Trial Outcomes & Findings for A Study of MK-6913 for the Treatment of Hot Flashes in Postmenopausal Women (6913-004) (NCT NCT01015677)
NCT ID: NCT01015677
Last Updated: 2018-08-31
Results Overview
Hot flashes were recorded in real time and hot flashes recorded retrospectively in the morning and evening reports in a diary day via the Hot Flash e-diary were summed to determine the total number of hot flashes over a diary day. The total number of weekly moderate or worse hot flashes were calculated as the sum of the total number of hot flashes that occur over a diary week (non-missing diary day), divided by the number of days of diary completion, and multiplied by 7 (standardized week). At least 4 non-missing diary days were required to define the total number of weekly moderate or worse hot flashes. Hot flash data was excluded for participants whose number of moderate to severe hot flashes per week were in the top 1% of number of hot flashes reported to exclude any outlier effect.
TERMINATED
PHASE2
99 participants
Baseline and Week 4
2018-08-31
Participant Flow
Thirty sites in the United States, Canada, France, Belgium, New Zealand, and Australia received IRB/ERC approval. Of the 354 participants screened for inclusion, 255 participants were excluded during screening (235 participants did not meet specific exclusion criteria). Ninety-nine participants were randomized for the study.
The study was terminated at the end of Stage 1 so no participants entered Stage 2 and no participants received MK-6913 25 mg.
Participant milestones
| Measure |
MK-6913 75 mg
MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
17-β Estradiol 1 mg
17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
|
Placebo
Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
33
|
|
Overall Study
COMPLETED
|
33
|
28
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
0
|
Reasons for withdrawal
| Measure |
MK-6913 75 mg
MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
17-β Estradiol 1 mg
17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
|
Placebo
Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
Baseline Characteristics
A Study of MK-6913 for the Treatment of Hot Flashes in Postmenopausal Women (6913-004)
Baseline characteristics by cohort
| Measure |
MK-6913 75 mg
n=34 Participants
MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
17-β Estradiol 1 mg
n=32 Participants
17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
|
Placebo
n=33 Participants
Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.1 Years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
53.2 Years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
52.2 Years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
52.5 Years
STANDARD_DEVIATION 4.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
99 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
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: The Full Analysis Set (FAS) population consists of all randomized participants who receive at least 1 dose of study treatment, have at least 1 post-randomization observation for the analysis endpoint, and have baseline data for those analyses.
Hot flashes were recorded in real time and hot flashes recorded retrospectively in the morning and evening reports in a diary day via the Hot Flash e-diary were summed to determine the total number of hot flashes over a diary day. The total number of weekly moderate or worse hot flashes were calculated as the sum of the total number of hot flashes that occur over a diary week (non-missing diary day), divided by the number of days of diary completion, and multiplied by 7 (standardized week). At least 4 non-missing diary days were required to define the total number of weekly moderate or worse hot flashes. Hot flash data was excluded for participants whose number of moderate to severe hot flashes per week were in the top 1% of number of hot flashes reported to exclude any outlier effect.
Outcome measures
| Measure |
MK-6913 75 mg
n=34 Participants
MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
17-β Estradiol 1 mg
n=31 Participants
17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
|
Placebo
n=33 Participants
Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
|---|---|---|---|
|
Percent Change From Baseline in the Number of Weekly Moderate to Very Severe Hot Flashes (Excluding Outliers) at Week 4
|
-40.69 Percent change
Interval -54.82 to -26.56
|
-51.86 Percent change
Interval -66.38 to -37.34
|
-34.41 Percent change
Interval -48.99 to -19.83
|
PRIMARY outcome
Timeframe: Up to 6 weeksPopulation: The All-Patients-as Treated (APaT) population is all participants who received at least one dose of study drug.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Outcome measures
| Measure |
MK-6913 75 mg
n=34 Participants
MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
17-β Estradiol 1 mg
n=32 Participants
17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
|
Placebo
n=33 Participants
Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
|---|---|---|---|
|
Number of Participants Who Experienced at Least One or More Adverse Events (AE)
|
17 Participants
|
15 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: The APaT population is all participants who received at least one dose of study drug.
