Trial Outcomes & Findings for Phase II Study With Abraxane, Bevacizumab and Carboplatin in Triple Negative Metastatic Breast Cancer (NCT NCT00479674)
NCT ID: NCT00479674
Last Updated: 2015-02-18
Results Overview
Best clinical response is based on RECIST criteria, the proportion in each response category along with the exact binomial confidence intervals are estimated. Toxicity summaries are also provided.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
5 years
Results posted on
2015-02-18
Participant Flow
Participant milestones
| Measure |
Abraxane, Carboplatin, Bevacizumab
Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
Abraxane, Carboplatin, Bevacizumab
Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.
|
|---|---|
|
Overall Study
Adverse Event
|
18
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Physician Decision
|
14
|
|
Overall Study
none provided
|
3
|
Baseline Characteristics
Phase II Study With Abraxane, Bevacizumab and Carboplatin in Triple Negative Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Abraxane, Carboplatin, Bevacizumab
n=41 Participants
Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.
|
|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 11 • n=99 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: 2 subjects withdrew and were not assessed for response
Best clinical response is based on RECIST criteria, the proportion in each response category along with the exact binomial confidence intervals are estimated. Toxicity summaries are also provided.
Outcome measures
| Measure |
Abraxane, Carboplatin, Bevacizumab
n=39 Participants
Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.
|
|---|---|
|
Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III "Triple Negative" Metastatic Breast Cancer.
Complete Response
|
18 percentage of participants
Interval 8.0 to 34.0
|
|
Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III "Triple Negative" Metastatic Breast Cancer.
Partial Response
|
69 percentage of participants
Interval 52.0 to 83.0
|
|
Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III "Triple Negative" Metastatic Breast Cancer.
Stable Disease
|
8 percentage of participants
Interval 2.0 to 21.0
|
|
Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III "Triple Negative" Metastatic Breast Cancer.
Progressive Disease
|
5 percentage of participants
Interval 1.0 to 17.0
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: One subject lost to follow up and not included in analysis.
PFS was defined as time from trial enrollment to disease progression or death, whichever occurred first.
Outcome measures
| Measure |
Abraxane, Carboplatin, Bevacizumab
n=40 Participants
Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.
|
|---|---|
|
Median Proportion Progression-free as Estimated by Kaplan-Meier Methods
|
15 months
Interval 10.0 to 25.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Analysis of samples was not performed, as there was inadequate funding to support the testing and analysis of the samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: Samples were collected, but analysis was not performed as there was inadequate funding to support the testing and analysis of samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: Study plan stipulated that tissue samples would not be assessed for quantitatively if no difference in SPARC expression was observed between tumor and non-tumor cells was observed qualitatively.
Outcome measures
Outcome data not reported
Adverse Events
Abraxane, Carboplatin, Bevacizumab
Serious events: 22 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abraxane, Carboplatin, Bevacizumab
n=41 participants at risk
Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/41
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/41
|
|
Gastrointestinal disorders
Mucositis oral
|
2.4%
1/41
|
|
Gastrointestinal disorders
Nausea
|
7.3%
3/41
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41
|
|
General disorders
Pain
|
7.3%
3/41
|
|
Immune system disorders
Allergic reaction
|
2.4%
1/41
|
|
Infections and infestations
Infections and infestations - Other, specify:
|
2.4%
1/41
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
7.3%
3/41
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/41
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
1/41
|
|
Investigations
Neutrophil count decreased
|
7.3%
3/41
|
|
Investigations
Platelet count decreased
|
9.8%
4/41
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/41
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.4%
1/41
|
|
Nervous system disorders
Headache
|
4.9%
2/41
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Leptomeningeal Carcinomatosis
|
2.4%
1/41
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.4%
1/41
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.9%
2/41
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/41
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.4%
1/41
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/41
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: epistaxis
|
2.4%
1/41
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/41
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: scalp discoloration
|
2.4%
1/41
|
|
Vascular disorders
Hypertension
|
2.4%
1/41
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/41
|
Other adverse events
| Measure |
Abraxane, Carboplatin, Bevacizumab
n=41 participants at risk
Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
48.8%
20/41
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify: Anemia
|
2.4%
1/41
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify: upper extremity lymphedema
|
2.4%
1/41
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
1/41
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.4%
1/41
|
|
Blood and lymphatic system disorders
Lymph node pain
|
4.9%
2/41
|
|
Cardiac disorders
Cardiac disorders - Other, specify: Palpitations
|
2.4%
1/41
|
|
Cardiac disorders
Palpitations
|
4.9%
2/41
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify: Ringing in ears
|
7.3%
3/41
|
|
Ear and labyrinth disorders
Tinnitus
|
14.6%
6/41
|
|
Endocrine disorders
Hypothyroidism
|
2.4%
1/41
|
|
Eye disorders
Blurred vision
|
14.6%
6/41
|
|
Eye disorders
Conjunctivitis
|
2.4%
1/41
|
|
Eye disorders
Extraocular muscle paresis
|
4.9%
2/41
|
|
Eye disorders
Eye disorders - Other, specify: vision changes
|
7.3%
3/41
|
|
Eye disorders
Flashing lights
|
2.4%
1/41
|
|
Eye disorders
Watering eyes
|
4.9%
2/41
|
|
Gastrointestinal disorders
Abdominal pain
|
19.5%
8/41
|
|
Gastrointestinal disorders
Anal fistula
|
2.4%
1/41
|
|
Gastrointestinal disorders
Anal hemorrhage
|
2.4%
1/41
|
|
Gastrointestinal disorders
Anal mucositis
|
4.9%
2/41
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/41
|
|
Gastrointestinal disorders
Constipation
|
61.0%
25/41
|
|
Gastrointestinal disorders
Diarrhea
|
36.6%
15/41
|
|
Gastrointestinal disorders
Dry mouth
|
7.3%
3/41
|
|
Gastrointestinal disorders
Dyspepsia
|
19.5%
8/41
|
|
Gastrointestinal disorders
Dysphagia
|
4.9%
2/41
|
|
Gastrointestinal disorders
Esophageal pain
|
2.4%
1/41
|
|
Gastrointestinal disorders
Esophagitis
|
2.4%
1/41
|
|
Gastrointestinal disorders
Gastritis
|
4.9%
2/41
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: dyspepsia
|
2.4%
1/41
|
|
Gastrointestinal disorders
Hemorrhoids
|
9.8%
4/41
|
|
Gastrointestinal disorders
Mucositis oral
|
48.8%
20/41
|
|
Gastrointestinal disorders
Nausea
|
63.4%
26/41
|
|
Gastrointestinal disorders
Oral pain
|
2.4%
1/41
|
|
Gastrointestinal disorders
Rectal fistula
|
2.4%
1/41
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.4%
1/41
|
|
Gastrointestinal disorders
Rectal pain
|
2.4%
1/41
|
|
Gastrointestinal disorders
Vomiting
|
24.4%
10/41
|
|
General disorders
Chills
|
4.9%
2/41
|
|
General disorders
Edema face
|
2.4%
1/41
|
|
General disorders
Edema limbs
|
19.5%
8/41
|
|
General disorders
Edema trunk
|
2.4%
1/41
|
|
General disorders
Facial pain
|
2.4%
1/41
|
|
General disorders
Fatigue
|
82.9%
34/41
|
|
General disorders
Fever
|
4.9%
2/41
|
|
General disorders
General disorders and administration site conditions - Other, specify: mouth sores
|
17.1%
7/41
|
|
General disorders
Non-cardiac chest pain
|
9.8%
4/41
|
|
General disorders
Pain
|
39.0%
16/41
|
|
Immune system disorders
Allergic reaction
|
7.3%
3/41
|
|
Immune system disorders
Cytokine release syndrome
|
2.4%
1/41
|
|
Infections and infestations
Anorectal infection
|
2.4%
1/41
|
|
Infections and infestations
Bladder infection
|
2.4%
1/41
|
|
Infections and infestations
Infections and infestations - Other, specify:
|
2.4%
1/41
|
|
Infections and infestations
Infections and infestations - Other, specify: URI/Sinusitis/laryngitis
|
4.9%
2/41
|
|
Infections and infestations
Sinusitis
|
7.3%
3/41
|
|
Infections and infestations
Tooth infection
|
4.9%
2/41
|
|
Infections and infestations
Upper respiratory infection
|
2.4%
1/41
|
|
Infections and infestations
Urinary tract infection
|
9.8%
4/41
|
|
Injury, poisoning and procedural complications
Bruising
|
2.4%
1/41
|
|
Injury, poisoning and procedural complications
Tracheal hemorrhage
|
7.3%
3/41
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.4%
1/41
|
|
Investigations
Alanine aminotransferase increased
|
12.2%
5/41
|
|
Investigations
Alkaline phosphatase increased
|
14.6%
6/41
|
|
Investigations
Aspartate aminotransferase increased
|
9.8%
4/41
|
|
Investigations
Blood bilirubin increased
|
4.9%
2/41
|
|
Investigations
Creatinine increased
|
2.4%
1/41
|
|
Investigations
INR increased
|
2.4%
1/41
|
|
Investigations
Investigations - Other, specify: hypokalemia
|
2.4%
1/41
|
|
Investigations
Neutrophil count decreased
|
75.6%
31/41
|
|
Investigations
Platelet count decreased
|
43.9%
18/41
|
|
Investigations
Weight gain
|
4.9%
2/41
|
|
Investigations
Weight loss
|
9.8%
4/41
|
|
Investigations
White blood cell decreased
|
19.5%
8/41
|
|
Metabolism and nutrition disorders
Anorexia
|
41.5%
17/41
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
2/41
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.8%
4/41
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.2%
5/41
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.6%
6/41
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.4%
1/41
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.6%
6/41
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.4%
1/41
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.2%
5/41
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.0%
9/41
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
24.4%
10/41
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
19.5%
8/41
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
14.6%
6/41
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
4.9%
2/41
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.3%
3/41
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Cramping in Left Calf
|
7.3%
3/41
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.8%
4/41
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.9%
2/41
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.0%
9/41
|
|
Nervous system disorders
Ataxia
|
4.9%
2/41
|
|
Nervous system disorders
Dizziness
|
14.6%
6/41
|
|
Nervous system disorders
Dysgeusia
|
29.3%
12/41
|
|
Nervous system disorders
Extrapyramidal disorder
|
4.9%
2/41
|
|
Nervous system disorders
Glossopharyngeal nerve disorder
|
2.4%
1/41
|
|
Nervous system disorders
Headache
|
39.0%
16/41
|
|
Nervous system disorders
Memory impairment
|
4.9%
2/41
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Leptomeningeal Carcinomatosis
|
4.9%
2/41
|
|
Nervous system disorders
Olfactory nerve disorder
|
2.4%
1/41
|
|
Nervous system disorders
Peripheral motor neuropathy
|
12.2%
5/41
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
56.1%
23/41
|
|
Nervous system disorders
Sinus pain
|
4.9%
2/41
|
|
Nervous system disorders
Tremor
|
4.9%
2/41
|
|
Psychiatric disorders
Anxiety
|
26.8%
11/41
|
|
Psychiatric disorders
Depression
|
26.8%
11/41
|
|
Psychiatric disorders
Insomnia
|
39.0%
16/41
|
|
Psychiatric disorders
Personality change
|
2.4%
1/41
|
|
Renal and urinary disorders
Proteinuria
|
4.9%
2/41
|
|
Renal and urinary disorders
Urinary frequency
|
4.9%
2/41
|
|
Renal and urinary disorders
Urinary incontinence
|
2.4%
1/41
|
|
Renal and urinary disorders
Urinary tract pain
|
2.4%
1/41
|
|
Renal and urinary disorders
Urine discoloration
|
4.9%
2/41
|
|
Reproductive system and breast disorders
Breast pain
|
12.2%
5/41
|
|
Reproductive system and breast disorders
Ovulation pain
|
2.4%
1/41
|
|
Reproductive system and breast disorders
Vaginal dryness
|
4.9%
2/41
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.4%
1/41
|
|
Reproductive system and breast disorders
Vaginal pain
|
2.4%
1/41
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
22.0%
9/41
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.4%
1/41
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
39.0%
16/41
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
34.1%
14/41
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
26.8%
11/41
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
9.8%
4/41
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.4%
1/41
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: epistaxis
|
14.6%
6/41
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
24.4%
10/41
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
24.4%
10/41
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
48.8%
20/41
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
19.5%
8/41
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.9%
2/41
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
19.5%
8/41
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.4%
1/41
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.8%
4/41
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.3%
3/41
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
24.4%
10/41
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: scalp discoloration
|
26.8%
11/41
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
12.2%
5/41
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
2.4%
1/41
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
7.3%
3/41
|
|
Vascular disorders
Flushing
|
9.8%
4/41
|
|
Vascular disorders
Hot flashes
|
34.1%
14/41
|
|
Vascular disorders
Hypertension
|
12.2%
5/41
|
|
Vascular disorders
Lymphedema
|
4.9%
2/41
|
|
Vascular disorders
Vascular disorders - Other, specify: Nose bleed
|
12.2%
5/41
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place