Trial Outcomes & Findings for Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain. (NCT NCT03992846)
NCT ID: NCT03992846
Last Updated: 2025-04-02
Results Overview
Percentage of subjects with reduction of 1.1 for DYS in mean pelvic pain score within last 28 days prior to Month 3 or discontinuation, and stable or decreased use of analgesics for Endometriosis-associated pain (=EAP) within the same calendar days.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
486 participants
Primary outcome timeframe
Baseline to Month 3
Results posted on
2025-04-02
Participant Flow
Of the 854 subjects screened, 486 were randomized. Between randomization and Day 1 (i.e., first day of dosing), 2 subjects in the LGX 75 mg group discontinued due to protocol deviation. Thus, 484 randomized subjects were treated and comprised the FAS and SAF.
Participants with a diagnosis of endometriosis were enrolled in a 1:1:1 ratio in one of three treatment groups: Linzagolix (=LGX) 75 mg, LGX 200 mg+Add-back (=ABT) or Placebo.
Participant milestones
| Measure |
LGX 75 mg
One Linzagolix 75 mg tablet, One Linzagolix 200 mg matching placebo tablet and one Add-back matching placebo capsule were administered once daily orally for 6 months.
|
LGX 200 mg+ABT
One Linzagolix 200 mg tablet, One Linzagolix 75 mg matching placebo tablet and one Add-back capsule (E2 1 mg / NETA 0.5 mg) were administered once daily orally for 6 months.
|
Placebo
One Linzagolix 75 mg matching placebo tablet, one Linzagolix 200 mg matching placebo tablet and one Add-back matching placebo capsule were administered once daily orally for 6 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
160
|
162
|
162
|
|
Overall Study
Month 3
|
149
|
155
|
149
|
|
Overall Study
Month 6
|
140
|
143
|
137
|
|
Overall Study
COMPLETED
|
140
|
143
|
137
|
|
Overall Study
NOT COMPLETED
|
20
|
19
|
25
|
Reasons for withdrawal
| Measure |
LGX 75 mg
One Linzagolix 75 mg tablet, One Linzagolix 200 mg matching placebo tablet and one Add-back matching placebo capsule were administered once daily orally for 6 months.
|
LGX 200 mg+ABT
One Linzagolix 200 mg tablet, One Linzagolix 75 mg matching placebo tablet and one Add-back capsule (E2 1 mg / NETA 0.5 mg) were administered once daily orally for 6 months.
|
Placebo
One Linzagolix 75 mg matching placebo tablet, one Linzagolix 200 mg matching placebo tablet and one Add-back matching placebo capsule were administered once daily orally for 6 months.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
|
Overall Study
Pregnancy
|
2
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
10
|
20
|
|
Overall Study
Sponsor decided to exclude the patient
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.
Baseline characteristics by cohort
| Measure |
LGX 75 mg
n=160 Participants
One Linzagolix 75 mg tablet, One Linzagolix 200 mg matching placebo tablet and one Add-back matching placebo capsule were administered once daily orally for 6 months.
|
LGX 200 mg+ABT
n=162 Participants
One Linzagolix 200 mg tablet, One Linzagolix 75 mg matching placebo tablet and one Add-back capsule (E2 1 mg / NETA 0.5 mg) were administered once daily orally for 6 months.
|
Placebo
n=162 Participants
One Linzagolix 75 mg matching placebo tablet, one Linzagolix 200 mg matching placebo tablet and one Add-back matching placebo capsule were administered once daily orally for 6 months.
