zero and ten on a eDiary device.
Outcome measures
| Measure |
EMA401 100mg BID DB
n=70 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=67 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
Placebo BID -> Placebo BID TW
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|
|
Change in Weekly Mean of the 24-hour Worst Pain Score, Using an 11-point NRS, From Baseline to Week 12
|
-1.63 scores on numeric rating scale
Standard Deviation 1.837
|
-1.28 scores on numeric rating scale
Standard Deviation 1.577
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12The Patient Global Impression of Change (PGIC) is a patient-reported instrument that measures change in overall status on a scale ranging from one ("very much improved") to seven ("very much worse"). The PGIC is based on the validated Clinical Global Impression of Change scale. The PGIC was to be completed by patients using the electronic tablet at the site
Outcome measures
| Measure |
EMA401 100mg BID DB
n=70 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=67 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
Placebo BID -> Placebo BID TW
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
Very much improved
|
4 Participants
|
2 Participants
|
—
|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
Much improved
|
7 Participants
|
11 Participants
|
—
|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
Minimally improved
|
17 Participants
|
18 Participants
|
—
|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
No change
|
18 Participants
|
14 Participants
|
—
|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
Minimally worse
|
3 Participants
|
2 Participants
|
—
|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
Much worse
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
Very much worse
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
Missing
|
21 Participants
|
20 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Full analysis set
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The number of patients with observed response, i.e. a decrease of 30% units in weekly mean of the 24-hour average pain score NRS. Logistic regression model with region, treatment, sex, use of PHN medications (yes/no) as factors and age and baseline NRS as covariates. An odds ratio \>1 = higher chance of a clinically important improvement.
Outcome measures
| Measure |
EMA401 100mg BID DB
n=70 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=67 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
Placebo BID -> Placebo BID TW
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|
|
Percentage of Patients Achieving at Least 30% Pain Reduction at Week 12 on NRS 11 Point Scale
Week 4 - at least 30% pain reduction
|
34.0 % of participants - model adjusted rate
|
24.7 % of participants - model adjusted rate
|
—
|
|
Percentage of Patients Achieving at Least 30% Pain Reduction at Week 12 on NRS 11 Point Scale
Week 12 - at least 30% pain reduction
|
52.7 % of participants - model adjusted rate
|
40.4 % of participants - model adjusted rate
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Full analysis set
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The number of patients with observed response, i.e. a decrease of 50% units in weekly mean of the 24-hour average pain score NRS. Logistic regression model with region, treatment, sex, use of PHN medications (yes/no) as factors and age and baseline NRS as covariates. An odds ratio \>1 = higher chance of a clinically important improvement.
Outcome measures
| Measure |
EMA401 100mg BID DB
n=70 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=67 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
Placebo BID -> Placebo BID TW
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|
|
Percentage of Patients Achieving at Least 50% Pain Reduction at Week 12 on NRS 11 Point Scale
|
31.4 % of participants - model adjusted rate
|
14.1 % of participants - model adjusted rate
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Full analysis set
Patients were asked to complete the ISI using five-point Likert-style scale as a measure of perceived sleep difficulties. The questionnaire assessed the severity of insomnia, satisfaction with current sleep pattern, sleep interference, "noticeability" of sleeping problem to others and concern about sleeping problems. The scale consists of 7 items. The sum of seven items represents the total score. Each of the 7 items is scored using a range from 0 to 4, thus the total score values ranges from zero to 28. Lower values represent better outcomes.
