Trial Outcomes & Findings for Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2) (NCT NCT04140695)
NCT ID: NCT04140695
Last Updated: 2024-05-14
Results Overview
The WI-NRS responder is defined as a patient achieving at least 4 points reduction from baseline in weekly average of diary WI-NRS. Responses were measured on a scale of 0 - 10, with 0 being "no itch" and 10 being the "worst itch imaginable".
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
87 participants
Primary outcome timeframe
2 weeks
Results posted on
2024-05-14
Participant Flow
Participant milestones
| Measure |
Tradipitant
Oral Capsule
Tradipitant: BID
|
Placebo
Oral Capsule
Placebo: BID
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
44
|
|
Overall Study
COMPLETED
|
33
|
32
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2)
Baseline characteristics by cohort
| Measure |
Tradipitant
n=43 Participants
Oral Capsule
Tradipitant: BID
|
Placebo
n=44 Participants
Oral Capsule
Placebo: BID
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 14.63 • n=5 Participants
|
39.2 years
STANDARD_DEVIATION 15.10 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 14.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: All participants randomized (1:1) to placebo or tradipitant.
The WI-NRS responder is defined as a patient achieving at least 4 points reduction from baseline in weekly average of diary WI-NRS. Responses were measured on a scale of 0 - 10, with 0 being "no itch" and 10 being the "worst itch imaginable".
Outcome measures
| Measure |
Tradipitant
n=42 Participants
Oral Capsule
Tradipitant: BID
|
Placebo
n=43 Participants
Oral Capsule
Placebo: BID
|
|---|---|---|
|
Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2
|
2 Participants
|
4 Participants
|
Adverse Events
Tradipitant
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tradipitant
n=43 participants at risk
Oral Capsule
Tradipitant: BID
|
Placebo
n=44 participants at risk
Oral Capsule
Placebo: BID
|
|---|---|---|
|
Injury, poisoning and procedural complications
Procedural Complication
|
2.3%
1/43 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Gastrointestinal disorders
Obstructive Pancreatitis
|
0.00%
0/43 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
2.3%
1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
Other adverse events
| Measure |
Tradipitant
n=43 participants at risk
Oral Capsule
Tradipitant: BID
|
Placebo
n=44 participants at risk
Oral Capsule
Placebo: BID
|
|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.7%
2/43 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
2.3%
1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Infections and infestations
Chlamydial Infection
|
0.00%
0/43 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
2.3%
1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Infections and infestations
Conjunctivitis
|
2.3%
1/43 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Infections and infestations
Herpes Virus Infection
|
2.3%
1/43 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/43 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
2.3%
1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/43 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
2.3%
1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Infections and infestations
Skin Infection
|
2.3%
1/43 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/43 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
2.3%
1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/43 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
2.3%
1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/43 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
4.5%
2/44 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Gastrointestinal disorders
Dry Mouth
|
4.7%
2/43 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/43 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
4.5%
2/44 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Gastrointestinal disorders
Angular Cheilitis
|
2.3%
1/43 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Gastrointestinal disorders
Feces Discolored
|
0.00%
0/43 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
2.3%
1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Gastrointestinal disorders
Obstructive Pancreatitis
|
0.00%
0/43 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
2.3%
1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Gastrointestinal disorders
Toothache
|
2.3%
1/43 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/43 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
2.3%
1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/43 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
4.5%
2/44 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.3%
1/43 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.3%
1/43 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/43 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
2.3%
1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
2.3%
1/43 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Nervous system disorders
Paresthesia
|
4.7%
2/43 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Nervous system disorders
Somnolence
|
4.7%
2/43 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Nervous system disorders
Headache
|
2.3%
1/43 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
2.3%
1/43 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Injury, poisoning and procedural complications
Procedural Complication
|
2.3%
1/43 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Investigations
Heart Rate Increased
|
2.3%
1/43 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Investigations
Liver Function Test Increased
|
0.00%
0/43 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
2.3%
1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Eye disorders
Periorbital Oedema
|
0.00%
0/43 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
2.3%
1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/43 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
2.3%
1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
2.3%
1/43 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
0.00%
0/44 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER