Trial Outcomes & Findings for A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain (NCT NCT03986944)

Last Updated: 2025-04-02

Results Overview

Change at Month 3 from baseline in the mean daily assessment of dysmenorrhea (DYS) measured on a 4-point Verbal Rating Scale (VRS) using an electronicdiary * The 4-point VRS scale for DYS ranges from 0 to 3 (0: No pain; 1: Mild pain; 2: Moderate pain; 3: Severe pain). * A negative change in scores would be indicative of an improvement in the pain of DYS.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

85 participants

Primary outcome timeframe

Baseline to Month 3

Results posted on

2025-04-02

Participant Flow

Of the 492 subjects screened, 85 were randomized. Between randomization and Day 1 (i.e., first day of dosing), 1 subject in the placebo group discontinued due to protocol deviation. Thus, 84 randomized subjects were treated and comprised the Safety Analysis Set.

Participants with a diagnosis of pelvic endometriosis were enrolled in a 1:1:1 ratio in one of three treatment groups: LGX 75 mg, LGX 200 mg+ABT or Placebo.

Participant milestones

Participant milestones
Measure	LGX 75 mg One Linzagolix 75 mg tablet, one Linzagolix 200 mg matching placebo tablet and one ABT matching placebo capsule were administered once daily orally for 6 months.	LGX 200 mg+ABT One Linzagolix 200 mg tablet and one Linzagolix 75 mg matching placebo tablet and ABT capsules (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 ABT matching placebo capsule were administered once daily orally for 6 months.
Overall Study STARTED	28	29	27
Overall Study COMPLETED	13	10	8
Overall Study NOT COMPLETED	15	19	19

Reasons for withdrawal

Reasons for withdrawal
Measure	LGX 75 mg One Linzagolix 75 mg tablet, one Linzagolix 200 mg matching placebo tablet and one ABT matching placebo capsule were administered once daily orally for 6 months.	LGX 200 mg+ABT One Linzagolix 200 mg tablet and one Linzagolix 75 mg matching placebo tablet and ABT capsules (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 ABT matching placebo capsule were administered once daily orally for 6 months.
Overall Study Adverse Event	1	2	3
Overall Study Protocol Violation	0	1	1
Overall Study Withdrawal by Subject	3	5	5
Overall Study Study termination	10	10	10
Overall Study Discontinuation after moving to Follow-up Period [Study termination per Sponsor]	1	0	0
Overall Study Discontinuation after moving to Follow-up Period [Subject's Request (Family Issue)]	0	1	0

Baseline Characteristics

A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LGX 75 mg n=28 Participants One Linzagolix 75 mg tablet, one Linzagolix 200 mg matching placebo tablet and one ABT matching placebo capsule were administered once daily orally for 6 months.	LGX 200 mg+ABT n=29 Participants One Linzagolix 200 mg tablet and one Linzagolix 75 mg matching placebo tablet and ABT capsules (E2 1 mg / NETA 0.5 mg) were administered once daily orally for 6 months.	Placebo n=27 Participants One Linzagolix 75 mg matching placebo tablet one Linzagolix 200 mg matching placebo tablet and ABT matching placebo capsule were administered once daily orally for 6 months.	Total n=84 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	29 Participants n=7 Participants	27 Participants n=5 Participants	84 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	32.6 years STANDARD_DEVIATION 7.2 • n=5 Participants	33.4 years STANDARD_DEVIATION 6.4 • n=7 Participants	32.1 years STANDARD_DEVIATION 6.9 • n=5 Participants	32.7 years STANDARD_DEVIATION 6.8 • n=4 Participants
Age, Customized	32.5 years n=5 Participants	34.0 years n=7 Participants	31.0 years n=5 Participants	33.0 years n=4 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	29 Participants n=7 Participants	27 Participants n=5 Participants	84 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	12 Participants n=7 Participants	9 Participants n=5 Participants	28 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	17 Participants n=7 Participants	18 Participants n=5 Participants	55 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	27 Participants n=7 Participants	20 Participants n=5 Participants	69 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Canada	1 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment Puerto Rico	4 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	6 participants n=4 Participants
Region of Enrollment United States	23 participants n=5 Participants	25 participants n=7 Participants	28 participants n=5 Participants	76 participants n=4 Participants
Weight	78.130 kg STANDARD_DEVIATION 16.904 • n=5 Participants	76.540 kg STANDARD_DEVIATION 20.207 • n=7 Participants	71.280 kg STANDARD_DEVIATION 16.050 • n=5 Participants	75.379 kg STANDARD_DEVIATION 17.885 • n=4 Participants
BMI	29.08 kg/m2 STANDARD_DEVIATION 5.57 • n=5 Participants	28.54 kg/m2 STANDARD_DEVIATION 8.48 • n=7 Participants	26.61 kg/m2 STANDARD_DEVIATION 5.84 • n=5 Participants	28.10 kg/m2 STANDARD_DEVIATION 6.79 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Month 3

Population: Due to the COVID-19 pandemic, the study was terminated early and only 85 out of the planned 450 subjects were randomized. As there were insufficient number of treated subjects at study termination, no analyses of efficacy were conducted. This time, we calculated mean±SD from only 6 subjects with DYS \& NMPP data on both D1 \& M3 and entered them as efficacy results in this table. There were no other subjects besides these 6 who had both data at baseline and another time point (M3, M6, M9 or M12).

Outcome measures

Outcome measures
Measure	LGX 75 mg n=2 Participants One Linzagolix 75 mg tablet, one Linzagolix 200 mg matching placebo tablet and one ABT matching placebo capsule were administered once daily orally for 6 months.	LGX 200 mg+ABT n=2 Participants One Linzagolix 200 mg tablet and one Linzagolix 75 mg matching placebo tablet and ABT capsules (E2 1 mg / NETA 0.5 mg) were administered once daily orally for 6 months.	Placebo n=2 Participants One Linzagolix 75 mg matching placebo tablet one Linzagolix 200 mg matching placebo tablet and ABT matching placebo capsule were administered once daily orally for 6 months.
Dysmenorrhea	-0.5 score on a scale Standard Deviation 0.5	0.0 score on a scale Standard Deviation 0.0	0.5 score on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: Baseline to Month 3

Change at Month 3 from baseline in the mean daily assessment of non-menstrual pelvic pain (NMPP) measured on a 4-point Verbal Rating Scale (VRS) using anelectronic diary * The 4-point VRS scale for NMPP ranges from 0 to 3 (0: No pain; 1: Mild pain; 2: Moderate pain; 3: Severe pain). * A negative change in scores would be indicative of an improvement in the NMPP.

Outcome measures

Outcome measures
Measure	LGX 75 mg n=2 Participants One Linzagolix 75 mg tablet, one Linzagolix 200 mg matching placebo tablet and one ABT matching placebo capsule were administered once daily orally for 6 months.	LGX 200 mg+ABT n=2 Participants One Linzagolix 200 mg tablet and one Linzagolix 75 mg matching placebo tablet and ABT capsules (E2 1 mg / NETA 0.5 mg) were administered once daily orally for 6 months.	Placebo n=2 Participants One Linzagolix 75 mg matching placebo tablet one Linzagolix 200 mg matching placebo tablet and ABT matching placebo capsule were administered once daily orally for 6 months.
Non-menstrual Pelvic Pain	-1.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0

Adverse Events

LGX 75 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

LGX 200 mg+ABT

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LGX 75 mg n=28 participants at risk One Linzagolix 75 mg tablet, one Linzagolix 200 mg matching placebo tablet and one ABT matching placebo capsule were administered once daily orally for 6 months.	LGX 200 mg+ABT n=29 participants at risk One Linzagolix 200 mg tablet and one Linzagolix 75 mg matching placebo tablet and ABT capsules (E2 1 mg / NETA 0.5 mg) were administered once daily orally for 6 months.	Placebo n=27 participants at risk One Linzagolix 75 mg matching placebo tablet one Linzagolix 200 mg matching placebo tablet and ABT matching placebo capsule were administered once daily orally for 6 months.
Infections and infestations COVID-19	0.00% 0/28 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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.	3.4% 1/29 • Number of events 1 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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.	11.1% 3/27 • Number of events 3 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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 Upper respiratory tract infection	0.00% 0/28 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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.	6.9% 2/29 • Number of events 2 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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% 0/27 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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	7.1% 2/28 • Number of events 2 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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.	10.3% 3/29 • Number of events 3 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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.	11.1% 3/27 • Number of events 3 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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	0.00% 0/28 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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.	6.9% 2/29 • Number of events 2 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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% 0/27 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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	7.1% 2/28 • Number of events 2 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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.	6.9% 2/29 • Number of events 2 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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.	7.4% 2/27 • Number of events 2 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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 Dizziness	7.1% 2/28 • Number of events 2 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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.	6.9% 2/29 • Number of events 2 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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% 0/27 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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 Ovarian cyst	7.1% 2/28 • Number of events 2 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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% 0/29 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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% 0/27 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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	0.00% 0/28 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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.	6.9% 2/29 • Number of events 2 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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% 0/27 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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 Insomnia	0.00% 0/28 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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.	6.9% 2/29 • Number of events 2 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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% 1/27 • Number of events 1 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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	7.1% 2/28 • Number of events 2 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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% 0/29 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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% 1/27 • Number of events 1 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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 Chest discomfort	0.00% 0/28 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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% 0/29 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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.	7.4% 2/27 • Number of events 2 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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 Vomiting	3.6% 1/28 • Number of events 1 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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.	6.9% 2/29 • Number of events 2 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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% 0/27 • - Treatment Period: 6 months (Day 1 to Month 6) - Follow-up Period: 6 months (Month 6 to Month 6 FU) 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 unfavourable 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