Trial Outcomes & Findings for Study Evaluating the Efficacy of Oral Vismodegib in Various Histologic Subtypes (NCT NCT01700049)
NCT ID: NCT01700049
Last Updated: 2019-05-23
Results Overview
The efficacy of vismodegib was defined as the number of tumor biopsies with positive pathology after 24 weeks. Subjects had one target lesion and up to 3 additional non-target lesions. A cumulative total of 65 tumors was measured after 24 weeks of treatment. Histopathological subtypes were categorized primarily as infiltrative, nodular and superficial.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Week 24
Results posted on
2019-05-23
Participant Flow
Participant milestones
| Measure |
Open Label Oral Vismodegib
This is a Phase 2B single-site, open-label, nonrandomized 24-week study of the efficacy and safety of vismodegib (150 mg PO daily) in subjects with high risk and/or locally advanced basal cell carcinoma (BCC).
vismodegib (150 mg PO daily): Biopsies will be performed on all participants at baseline, week 12 and week 24.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Open Label Oral Vismodegib
This is a Phase 2B single-site, open-label, nonrandomized 24-week study of the efficacy and safety of vismodegib (150 mg PO daily) in subjects with high risk and/or locally advanced basal cell carcinoma (BCC).
vismodegib (150 mg PO daily): Biopsies will be performed on all participants at baseline, week 12 and week 24.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study Evaluating the Efficacy of Oral Vismodegib in Various Histologic Subtypes
Baseline characteristics by cohort
| Measure |
Open Label Oral Vismodegib
n=28 Participants
This is a Phase 2B single-site, open-label, nonrandomized 24-week study of the efficacy and safety of vismodegib (150 mg PO daily) in subjects with high risk and/or locally advanced basal cell carcinoma.
vismodegib (150 mg PO daily): Biopsies will be performed on all participants at baseline, week 12 and week 24.
|
|---|---|
|
Age, Continuous
|
69.5 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: A total of 65 tumors were categorized into histopathologic subtype where 24 of 65 were infiltrative, 29 of 65 were nodular, 10 of 65 were superficial and 2 out of 65 were keratotic.
The efficacy of vismodegib was defined as the number of tumor biopsies with positive pathology after 24 weeks. Subjects had one target lesion and up to 3 additional non-target lesions. A cumulative total of 65 tumors was measured after 24 weeks of treatment. Histopathological subtypes were categorized primarily as infiltrative, nodular and superficial.
Outcome measures
| Measure |
Open Label Oral Vismodegib
n=65 tumors
This is a Phase 2B single-site, open-label, nonrandomized 24-week study of the efficacy and safety of vismodegib (150 mg PO daily) in subjects with high risk and/or locally advanced basal cell carcinoma.
vismodegib (150 mg PO daily): Biopsies will be performed on all participants at baseline, week 12 and week 24.
|
|---|---|
|
Efficacy of Vismodegib
Infiltrative
|
2 tumors
|
|
Efficacy of Vismodegib
Nodular
|
5 tumors
|
|
Efficacy of Vismodegib
Superficial
|
1 tumors
|
|
Efficacy of Vismodegib
Keratotic
|
1 tumors
|
SECONDARY outcome
Timeframe: Up to 18 monthsThe safety of Vismodegib was evaluated by monitoring adverse effects. All adverse events, expected and unexpected, were recorded and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) guide. This is a set of criteria from the National Cancer Institute (NCI) used to standardize classification of adverse effects of drugs. Grade 1 events are defined as mild, grade 2 as moderate, grade 3 as severe; grade 4 as life-threatening and grade 5 as death.
Outcome measures
| Measure |
Open Label Oral Vismodegib
n=28 Participants
This is a Phase 2B single-site, open-label, nonrandomized 24-week study of the efficacy and safety of vismodegib (150 mg PO daily) in subjects with high risk and/or locally advanced basal cell carcinoma.
vismodegib (150 mg PO daily): Biopsies will be performed on all participants at baseline, week 12 and week 24.
|
|---|---|
|
Safety of Vismodegib
Grade 1
|
133 adverse events
|
|
Safety of Vismodegib
Grade 2
|
48 adverse events
|
|
Safety of Vismodegib
Grade 3
|
8 adverse events
|
|
Safety of Vismodegib
Grade 4
|
1 adverse events
|
|
Safety of Vismodegib
Grade 5
|
2 adverse events
|
SECONDARY outcome
Timeframe: Up to week 24Onset of efficacy was measured by tumor surface area reduction or increase. Subjects had one target lesion and up to 3 additional non-target lesions. Surface area of a cumulative total of 65 tumors (27 target lesions and 38 non-target lesions) was measured after 24 weeks of treatment. A complete response was defined as 100% reduction in tumor surface area. Partial response was defined as greater than 50% reduction in tumor surface area. Stable disease was defined as less than 50% reduction in tumor surface area and Progressive disease was defined as greater than 20% increase in tumor surface area.
Outcome measures
| Measure |
Open Label Oral Vismodegib
n=65 tumors
This is a Phase 2B single-site, open-label, nonrandomized 24-week study of the efficacy and safety of vismodegib (150 mg PO daily) in subjects with high risk and/or locally advanced basal cell carcinoma.
vismodegib (150 mg PO daily): Biopsies will be performed on all participants at baseline, week 12 and week 24.
|
|---|---|
|
Onset of Efficacy of Vismodegib
Progressive Disease
|
1 tumors
|
|
Onset of Efficacy of Vismodegib
Complete response
|
13 tumors
|
|
Onset of Efficacy of Vismodegib
Partial response
|
27 tumors
|
|
Onset of Efficacy of Vismodegib
Stable Disease
|
24 tumors
|
Adverse Events
Open Label Oral Vismodegib
Serious events: 4 serious events
Other events: 28 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Open Label Oral Vismodegib
n=28 participants at risk
This is a Phase 2B single-site, open-label, nonrandomized 24-week study of the efficacy and safety of vismodegib (150 mg PO daily) in subjects with high risk and/or locally advanced basal cell carcinoma.
vismodegib (150 mg PO daily): Biopsies will be performed on all participants at baseline, week 12 and week 24.
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Nervous system disorders
Neurogenic claudication
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Exacerbation of low back pain
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Cardiac disorders
Congestive Heart Failure
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
Other adverse events
| Measure |
Open Label Oral Vismodegib
n=28 participants at risk
This is a Phase 2B single-site, open-label, nonrandomized 24-week study of the efficacy and safety of vismodegib (150 mg PO daily) in subjects with high risk and/or locally advanced basal cell carcinoma.
vismodegib (150 mg PO daily): Biopsies will be performed on all participants at baseline, week 12 and week 24.
|
|---|---|
|
General disorders
Dysgeusia/Loss of Taste
|
85.7%
24/28 • Number of events 24 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
82.1%
23/28 • Number of events 23 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
71.4%
20/28 • Number of events 20 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Metabolism and nutrition disorders
Decreased appetite/anorexia/weight loss
|
32.1%
9/28 • Number of events 9 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Nausea
|
28.6%
8/28 • Number of events 8 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Fatigue
|
25.0%
7/28 • Number of events 7 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
7/28 • Number of events 7 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Joint aches
|
17.9%
5/28 • Number of events 5 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Infections and infestations
Upper respiratory infection
|
17.9%
5/28 • Number of events 5 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Itching/pruritus
|
14.3%
4/28 • Number of events 4 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Swelling
|
14.3%
4/28 • Number of events 4 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
7.1%
2/28 • Number of events 2 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
2/28 • Number of events 2 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
2/28 • Number of events 2 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Gastrointestinal disorders
Gastroenteritis
|
7.1%
2/28 • Number of events 2 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Infections and infestations
Wound infection
|
7.1%
2/28 • Number of events 2 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Abnormal hair growth
|
7.1%
2/28 • Number of events 2 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Insomnia
|
7.1%
2/28 • Number of events 2 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Comedones
|
7.1%
2/28 • Number of events 2 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Scalp tenderness
|
7.1%
2/28 • Number of events 2 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Ear and labyrinth disorders
Vertigo
|
7.1%
2/28 • Number of events 2 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Headache
|
7.1%
2/28 • Number of events 2 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Eye disorders
Blurry vision
|
7.1%
2/28 • Number of events 2 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Infections and infestations
Urinary Tract Infection
|
7.1%
2/28 • Number of events 2 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
7.1%
2/28 • Number of events 2 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Falls
|
7.1%
2/28 • Number of events 2 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Vomiting
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Dehydration
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Decrease in eyelashes/eyebrows
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Biopsy site inflammation
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Infections and infestations
Viral syndrome
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Gastrointestinal disorders
Esophagitis
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Stunted nail growth
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Maxillary fibrous cyst
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Bloating
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Dry mouth
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Tooth pain
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Numbness
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Rhinorrhea
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Rosacea flare
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Visual hallucinations
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Dislocation
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Sprain
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Burning sensation of tongue
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Halitosis
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Surgical and medical procedures
Eyelid reconstruction
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Infections and infestations
Bronchitis
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Vascular disorders
Peripheral arterial disease
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Infections and infestations
Sinus infection
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Infections and infestations
Salivary gland infection
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Gout
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Orthostatic tremor
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Lower extremity edema/intermittent swelling
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Cardiac disorders
Elevated blood pressure
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Squamous cell carcinoma
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
General disorders
Vitamin D deficiency
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
|
Blood and lymphatic system disorders
Hyperlipidemia
|
3.6%
1/28 • Number of events 1 • The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place