Trial Outcomes & Findings for A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism (NCT NCT04274894)
NCT ID: NCT04274894
Last Updated: 2022-12-15
Results Overview
Systolic blood pressure was measured by the ambulatory blood pressure monitoring (ABPM) procedure. Measurements were obtained from participants using a portable data-monitoring device. The ABPM procedure was performed over a 24-hour period across 2 days and included ABPM device application by site (1st Day) and ABPM device removal by site (2nd Day).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
246 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2022-12-15
Participant Flow
All enrolled participants
Participant milestones
| Measure |
AndroGel 1.62%
AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.
|
|---|---|
|
Overall Study
STARTED
|
246
|
|
Overall Study
COMPLETED
|
204
|
|
Overall Study
NOT COMPLETED
|
42
|
Reasons for withdrawal
| Measure |
AndroGel 1.62%
AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.
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|---|---|
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Overall Study
Adverse Event
|
7
|
|
Overall Study
Withdrew consent
|
5
|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
COVID-19 infection
|
1
|
|
Overall Study
Other, not specified
|
20
|
Baseline Characteristics
A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
Baseline characteristics by cohort
| Measure |
AndroGel 1.62%
n=246 Participants
AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.
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|---|---|
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Age, Continuous
|
57.6 years
STANDARD_DEVIATION 10.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
246 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
209 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: Per protocol set analysis: all participants who received at least 1 dose of study drug, were at least 85% compliant to study drug, and had valid Baseline and end of treatment systolic ABPM data
Systolic blood pressure was measured by the ambulatory blood pressure monitoring (ABPM) procedure. Measurements were obtained from participants using a portable data-monitoring device. The ABPM procedure was performed over a 24-hour period across 2 days and included ABPM device application by site (1st Day) and ABPM device removal by site (2nd Day).
Outcome measures
| Measure |
AndroGel 1.62%
n=169 Participants
AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.
|
|---|---|
|
Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP)
|
1.9 mmHg
Standard Deviation 8.99
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Adverse Events
AndroGel 1.62%
Serious events: 8 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AndroGel 1.62%
n=246 participants at risk
AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.
|
|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Infections and infestations
COVID-19
|
1.6%
4/246 • Number of events 4 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Vascular disorders
HYPOTENSION
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
Other adverse events
| Measure |
AndroGel 1.62%
n=246 participants at risk
AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.
|
|---|---|
|
Ear and labyrinth disorders
VERTIGO
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Gastrointestinal disorders
DIVERTICULUM GASTRIC
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Gastrointestinal disorders
NAUSEA
|
0.81%
2/246 • Number of events 2 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Gastrointestinal disorders
VOMITING
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
General disorders
PYREXIA
|
0.81%
2/246 • Number of events 2 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Infections and infestations
ABSCESS LIMB
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Infections and infestations
BRONCHITIS
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Infections and infestations
COVID-19
|
1.2%
3/246 • Number of events 3 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Infections and infestations
CELLULITIS
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Infections and infestations
INFLUENZA
|
0.81%
2/246 • Number of events 2 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Infections and infestations
OTITIS EXTERNA CANDIDA
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Infections and infestations
OTITIS MEDIA
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Injury, poisoning and procedural complications
LIP INJURY
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
1.6%
4/246 • Number of events 4 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Investigations
BLOOD PRESSURE SYSTOLIC INCREASED
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Investigations
HEART RATE INCREASED
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Investigations
LIVER FUNCTION TEST INCREASED
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Investigations
PROSTATIC SPECIFIC ANTIGEN INCREASED
|
0.81%
2/246 • Number of events 2 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Metabolism and nutrition disorders
GOUT
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.81%
2/246 • Number of events 2 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Nervous system disorders
DIZZINESS
|
0.81%
2/246 • Number of events 2 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Nervous system disorders
HEADACHE
|
0.81%
2/246 • Number of events 2 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Nervous system disorders
PARAESTHESIA
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Nervous system disorders
PAROSMIA
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Psychiatric disorders
DEPRESSION
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Psychiatric disorders
INSOMNIA
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Psychiatric disorders
IRRITABILITY
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Renal and urinary disorders
DYSURIA
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Reproductive system and breast disorders
NIPPLE PAIN
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Reproductive system and breast disorders
PRIAPISM
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
1.2%
3/246 • Number of events 3 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLOURATION
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
0.41%
1/246 • Number of events 1 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
|
Vascular disorders
HYPERTENSION
|
2.0%
5/246 • Number of events 5 • All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER