Trial Outcomes & Findings for A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men (NCT NCT02722278)
NCT ID: NCT02722278
Last Updated: 2018-02-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
222 participants
Primary outcome timeframe
Day 105
Results posted on
2018-02-23
Participant Flow
Participant milestones
| Measure |
Oral Testosterone Undecanoate
166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).
Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
|
Axiron Testosterone Topical Solution
56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.
Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.
Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
56
|
|
Overall Study
COMPLETED
|
154
|
49
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
Reasons for withdrawal
| Measure |
Oral Testosterone Undecanoate
166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).
Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
|
Axiron Testosterone Topical Solution
56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.
Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.
Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
High PSA pre-study/ not eligible
|
0
|
1
|
|
Overall Study
Subject declined after tx assignment
|
0
|
1
|
|
Overall Study
Site closure not study related
|
0
|
1
|
Baseline Characteristics
A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Baseline characteristics by cohort
| Measure |
Oral Testosterone Undecanoate
n=166 Participants
Approximately 135 subjects will receive oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).
Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
|
Axiron Testosterone Topical Solution
n=56 Participants
Subjects randomly assigned to the Axiron treatment group will begin treatment at a dose of 60 mg every morning.
Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.
Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
160 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 9.08 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 7.86 • n=7 Participants
|
52 years
STANDARD_DEVIATION 8.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
166 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
141 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
133 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
166 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 105Population: Intent-to-treat study population All subjects randomized to either Oral TU or Axiron
Outcome measures
| Measure |
Oral Testosterone Undecanoate
n=166 Participants
166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).
Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
|
Axiron Testosterone Topical Solution
n=56 Participants
56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.
Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.
Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
|
|---|---|---|
|
Number of Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7
|
145 Participants
|
48 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 4.5 monthsCompare the Oral TU-treated subjects and the Topical Axiron®-treated subjects with respect to number of subjects in the cosyntropin stimulation test substudy with a normal maximum post-stimulation (cosyntropin stimulation) cortisol level at Visit 8.
Outcome measures
| Measure |
Oral Testosterone Undecanoate
n=24 Participants
166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).
Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
|
Axiron Testosterone Topical Solution
n=8 Participants
56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.
Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.
Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
|
|---|---|---|
|
Number of Participants With Post-stimulation Cortisol Level of >18 ug/dL at Visit 8
|
19 Participants
|
8 Participants
|
Adverse Events
Oral Testosterone Undecanoate
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Axiron Testosterone Topical Solution
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Testosterone Undecanoate
n=166 participants at risk
166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).
Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
|
Axiron Testosterone Topical Solution
n=55 participants at risk
56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.
Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.
Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
|
|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.60%
1/166 • Number of events 1 • 9 months
|
0.00%
0/55 • 9 months
|
|
Infections and infestations
Periumbilical abscess
|
0.60%
1/166 • Number of events 1 • 9 months
|
0.00%
0/55 • 9 months
|
Other adverse events
| Measure |
Oral Testosterone Undecanoate
n=166 participants at risk
166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).
Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
|
Axiron Testosterone Topical Solution
n=55 participants at risk
56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.
Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.
Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
|
|---|---|---|
|
Investigations
High Density Lipoprotein Decreased
|
3.0%
5/166 • Number of events 5 • 9 months
|
0.00%
0/55 • 9 months
|
|
Investigations
Blood triglycerides increased
|
0.60%
1/166 • Number of events 1 • 9 months
|
0.00%
0/55 • 9 months
|
|
Investigations
Blood pressure increased
|
1.2%
2/166 • Number of events 2 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Investigations
Prostatic specific antigen increased
|
1.2%
2/166 • Number of events 2 • 9 months
|
0.00%
0/55 • 9 months
|
|
Gastrointestinal disorders
Nausea
|
2.4%
4/166 • Number of events 4 • 9 months
|
0.00%
0/55 • 9 months
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
3/166 • Number of events 3 • 9 months
|
0.00%
0/55 • 9 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.8%
3/166 • Number of events 3 • 9 months
|
0.00%
0/55 • 9 months
|
|
Gastrointestinal disorders
Abdominal distension
|
1.2%
2/166 • Number of events 2 • 9 months
|
0.00%
0/55 • 9 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
2/166 • Number of events 2 • 9 months
|
0.00%
0/55 • 9 months
|
|
Gastrointestinal disorders
Dry mouth
|
1.2%
2/166 • Number of events 2 • 9 months
|
0.00%
0/55 • 9 months
|
|
Gastrointestinal disorders
Eructation
|
1.2%
2/166 • Number of events 2 • 9 months
|
0.00%
0/55 • 9 months
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
6/166 • Number of events 6 • 9 months
|
0.00%
0/55 • 9 months
|
|
Infections and infestations
Atypical pneumonia
|
1.2%
2/166 • Number of events 2 • 9 months
|
0.00%
0/55 • 9 months
|
|
Investigations
Haematocrit Increased
|
4.8%
8/166 • Number of events 8 • 9 months
|
0.00%
0/55 • 9 months
|
|
Nervous system disorders
Headache
|
4.8%
8/166 • Number of events 8 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Nervous system disorders
Hypoaesthesia
|
1.2%
2/166 • Number of events 2 • 9 months
|
0.00%
0/55 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.2%
2/166 • Number of events 2 • 9 months
|
0.00%
0/55 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
2/166 • Number of events 2 • 9 months
|
0.00%
0/55 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
2/166 • Number of events 2 • 9 months
|
0.00%
0/55 • 9 months
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
2/166 • Number of events 2 • 9 months
|
0.00%
0/55 • 9 months
|
|
Psychiatric disorders
Insomnia
|
1.8%
3/166 • Number of events 3 • 9 months
|
0.00%
0/55 • 9 months
|
|
Psychiatric disorders
Anxiety
|
1.2%
2/166 • Number of events 2 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Psychiatric disorders
Depression
|
1.2%
2/166 • Number of events 2 • 9 months
|
0.00%
0/55 • 9 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
2/166 • Number of events 3 • 9 months
|
3.6%
2/55 • Number of events 2 • 9 months
|
|
Vascular disorders
Hypertension
|
3.0%
5/166 • Number of events 5 • 9 months
|
0.00%
0/55 • 9 months
|
|
Vascular disorders
Flushing
|
1.2%
2/166 • Number of events 2 • 9 months
|
0.00%
0/55 • 9 months
|
|
General disorders
Oedema Peripheral
|
1.8%
3/166 • Number of events 3 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Investigations
Weight Increased
|
0.60%
1/166 • Number of events 1 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Infections and infestations
Cellulitis
|
0.60%
1/166 • Number of events 1 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Infections and infestations
Sinusitis
|
0.60%
1/166 • Number of events 1 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Nervous system disorders
Dizziness
|
0.60%
1/166 • Number of events 1 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Nervous system disorders
Presyncope
|
0.60%
1/166 • Number of events 1 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Nervous system disorders
Nerve Compression
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.60%
1/166 • Number of events 1 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.60%
1/166 • Number of events 1 • 9 months
|
3.6%
2/55 • Number of events 3 • 9 months
|
|
Injury, poisoning and procedural complications
Pelvic Facture
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Psychiatric disorders
Libido increases
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
General disorders
Application site pain
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
General disorders
Feeling jittery
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
General disorders
Infusion site thrombosis
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
2/166 • Number of events 2 • 9 months
|
0.00%
0/55 • 9 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.60%
1/166 • Number of events 1 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Renal and urinary disorders
Hematuria
|
1.2%
2/166 • Number of events 2 • 9 months
|
0.00%
0/55 • 9 months
|
|
Renal and urinary disorders
Pollakiuria
|
0.60%
1/166 • Number of events 1 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.60%
1/166 • Number of events 1 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/166 • 9 months
|
1.8%
1/55 • Number of events 1 • 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60