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Outcome measures
| Measure |
MK-6913 75 mg
n=34 Participants
MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
17-β Estradiol 1 mg
n=32 Participants
17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
|
Placebo
n=33 Participants
Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an AE
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: The Full Analysis Set (FAS) population consists of all randomized participants who receive at least 1 dose of study treatment, have at least 1 post-randomization observation for the analysis endpoint, and have baseline data for those analyses.
Hot flash severity score is calculated by the sum of: the number of mild hot flashes, 2 times number of moderate hot flashes, 3 times the number of severe hot flashes, and 4 times the number of very severe hot flashes. This sum was standardized to a 7-day week if there were any missing days in the e-diary. The severity of each hot flash was recorded by the Hot Flash e-diary.
Outcome measures
| Measure |
MK-6913 75 mg
n=34 Participants
MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
17-β Estradiol 1 mg
n=31 Participants
17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
|
Placebo
n=33 Participants
Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
|---|---|---|---|
|
Percent Change From Baseline in the Weekly Hot Flash Severity Score (Combining Severe and Very Severe Score) at Week 4
|
-39.92 Percent change
Interval -54.57 to -25.26
|
-45.09 Percent change
Interval -60.15 to -30.02
|
-33.87 Percent change
Interval -48.92 to -18.81
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: The Per-Protocol (PP) population excludes participants due to important deviations from the protocol that may substantially affect the results of the primary and key secondary efficacy endpoints.
FSH was measured to assess estrogen receptor (ER) selectivity (a biomarker for ERα activity and a pharmacodynamic endpoint).
Outcome measures
| Measure |
MK-6913 75 mg
n=21 Participants
MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
17-β Estradiol 1 mg
n=21 Participants
17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
|
Placebo
n=28 Participants
Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
|---|---|---|---|
|
Change From Baseline in Follicle-stimulating Hormone (FSH) Level at Week 4
|
-2.02 mIU/mL
Interval -7.91 to 3.87
|
-17.48 mIU/mL
Interval -23.08 to -11.89
|
-2.96 mIU/mL
Interval -8.54 to 2.62
|
Adverse Events
MK-6913 75 mg
17-β Estradiol 1 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-6913 75 mg
n=34 participants at risk
MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
17-β Estradiol 1 mg
n=32 participants at risk
17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
|
Placebo
n=33 participants at risk
Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/34 • Up to 6 weeks
|
6.2%
2/32 • Up to 6 weeks
|
6.1%
2/33 • Up to 6 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/34 • Up to 6 weeks
|
6.2%
2/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Gastrointestinal disorders
Flatulence
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
General disorders
Chest pain
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
General disorders
Fatigue
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
General disorders
Irritability
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Infections and infestations
Bronchitis
|
2.9%
1/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Infections and infestations
Ear infection
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Infections and infestations
Fungal infection
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Infections and infestations
Influenza
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Infections and infestations
Oral herpes
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
6.1%
2/33 • Up to 6 weeks
|
|
Infections and infestations
Sinusitis
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
6.1%
2/33 • Up to 6 weeks
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Injury, poisoning and procedural complications
Joint sprain
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Investigations
Blood glucose increased
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Investigations
Crystal urine
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Investigations
Crystal urine present
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Investigations
Liver function test abnormal
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Investigations
Protein urine
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Investigations
Weight increased
|
0.00%
0/34 • Up to 6 weeks
|
6.2%
2/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
2/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Nervous system disorders
Dizziness
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
12.1%
4/33 • Up to 6 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
33.3%
11/33 • Up to 6 weeks
|
|
Nervous system disorders
Sinus headache
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Psychiatric disorders
Elevated mood
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Reproductive system and breast disorders
Breast mass
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Reproductive system and breast disorders
Pelvic floor muscle weakness
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
5.9%
2/34 • Up to 6 weeks
|
9.4%
3/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
6.1%
2/33 • Up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar disorder
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
1/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/34 • Up to 6 weeks
|
3.1%
1/32 • Up to 6 weeks
|
0.00%
0/33 • Up to 6 weeks
|
|
Vascular disorders
Varicose vein
|
0.00%
0/34 • Up to 6 weeks
|
0.00%
0/32 • Up to 6 weeks
|
3.0%
1/33 • Up to 6 weeks
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER