Trial Outcomes & Findings for Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006 (NCT NCT02428608)
NCT ID: NCT02428608
Last Updated: 2019-04-24
Results Overview
The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
570 participants
Primary outcome timeframe
365 days
Results posted on
2019-04-24
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin, Tyoe A
DWP-450 (Botulinum toxin, Type A)
DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A
|
|---|---|
|
Overall Study
STARTED
|
570
|
|
Overall Study
COMPLETED
|
487
|
|
Overall Study
NOT COMPLETED
|
83
|
Reasons for withdrawal
| Measure |
Botulinum Toxin, Tyoe A
DWP-450 (Botulinum toxin, Type A)
DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A
|
|---|---|
|
Overall Study
Pregnancy
|
2
|
|
Overall Study
Lost to Follow-up
|
37
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
scheduling conflicts
|
15
|
|
Overall Study
moved away
|
10
|
|
Overall Study
Death
|
1
|
|
Overall Study
various
|
16
|
Baseline Characteristics
Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006
Baseline characteristics by cohort
| Measure |
Botulinum Toxin, Type A
n=570 Participants
DWP-450 (Botulinum toxin, Type A)
DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
519 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
510 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 365 daysThe primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.
Outcome measures
| Measure |
Botulinum Toxin, Tyoe A
n=570 Participants
DWP-450 (Botulinum toxin, Type A)
DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A
|
|---|---|
|
The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
|
235 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 365 daysPopulation: By Investigator assessment, 500 subjects had a GLS score at rest \>0 (i.e., 1, 2 or 3) at baseline and therefore could potentially have had a ≥1 point improvement in GLS score at rest at a post-baseline visit; 64 subjects were missing the EOS GLS assessment
Proportion of subjects with an improvement of 1 point or more (i.e., ≥1 point responders) on the GLS at rest at end of study/early termination: by Investigator assessment
Outcome measures
| Measure |
Botulinum Toxin, Tyoe A
n=500 Participants
DWP-450 (Botulinum toxin, Type A)
DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A
|
|---|---|
|
Change From Baseline Glabellar Line Scale (GLS) Score at Rest and at Maximum Frown
|
355 Participants
|
Adverse Events
Botulinum Toxin, Type A
Serious events: 7 serious events
Other events: 228 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botulinum Toxin, Type A
n=570 participants at risk
DWP-450 (Botulinum toxin, Type A)
DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A
|
|---|---|
|
Nervous system disorders
Carotid artery stenosis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Overdose
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Anxiety
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.18%
1/570 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Botulinum Toxin, Type A
n=570 participants at risk
DWP-450 (Botulinum toxin, Type A)
DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A
|
|---|---|
|
Nervous system disorders
Headache
|
13.2%
75/570 • Number of events 94 • 1 year
|
|
Nervous system disorders
Migraine
|
0.70%
4/570 • Number of events 6 • 1 year
|
|
Nervous system disorders
Tension headache
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Nervous system disorders
dizziness
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Nervous system disorders
hypoaesthesia
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Nervous system disorders
paraesthesia
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Nervous system disorders
presyncope
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Nervous system disorders
radiculitis cervical
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
Bronchitis
|
1.2%
7/570 • Number of events 7 • 1 year
|
|
Infections and infestations
Herpes zoster
|
0.53%
3/570 • Number of events 3 • 1 year
|
|
Infections and infestations
Hordeolum
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Infections and infestations
Influenza
|
0.88%
5/570 • Number of events 5 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
13/570 • Number of events 16 • 1 year
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Infections and infestations
Sinusitis
|
2.5%
14/570 • Number of events 15 • 1 year
|
|
Infections and infestations
Tooth abscess
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
16/570 • Number of events 19 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
1.8%
10/570 • Number of events 10 • 1 year
|
|
Infections and infestations
cellulitis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
conjunctivitis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
cystitis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
diverticulitis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
ear infection
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
eye infection
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
folliculitis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
gastroenteritis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
genital herpes
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
Helicobacter gastritis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
Herpes simplex
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
oral herpes
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
otitis media
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
pharyngitis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
tooth infection
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
vaginitis gardnerella
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Infections and infestations
viral infection
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
9/570 • Number of events 10 • 1 year
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.70%
4/570 • Number of events 4 • 1 year
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.70%
4/570 • Number of events 4 • 1 year
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Concussion
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Eye laser scar
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Laceration
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.1%
6/570 • Number of events 6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.53%
3/570 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.1%
6/570 • Number of events 6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.35%
2/570 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Post inflammatory pigmentation change
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.53%
3/570 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.70%
4/570 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.35%
2/570 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.70%
4/570 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
6/570 • Number of events 6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.18%
1/570 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
fibromyalgia
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
fracture pain
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
mobility decreased
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
pain in jaw
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
spinal osteoarthritis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Eye disorders
Blepharospasm
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Eye disorders
Brow ptosis
|
0.53%
3/570 • Number of events 3 • 1 year
|
|
Eye disorders
Eyelid ptosis
|
1.2%
7/570 • Number of events 8 • 1 year
|
|
Eye disorders
Vision blurred
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Eye disorders
blepharitis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Eye disorders
cataract
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Eye disorders
chalazion
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Eye disorders
dry eye
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Eye disorders
eye swelling
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Eye disorders
eyelid oedema
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Eye disorders
eyelid sensory disorder
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Eye disorders
ocular rosacea
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Toothache
|
0.53%
3/570 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
abdominal discomfort
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
abdominal pain
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
abdominal pain upper
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
diverticulum
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
dyspepsia
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
gastritis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
large intestine polyp
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
nausea
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
paraesthesia oral
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
salivary gland disorder
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
tooth disorder
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
General disorders
Injection site bruising
|
0.35%
2/570 • Number of events 3 • 1 year
|
|
General disorders
Injection site pain
|
0.53%
3/570 • Number of events 3 • 1 year
|
|
General disorders
Injection site swelling
|
0.53%
3/570 • Number of events 3 • 1 year
|
|
General disorders
Pyrexia
|
0.53%
3/570 • Number of events 5 • 1 year
|
|
General disorders
fatigue
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
General disorders
injection site pruritus
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
General disorders
injection site reaction
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
General disorders
local swelling
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
General disorders
tenderness
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
7/570 • Number of events 7 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary mass
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
sinus disorder
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
upper-airway cough syndrome
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Cardiac disorders
Bradycardia
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Cardiac disorders
Bundle branch block right
|
0.53%
3/570 • Number of events 3 • 1 year
|
|
Cardiac disorders
Sinus arrhythmia
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Cardiac disorders
Sinus bradycardia
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Cardiac disorders
atrioventricular block first degree
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Cardiac disorders
myocardial infarction
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Cardiac disorders
supraventricular extrasystoles
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Cardiac disorders
tachycardia
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Vascular disorders
Hot flush
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension
|
1.8%
10/570 • Number of events 10 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
acrochordon
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
dysplastic naevus
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
melanocytic naevus
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
seborrhoeic keratosis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Anxiety
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Depression
|
0.70%
4/570 • Number of events 4 • 1 year
|
|
Psychiatric disorders
adjustment disorder with depressed mood
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Psychiatric disorders
attention deficit/hyperactivity disorder
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Psychiatric disorders
insomnia
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Tinnitus
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
0.53%
3/570 • Number of events 3 • 1 year
|
|
Immune system disorders
Hypersensitivity
|
0.53%
3/570 • Number of events 3 • 1 year
|
|
Immune system disorders
Seasonal allergy
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Investigations
Blood creatinine increased
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Investigations
electrocardiogram QT prolonged
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Investigations
electrocardiogram T wave abnormal
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Investigations
electrocardiogram abnormal
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Investigations
intraocular pressure test
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Investigations
QRS axis abnormal
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
hypercholesterolaemia
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
vitamin D deficiency
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
breast tenderness
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
vaginal discharge
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
vaginal haemorrhage
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Endocrine disorders
hypothyroidism
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
nephrolithiasis
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
proteinuria
|
0.18%
1/570 • Number of events 1 • 1 year
|
|
Social circumstances
menopause
|
0.35%
2/570 • Number of events 2 • 1 year
|
|
Hepatobiliary disorders
hepatic cyst
|
0.18%
1/570 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place