Trial Outcomes & Findings for Molecularly Targeted Therapy in Treating Patients With BRAF Wild-type Melanoma That is Metastatic (NCT NCT02094872)
NCT ID: NCT02094872
Last Updated: 2020-01-02
Results Overview
The best overall response rate (BORR) was assessed up to 1 year.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2020-01-02
Participant Flow
Based on the initial 23 patients enrolled on this study who underwent molecular profiling and tumor board evaluation, 20 were assigned MEK162 by the tumor board. Patients not assigned MEK162 still received their assigned treatment, but were not considered evaluable for the primary endpoint.
Participant milestones
| Measure |
Arm I (Molecularly Targeted Therapy)
Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
cytology specimen collection procedure: Undergo collection of tissue and blood samples
MEK 162 therapy or molecularly targeted therapy: molecularly targeted therapy, MEK 162 therapy
therapeutic procedure
laboratory biomarker analysis: Correlative studies
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
Received Biopsy
|
37
|
|
Overall Study
Received Tumor-board Recommendation
|
36
|
|
Overall Study
Received Targeted Therapy
|
20
|
|
Overall Study
Received Standard of Care
|
9
|
|
Overall Study
Patients Treated With MEK162
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Molecularly Targeted Therapy in Treating Patients With BRAF Wild-type Melanoma That is Metastatic
Baseline characteristics by cohort
| Measure |
Arm I (Molecularly Targeted Therapy)
n=49 Participants
Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
cytology specimen collection procedure: Undergo collection of tissue and blood samples
MEK 162 therapy or molecularly targeted therapy: molecularly targeted therapy, MEK 162 therapy
therapeutic procedure
laboratory biomarker analysis: Correlative studies
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Age, Customized
30-39
|
1 Participants
n=5 Participants
|
|
Age, Customized
40-49
|
6 Participants
n=5 Participants
|
|
Age, Customized
50-59
|
10 Participants
n=5 Participants
|
|
Age, Customized
60-69
|
13 Participants
n=5 Participants
|
|
Age, Customized
70-79
|
15 Participants
n=5 Participants
|
|
Age, Customized
80-89
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, not of Hispanic Origin
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, not of Hispanic Origin
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearThe best overall response rate (BORR) was assessed up to 1 year.
Outcome measures
| Measure |
Arm I (Molecularly Targeted Therapy)
n=20 Participants
Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
cytology specimen collection procedure: Undergo collection of tissue and blood samples
MEK 162 therapy or molecularly targeted therapy: molecularly targeted therapy, MEK 162 therapy
therapeutic procedure
laboratory biomarker analysis: Correlative studies
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Best Overall Response Rate (BORR)
Progressive Disease
|
2 Participants
|
|
Best Overall Response Rate (BORR)
Stable Disease
|
17 Participants
|
|
Best Overall Response Rate (BORR)
Partial Response
|
1 Participants
|
SECONDARY outcome
Timeframe: From start of treatment to time of progression or death, whichever occurs first, assessed up to 1 yearPopulation: Given the lack of response in this study and the decision to terminate it early, no data for PFS data were collected or analyzed. In addition, with the study amendment removing the second arm, this analysis would not have been possible to conduct.
A log rank test will be performed for the comparison between the two groups.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Molecularly Targeted Therapy)
Serious events: 48 serious events
Other events: 32 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Arm I (Molecularly Targeted Therapy)
n=49 participants at risk
Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
cytology specimen collection procedure: Undergo collection of tissue and blood samples
MEK 162 therapy or molecularly targeted therapy: molecularly targeted therapy, MEK 162 therapy
therapeutic procedure
laboratory biomarker analysis: Correlative studies
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Immune system disorders
Anaphylactic reaction to taxol, hospitalized
|
2.0%
1/49 • 1 year
|
|
Immune system disorders
Allergic reaction to Augmentin; Acute kidney Injury (patient never received drug)
|
2.0%
1/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Acneiform rash
|
2.0%
1/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Elevated alkaline phosphatase
|
2.0%
1/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Elevated aspartate aminotransferase
|
6.1%
3/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Elevated alanine aminotransferase
|
2.0%
1/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Transaminitis
|
2.0%
1/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Creatine phosphokinase elevation
|
4.1%
2/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Uric acid elevations
|
2.0%
1/49 • 1 year
|
|
Vascular disorders
Hospitalized for hypotension related to adrenal insufficiency
|
2.0%
1/49 • 1 year
|
|
Vascular disorders
Hospitalized for hypotension
|
2.0%
1/49 • 1 year
|
|
Vascular disorders
Hypertension
|
2.0%
1/49 • 1 year
|
|
Vascular disorders
Hospitalized for pulmonary embolism
|
6.1%
3/49 • 1 year
|
|
Vascular disorders
Hypotensive, AKI (patient never received drug)
|
2.0%
1/49 • 1 year
|
|
General disorders
Generalized Weakness
|
2.0%
1/49 • 1 year
|
|
General disorders
Fatigue
|
4.1%
2/49 • 1 year
|
|
General disorders
Weakness and fatigue
|
2.0%
1/49 • 1 year
|
|
General disorders
Hospitalized for generalized weakness
|
2.0%
1/49 • 1 year