Outcome measures
| Measure |
EMA401 100mg BID DB
n=70 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=67 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
Placebo BID -> Placebo BID TW
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|
|
Mean Change in Insomnia Severity Index (ISI) From Baseline to Week 12
|
-4.00 scores on a scale
Standard Deviation 4.854
|
-1.03 scores on a scale
Standard Deviation 6.312
|
—
|
SECONDARY outcome
Timeframe: Week 8 (Prior dose, 1-3 hours, 4-6 hours), Week 12 (Prior dose, 1-3 hours, 4-6 hours)Population: PK analysis set
Due to the premature termination of the study, the number of patients and observations providing PK data was much smaller than planned, and no PK model was developed. As a consequence, no PK parameters (Cmax, Tmax, AUC) were derived for this study. Only, summary statistics of the plasma concentrations were calculated
Outcome measures
| Measure |
EMA401 100mg BID DB
n=32 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
Placebo BID -> Placebo BID TW
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|
|
Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12
Week 8 Prior dose
|
30.5 ng/mL
Geometric Coefficient of Variation 126.6
|
—
|
—
|
|
Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12
Week 8 1-3 hours
|
205.1 ng/mL
Geometric Coefficient of Variation 212.8
|
—
|
—
|
|
Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12
Week 8 4-6 hours
|
72.8 ng/mL
Geometric Coefficient of Variation 115.2
|
—
|
—
|
|
Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12
Week 12 Prior dose
|
29.5 ng/mL
Geometric Coefficient of Variation 209.3
|
—
|
—
|
|
Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12
Week 12 1-3 hours
|
118.4 ng/mL
Geometric Coefficient of Variation 278.3
|
—
|
—
|
|
Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12
Week 12 4-6 hours
|
89.8 ng/mL
Geometric Coefficient of Variation 117.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and weekly up to 12 weeks, once during double-blind periodPopulation: Full analysis set
Patients were allowed to take acetaminophen/paracetamol up to a maximum of 3 g daily (divided into 4 times/day) for unacceptable pain due to any reason during the study. This medication use was to be recorded in eDiary prior to use. Percentages of patients presented are those who required rescue meds within 7 days prior to visit.
Outcome measures
| Measure |
EMA401 100mg BID DB
n=70 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=67 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
Placebo BID -> Placebo BID TW
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|
|
Percentage of Patients Who Required Rescue Medication in Double-blind Treatment Period
Week 1
|
13.0 Percentage of participants
|
10.6 Percentage of participants
|
—
|
|
Percentage of Patients Who Required Rescue Medication in Double-blind Treatment Period
Week 2
|
7.7 Percentage of participants
|
9.5 Percentage of participants
|
—
|
|
Percentage of Patients Who Required Rescue Medication in Double-blind Treatment Period
Week 4
|
8.6 Percentage of participants
|
7.0 Percentage of participants
|
—
|
|
Percentage of Patients Who Required Rescue Medication in Double-blind Treatment Period
Week 6
|
7.8 Percentage of participants
|
7.5 Percentage of participants
|
—
|
|
Percentage of Patients Who Required Rescue Medication in Double-blind Treatment Period
Week 8
|
9.3 Percentage of participants
|
9.5 Percentage of participants
|
—
|
|
Percentage of Patients Who Required Rescue Medication in Double-blind Treatment Period
Week 10
|
5.3 Percentage of participants
|
13.2 Percentage of participants
|
—
|
|
Percentage of Patients Who Required Rescue Medication in Double-blind Treatment Period
Week 12
|
2.9 Percentage of participants
|
8.6 Percentage of participants
|
—
|
|
Percentage of Patients Who Required Rescue Medication in Double-blind Treatment Period
At least once during double-blind period
|
20.0 Percentage of participants
|
19.4 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 12 to Week 13 (planned duration subject to varibility in visit scheduling)Population: Full analysis set
Patients were allowed to take acetaminophen/paracetamol up to a maximum of 3 g daily (divided into 4 times/day) for unacceptable pain due to any reason during the study. This medication use was to be recorded in eDiary prior to use. Percentages of patients presented are those who required rescue meds within 7 days prior to visit.
Outcome measures
| Measure |
EMA401 100mg BID DB
n=35 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=35 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
Placebo BID -> Placebo BID TW
n=67 Participants
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|
|
Percentage of Patients Who Required Rescue Medication in Treatment Withdrawal Period
|
14.3 Percentage of participants
|
8.3 Percentage of participants
|
7.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to day 92Population: Full analysis set
Patients were allowed to take acetaminophen/paracetamol up to a maximum of 3 g daily (divided into 4 times/day) for unacceptable pain due to any reason during the study. This medication use was to be recorded in eDiary prior to use. Patients who did not take any rescue medication were censored at the last date of double-blind treatment period.
