Trial Outcomes & Findings for A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause (NCT NCT04003389)

Last Updated: 2024-11-05

Results Overview

An AE is any untoward medical occurrence in a participant administered a study drug, \& which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign, symptom, or disease temporally associated with the use of medicinal product (MP) whether or not considered related to MP. An AE is considered "serious" if it results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires inpatient hospitalization or leads to prolongation of hospitalization, hospitalization for treatment/observation/examination caused by AE is to be considered as serious, discontinuation due to increases in liver enzymes, other medically important events. A TEAE is defined as an AE observed after starting administration of study drug \& 21 days after the last dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1831 participants

Primary outcome timeframe

From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks)

Results posted on

2024-11-05

Participant Flow

Female participants aged ≥ 40 and ≤ 65 years seeking treatment for vasomotor symptoms (VMS) associated with menopause and who met the inclusion criteria and none of the exclusion criteria were enrolled in this study.

Prior to randomization, participants had a screening period during which participants had transvaginal ultrasound, endometrial biopsy, dual-energy X-ray absorptiometry scan.

Participant milestones

Participant milestones
Measure	Placebo Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, once daily (QD) for a of period of 52 Weeks.	Fezolinetant 30 mg Participants received fezolinetant 30 milligrams (mg) (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Overall Study STARTED	611	611	609
Overall Study Treated	610	611	609
Overall Study COMPLETED	410	451	444
Overall Study NOT COMPLETED	201	160	165

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, once daily (QD) for a of period of 52 Weeks.	Fezolinetant 30 mg Participants received fezolinetant 30 milligrams (mg) (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Overall Study Adverse Event	27	34	28
Overall Study Lost to Follow-up	39	30	33
Overall Study Protocol Violation	1	6	5
Overall Study Withdrawal by Subject	119	79	85
Overall Study Miscellaneous	14	11	14
Overall Study Participant did not receive study drug	1	0	0

Baseline Characteristics

A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=611 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a of period of 52 Weeks.	Fezolinetant 30 mg n=611 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg n=609 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.	Total n=1831 Participants Total of all reporting groups
Age, Continuous	54.8 Years STANDARD_DEVIATION 4.8 • n=5 Participants	54.7 Years STANDARD_DEVIATION 4.7 • n=7 Participants	54.7 Years STANDARD_DEVIATION 4.8 • n=5 Participants	54.7 Years STANDARD_DEVIATION 4.8 • n=4 Participants
Sex: Female, Male Female	611 Participants n=5 Participants	611 Participants n=7 Participants	609 Participants n=5 Participants	1831 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	133 Participants n=5 Participants	118 Participants n=7 Participants	116 Participants n=5 Participants	367 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	478 Participants n=5 Participants	493 Participants n=7 Participants	491 Participants n=5 Participants	1462 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants	29 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	92 Participants n=5 Participants	114 Participants n=7 Participants	110 Participants n=5 Participants	316 Participants n=4 Participants
Race (NIH/OMB) White	502 Participants n=5 Participants	479 Participants n=7 Participants	479 Participants n=5 Participants	1460 Participants n=4 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Smoking status Current	117 participants n=5 Participants	116 participants n=7 Participants	116 participants n=5 Participants	349 participants n=4 Participants
Smoking status Former/Never	494 participants n=5 Participants	495 participants n=7 Participants	493 participants n=5 Participants	1482 participants n=4 Participants

PRIMARY outcome

Timeframe: From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks)

Population: Safety analysis set (SAF) consisted of all randomized participants who took at least 1 dose of study intervention.

Outcome measures

Outcome measures
Measure	Placebo n=610 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a period of 52 Weeks.	Fezolinetant 30 mg n=611 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg n=609 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) TEAE	391 participants	415 participants	389 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Drug-Related TEAE	106 participants	94 participants	110 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Serious TEAE	14 participants	20 participants	23 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Drug-Related Serious TEAE	1 participants	0 participants	0 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) TEAE Leading to Death	0 participants	1 participants	0 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Drug-Related TEAE Leading to Death	0 participants	0 participants	0 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) TEAE Leading to Withdrawal of Treatment	26 participants	34 participants	28 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Drug-Related TEAE Leading to Withdrawal of Treatment	16 participants	16 participants	17 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Death	0 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks)

Population: SAF population

An adverse event (AE) is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. A TEAE is defined as an AE observed after starting administration of the study drug and 21 days after the last dose of study drug. Severity of AE we were classified as Mild: No disruption of normal daily activities; Moderate: Affect normal daily activities; and Severe: Inability to perform daily activities.

Outcome measures

Outcome measures
Measure	Placebo n=610 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a period of 52 Weeks.	Fezolinetant 30 mg n=611 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg n=609 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Number of Participants With Mild, Moderate and Severe TEAE Mild	180 participants	215 participants	195 participants
Number of Participants With Mild, Moderate and Severe TEAE Moderate	191 participants	185 participants	171 participants
Number of Participants With Mild, Moderate and Severe TEAE Severe	20 participants	15 participants	23 participants

PRIMARY outcome

Timeframe: Baseline Up to 52 weeks

Population: Endometrial health set (EHS):All randomized participants who received at least 1 dose of study drug, had postbaseline (PB) biopsy done within 30 days after last dose, \& had an acceptable biopsy at baseline (at least 1 endometrial biopsy (EB) with satisfactory tissue \& no read of hyperplasia, disordered proliferative pattern or malignant) \& had a satisfactory EB result after or on day 326 or had a PB final diagnosis of hyperplasia, disordered proliferative pattern or malignant prior to day 326.

Endometrial hyperplasia was confirmed from the endometrial biopsy report.

Outcome measures

Outcome measures
Measure	Placebo n=186 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a period of 52 Weeks.	Fezolinetant 30 mg n=210 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg n=203 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Percentage of Participants With Endometrial Hyperplasia	0 percentage of participants	0 percentage of participants	0.5 percentage of participants

PRIMARY outcome

Timeframe: Baseline Up to 52 weeks

Population: Endometrial Health Set

Endometrial cancer was confirmed from the endometrial biopsy report.

Outcome measures

Outcome measures
Measure	Placebo n=186 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a period of 52 Weeks.	Fezolinetant 30 mg n=210 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg n=203 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Percentage of Participants With Endometrial Cancer	0 percentage of participants	0.5 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and week 52

Population: SAF population with available data at specified time point.

Endometrial thicness was obtained from the transvaginal ultrasound. The endometrium was measured in the long axis or sagittal plane. The measurement was of the thickest echogenic area from 1 basal endometrial interface across the endometrial canal to the other basal surface.

Outcome measures

Outcome measures
Measure	Placebo n=316 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a period of 52 Weeks.	Fezolinetant 30 mg n=334 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg n=346 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Change From Baseline in Endometrial Thickness at Week 52	-0.17 millimeter (mm) Standard Deviation 2.35	-0.15 millimeter (mm) Standard Deviation 1.97	-0.28 millimeter (mm) Standard Deviation 2.30

SECONDARY outcome

Timeframe: Baseline Up to 52 weeks

Population: Endometrial Health Set

Disordered proliferative endometrium was confirmed from the endometrial biopsy report.

Outcome measures

Outcome measures
Measure	Placebo n=186 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a period of 52 Weeks.	Fezolinetant 30 mg n=210 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg n=203 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Percentage of Participants With Disordered Proliferative Endometrium	2.2 percentage of participants	1.4 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and week 52

Population: SAF population with available data at specified time point.

Changes in BMD hip was assessed by dual-energy X-ray absorptiometry (DXA) scan.

Outcome measures

Outcome measures
Measure	Placebo n=246 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a period of 52 Weeks.	Fezolinetant 30 mg n=221 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg n=234 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Change From Baseline in Bone Mineral Density (BMD) at Hip at Week 52 Hip (Trochanter)	-0.008 gram per square centimeter (g/cm^2) Standard Deviation 0.027	-0.001 gram per square centimeter (g/cm^2) Standard Deviation 0.042	-0.004 gram per square centimeter (g/cm^2) Standard Deviation 0.026
Change From Baseline in Bone Mineral Density (BMD) at Hip at Week 52 Hip (Femoral Neck)	-0.010 gram per square centimeter (g/cm^2) Standard Deviation 0.033	-0.001 gram per square centimeter (g/cm^2) Standard Deviation 0.044	-0.009 gram per square centimeter (g/cm^2) Standard Deviation 0.033
Change From Baseline in Bone Mineral Density (BMD) at Hip at Week 52 Hip (Femur)	-0.011 gram per square centimeter (g/cm^2) Standard Deviation 0.022	-0.003 gram per square centimeter (g/cm^2) Standard Deviation 0.041	-0.008 gram per square centimeter (g/cm^2) Standard Deviation 0.024

SECONDARY outcome

Timeframe: Baseline and week 52

Population: SAF population with available data at specified time point.

TBS was a bone texture assessment that serves as a substitute for bone microarchitecture and predicts fracture risk independent of BMD and clinical risk factors. The DXA imaging was processed and analyzed as it would normally be and then evaluated using an automated algorithm to determine the TBS. T-score ≥1.350 was considered to be normal; T-score between 1.200 and 1.350 is considered to be consistent with partially degraded microarchitecture; and T-score ≤1.200 defines degraded microarchitecture.

Outcome measures

Outcome measures
Measure	Placebo n=246 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a period of 52 Weeks.	Fezolinetant 30 mg n=221 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg n=234 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Change From Baseline in Trabecular Bone Score (TBS) at Hip at Week 52 Hip (Femoral Neck)	-0.078 T-Score (Index) Standard Deviation 0.246	-0.011 T-Score (Index) Standard Deviation 0.372	-0.073 T-Score (Index) Standard Deviation 0.265
Change From Baseline in Trabecular Bone Score (TBS) at Hip at Week 52 Hip (Femur)	-0.085 T-Score (Index) Standard Deviation 0.192	-0.024 T-Score (Index) Standard Deviation 0.354	-0.063 T-Score (Index) Standard Deviation 0.192
Change From Baseline in Trabecular Bone Score (TBS) at Hip at Week 52 Hip (Trochanter)	-0.071 T-Score (Index) Standard Deviation 0.255	-0.009 T-Score (Index) Standard Deviation 0.426	-0.036 T-Score (Index) Standard Deviation 0.246

SECONDARY outcome

Timeframe: Baseline and week 52

Population: SAF population with available data at specified time point.

Changes in BMD spine was assessed by DXA scan.

Outcome measures

Outcome measures
Measure	Placebo n=253 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a period of 52 Weeks.	Fezolinetant 30 mg n=225 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg n=242 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Change From Baseline in BMD at Spine at Week 52	-0.013 g/cm^2 Standard Deviation 0.035	-0.010 g/cm^2 Standard Deviation 0.049	-0.014 g/cm^2 Standard Deviation 0.034

SECONDARY outcome

Timeframe: Baseline and week 52

Population: SAF population with available data at specified time point.

Outcome measures

Outcome measures
Measure	Placebo n=253 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a period of 52 Weeks.	Fezolinetant 30 mg n=225 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg n=242 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Change From Baseline in TBS at Spine at Week 52	-0.117 T-Score (Index) Standard Deviation 0.296	-0.084 T-Score (Index) Standard Deviation 0.025	-0.119 T-Score (Index) Standard Deviation 0.298

SECONDARY outcome

Timeframe: Baseline, week 12, week 24, week 52 and follow-up (week 55)

Population: SAF population with available data at specified time point.

The C-SSRS assessed the risk for suicidal behavior and suicide ideation. Participants responded as "Yes" or "No" 10 items. Suicidal ideation (1. Wish to be dead; 2. Non-specific active suicidal thoughts; 3. Active suicidal ideation with any methods (not plan) without intent to act; 4. Active suicidal ideation with some intent to act, without specific plan; 5. Active suicidal ideation with specific plan and intent; ). Suicidal behaviour (1. Preparatory acts or behavior 2. Aborted attempt 3. Interrupted attempt 4. Actual attempt 5. Completed suicide). Participants with 'Yes' to any one of the above 10 questions for suicidal ideation and behavior were reported.

Outcome measures

Outcome measures
Measure	Placebo n=610 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a period of 52 Weeks.	Fezolinetant 30 mg n=611 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg n=609 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Number of Participants With Suicidal Ideation and/or Behaviour as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Week 24	1 participants	1 participants	2 participants
Number of Participants With Suicidal Ideation and/or Behaviour as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline	2 participants	2 participants	4 participants
Number of Participants With Suicidal Ideation and/or Behaviour as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Week 12	0 participants	0 participants	1 participants
Number of Participants With Suicidal Ideation and/or Behaviour as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Week 52	1 participants	0 participants	0 participants
Number of Participants With Suicidal Ideation and/or Behaviour as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Follow-up (Week 55)	0 participants	1 participants	2 participants

SECONDARY outcome

Timeframe: Baseline, week 12, week 24, week 52 and follow-up (week 55)

Population: SAF population with available data at specified time point.

The C-SSRS assessed the risk for Self-injurious Behavior without Suicidal Intent. Question was asked "Has participant engaged in Non-Suicidal Self-Injurious Behavior?". Participants with 'yes' to the question were reported.

Outcome measures

Outcome measures
Measure	Placebo n=610 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a period of 52 Weeks.	Fezolinetant 30 mg n=611 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg n=609 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Number of Participants With Self-injurious Behavior Without Suicidal Intent as Assessed by C-SSRS Follow-up (Week 55)	1 participants	0 participants	0 participants
Number of Participants With Self-injurious Behavior Without Suicidal Intent as Assessed by C-SSRS Baseline	0 participants	1 participants	0 participants
Number of Participants With Self-injurious Behavior Without Suicidal Intent as Assessed by C-SSRS Week 12	1 participants	0 participants	0 participants
Number of Participants With Self-injurious Behavior Without Suicidal Intent as Assessed by C-SSRS Week 24	0 participants	0 participants	0 participants
Number of Participants With Self-injurious Behavior Without Suicidal Intent as Assessed by C-SSRS Week 52	0 participants	0 participants	0 participants

Adverse Events

Placebo

Serious events: 14 serious events

Other events: 90 other events

Deaths: 0 deaths

Fezolinetant 30 mg

Serious events: 20 serious events

Other events: 86 other events

Deaths: 1 deaths

Fezolinetant 45 mg

Serious events: 23 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=610 participants at risk Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a period of 52 Weeks.	Fezolinetant 30 mg n=611 participants at risk Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD for a period of 52 Weeks.	Fezolinetant 45 mg n=609 participants at risk Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Infections and infestations COVID-19	6.1% 37/610 • Number of events 37 • From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks) SAF Population	6.2% 38/611 • Number of events 38 • From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks) SAF Population	4.9% 30/609 • Number of events 30 • From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks) SAF Population
Nervous system disorders Headache	9.2% 56/610 • Number of events 60 • From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks) SAF Population	8.5% 52/611 • Number of events 57 • From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks) SAF Population	8.9% 54/609 • Number of events 72 • From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks) SAF Population

Additional Information

Clinical Trial Disclosure

Astellas Pharma Global Development, Inc

Phone: 8008887704

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
Publication restrictions are in place

Restriction type: OTHER