|
Total
n=484 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
160 Participants
n=99 Participants
|
162 Participants
n=107 Participants
|
162 Participants
n=206 Participants
|
484 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
35.1 Years
STANDARD_DEVIATION 6.4 • n=99 Participants
|
34.6 Years
STANDARD_DEVIATION 6.8 • n=107 Participants
|
34.9 Years
STANDARD_DEVIATION 6.8 • n=206 Participants
|
34.9 Years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
|
Age, Customized
|
35.5 Years
n=99 Participants
|
35.0 Years
n=107 Participants
|
35.0 Years
n=206 Participants
|
35.0 Years
n=7 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=99 Participants
|
162 Participants
n=107 Participants
|
162 Participants
n=206 Participants
|
484 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
155 Participants
n=99 Participants
|
155 Participants
n=107 Participants
|
161 Participants
n=206 Participants
|
471 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
158 Participants
n=99 Participants
|
159 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
477 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Austria
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
Romania
|
18 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
|
Region of Enrollment
Hungary
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Region of Enrollment
Czechia
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Region of Enrollment
Ukraine
|
70 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
203 Participants
n=7 Participants
|
|
Region of Enrollment
Poland
|
58 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
179 Participants
n=7 Participants
|
|
Region of Enrollment
Bulgaria
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Weight
|
67.73 kg
STANDARD_DEVIATION 14.45 • n=99 Participants
|
65.75 kg
STANDARD_DEVIATION 14.75 • n=107 Participants
|
65.81 kg
STANDARD_DEVIATION 11.96 • n=206 Participants
|
66.42 kg
STANDARD_DEVIATION 13.77 • n=7 Participants
|
|
BMI
|
24.60 kg/m^2
STANDARD_DEVIATION 5.23 • n=99 Participants
|
24.09 kg/m^2
STANDARD_DEVIATION 5.17 • n=107 Participants
|
24.14 kg/m^2
STANDARD_DEVIATION 4.44 • n=206 Participants
|
24.27 kg/m^2
STANDARD_DEVIATION 4.95 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 3Percentage of subjects with reduction of 1.1 for DYS in mean pelvic pain score within last 28 days prior to Month 3 or discontinuation, and stable or decreased use of analgesics for Endometriosis-associated pain (=EAP) within the same calendar days.
Outcome measures
| Measure |
LGX 75 mg
n=160 Participants
One Linzagolix 75 mg tablet, One Linzagolix 200 mg matching placebo tablet and one Add-back matching placebo capsule were administered once daily orally for 6 months.
|
LGX 200 mg+ABT
n=162 Participants
One Linzagolix 200 mg tablet, One Linzagolix 75 mg matching placebo tablet and one Add-back capsule (E2 1 mg / NETA 0.5 mg) were administered once daily orally for 6 months.
|
Placebo
n=162 Participants
One Linzagolix 75 mg matching placebo tablet, one Linzagolix 200 mg matching placebo tablet and one Add-back matching placebo capsule were administered once daily orally for 6 months.
|
|---|---|---|---|
|
Reduction of Dysmenorrhea (DYS) at Month 3 - Proportion of Responders
|
44.0 Percentage of responders
Interval 36.3 to 52.0
|
72.9 Percentage of responders
Interval 65.3 to 79.4
|
23.5 Percentage of responders
Interval 17.5 to 30.7
|
PRIMARY outcome
Timeframe: Baseline to Month 3Percentage of subjects with reduction of 0.8 for NMPP in mean pelvic pain score within last 28 days prior to Month 3 or discontinuation, and stable or decreased use of analgesics for Endometriosis-associated pain (=EAP) within the same calendar days.
Outcome measures
| Measure |
LGX 75 mg
n=160 Participants
One Linzagolix 75 mg tablet, One Linzagolix 200 mg matching placebo tablet and one Add-back matching placebo capsule were administered once daily orally for 6 months.
|
LGX 200 mg+ABT
n=162 Participants
One Linzagolix 200 mg tablet, One Linzagolix 75 mg matching placebo tablet and one Add-back capsule (E2 1 mg / NETA 0.5 mg) were administered once daily orally for 6 months.
|
Placebo
n=162 Participants
One Linzagolix 75 mg matching placebo tablet, one Linzagolix 200 mg matching placebo tablet and one Add-back matching placebo capsule were administered once daily orally for 6 months.
|
|---|---|---|---|
|
Reduction of Non-menstrual Pelvic Pain (NMPP) at Month 3 - Proportion of Responders
|
38.9 Percentage of responders
Interval 31.5 to 46.9
|
47.3 Percentage of responders
Interval 39.5 to 55.3
|
30.9 Percentage of responders
Interval 24.1 to 38.6
|
Adverse Events
LGX 75 mg
Serious events: 1 serious events
Other events: 83 other events
Deaths: 0 deaths
LGX 200 mg+ABT
Serious events: 2 serious events
Other events: 94 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LGX 75 mg
n=160 participants at risk
One Linzagolix 75 mg tablet, One Linzagolix 200 mg matching placebo tablet and one Add-back matching placebo capsule were administered once daily orally for 6 months.
