Trial Outcomes & Findings for STAR Cape+BKM120 MBC With Brain Met (NCT NCT02000882)
NCT ID: NCT02000882
Last Updated: 2022-02-07
Results Overview
CBR in the patients following WBRT or SRS or both will be the primary endpoint and is calculated as the total number of responders (CR or PR, assessed by RECIST 1.1) plus stable disease greater than or equal to 24 weeks (CR + PR + SD ≥ 24 weeks) divided by the total number of evaluable patients. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death, or discontinuation from study for any other reason, up to 2 years from date of patient registration
Results posted on
2022-02-07
Participant Flow
Participant milestones
| Measure |
BKM120 Plus Capecitabine
BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off.
For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120.
BKM120
capecitabine
Trastuzumab
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
BKM120 Plus Capecitabine
BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off.
For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120.
BKM120
capecitabine
Trastuzumab
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
STAR Cape+BKM120 MBC With Brain Met
Baseline characteristics by cohort
| Measure |
BKM120 Plus Capecitabine
n=10 Participants
BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off.
For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120.
BKM120
capecitabine
Trastuzumab
|
|---|---|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death, or discontinuation from study for any other reason, up to 2 years from date of patient registrationCBR in the patients following WBRT or SRS or both will be the primary endpoint and is calculated as the total number of responders (CR or PR, assessed by RECIST 1.1) plus stable disease greater than or equal to 24 weeks (CR + PR + SD ≥ 24 weeks) divided by the total number of evaluable patients. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
BKM120 Plus Capecitabine
n=10 Participants
BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off.
For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120.
BKM120
capecitabine
Trastuzumab
|
|---|---|
|
Clinical Benefit Rate (CBR)
|
0.1 proportion of patients with CBR
Interval -0.56 to 0.256
|
SECONDARY outcome
Timeframe: until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death, or discontinuation from study for any other reason, up to 2 years from date of patient registrationTo assess ORR (CR + PR) associated with BKM120 plus capecitabine in the central nervous system based on local investigator assessment. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
BKM120 Plus Capecitabine
n=10 Participants
BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off.
For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120.
BKM120
capecitabine
Trastuzumab
|
|---|---|
|
Objective Response Rate (ORR)
|
0.0 proportion of patients with ORR
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death, or discontinuation from study for any other reason, up to 2 years from date of patient registrationTo assess median time to progression (TTP) associated with BKM120 plus capecitabine.
Outcome measures
| Measure |
BKM120 Plus Capecitabine
n=10 Participants
BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off.
For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120.
BKM120
capecitabine
Trastuzumab
|
|---|---|
|
Median Time to Progression
|
5.59 months
Standard Deviation 4.64
|
SECONDARY outcome
Timeframe: up to 2 years from date of patient registrationTo determine median overall survival (OS) associated with BKM120 plus capecitabine.
Outcome measures
| Measure |
BKM120 Plus Capecitabine
n=10 Participants
BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off.
For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120.
BKM120
capecitabine
Trastuzumab
|
|---|---|
|
Median Overall Survival
|
11.135 months
Standard Deviation 6.302
|
SECONDARY outcome
Timeframe: until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death, or discontinuation from study for any other reason, up to 2 years from date of patient registrationTo characterize the safety and tolerability of BKM120 plus capecitabine, with or without trastuzumab
Outcome measures
| Measure |
BKM120 Plus Capecitabine
n=10 Participants
BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off.
For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120.
BKM120
capecitabine
Trastuzumab
|
|---|---|
|
Number of Treatment-related Serious AEs
|
7 Number of Treatment-related Serious AEs
|
Adverse Events
BKM120 Plus Capecitabine
Serious events: 7 serious events
Other events: 10 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
BKM120 Plus Capecitabine
n=10 participants at risk
BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off.
For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120.
BKM120
capecitabine
Trastuzumab
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
General disorders
Weakness generalized
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Nervous system disorders
Epilepsy
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Nervous system disorders
Seizure
|
20.0%
2/10 • Number of events 2 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Renal and urinary disorders
Urinary tract infection
|
20.0%
2/10 • Number of events 2 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
Other adverse events
| Measure |
BKM120 Plus Capecitabine
n=10 participants at risk
BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off.
For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120.
BKM120
capecitabine
Trastuzumab
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Blood and lymphatic system disorders
Hypovolemia
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Ear and labyrinth disorders
Disorder ear
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Eye disorders
Blurred vision
|
20.0%
2/10 • Number of events 2 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Eye disorders
Disorder eye
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Eye disorders
Eye floaters
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Eye disorders
Vision abnormal
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Eye disorders
Visual disturbance
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Anorexia
|
50.0%
5/10 • Number of events 5 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Canker sore oral
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 2 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Cramp abdominal
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
4/10 • Number of events 4 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Hemorrhoids
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Mucositis oral
|
40.0%
4/10 • Number of events 4 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Nausea
|
60.0%
6/10 • Number of events 6 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Pancreatitis
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Spasm oropharyngeal
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
5/10 • Number of events 5 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
General disorders
Falling down
|
20.0%
2/10 • Number of events 2 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
General disorders
Fatigue
|
50.0%
5/10 • Number of events 5 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
General disorders
Hand-foot syndrome
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
General disorders
Legs restless
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
General disorders
Taste alteration
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Immune system disorders
Allergic reaction
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Infections and infestations
Thrush
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Investigations
Bilirubin increased
|
20.0%
2/10 • Number of events 2 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Investigations
Creatinine serum increased
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Metabolism and nutrition disorders
ALT increased
|
20.0%
2/10 • Number of events 2 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Metabolism and nutrition disorders
Amylase increased
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Metabolism and nutrition disorders
AST increased
|
20.0%
2/10 • Number of events 2 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Metabolism and nutrition disorders
Dehyrdration
|
20.0%
2/10 • Number of events 2 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Metabolism and nutrition disorders
Growth accelerated
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
5/10 • Number of events 5 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
2/10 • Number of events 2 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Metabolism and nutrition disorders
Lipase increased
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Metabolism and nutrition disorders
Potassium deficiency
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Nervous system disorders
Edema cerebral
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 2 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Nervous system disorders
Neuropathy
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Nervous system disorders
Numbness
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Psychiatric disorders
Agitation
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Psychiatric disorders
Emotional lability
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Psychiatric disorders
Insomnia
|
30.0%
3/10 • Number of events 3 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Renal and urinary disorders
Incontinence urinary
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Renal and urinary disorders
Renal function abnormal
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Renal and urinary disorders
Urinary tract infection
|
40.0%
4/10 • Number of events 4 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Skin and subcutaneous tissue disorders
Facial swelling
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia
|
30.0%
3/10 • Number of events 3 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10 • Number of events 3 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Number of events 1 • until 30 days after last dose of patient's study treatment, for up 2 years from date of registration (enrollment into study)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60