Trial Outcomes & Findings for Pembrolizumab With or Without Vismodegib in Treating Metastatic or Unresectable Basal Cell Skin Cancer (NCT NCT02690948)
NCT ID: NCT02690948
Last Updated: 2019-03-08
Results Overview
The overall response rate (ORR) of participants with unresectable or metastatic basal cell carcinoma (BCC) after treatment with A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib, will be assessed as the percentage of participants with partial response (PR) or complete response (CR) as determined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria, after 9 and 18 weeks of treatment. ORR is calculated as the ratio of patients with CR or PR as a percentage of the participants evaluable for OR. RECIST criteria: * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
18 weeks
Results posted on
2019-03-08
Participant Flow
Participant milestones
| Measure |
Pembrolizumab Monotherapy
Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
|
Pembrolizumab Plus Vismodegib Combination Therapy
Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Vismodegib: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab With or Without Vismodegib in Treating Metastatic or Unresectable Basal Cell Skin Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab Monotherapy
n=9 Participants
Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
|
Pembrolizumab Plus Vismodegib Combination Therapy
n=7 Participants
Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Vismodegib: Given PO
|
Total
n=16 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
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
69.7 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
61.9 Years
STANDARD_DEVIATION 7.51 • n=7 Participants
|
65.1 Years
STANDARD_DEVIATION 9.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 weeksThe overall response rate (ORR) of participants with unresectable or metastatic basal cell carcinoma (BCC) after treatment with A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib, will be assessed as the percentage of participants with partial response (PR) or complete response (CR) as determined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria, after 9 and 18 weeks of treatment. ORR is calculated as the ratio of patients with CR or PR as a percentage of the participants evaluable for OR. RECIST criteria: * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria
Outcome measures
| Measure |
Pembrolizumab Monotherapy
n=9 Participants
Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
|
Pembrolizumab Plus Vismodegib Combination Therapy
n=7 Participants
Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Vismodegib: Given PO
|
|---|---|---|
|
Overall Response Rate (ORR)
|
44 Percentage of participants
Interval 14.0 to 79.0
|
29 Percentage of participants
Interval 4.0 to 71.0
|
SECONDARY outcome
Timeframe: up to 2 yearsIncidence of Adverse Events is assessed as the percentage of participants receiving treatment who experience adverse events of any grade, in participants receiving A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib. Enrolled participants receiving at least one dose of study agent and with at least one follow-up evaluation will be included.
Outcome measures
| Measure |
Pembrolizumab Monotherapy
n=9 Participants
Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
|
Pembrolizumab Plus Vismodegib Combination Therapy
n=7 Participants
Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Vismodegib: Given PO
|
|---|---|---|
|
Percentage of Participants Experiencing Adverse Events
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 yearsAdverse events were assessed for relationship to pembrolizumab treatment. The outcome is reported as the number (without dispersion) of Grade 3 or higher adverse events considered possibly, probably, or definitely-related to pembrolizumab treatment,.
Outcome measures
| Measure |
Pembrolizumab Monotherapy
n=9 Participants
Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
|
Pembrolizumab Plus Vismodegib Combination Therapy
n=7 Participants
Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Vismodegib: Given PO
|
|---|---|---|
|
Related Adverse Events
|
1 Related adverse events
|
0 Related adverse events
|
SECONDARY outcome
Timeframe: up to 2 yearsThe duration of response (DOR) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria in participants receiving A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib, assessed as the median value for subjects who complete 9 and 18 weeks of treatment. RECIST criteria: * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria
Outcome measures
| Measure |
Pembrolizumab Monotherapy
n=4 Participants
Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
|
Pembrolizumab Plus Vismodegib Combination Therapy
n=2 Participants
Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Vismodegib: Given PO
|
|---|---|---|
|
Duration of Response (DOR)
|
67.57 Weeks
Interval 31.43 to 82.0
|
52.78 Weeks
Interval 28.0 to 77.57
|
SECONDARY outcome
Timeframe: 1 yearThe overall survival (OS) participants with unresectable or metastatic basal cell carcinoma (BCC) after treatment with A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib, will be reported as the number and percentage of participants remaining alive 1 year after the start of treatment.
Outcome measures
| Measure |
Pembrolizumab Monotherapy
n=9 Participants
Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
|
Pembrolizumab Plus Vismodegib Combination Therapy
n=7 Participants
Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Vismodegib: Given PO
|
|---|---|---|
|
Overall Survival (OS)
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 1 yearThe progression-free survival (PFS) will be participants with unresectable or metastatic basal cell carcinoma (BCC) after treatment with A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib, will be reported as the percentage of participants without progression 1 year after the start of treatment.
Outcome measures
| Measure |
Pembrolizumab Monotherapy
n=9 Participants
Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
|
Pembrolizumab Plus Vismodegib Combination Therapy
n=7 Participants
Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Vismodegib: Given PO
|
|---|---|---|
|
Progression-free Survival (PFS)
|
3 Participants
|
1 Participants
|
Adverse Events
Pembrolizumab Monotherapy
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Pembrolizumab Plus Vismodegib Combination Therapy
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pembrolizumab Monotherapy
n=9 participants at risk
Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
|
Pembrolizumab Plus Vismodegib Combination Therapy
n=7 participants at risk
Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Vismodegib: Given PO
|
|---|---|---|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 3 • 2 years
|
0.00%
0/7 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, right shoulder four quarter amputation
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - tumor resection
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, Peri-incisional cellulitis
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
Other adverse events
| Measure |
Pembrolizumab Monotherapy
n=9 participants at risk
Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
|
Pembrolizumab Plus Vismodegib Combination Therapy
n=7 participants at risk
Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Vismodegib: Given PO
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
General disorders
Edema limbs
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
General disorders
Fatigue
|
66.7%
6/9 • Number of events 6 • 2 years
|
42.9%
3/7 • Number of events 3 • 2 years
|
|
General disorders
Fever
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
General disorders
Pain
|
44.4%
4/9 • Number of events 6 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
11.1%
1/9 • Number of events 2 • 2 years
|
0.00%
0/7 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
2/9 • Number of events 2 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
3/9 • Number of events 4 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder -Other, muscle cramp
|
11.1%
1/9 • Number of events 1 • 2 years
|
42.9%
3/7 • Number of events 3 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.2%
2/9 • Number of events 2 • 2 years
|
0.00%
0/7 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder -Other, gout
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Investigations
Weight loss
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Nervous system disorders
Paresthesia
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Eye disorders
Eye disorders - Other, ptosis
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Agitation
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 1 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, actinic keratosis
|
22.2%
2/9 • Number of events 2 • 2 years
|
28.6%
2/7 • Number of events 3 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
44.4%
4/9 • Number of events 5 • 2 years
|
57.1%
4/7 • Number of events 4 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
22.2%
2/9 • Number of events 2 • 2 years
|
0.00%
0/7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, laceration
|
11.1%
1/9 • Number of events 1 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, seborrheic keratosis
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Verruca
|
22.2%
2/9 • Number of events 3 • 2 years
|
0.00%
0/7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, psoraisis
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Eye disorders
Conjunctivitis
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Eye disorders
Eye disorders - Other, Eye Erosion
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
1/9 • Number of events 3 • 2 years
|
0.00%
0/7 • 2 years
|
|
Infections and infestations
Bronchitis
|
22.2%
2/9 • Number of events 2 • 2 years
|
0.00%
0/7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
3/9 • Number of events 3 • 2 years
|
28.6%
2/7 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Cardiac disorders
Hypertension
|
22.2%
2/9 • Number of events 3 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Cardiac disorders
Cardiac disorders - Other, Premature ventricular contraction
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders-Other, Lymphadenopathy
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Endocrine disorders
Hypothyroidism
|
22.2%
2/9 • Number of events 2 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
3/9 • Number of events 3 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Infections and infestations
Infections and infestations -Other, Paronychia
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Infections and infestations
Rhinitis infective
|
11.1%
1/9 • Number of events 1 • 2 years
|
14.3%
1/7 • Number of events 2 • 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, Elective Surgery-Foot
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, Root Canal
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, Mohs Surgery
|
11.1%
1/9 • Number of events 1 • 2 years
|
0.00%
0/7 • 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, Skin tag removal
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Other, Neoplasm Benign
|
0.00%
0/9 • 2 years
|
14.3%
1/7 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) -Other, squamous cell carcinoma)
|
22.2%
2/9 • Number of events 2 • 2 years
|
0.00%
0/7 • 2 years
|
Additional Information
Anne Lynn S. Chang, Associate Professor of Dermatology
Stanford University
Phone: 650-721-7151
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place