Outcome measures
| Measure |
EMA401 100mg BID DB
n=70 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=67 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
Placebo BID -> Placebo BID TW
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|
|
Time to First Rescue Medication Intake
|
44.0 days
Interval 2.0 to 90.0
|
56.5 days
Interval 2.0 to 92.0
|
—
|
SECONDARY outcome
Timeframe: Approximately from 3 weeks after end of study up to 16 weeksPopulation: The Overall Number of Participants Analyzed reflects the Safety population, regardless of whether they completed the study
Participants were instructed to stop taking drug immediately upon termination of study and asked to come in for two unscheduled visits for follow up safety assessments
Outcome measures
| Measure |
EMA401 100mg BID DB
n=34 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=35 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
Placebo BID -> Placebo BID TW
n=66 Participants
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|
|
Treatment Emergent Adverse Events During Urgent Safety Measure (USM) Follow-Up
Peritoneal adhesions
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events During Urgent Safety Measure (USM) Follow-Up
Cholelithiasis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events During Urgent Safety Measure (USM) Follow-Up
Liver abscess
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events During Urgent Safety Measure (USM) Follow-Up
Blood creatinine increased
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
EMA401 100mg BID DB
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo BID DB
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
EMA401 100mg BID -> EMA401 100mg BID TW
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
EMA401 100mg BID -> Placebo BID TW
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo BID -> Placebo BID TW
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EMA401 100mg BID DB
n=69 participants at risk
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=66 participants at risk
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID -> EMA401 100mg BID TW
n=14 participants at risk
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of DB treatment period (week 12)
|
EMA401 100mg BID -> Placebo BID TW
n=12 participants at risk
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of DB treatment period (week 12)
|
Placebo BID -> Placebo BID TW
n=26 participants at risk
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
1.5%
1/66 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/14 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
|
General disorders
Product intolerance
|
1.4%
1/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/66 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/14 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.9%
2/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/66 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/14 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.4%
1/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/66 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/14 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
|
Infections and infestations
Erysipelas
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
1.5%
1/66 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/14 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
|
Infections and infestations
Localised infection
|
1.4%
1/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/66 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/14 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
1.5%
1/66 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/14 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
Other adverse events
| Measure |
EMA401 100mg BID DB
n=69 participants at risk
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=66 participants at risk
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID -> EMA401 100mg BID TW
n=14 participants at risk
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of DB treatment period (week 12)
|
EMA401 100mg BID -> Placebo BID TW
n=12 participants at risk
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of DB treatment period (week 12)
|
Placebo BID -> Placebo BID TW
n=26 participants at risk
Participants on placebo remained on placebo at end of DB treatment period (week 12)
|
|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
1.5%
1/66 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/14 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.2%
5/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/66 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/14 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
|
Gastrointestinal disorders
Nausea
|
5.8%
4/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
1.5%
1/66 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/14 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
4/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
9.1%
6/66 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/14 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.8%
4/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
1.5%
1/66 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/14 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
|
Investigations
Lipase increased
|
8.7%
6/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/66 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
7.1%
1/14 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
|
Nervous system disorders
Headache
|
5.8%
4/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
6.1%
4/66 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/14 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
|
Vascular disorders
Hypertension
|
1.4%
1/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
3.0%
2/66 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/14 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 111 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment are reported in adverse event (AE) section. Upon termination of study, participants were instructed to attend two unscheduled visits for follow-up safety assessments for Urgent Safety Measure (USM) follow-up. Adverse events collected during USM are not included in this AE section but reported in secondary outcome measure 13 entitled Treatment Emergent Adverse Events During Urgent Safety Measure Follow-up
|
Additional Information
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER