Drug Trials Snapshots: LYNKUET
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.
Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the LYNKUET Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).
Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).
LYNKUET (elinzanetant)
lin-kew-ET
Bayer Health Care Pharmaceuticals, Inc.
Approval date: October 24, 2025
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
LYNKUET is a prescription medicine used to reduce moderate to severe hot flashes (also known as vasomotor symptoms or VMS) due to menopause.
How is this drug used?
LYNKUET is taken as two capsules by mouth, with or without food, at about the same time each day at bedtime. For patients taking certain medicines, healthcare providers may reduce the dose to one capsule each day.
Who participated in the clinical trials?
The FDA approved LYNKUET based on evidence from three clinical studies (OASIS-1 [NCT05042362], OASIS-2 [NCT05099159], and OASIS-3 [NCT05030584]) involving 1,423 participants. Of these participants, 1,420 received treatment with either LYNKUET 120 mg or placebo during the studies.
These trials were conducted at 267 clinical sites in 21 countries, with OASIS-1 taking place in 89 centers in nine countries (Austria, Czech Republic, Greece, Hungary, Israel, Italy, Netherlands, and the United States), OASIS-2 in 95 centers in 10 countries (Canada, Czech Republic, Germany, Italy, Norway, Poland, Portugal, Slovakia, Switzerland, and the United States), and OASIS-3 in 83 centers in nine countries (Belgium, Bulgaria, Canada, Denmark, Finland, Poland, Spain, the United Kingdom, and the United States).
OASIS-1 and OASIS-2 were used to assess the efficacy of LYNKUET. OASIS-1, OASIS-2, and OASIS 3 were used to assess the safety of LYNKUET. Only OASIS-3 was placebo-controlled for the duration of 52 weeks.
How were the trials designed?
LYNKUET was only studied in females. There were 793 postmenopausal participants who received treatment in OASIS-1 and OASIS-2. There were 627 postmenopausal participants who received treatment in OASIS-3.
The total number of postmenopausal participants receiving LYNKUET in the combined trials (OASIS-1, OASIS-2, and OASIS-3), which includes re-randomized participants previously receiving placebo in Trials 1 and 2, was 1,061.
Efficacy and safety of LYNKUET were evaluated in two 26-week clinical trials (OASIS-1 and OASIS-2) of 796 participants who reported at least 50 moderate-to-severe hot flashes per week. In the first 12 weeks, these patients were randomized to LYNKUET 120 mg or placebo. After completing the first 12 weeks of treatment, placebo patients received LYNKUET 120 mg while LYNKUET patients continued their treatment for additional 14 weeks. In a separate 52-week long-term safety trial, 628 patients were randomized to LYNKUET 120 mg or placebo.
How were the trials designed?
OASIS-1 and OASIS-2 were identical designs and randomized 796 postmenopausal females—793 of whom received treatment (393 in OASIS-1 and 400 in OASIS-2)—who reported at least 50 moderate-to-severe hot flashes per week, assigning them in a 1:1 ratio to LYNKUET 120 mg or placebo. Randomization was stratified by region (United States and Canada and the rest of the world).
OASIS-1 and OASIS-2 evaluated the efficacy and safety of LYNKUET. In both trials, the mean age of the postmenopausal participants was 55 years. In these trials, participants self-identified as White (77% in OASIS-1 and 84% in OASIS-2), Black or African American (19% in OASIS-1 and 15% in OASIS-2), Asian (<1% in both trials), and Hispanic or Latina ethnicity (8% in OASIS-1 and 9% in OASIS-2). The trial population included menopausal females with one or more of the following: prior hysterectomy (58% in OASIS-1 and 64% in OASIS-2), oophorectomy (75% in OASIS-1 and 84% in OASIS-2), and hormone therapy use (68% in OASIS-1 and 69% in OASIS-2).
The co-primary efficacy endpoints for both trials were the mean change from baseline in moderate to severe VMS frequency and severity at Weeks 4 and 12. Data from each trial demonstrated statistically significant and clinically meaningful reduction from baseline in the frequency of moderate to severe VMS (≥2 hot flashes over 24 hours) for LYNKUET 120 mg when compared to placebo at Weeks 4 and 12. Data from each trial also demonstrated a statistically significant reduction from baseline in the severity of moderate to severe VMS (over 24 hours) at Weeks 4 and 12 for LYNKUET 120 mg compared to placebo.
In OASIS-3, 628 postmenopausal females were randomized in a 1:1 ratio to LYNKUET 120 mg (n=313) or placebo (n=315); 627 participants received treatment. OASIS-3 evaluated the long-term safety and tolerability of LYNKUET. The mean age of participants in OASIS-3 was 55 years. In this trial, participants self-identified as White (80%), Black or African American (14%), Asian (0.6%), and Hispanic and Latina ethnicity (11%).
DEMOGRAPHICS SNAPSHOT
Figure 1 summarizes the percentage of females by their self-identified race who were enrolled in the combined clinical trials OASIS-1 and OASIS-2 used to evaluate the efficacy of LYNKUET.
Figure 1. Baseline Demographics by Race, Efficacy Population
Source: Adapted from FDA Review.
* Other includes: Asian (4 participants; 0.5% of total), American Indian or Alaska Native (4 participants; 0.5% of total), multiple races (4 participants; 0.5% of total), and missing race information (8 participants; 1% of total).
Figure 2 summarizes the percentage of females by their self-identified age who were enrolled in the combined clinical trials OASIS-1 and OASIS-2 used to evaluate the efficacy of LYNKUET.
Figure 2. Baseline Demographics by Age, Efficacy Population
Source: Adapted from FDA Review.
Figure 3 summarizes the percentage of females by their self-identified ethnicity who were enrolled in the combined clinical trials OASIS-1 and OASIS-2 used to evaluate the efficacy of LYNKUET.
Figure 3. Baseline Demographics by Ethnicity, Efficacy Population
Source: Adapted from FDA Review.
Figure 4 summarizes the percentage of females by their self-identified race who were enrolled in the combined clinical trials OASIS-1, OASIS-2, and OASIS-3 used to evaluate the safety of LYNKUET.
Figure 4. Baseline Demographics by Race, Safety Population
Source: Adapted from FDA Review.
* Other includes: Asian (7 participants; 0.5% of total), American Indian or Alaska Native (4 participants; 0.3% of total), Native Hawaiian or other Pacific Islander (1 participant; 0.1% of total), multiple races (5 participants; 0.4% of total), and missing race information (42 participants; 4.4% of total).
Figure 5 summarizes the percentage of females by their self-identified age who were enrolled in the combined clinical trials OASIS-1, OASIS-2, and OASIS-3 used to evaluate the safety of LYNKUET.
Figure 5. Baseline Demographics by Age, Safety Population
Source: Adapted from FDA Review.
Figure 6 summarizes the percentage of females by their self-identified ethnicity who were enrolled in the combined clinical trials OASIS-1, OASIS-2, and OASIS-3 used to evaluate the safety of LYNKUET.
Figure 6. Baseline Demographics by Ethnicity, Safety Population
Source: Adapted from FDA Review.
Who participated in the trials?
Table 1. Baseline Demographics
| Demographic |
OASIS-1 and OASIS-2 Efficacy Population N=796 |
OASIS-1, OASIS-2, and OASIS-3 Safety Population N=1420 |
|---|---|---|
| Self-identified race, n (%) |
|
|
| White | 640 (80.4) |
1133 (79.8) |
| Black or African American | 136 (17.1) |
228 (16.1) |
| Asian | 4 (0.5) |
7 (0.5) |
| American Indian or Alaska Native | 4 (0.5) |
4 (0.3) |
| Native Hawaiian or other Pacific Islander | 0 |
1 (0.1) |
| Multiple | 4 (0.5) |
5 (0.4) |
| Not reported | 8 (1.0) |
42 (4.4) |
| Age, years |
|
|
| Mean (SD) | 54.6 (4.8) |
54.7 (4.8) |
| Median (min, max) | 54.5 (40, 65) |
54.0 (40, 65) |
| Age group, years, n (%) |
|
|
| 45 to 49 | 113 (14.2) |
200 (14.1) |
| 50 to 59 | 543 (68.2) |
965 (68.0) |
| 60 to 65 | 140 (17.6) |
255 (18.0) |
| Self-identified ethnicity, n (%) |
|
|
| Hispanic or Latino | 68 (8.5) |
136 (9.6) |
| Not Hispanic or Latino | 720 (90.5) |
1255 (88.4) |
| Not reported | 8 (1.0) |
29 (2.0) |
Source: Adapted from FDA Review
Abbreviations: SD, standard deviation
What are the benefits of this drug?
LYNKUET reduces the frequency and severity of moderate to severe VMS in non-hysterectomized and hysterectomized postmenopausal females.
What are the benefits of this drug (results of trials used to assess efficacy)?
The efficacy of LYNKUET for the treatment of moderate to severe VMS due to menopause was demonstrated in the first 12 weeks of the phase 3 clinical trials (OASIS 1 and OASIS-2). The co-primary efficacy endpoints in both trials were the mean change in frequency and severity of moderate to severe VMS from baseline to Weeks 4 and 12 when compared to placebo. To demonstrate substantial evidence of efficacy, LYNKUET 120 mg in each trial had to be statistically superior to placebo in the reduction of the frequency and severity of VMS. In addition, the reduction in frequency in the LYNKUET 120 mg arm had to exceed the clinical threshold of two VMS per day (or 14 per week) when compared to placebo in each trial.
Table 2 and Table 3 summarize the efficacy results (co-primary endpoints) for the efficacy population for OASIS-1 and OASIS-2.
Table 2. Mean Baseline and Change From Baseline to Weeks 4 and 12 for Mean Frequency of Moderate to Severe Vasomotor Symptoms Over 24 Hours, OASIS-1 and OASIS-2
| Parameter | OASIS-1 |
OASIS-2 |
||
|---|---|---|---|---|
|
LYNKUET N=199 |
Placebo N=197 |
LYNKUET N=199 |
Placebo N=197 |
|
| Baseline |
|
|
|
|
| Mean (SD) | 13.4 (6.6) |
14.3 (13.9) |
14.7 (11.1) |
16.2 (11.2) |
| Change from Baseline to Week 4 |
|
|||
| LS mean (SE) | -7.6 (0.4) |
-4.3 (0.4) |
-8.6 (0.5) |
-5.5 (0.5) |
| Difference (95% CI) | -3.3 (-4.5, -2.1) |
-3.0 (-4.4, -1.7) |
||
| p-value | < 0.0001 |
< 0.0001 |
||
| Change from Baseline to Week 12 |
|
|||
| LS mean (SE) | -8.7 (0.6) |
-5.4 (0.6) |
-9.7 (0.5) |
-6.5 (0.5) |
| Difference (95% CI) | -3.2 (-4.8, -1.6) |
-3.2 (-4.6, -1.9) |
||
| p-value | < 0.0001 |
< 0.0001 |
||
Source: Adapted from LYNKUET Prescribing Information
Abbreviations: CI, confidence interval; LS mean, least squares mean estimated from a mixed model for repeated measures analysis of covariance; SD, standard deviation; SE, standard error
Table 3. Mean Baseline and Change From Baseline to Weeks 4 and 12 for Mean Severity of Moderate to Severe Vasomotor Symptoms Over 24 Hours, OASIS-1 and OASIS-2
| Parameter | OASIS-1 |
OASIS-2 |
||
|---|---|---|---|---|
|
LYNKUET N=199 |
Placebo N=197 |
LYNKUET N=199 |
Placebo N=197 |
|
| Baseline |
|
|
|
|
| Mean (SD) | 2.6 (0.2) |
2.5 (0.2) |
2.5 (0.2) |
2.5 (0.2) |
| Change from Baseline to Week 4 |
|
|||
| LS mean (SE) | -0.7 (0.04) |
-0.4 (0.04) |
-0.8 (0.04) |
-0.5 (0.04) |
| Difference (95% CI) | -0.3 (-0.4, -0.2) |
-0.2 (-0.3, -0.1) |
||
| p-value | < 0.0001 |
0.0003 |
||
| Change from Baseline to Week 12 |
|
|||
| LS mean (SE) | -0.9 (0.1) |
-0.5 (0.1) |
-0.9 (0.1) |
-0.6 (0.1) |
| Difference (95% CI) | -0.4 (-0.5, -0.3) |
-0.3 (-0.4, -0.1) |
||
| p-value | < 0.0001 |
< 0.0001 |
||
Source: Adapted from LYNKUET Prescribing Information
Abbreviations: CI, confidence interval; LS mean, least squares mean estimated from a mixed model for repeated measures analysis of covariance; SD, standard deviation; SE, standard error
Were there any differences in how well the drug worked in clinical trials among sex, race, and age?
- Sex: LYNKUET was only studied in healthy postmenopausal females
- Race: LYNKUET worked similarly in White and Black or African American participants. The number of patients of races other than White and Black or African American was small, therefore differences in how LYNKUET worked among races could not be determined.
- Age: Females 65 years of age and older were not included in LYNKUET clinical trials.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
Table 4 and Table 5 summarize the results of the co-primary efficacy endpoints by race for OASIS-1 and OASIS-2.
Table 4. Mean Change From Baseline to Weeks 4 and 12 for Mean Frequency of Moderate to Severe Vasomotor Symptoms Over 24 Hours by Race, OASIS-1 and OASIS 2
| Self-Identified Race | Statistic | OASIS-1 |
OASIS-2 |
||
|---|---|---|---|---|---|
LYNKUET |
Placebo |
LYNKUET |
Placebo |
||
| Week 4 | |||||
| White | LS mean (SE) | -7.6 (0.4) |
-4.5 (0.4) |
-8.4 (0.5) |
-5.3 (0.5) |
| Difference (95% CI) | -3.1 (-4.1, -2.1) |
-3.1 (-4.5, -1.7) |
|||
| Black or African American | LS mean (SE) | -6.5 (1.3) |
-3.5 (1.3) |
-9.7 (1.4) |
-7.4 (1.6) |
| Difference (95% CI) | -3.0 (-6.6, 0.7) |
-2.4 (-6.5, 1.8) |
|||
| Week 12 | |||||
| White | LS mean (SE) | -8.5 (0.4) |
-5.6 (0.4) |
-9.6 (0.5) |
-6.4 (0.5) |
| Difference (95% CI) | -2.9 (-4.1, -1.7) |
-3.3 (-4.7, -1.8) |
|||
| Black or African American | LS mean (SE) | -8.3 (2.3) |
-4.2 (2.3) |
-10.7 (1.3) |
-8.9 (1.5) |
| Difference (95% CI) | -4.2 (-10.6, 2.2) |
-1.8 (-5.7, 2.0) |
|||
Source: Adapted from FDA Review
Abbreviations: CI, confidence interval; LS, least squares; SE, standard error
Table 5. Mean Change From Baseline to Weeks 4 and 12 for Mean Severity of Moderate to Severe Vasomotor Symptoms Over 24 Hours by Race, OASIS-1 and OASIS 2
| Self-Identified Race | Statistic | OASIS-1 |
OASIS-2 |
||
|---|---|---|---|---|---|
LYNKUET |
Placebo |
LYNKUET |
Placebo |
||
| Week 4 |
|
||||
| White | LS mean (SE) | -0.7 (0.04) |
-0.4 (0.04) |
-0.8 (0.1) |
-0.5 (-.1) |
| Difference (95% CI) | -0.4 (-0.5, -0.2) |
-0.3 (-0.4, -0.1) |
|||
| Black or African American | LS mean (SE) | -0.6 (0.1) |
-0.4 (0.1) |
-0.62 (0.1) |
-0.65 (0.1) |
| Difference (95% CI) | -0.2 (-0.4, 0.02) |
0.03 (-0.3, 0.3) |
|||
| Week 12 |
|
||||
| White | LS mean (SE) | -0.9 (0.1) |
-0.5 (0.1) |
-0.9 (0.1) |
-0.6 (0.1) |
| Difference (95% CI) | -0.4 (-0.6, -0.2) |
-0.3 (-0.5, -0.2) |
|||
| Black or African American | LS mean (SE) | -0.9 (0.1) |
-0.5 (0.1) |
-0.7 (0.1) |
-0.6 (0.1) |
| Difference (95% CI) | -0.4 (-0.6, -0.1) |
-0.1 (-0.4, 0.3) |
|||
Source: Adapted from FDA Review
Abbreviations: CI, confidence interval; LS, least squares; SE, standard error
What are the possible side effects?
The safety of LYNKUET was evaluated in two 26-week clinical trials (OASIS-1 and OASIS-2) and in one 52-week clinical trial (OASIS-3). OASIS-1 and OASIS-2 were placebo-controlled for the first 12 weeks, after which participants previously receiving placebo were switched to LYNKUET 120 mg while participants previously randomized to LYNKUET 120 mg continued on treatment for an additional 14 weeks of uncontrolled treatment. OASIS-3 was a randomized, placebo-controlled, double-blind safety study evaluating the safety of LYNKUET 120 mg for 52 weeks.
In the combined trials OASIS-1 and OASIS-2, commonly reported adverse reactions through the first 12 weeks included headache, fatigue, gastroesophageal reflux disease, dizziness, nausea, and somnolence.
In OASIS-3, the most common adverse reactions included headache, fatigue, dizziness, somnolence, abdominal pain, rash, diarrhea, and muscle spasms.
What are the possible side effects (results of trials used to assess safety)?
The adverse reactions reported in at least 2% of participants receiving LYNKUET, and greater than those receiving placebo, are presented in Table 6.
Table 6. Adverse Reactions Reported in at Least 2% of Participants Receiving LYNKUET and Greater Than Placebo, OASIS-3
| Adverse Reaction |
LYNKUET N=313 n (%) |
Placebo N=314 n (%) |
|---|---|---|
| Headache | 30 (9.6) |
22 (7.0) |
| Fatiguea | 23 (7.3) |
9 (2.9) |
| Dizzinessb | 19 (6.1) |
6 (1.9) |
| Somnolencec | 17 (5.4) |
4 (1.3) |
| Abdominal paind | 14 (4.5) |
8 (2.5) |
| Rashe | 13 (4.2) |
5 (1.6) |
| Diarrhea | 12 (3.8) |
3 (1.0) |
| Muscle spasmsf | 10 (3.2) |
2 (0.6) |
Source: Adapted from FDA Review and Prescribing Information for LYNKUET
a Includes asthenia
b Includes balance disorder, presyncope, vertigo, vertigo CNS origin, vertigo positional, and vestibular neuronitis
c Includes lethargy
d Includes abdominal discomfort and abdominal pain lower/upper
e Includes dermatitis and urticaria
f Includes muscle tightness
Were there any differences in side effects among sex, race, and age?
- Sex: LYNKUET was only studied in postmenopausal females.
- Race: The occurrence of side effects was similar in participants who self-identified as White and those who self-identified as Black or African American. The number of patients of races other than White and Black or African American was small, therefore differences in side effects among other races could not be determined.
- Age: Females 65 years of age and older were not included in LYNKUET clinical trials.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
Adverse reactions reported by race, age, and ethnicity in the pooled clinical trials OASIS 1 and OASIS-2 is shown in Table 7.
Table 7. Adverse Reactions by Race, Age Group, and Ethnicity, Safety Population (Pooled), Weeks 1 to 12, OASIS-1 and OASIS-2
| Adverse Events | Demographic Subgroup | LYNKUET |
Placebo |
|---|---|---|---|
| Race |
|
|
|
| Headache | American Indian or Alaska Native | 0/2 (0) |
0/2 (0) |
| Asian | 0/2 (0) |
0/1 (0) |
|
| Black or African American | 3/73 (4.1) |
1/61 (1.6) |
|
| Multiple | 0/3 (0) |
0/1 (0) |
|
| Not reported | 1/5 (20.0) |
0/3 (0) |
|
| White | 28/315 (8.9) |
9/325 (2.8) |
|
| Fatigue | American Indian or Alaska Native | 0/2 (0) |
0/2 (0) |
| Asian | 0/2 (0) |
0/1 (0) |
|
| Black or African American | 3/73 (4.1) |
2/61 (3.3) |
|
| Multiple | 0/3 (0) |
0/1 (0) |
|
| Not reported | 0/5 (0) |
0/3 (0) |
|
| White | 23/315 (7.3) |
5/325 (1.5) |
|
| Dizziness | American Indian or Alaska Native | 0/2 (0) |
0/2 (0) |
| Asian | 0/2 (0) |
0/1 (0) |
|
| Black or African American | 2/73 (2.7) |
0/61 (0) |
|
| Multiple | 0/3 (0) |
0/1 (0) |
|
| Not reported | 1/5 (20.0) |
0/3 (0) |
|
| White | 10/315 (3.2) |
6/325 (1.8) |
|
| Somnolence | American Indian or Alaska Native | 0/2 (0) |
0/2 (0) |
| Asian | 0/2 (0) |
0/1 (0) |
|
| Black or African American | 4/73 (5.5) |
0/61 (0) |
|
| Multiple | 0/3 (0) |
0/1 (0) |
|
| Not reported | 0/5 (0) |
0/3 (0) |
|
| White | 7/315 (2.2) |
2/325 (0.6) |
|
| Diarrhea | American Indian or Alaska Native | 0/2 (0) |
0/2 (0) |
| Asian | 0/2 (0) |
0/1 (0) |
|
| Black or African American | 1/73 (1.4) |
2/61 (3.3) |
|
| Multiple | 0/3 (0) |
0/1 (0) |
|
| Not reported | 1/5 (20.0) |
0/3 (0) |
|
| White | 7/315 (2.2) |
7/325 (2.2) |
|
| Abdominal pain | American Indian or Alaska Native | 0/2 (0) |
0/2 (0) |
| Asian | 0/2 (0) |
0/1 (0) |
|
| Black or African American | 1/73 (1.4) |
0/61 (0) |
|
| Multiple | 0/3 (0) |
0/1 (0) |
|
| Not reported | 0/5 (0) |
0/3 (0) |
|
| White | 6/315 (1.9) |
2/325 (0.6) |
|
| Muscle spasms | American Indian or Alaska Native | 0/2 (0) |
0/2 (0) |
| Asian | 0/2 (0) |
0/1 (0) |
|
| Black or African American | 0/73 (0) |
0/61 (0) |
|
| Multiple | 0/3 (0) |
0/1 (0) |
|
| Not reported | 0/5 (0) |
1/3 (33.3) |
|
| White | 5/315 (1.6) |
2/325 (0.6) |
|
| Rash | American Indian or Alaska Native | 0/2 (0) |
0/2 (0) |
| Asian | 0/2 (0) |
0/1 (0) |
|
| Black or African American | 0/73 (0) |
1/61 (1.6) |
|
| Multiple | 0/3 (0) |
0/1 (0) |
|
| Not reported | 0/5 (0) |
1/3 (33.3) |
|
| White | 2/315 (0.6) |
1/325 (0.3) |
|
| Age, years |
|
|
|
| Headache | 40 to 49 | 3/53 (5.7) |
1/58 (1.7) |
| 50 to 59 | 23/270 (8.5) |
9/272 (3.3) |
|
| 60 to 65 | 6/77 (7.8) |
0/63 (0) |
|
| Fatigue | 40 to 49 | 0/53 (0) |
1/58 (1.7) |
| 50 to 59 | 20/270 (7.4) |
5/272 (1.8) |
|
| 60 to 65 | 6/77 (7.8) |
1/63 (1.6) |
|
| Dizziness | 40 to 49 | 0/53 (0) |
0/58 (0) |
| 50 to 59 | 10/270 (3.7) |
5/272 (1.8) |
|
| 60 to 65 | 3/77 (3.9) |
1/63 (1.6) |
|
| Somnolence | 40 to 49 | 0/53 (0) |
0/58 (0) |
| 50 to 59 | 8/270 (3.0) |
1/272 (0.4) |
|
| 60 to 65 | 3/77 (3.9) |
1/63 (1.6) |
|
| Diarrhea | 40 to 49 | 0/53 (0) |
1/58 (1.7) |
| 50 to 59 | 6/270 (2.2) |
7/272 (2.6) |
|
| 60 to 65 | 3/77 (3.9) |
1/63 (1.6) |
|
| Abdominal pain | 40 to 49 | 0/53 (0) |
0/58 (0) |
| 50 to 59 | 7/270 (2.6) |
2/272 (0.7) |
|
| 60 to 65 | 0/77 (0) |
0/63 (0) |
|
| Muscle spasms | 40 to 49 | 0/53 (0) |
0/58 (0) |
| 50 to 59 | 3/270 (1.1) |
3/272 (1.1) |
|
| 60 to 65 | 2/77 (2.6) |
0/63 (0) |
|
| Rash | 40 to 49 | 0/53 (0) |
2/58 (3.4) |
| 50 to 59 | 1/270 (0.4) |
1/272 (0.4) |
|
| 60 to 65 | 1/77 (1.3) |
0/63 (0) |
|
| Ethnicity |
|
|
|
| Headache | Hispanic or Latino | 2/30 (6.7) |
0/38 (0) |
| Not Hispanic or Latino | 30/367 (8.2) |
9/350 (2.6) |
|
| Not reported | 0/3 (0) |
1/5 (20.0) |
|
| Fatigue | Hispanic or Latino | 1/30 (3.3) |
1/38 (2.6) |
| Not Hispanic or Latino | 25/367 (6.8) |
6/350 (1.7) |
|
| Not reported | 0/3 (0) |
0/5 (0) |
|
| Dizziness | Hispanic or Latino | 1/30 (3.3) |
0/38 (0) |
| Not Hispanic or Latino | 12/367 (3.3) |
6/350 (1.7) |
|
| Not reported | 0/3 (0) |
0/5 (0) |
|
| Somnolence | Hispanic or Latino | 0/30 (0) |
0/38 (0) |
| Not Hispanic or Latino | 11/367 (3.0) |
2/350 (0.6) |
|
| Not reported | 0/3 (0) |
0/5 (0) |
|
| Diarrhea | Hispanic or Latino | 2/30 (6.7) |
0/38 (0) |
| Not Hispanic or Latino | 7/367 (1.9) |
9/350 (2.6) |
|
| Not reported | 0/3 (0) |
0/5 (0) |
|
| Abdominal pain | Hispanic or Latino | 0/30 (0) |
0/38 (0) |
| Not Hispanic or Latino | 7/367 (1.9) |
2/350 (0.6) |
|
| Not reported | 0/3 (0) |
0/5 (0) |
|
| Muscle spasms | Hispanic or Latino | 0/30 (0) |
1/38 (2.6) |
| Not Hispanic or Latino | 5/367 (1.4) |
2/350 (0.6) |
|
| Not reported | 0/3 (0) |
0/5 (0) |
|
| Rash | Hispanic or Latino | 0/30 (0) |
1/38 (2.6) |
| Not Hispanic or Latino | 2/367 (0.5) |
2/350 (0.6) |
|
| Not reported | 0/3 (0) |
0/5 (0) |
Source: adsl.xpt, adae.xpt; Software: R
Common side effects are presented by subgroups in the table, including abdominal pain (contains abdominal pain lower, abdominal discomfort, and abdominal pain upper), diarrhea, dizziness (contains dizziness, vertigo, and balance disorder), fatigue (contains fatigue and asthenia), headache, muscle spasms (contains muscle spasms and muscle tightness), rash, somnolence (contains somnolence and lethargy).
Abbreviations: N, number of patients in treatment arm; n, number of patients with adverse event; Ns, total number of patients for each specific subgroup and were assigned to that specific arm
Adverse reactions reported by race, age, and ethnicity in OASIS-3 is shown in Table 8.
Table 8. Adverse Reactions by Race, Age Group, and Ethnicity, Safety Population, OASIS-3
| Adverse Events | Demographic Subgroup | LYNKUET |
Placebo |
|---|---|---|---|
| Race |
|
|
|
| Headache | Asian | 1/2 (50.0) |
0/2 (0) |
| Black or African American | 2/50 (4.0) |
3/44 (6.8) |
|
| Multiple | 0/0 (NA) |
0/1 (0) |
|
| Native Hawaiian or other Pacific Islander | 0/1 (0) |
0/0 (NA) |
|
| Not reported | 5/19 (26.3) |
2/15 (13.3) |
|
| White | 22/241 (9.1) |
17/252 (6.7) |
|
| Fatigue | Asian | 0/2 (0) |
0/2 (0) |
| Black or African American | 0/50 (0) |
0/44 (0) |
|
| Multiple | 0/0 (NA) |
0/1 (0) |
|
| Native Hawaiian or other Pacific Islander | 0/1 (0) |
0/0 (NA) |
|
| Not reported | 3/19 (15.8) |
1/15 (6.7) |
|
| White | 20/241 (8.3) |
8/252 (3.2) |
|
| Dizziness | Asian | 0/2 (0) |
1/2 (50.0) |
| Black or African American | 0/50 (0) |
2/44 (4.5) |
|
| Multiple | 0/0 (NA) |
0/1 (0) |
|
| Native Hawaiian or other Pacific Islander | 0/1 (0) |
0/0 (NA) |
|
| Not reported | 3/19 (15.8) |
0/15 (0) |
|
| White | 16/241 (6.6) |
3/252 (1.2) |
|
| Somnolence | Asian | 0/2 (0) |
1/2 (50.0) |
| Black or African American | 1/50 (2.0) |
0/44 (0) |
|
| Multiple | 0/0 (NA) |
0/1 (0) |
|
| Native Hawaiian or other Pacific Islander | 0/1 (0) |
0/0 (NA) |
|
| Not reported | 0/19 (0) |
0/15 (0) |
|
| White | 16/241 (6.6) |
3/252 (1.2) |
|
| Abdominal pain | Asian | 0/2 (0) |
0/2 (0) |
| Black or African American | 0/50 (0) |
1/44 (2.3) |
|
| Multiple | 0/0 (NA) |
0/1 (0) |
|
| Native Hawaiian or other Pacific Islander | 0/1 (0) |
0/0 (NA) |
|
| Not reported | 1/19 (5.3) |
1/15 (6.7) |
|
| White | 13/241 (5.4) |
6/252 (2.4) |
|
| Rash | Asian | 0/2 (0) |
0/2 (0) |
| Black or African American | 1/50 (2.0) |
1/44 (2.3) |
|
| Multiple | 0/0 (NA) |
0/1 (0) |
|
| Native Hawaiian or other Pacific Islander | 0/1 (0) |
0/0 (NA) |
|
| Not reported | 2/19 (10.5) |
2/15 (13.3) |
|
| White | 10/241 (4.1) |
2/252 (0.8) |
|
| Diarrhea | Asian | 1/2 (50.0) |
0/2 (0) |
| Black or African American | 0/50 (0) |
1/44 (2.3) |
|
| Multiple | 0/0 (NA) |
0/1 (0) |
|
| Native Hawaiian or other Pacific Islander | 0/1 (0) |
0/0 (NA) |
|
| Not reported | 2/19 (10.5) |
1/15 (6.7) |
|
| White | 9/241 (3.7) |
1/252 (0.4) |
|
| Muscle spasms | Asian | 0/2 (0) |
0/2 (0) |
| Black or African American | 0/50 (0) |
0/44 (0) |
|
| Multiple | 0/0 (NA) |
0/1 (0) |
|
| Native Hawaiian or other Pacific Islander | 0/1 (0) |
0/0 (NA) |
|
| Not reported | 3/19 (15.8) |
0/15 (0) |
|
| White | 7/241 (2.9) |
2/252 (0.8) |
|
| Age, years |
|
|
|
| Headache | 40 to 49 | 2/46 (4.3) |
2/43 (4.7) |
| 50 to 59 | 23/211 (10.9) |
17/212 (8.0) |
|
| 60 to 65 | 5/56 (8.9) |
3/59 (5.1) |
|
| Fatigue | 40 to 49 | 1/46 (2.2) |
1/43 (2.3) |
| 50 to 59 | 17/211 (8.1) |
4/212 (1.9) |
|
| 60 to 65 | 5/56 (8.9) |
4/59 (6.8) |
|
| Dizziness | 40 to 49 | 1/46 (2.2) |
0/43 (0) |
| 50 to 59 | 16/211 (7.6) |
5/212 (2.4) |
|
| 60 to 65 | 2/56 (3.6) |
1/59 (1.7) |
|
| Somnolence | 40 to 49 | 3/46 (6.5) |
0/43 (0) |
| 50 to 59 | 10/211 (4.7) |
4/212 (1.9) |
|
| 60 to 65 | 4/56 (7.1) |
0/59 (0) |
|
| Abdominal pain | 40 to 49 | 2/46 (4.3) |
1/43 (2.3) |
| 50 to 59 | 8/211 (3.8) |
6/212 (2.8) |
|
| 60 to 65 | 4/56 (7.1) |
1/59 (1.7) |
|
| Rash | 40 to 49 | 1/46 (2.2) |
0/43 (0) |
| 50 to 59 | 9/211 (4.3) |
4/212 (1.9) |
|
| 60 to 65 | 3/56 (5.4) |
1/59 (1.7) |
|
| Diarrhea | 40 to 49 | 0/46 (0) |
0/43 (0) |
| 50 to 59 | 8/211 (3.8) |
1/212 (0.5) |
|
| 60 to 65 | 4/56 (7.1) |
2/59 (3.4) |
|
| Muscle spasms | 40 to 49 | 0/46 (0) |
0/43 (0) |
| 50 to 59 | 5/211 (2.4) |
2/212 (0.9) |
|
| 60 to 65 | 5/56 (8.9) |
0/59 (0) |
|
| Ethnicity |
|
|
|
| Headache | Hispanic or Latino | 10/35 (28.6) |
5/33 (15.2) |
| Not Hispanic or Latino | 18/265 (6.8) |
17/273 (6.2) |
|
| Not reported | 2/13 (15.4) |
0/8 (0) |
|
| Fatigue | Hispanic or Latino | 6/35 (17.1) |
0/33 (0) |
| Not Hispanic or Latino | 16/265 (6.0) |
8/273 (2.9) |
|
| Not reported | 1/13 (7.7) |
1/8 (12.5) |
|
| Dizziness | Hispanic or Latino | 5/35 (14.3) |
1/33 (3.0) |
| Not Hispanic or Latino | 12/265 (4.5) |
5/273 (1.8) |
|
| Not reported | 2/13 (15.4) |
0/8 (0) |
|
| Somnolence | Hispanic or Latino | 4/35 (11.4) |
0/33 (0) |
| Not Hispanic or Latino | 10/265 (3.8) |
4/273 (1.5) |
|
| Not reported | 3/13 (23.1) |
0/8 (0) |
|
| Abdominal pain | Hispanic or Latino | 4/35 (11.4) |
2/33 (6.1) |
| Not Hispanic or Latino | 10/265 (3.8) |
6/273 (2.2) |
|
| Not reported | 0/13 (0) |
0/8 (0) |
|
| Rash | Hispanic or Latino | 2/35 (5.7) |
0/33 (0) |
| Not Hispanic or Latino | 11/265 (4.2) |
5/273 (1.8) |
|
| Not reported | 0/13 (0) |
0/8 (0) |
|
| Diarrhea | Hispanic or Latino | 2/35 (5.7) |
0/33 (0) |
| Not Hispanic or Latino | 9/265 (3.4) |
3/273 (1.1) |
|
| Not reported | 1/13 (7.7) |
0/8 (0) |
|
| Muscle spasms | Hispanic or Latino | 2/35 (5.7) |
0/33 (0) |
| Not Hispanic or Latino | 8/265 (3.0) |
2/273 (0.7) |
|
| Not reported | 0/13 (0) |
0/8 (0) |
Source: adsl.xpt, adae.xpt; Software: R
Common side effects are presented by subgroups in the table, including abdominal pain (contains abdominal pain lower, abdominal pain upper, abdominal discomfort, and abdominal pain), dizziness (contains vertigo, balance disorder, dizziness, presyncope, vertigo CNS origin, vestibular neuronitis, and vertigo positional), fatigue (contains fatigue and asthenia), muscle spasms (contains muscle spasms and muscle tightness), rash (contains urticaria, rash, and dermatitis), and somnolence (contains lethargy and somnolence).
Abbreviations: CNS, central nervous system; N, number of patients in treatment arm; n, number of patients with adverse event; Ns, total number of patients for each specific subgroup and were assigned to that specific arm
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
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