|
|
General disorders
Generalized weakness requiring hospitalization; outcome death
|
2.0%
1/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized for pneumonitis
|
2.0%
1/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized for pneumonia, sepsis, outcome death
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Hospitalized for Nausea and vomiting
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Anemia due to gastric hemorrhage
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Hospitalized for abdominal and back pain
|
2.0%
1/49 • 1 year
|
|
Hepatobiliary disorders
Hepatic Failure (patient never received drug)
|
2.0%
1/49 • 1 year
|
|
Surgical and medical procedures
Radical resection of malignant soft tissue tumor (melanoma) on back
|
2.0%
1/49 • 1 year
|
|
Blood and lymphatic system disorders
Hospitalized for anemia
|
2.0%
1/49 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/49 • 1 year
|
|
Nervous system disorders
Hospitalized for chronic intractable pain
|
2.0%
1/49 • 1 year
|
|
Nervous system disorders
Headache
|
2.0%
1/49 • 1 year
|
|
Nervous system disorders
Hospitalization for neurological symptoms: brain metastasis
|
2.0%
1/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Dropped Head Syndrome
|
2.0%
1/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Ocular muscle weakness
|
2.0%
1/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Hospitalized for back pain
|
2.0%
1/49 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.2%
4/49 • 1 year
|
|
Metabolism and nutrition disorders
Hypochloridemia
|
2.0%
1/49 • 1 year
|
|
Infections and infestations
Hospitalized for UTI
|
2.0%
1/49 • 1 year
|
|
Infections and infestations
Enterocolitis infectious (Clostridium difficile)
|
2.0%
1/49 • 1 year
|
|
Infections and infestations
Hospitalized for fever
|
2.0%
1/49 • 1 year
|
|
Infections and infestations
Strep B sepsis
|
2.0%
1/49 • 1 year
|
Other adverse events
| Measure |
Arm I (Molecularly Targeted Therapy)
n=49 participants at risk
Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
cytology specimen collection procedure: Undergo collection of tissue and blood samples
MEK 162 therapy or molecularly targeted therapy: molecularly targeted therapy, MEK 162 therapy
therapeutic procedure
laboratory biomarker analysis: Correlative studies
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
22.4%
11/49 • 1 year
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
10.2%
5/49 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.0%
1/49 • 1 year
|
|
Cardiac disorders
Cardiac disorders - Other
|
4.1%
2/49 • 1 year
|
|
Cardiac disorders
Sinus bradycardia
|
2.0%
1/49 • 1 year
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.0%
1/49 • 1 year
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/49 • 1 year
|
|
Endocrine disorders
Adrenal insufficiency
|
2.0%
1/49 • 1 year
|
|
Endocrine disorders
Endocrine disorders - Other
|
2.0%
1/49 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
6.1%
3/49 • 1 year
|
|
Eye disorders
Blurred vision
|
4.1%
2/49 • 1 year
|
|
Eye disorders
Cataract
|
2.0%
1/49 • 1 year
|
|
Eye disorders
Conjunctivitis
|
2.0%
1/49 • 1 year
|
|
Eye disorders
Eye disorders - Other
|
12.2%
6/49 • 1 year
|
|
Eye disorders
Glaucoma
|
2.0%
1/49 • 1 year
|
|
Eye disorders
retinal detachment
|
2.0%
1/49 • 1 year
|
|
Eye disorders
watering eyes
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
22.4%
11/49 • 1 year
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Bloating
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Cheilitis
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
28.6%
14/49 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
38.8%
19/49 • 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
8.2%
4/49 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Esophagitis
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Flatulence
|
4.1%
2/49 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
24.5%
12/49 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
6.1%
3/49 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
44.9%
22/49 • 1 year
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Oral pain
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Stomach pain
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
24.5%
12/49 • 1 year
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Anal hemorrhage
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.1%
2/49 • 1 year
|
|
General disorders
Chills
|
12.2%
6/49 • 1 year
|
|
General disorders
Edema face
|
4.1%
2/49 • 1 year
|
|
General disorders
Fatigue
|
51.0%
25/49 • 1 year
|
|
General disorders
Fever
|
8.2%
4/49 • 1 year
|
|
General disorders
Flu like symptoms
|
6.1%
3/49 • 1 year
|
|
General disorders
Gait disturbance
|
4.1%
2/49 • 1 year
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
24.5%
12/49 • 1 year
|
|
General disorders
Pain
|
2.0%
1/49 • 1 year
|
|
General disorders
Edema limbs
|
30.6%
15/49 • 1 year
|
|
General disorders
Infusion related reaction
|
2.0%
1/49 • 1 year
|
|
General disorders
Localized edema
|
4.1%
2/49 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/49 • 1 year
|
|
Immune system disorders
Anaphylaxis
|
2.0%
1/49 • 1 year
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.0%
1/49 • 1 year
|
|
Infections and infestations
Paronychia
|
2.0%
1/49 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
6.1%
3/49 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
6.1%
3/49 • 1 year
|
|
Infections and infestations
Wound infection
|
2.0%
1/49 • 1 year
|
|
Infections and infestations
Mucosal infection
|
4.1%
2/49 • 1 year
|
|
Injury, poisoning and procedural complications
Bruising
|
2.0%
1/49 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/49 • 1 year
|
|
Injury, poisoning and procedural complications