|
LGX 200 mg+ABT
n=162 participants at risk
One Linzagolix 200 mg tablet, One Linzagolix 75 mg matching placebo tablet and one Add-back capsule (E2 1 mg / NETA 0.5 mg) were administered once daily orally for 6 months.
|
Placebo
n=162 participants at risk
One Linzagolix 75 mg matching placebo tablet, one Linzagolix 200 mg matching placebo tablet and one Add-back matching placebo capsule were administered once daily orally for 6 months.
|
|---|---|---|---|
|
Reproductive system and breast disorders
Endometriosis
|
0.62%
1/160 • Number of events 1 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/162 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/162 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
Peritonitis
|
0.62%
1/160 • Number of events 1 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/162 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/162 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/160 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.62%
1/162 • Number of events 1 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/162 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/160 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.62%
1/162 • Number of events 1 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/162 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
Other adverse events
| Measure |
LGX 75 mg
n=160 participants at risk
One Linzagolix 75 mg tablet, One Linzagolix 200 mg matching placebo tablet and one Add-back matching placebo capsule were administered once daily orally for 6 months.
|
LGX 200 mg+ABT
n=162 participants at risk
One Linzagolix 200 mg tablet, One Linzagolix 75 mg matching placebo tablet and one Add-back capsule (E2 1 mg / NETA 0.5 mg) were administered once daily orally for 6 months.
|
Placebo
n=162 participants at risk
One Linzagolix 75 mg matching placebo tablet, one Linzagolix 200 mg matching placebo tablet and one Add-back matching placebo capsule were administered once daily orally for 6 months.
|
|---|---|---|---|
|
Vascular disorders
Hot flush
|
7.5%
12/160 • Number of events 15 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
6.8%
11/162 • Number of events 11 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
2.5%
4/162 • Number of events 4 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Nervous system disorders
Headache
|
8.1%
13/160 • Number of events 17 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
10.5%
17/162 • Number of events 24 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
8.0%
13/162 • Number of events 25 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
General disorders
Fatigue
|
3.8%
6/160 • Number of events 6 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
6.8%
11/162 • Number of events 11 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
2.5%
4/162 • Number of events 4 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
5/160 • Number of events 5 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
2.5%
4/162 • Number of events 4 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
6.2%
10/162 • Number of events 13 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
6/160 • Number of events 6 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.7%
6/162 • Number of events 6 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
4.3%
7/162 • Number of events 7 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.5%
4/160 • Number of events 4 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.7%
6/162 • Number of events 6 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.9%
3/162 • Number of events 4 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
4/160 • Number of events 4 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.2%
2/162 • Number of events 2 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.1%
5/162 • Number of events 5 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
3/160 • Number of events 3 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.1%
5/162 • Number of events 5 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.2%
2/162 • Number of events 2 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.5%
4/160 • Number of events 5 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.7%
6/162 • Number of events 7 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.62%
1/162 • Number of events 1 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Reproductive system and breast disorders
Breast pain
|
0.62%
1/160 • Number of events 1 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.2%
2/162 • Number of events 2 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.1%
5/162 • Number of events 5 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.62%
1/160 • Number of events 1 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.9%
3/162 • Number of events 3 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.1%
5/162 • Number of events 5 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Psychiatric disorders
Mood swings
|
5.0%
8/160 • Number of events 8 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.1%
5/162 • Number of events 6 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.9%
3/162 • Number of events 3 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
8/160 • Number of events 8 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.9%
3/162 • Number of events 3 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.2%
2/162 • Number of events 2 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
COVID-19
|
3.1%
5/160 • Number of events 5 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.7%
6/162 • Number of events 6 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.1%
5/162 • Number of events 5 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
3/160 • Number of events 3 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
4.3%
7/162 • Number of events 7 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/162 • Day 1 to Month 6 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
Additional Information
Clinical Development Division
Kissei Pharmaceutical Co., Ltd
Phone: Email only
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place