Trial Outcomes & Findings for A Study Called ARAMON to Learn to What Extent Does Study Treatment With Darolutamide Affects Testosterone Levels in Men With Prostate Cancer That Had Not Been Treated With Hormonal Therapy Compared to Treatment With Enzalutamide (NCT NCT05526248)
NCT ID: NCT05526248
Last Updated: 2025-12-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
From baseline to week 12
Results posted on
2025-12-18
Participant Flow
A total of 28 participants were screened and signed the informed consent form for the study. Three participants were screen failures and did not complete screening. The study was conducted at five centers in the United States from 19 Dec 2022 (First Patient First Visit) to 4 Dec 2024 (Last Patient Last Visit). The randomized phase was never started based on the results of the lead-in phase.
Of the 25 who completed screening, 24 began the intervention, while one opted not to start.
Participant milestones
| Measure |
Lead-in Phase: Darolutamide Treatment
Darolutamide treatment arm is single cohort in lead-in phase
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
All Participants in the Lead-in Phase Had Been on Treatment for 12 Weeks
|
24
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Lead-in Phase: Darolutamide Treatment
Darolutamide treatment arm is single cohort in lead-in phase
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Of the 23 participants, only 5 presented bone lesions
Baseline characteristics by cohort
| Measure |
Lead-in Phase: Darolutamide Treatment
n=23 Participants
Darolutamide treatment arm is single cohort in lead-in phase
|
|---|---|
|
Age, Continuous
|
72.1 Years
STANDARD_DEVIATION 7.5 • n=23 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=23 Participants
|
|
Number of participants with different baseline value of ECOG Performance Status
0
|
21 Participants
n=23 Participants
|
|
Number of participants with different baseline value of ECOG Performance Status
1
|
2 Participants
n=23 Participants
|
|
Number of participants with different Gleason score of prostate cancer at initial diagnosis
≤ 6
|
6 Participants
n=23 Participants
|
|
Number of participants with different Gleason score of prostate cancer at initial diagnosis
= 7
|
14 Participants
n=23 Participants
|
|
Number of participants with different Gleason score of prostate cancer at initial diagnosis
≥ 8
|
2 Participants
n=23 Participants
|
|
Number of participants with different Gleason score of prostate cancer at initial diagnosis
Unknown
|
1 Participants
n=23 Participants
|
|
Number of participants with Bone lesions at baseline
No
|
18 Participants
n=23 Participants
|
|
Number of participants with Bone lesions at baseline
Yes
|
5 Participants
n=23 Participants
|
|
Number of bone lesions at baseline
1
|
3 Participants
n=5 Participants • Of the 23 participants, only 5 presented bone lesions
|
|
Number of bone lesions at baseline
4
|
2 Participants
n=5 Participants • Of the 23 participants, only 5 presented bone lesions
|
|
Number of participants with different renal impairment
Normal: eGFR ≥ 90 mL/min
|
6 Participants
n=23 Participants
|
|
Number of participants with different renal impairment
Mild impairment: 60 ≤ eGFR < 90 mL/min
|
13 Participants
n=23 Participants
|
|
Number of participants with different renal impairment
Moderate impairment: 30 ≤ eGFR < 60 mL/min
|
4 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 12Population: The evaluable set was defined as all enrolled participants having testosterone data at baseline and week 12. Enrolled participants included those who signed informed consent and met all inclusion and none of the exclusion criteria.
Outcome measures
| Measure |
Lead-in Phase: Darolutamide Treatment
n=22 Participants
Darolutamide treatment arm is single cohort in lead-in phase
|
|---|---|
|
Percent Change in Serum Testosterone
|
53.46 percentage (%)
Interval 33.44 to 76.48
|
SECONDARY outcome
Timeframe: From baseline to week 24 and 52Population: The evaluable set was defined as all enrolled participants having testosterone data at baseline and week 12. Enrolled participants included those who signed informed consent and met all inclusion and none of the exclusion criteria.
Outcome measures
| Measure |
Lead-in Phase: Darolutamide Treatment
n=23 Participants
Darolutamide treatment arm is single cohort in lead-in phase
|
|---|---|
|
Percent Change in Serum Testosterone
Mean percent change from baseline at Week 24
|
56.25 Percentage (%)
Interval 39.87 to 74.55
|
|
Percent Change in Serum Testosterone
Mean percent change from baseline at Week 52
|
48.49 Percentage (%)
Interval 32.76 to 66.08
|
SECONDARY outcome
Timeframe: At week 4.12.24.36.52PSA50 is defined as a ≥50% reduction of the PSA level compared to the baseline value, confirmed by a second subsequent PSA value with a ≥50% reduction from baseline 3 or more weeks later.
Outcome measures
| Measure |
Lead-in Phase: Darolutamide Treatment
n=23 Participants
Darolutamide treatment arm is single cohort in lead-in phase
|
|---|---|
|
Number of Participants With Different Serum Prostate-specific Antigen (PSA) Response
Number of participants with confirmed PSA50 response at Week 4
|
23 Participants
|
|
Number of Participants With Different Serum Prostate-specific Antigen (PSA) Response
Number of participants with confirmed PSA50 response at Week 12
|
23 Participants
|
|
Number of Participants With Different Serum Prostate-specific Antigen (PSA) Response
Number of participants with confirmed PSA50 response at Week 24
|
23 Participants
|
|
Number of Participants With Different Serum Prostate-specific Antigen (PSA) Response
Number of participants with confirmed PSA50 response at Week 36
|
23 Participants
|
|
Number of Participants With Different Serum Prostate-specific Antigen (PSA) Response
Number of participants with confirmed PSA50 response at Week 52
|
23 Participants
|
|
Number of Participants With Different Serum Prostate-specific Antigen (PSA) Response
Number of participants with confirmed PSA50 response any time
|
23 Participants
|
Adverse Events
Darolutamide 600 mg BID
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Darolutamide 600 mg BID
n=24 participants at risk
Subjects received darolutamide 600 mg (BID) with food.
|
|---|---|
|
Eye disorders
Retinal detachment
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
General disorders
Pyrexia
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Infections and infestations
Pneumonia
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
Other adverse events
| Measure |
Darolutamide 600 mg BID
n=24 participants at risk
Subjects received darolutamide 600 mg (BID) with food.
|
|---|---|
|
Cardiac disorders
Palpitations
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Cardiac disorders
Sinus arrhythmia
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Ear and labyrinth disorders
Ear pain
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Ear and labyrinth disorders
Vertigo
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Endocrine disorders
Hyperparathyroidism
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
3/24 • Number of events 3 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
4/24 • Number of events 4 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Gastrointestinal disorders
Dry mouth
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
4.2%
1/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
4.2%
1/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
General disorders
Fatigue
|
29.2%
7/24 • Number of events 9 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
General disorders
Pain
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
General disorders
Pyrexia
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Infections and infestations
Influenza
|
4.2%
1/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
2/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Infections and infestations
Rhinitis
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Infections and infestations
Nail infection
|
8.3%
2/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Infections and infestations
Anorectal infection
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Infections and infestations
COVID-19
|
8.3%
2/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
2/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
8.3%
2/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
4.2%
1/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Investigations
Blood cholesterol increased
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Investigations
Electrocardiogram QT prolonged
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Investigations
Neutrophil count decreased
|
4.2%
1/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Investigations
Oestradiol increased
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Investigations
Weight decreased
|
8.3%
2/24 • Number of events 3 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Investigations
Cardiac stress test abnormal
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
4/24 • Number of events 4 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
3/24 • Number of events 3 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
2/24 • Number of events 3 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.5%
3/24 • Number of events 3 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
8.3%
2/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.2%
1/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Nervous system disorders
Dizziness
|
16.7%
4/24 • Number of events 4 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Nervous system disorders
Dysgeusia
|
12.5%
3/24 • Number of events 3 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Nervous system disorders
Brain fog
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Psychiatric disorders
Insomnia
|
8.3%
2/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Psychiatric disorders
Libido decreased
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Renal and urinary disorders
Micturition urgency
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Renal and urinary disorders
Pollakiuria
|
8.3%
2/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Reproductive system and breast disorders
Breast pain
|
16.7%
4/24 • Number of events 4 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Reproductive system and breast disorders
Breast tenderness
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
79.2%
19/24 • Number of events 31 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Reproductive system and breast disorders
Nipple pain
|
8.3%
2/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
3/24 • Number of events 4 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
2/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
1/24 • Number of events 2 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Skin and subcutaneous tissue disorders
Androgenetic alopecia
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Surgical and medical procedures
Knee arthroplasty
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Surgical and medical procedures
Skin cyst excision
|
4.2%
1/24 • Number of events 1 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Vascular disorders
Hypertension
|
16.7%
4/24 • Number of events 7 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
|
Vascular disorders
Hot flush
|
8.3%
2/24 • Number of events 4 • Treatment-emergent AE (TEAE) was defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug, up to 13 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place