Fracture
|
2.0%
1/49 • 1 year
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
4.1%
2/49 • 1 year
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
2.0%
1/49 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
7/49 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
6.1%
3/49 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
24.5%
12/49 • 1 year
|
|
Investigations
Blood bilirubin increased
|
4.1%
2/49 • 1 year
|
|
Investigations
Cardiac troponin I increased
|
2.0%
1/49 • 1 year
|
|
Investigations
Cardiac troponin T increased
|
2.0%
1/49 • 1 year
|
|
Investigations
CPK increased
|
20.4%
10/49 • 1 year
|
|
Investigations
Creatinine increased
|
12.2%
6/49 • 1 year
|
|
Investigations
INR increased
|
2.0%
1/49 • 1 year
|
|
Investigations
Investigations - Other, specify
|
8.2%
4/49 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
2.0%
1/49 • 1 year
|
|
Investigations
Neutrophil count decreased
|
2.0%
1/49 • 1 year
|
|
Investigations
Platelet count decreased
|
8.2%
4/49 • 1 year
|
|
Investigations
Weight gain
|
6.1%
3/49 • 1 year
|
|
Investigations
Weight loss
|
6.1%
3/49 • 1 year
|
|
Investigations
Hemoglobin increased
|
2.0%
1/49 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
18.4%
9/49 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
8.2%
4/49 • 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.0%
1/49 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.1%
2/49 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.0%
1/49 • 1 year
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.0%
1/49 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.2%
6/49 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.1%
2/49 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.2%
4/49 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.2%
4/49 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
7/49 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.1%
2/49 • 1 year
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
4.1%
2/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
3/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.0%
1/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.2%
6/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.1%
2/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.0%
1/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
18.4%
9/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
3/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.1%
2/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.2%
5/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.1%
2/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
2.0%
1/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
2.0%
1/49 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other,
|
2.0%
1/49 • 1 year
|
|
Nervous system disorders
Cognitive disturbance
|
2.0%
1/49 • 1 year
|
|
Nervous system disorders
Dizziness
|
22.4%
11/49 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
10.2%
5/49 • 1 year
|
|
Nervous system disorders
Headache
|
24.5%
12/49 • 1 year
|
|
Nervous system disorders
Hypersomnia
|
2.0%
1/49 • 1 year
|
|
Nervous system disorders
Lethargy
|
2.0%
1/49 • 1 year
|
|
Nervous system disorders
Movements involuntary
|
2.0%
1/49 • 1 year
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
14.3%
7/49 • 1 year
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.1%
2/49 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.1%
3/49 • 1 year
|
|
Nervous system disorders
Syncope
|
2.0%
1/49 • 1 year
|
|
Psychiatric disorders
Anxiety
|
8.2%
4/49 • 1 year
|
|
Psychiatric disorders
Confusion
|
2.0%
1/49 • 1 year
|
|
Psychiatric disorders
Depression
|
4.1%
2/49 • 1 year
|
|
Psychiatric disorders
Insomnia
|
14.3%
7/49 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/49 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
8.2%
4/49 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
12.2%
6/49 • 1 year
|
|
Renal and urinary disorders
Urinary incontinence
|
2.0%
1/49 • 1 year
|
|
Renal and urinary disorders
Urinary tract pain
|
2.0%
1/49 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/49 • 1 year
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.0%
1/49 • 1 year
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
2.0%
1/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.4%
9/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
24.5%
12/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.0%
1/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.1%
2/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.1%
3/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
4.1%
2/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.1%
2/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
2.0%
1/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
10.2%
5/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.2%
5/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
2.0%
1/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.2%
5/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
7/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
4.1%
2/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.0%
1/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.2%
5/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
28.6%
14/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
7/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
32.7%
16/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.0%
1/49 • 1 year
|
|
Vascular disorders
Hot flashes
|
2.0%
1/49 • 1 year
|
|
Vascular disorders
Hypertension
|
8.2%
4/49 • 1 year
|
|
Vascular disorders
Hypotension
|
6.1%
3/49 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
4.1%
2/49 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place