Trial Outcomes & Findings for Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer (NCT NCT01297491)
NCT ID: NCT01297491
Last Updated: 2016-03-11
Results Overview
PFS rate was defined as the percentage of participants who were progression free at 12 weeks. Participants were considered as a "success" for PFS rate evaluated at 12 weeks if they presented an overall response at their 2nd post-baseline tumor assessment.The enrollment into the study in either histology group would stop for futility if a PFS rate \<50% at 12 weeks was observed. No statistical analysis was planned for this primary outcome. The results of the primary objective was based on the data from the interim analysis that took place at the cut off dates: 10-Apr-2013 for non-squamous and 08-Jan-2014 for squamous group.
COMPLETED
PHASE2
63 participants
Week 12
2016-03-11
Participant Flow
Participant milestones
| Measure |
Squamous BKM120 100mg qd
Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
|
Non-Squamous BKM120 100mg qd
Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
33
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
30
|
33
|
Reasons for withdrawal
| Measure |
Squamous BKM120 100mg qd
Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
|
Non-Squamous BKM120 100mg qd
Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
6
|
|
Overall Study
Physician Decision
|
3
|
2
|
|
Overall Study
Progressive disease
|
11
|
20
|
|
Overall Study
Patient/Guardian decision
|
3
|
4
|
|
Overall Study
Death
|
2
|
1
|
Baseline Characteristics
Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Squamous BKM120 100mg qd
n=30 Participants
Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
|
Non-Squamous BKM120 100mg qd
n=33 Participants
Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 65 years
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.
PFS rate was defined as the percentage of participants who were progression free at 12 weeks. Participants were considered as a "success" for PFS rate evaluated at 12 weeks if they presented an overall response at their 2nd post-baseline tumor assessment.The enrollment into the study in either histology group would stop for futility if a PFS rate \<50% at 12 weeks was observed. No statistical analysis was planned for this primary outcome. The results of the primary objective was based on the data from the interim analysis that took place at the cut off dates: 10-Apr-2013 for non-squamous and 08-Jan-2014 for squamous group.
Outcome measures
| Measure |
Squamous BKM120 100mg qd
n=30 Participants
Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
|
Non-Squamous BKM120 100mg qd
n=30 Participants
Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
|
|---|---|---|
|
Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12
|
23.3 Percentage of participants
Interval 9.9 to 42.3
|
20.0 Percentage of participants
Interval 7.7 to 38.6
|
SECONDARY outcome
Timeframe: Every 8 weeks up to 24 monthsPopulation: Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.
OS was defined as the time from start of study drug (Stage 1) until death from any cause. If a patient was not known to have died, survival was censored at the date of last contact.
Outcome measures
| Measure |
Squamous BKM120 100mg qd
n=30 Participants
Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
|
Non-Squamous BKM120 100mg qd
n=33 Participants
Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
|
|---|---|---|
|
Overall Survival (OS) Using Kaplan-Meier Estimates
|
7.98 Months
Interval 5.95 to 10.09
|
7.20 Months
Interval 4.01 to 9.92
|
SECONDARY outcome
Timeframe: Every 6 weeks up to 24 monthsPopulation: Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.
ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Analyses of response rates were performed based on investigators' assessments (as per RECIST 1.1 criteria). ORR included all patients with and without measurable disease at baseline.
Outcome measures
| Measure |
Squamous BKM120 100mg qd
n=30 Participants
Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
|
Non-Squamous BKM120 100mg qd
n=33 Participants
Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
|
|---|---|---|
|
Overall Response Rate (ORR) Based on Investigator Assessment
|
3.3 Percentage of participants
|
3.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Every 6 weeks up tp 24 monthsPopulation: Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.
DCR defined as the percentage of participants with best overall response of CR or PR or stable disease (SD). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Analyses of response rates were performed based on investigators' assessments (as per RECIST 1.1 criteria). DCR included all participants with and without measurable disease at baseline.
Outcome measures
| Measure |
Squamous BKM120 100mg qd
n=30 Participants
Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
|
Non-Squamous BKM120 100mg qd
n=33 Participants
Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
46.7 Percentage of participants
|
45.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Every 6 weeks up to 24 monthsPopulation: Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least 1 dose of study drug. 1 partial response was observed as best overall response (BOR) for 1 patient in the squamous group. Also,1 patient experienced partial response as BOR in the non-squamous group.
TTR for a participant was defined as the time from the first treatment date to the date of first documented confirmed CR or PR evaluation. The date of event was defined as the date of response that was first determined and not using the date the response was confirmed.
Outcome measures
| Measure |
Squamous BKM120 100mg qd
n=30 Participants
Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
|
Non-Squamous BKM120 100mg qd
n=33 Participants
Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
|
|---|---|---|
|
Time to Response (TTR)
|
41 Days
|
42 Days
|
SECONDARY outcome
Timeframe: Every 6 weeks up to 24 monthsPopulation: Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least 1 dose of study drug. 1 partial response was observed as best overall response (BOR) for 1 patient in the squamous group. Also,1 patient experienced partial response as BOR in the non-squamous group.
DoR was defined as the elapsed time between the date of first documented CR or PR response (not the date of confirmed response) and the following date of event defined as the first documented progression or death due to underlying cancer.
Outcome measures
| Measure |
Squamous BKM120 100mg qd
n=30 Participants
Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
|
Non-Squamous BKM120 100mg qd
n=33 Participants
Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
|
|---|---|---|
|
Duration of Response (DoR)
|
73 Days
|
85 Days
|
Adverse Events
Squamous BKM120 100 mg qd
Non-Squamous BKM120 100 mg qd
Serious adverse events
| Measure |
Squamous BKM120 100 mg qd
n=30 participants at risk
Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
|
Non-Squamous BKM120 100 mg qd
n=33 participants at risk
Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
1/30
|
0.00%
0/33
|
|
Cardiac disorders
Cardiac failure
|
3.3%
1/30
|
0.00%
0/33
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/30
|
3.0%
1/33
|
|
Cardiac disorders
Myocardial infarction
|
3.3%
1/30
|
0.00%
0/33
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.3%
1/30
|
0.00%
0/33
|
|
Eye disorders
Blepharitis
|
0.00%
0/30
|
3.0%
1/33
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/30
|
3.0%
1/33
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/30
|
3.0%
1/33
|
|
Gastrointestinal disorders
Ileus
|
3.3%
1/30
|
0.00%
0/33
|
|
General disorders
Asthenia
|
3.3%
1/30
|
0.00%
0/33
|
|
General disorders
Fatigue
|
0.00%
0/30
|
3.0%
1/33
|
|
General disorders
General physical health deterioration
|
13.3%
4/30
|
0.00%
0/33
|
|
General disorders
Local swelling
|
3.3%
1/30
|
0.00%
0/33
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/30
|
3.0%
1/33
|
|
Infections and infestations
Escherichia sepsis
|
3.3%
1/30
|
0.00%
0/33
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/30
|
3.0%
1/33
|
|
Infections and infestations
Lung abscess
|
0.00%
0/30
|
3.0%
1/33
|
|
Infections and infestations
Lung infection
|
3.3%
1/30
|
0.00%
0/33
|
|
Infections and infestations
Pneumonia
|
10.0%
3/30
|
3.0%
1/33
|
|
Infections and infestations
Sepsis
|
3.3%
1/30
|
0.00%
0/33
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30
|
3.0%
1/33
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
3.3%
1/30
|
0.00%
0/33
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
1/30
|
0.00%
0/33
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
1/30
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
2/30
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
2/30
|
9.1%
3/33
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.3%
1/30
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.3%
1/30
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
1/30
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
3.3%
1/30
|
0.00%
0/33
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/30
|
3.0%
1/33
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
3.3%
1/30
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.3%
1/30
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
1/30
|
9.1%
3/33
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/30
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.3%
1/30
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
1/30
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/30
|
9.1%
3/33
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
3.3%
1/30
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
1/30
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/30
|
3.0%
1/33
|
|
Vascular disorders
Thrombosis
|
0.00%
0/30
|
3.0%
1/33
|
Other adverse events
| Measure |
Squamous BKM120 100 mg qd
n=30 participants at risk
Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
|
Non-Squamous BKM120 100 mg qd
n=33 participants at risk
Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
5/30
|
6.1%
2/33
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
2/30
|
0.00%
0/33
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
2/30
|
0.00%
0/33
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/30
|
6.1%
2/33
|
|
Eye disorders
Lacrimation increased
|
6.7%
2/30
|
3.0%
1/33
|
|
Eye disorders
Vision blurred
|
10.0%
3/30
|
6.1%
2/33
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
3/30
|
3.0%
1/33
|
|
Gastrointestinal disorders
Constipation
|
16.7%
5/30
|
9.1%
3/33
|
|
Gastrointestinal disorders
Diarrhoea
|
36.7%
11/30
|
33.3%
11/33
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
2/30
|
3.0%
1/33
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
2/30
|
0.00%
0/33
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
1/30
|
6.1%
2/33
|
|
Gastrointestinal disorders
Nausea
|
43.3%
13/30
|
27.3%
9/33
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
2/30
|
12.1%
4/33
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
6/30
|
15.2%
5/33
|
|
General disorders
Asthenia
|
20.0%
6/30
|
36.4%
12/33
|
|
General disorders
Fatigue
|
36.7%
11/30
|
18.2%
6/33
|
|
General disorders
Hypothermia
|
0.00%
0/30
|
6.1%
2/33
|
|
General disorders
Non-cardiac chest pain
|
10.0%
3/30
|
3.0%
1/33
|
|
General disorders
Oedema peripheral
|
10.0%
3/30
|
3.0%
1/33
|
|
General disorders
Pain
|
3.3%
1/30
|
6.1%
2/33
|
|
General disorders
Pyrexia
|
6.7%
2/30
|
12.1%
4/33
|
|
Infections and infestations
Bronchitis
|
13.3%
4/30
|
0.00%
0/33
|
|
Infections and infestations
Candida infection
|
6.7%
2/30
|
0.00%
0/33
|
|
Infections and infestations
Conjunctivitis
|
3.3%
1/30
|
9.1%
3/33
|
|
Infections and infestations
Lower respiratory tract infection
|
6.7%
2/30
|
0.00%
0/33
|
|
Infections and infestations
Rhinitis
|
0.00%
0/30
|
6.1%
2/33
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
6/30
|
18.2%
6/33
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
5/30
|
18.2%
6/33
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
3/30
|
3.0%
1/33
|
|
Investigations
Blood creatinine increased
|
6.7%
2/30
|
3.0%
1/33
|
|
Investigations
Blood glucose increased
|
6.7%
2/30
|
3.0%
1/33
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.7%
2/30
|
6.1%
2/33
|
|
Investigations
Blood urea increased
|
6.7%
2/30
|
0.00%
0/33
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
3/30
|
6.1%
2/33
|
|
Investigations
Insulin c-peptide increased
|
0.00%
0/30
|
6.1%
2/33
|
|
Investigations
Transaminases increased
|
6.7%
2/30
|
6.1%
2/33
|
|
Investigations
Weight decreased
|
26.7%
8/30
|
9.1%
3/33
|
|
Metabolism and nutrition disorders
Decreased appetite
|
36.7%
11/30
|
36.4%
12/33
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
2/30
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
36.7%
11/30
|
33.3%
11/33
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.3%
1/30
|
6.1%
2/33
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
2/30
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
3/30
|
9.1%
3/33
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
2/30
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.3%
1/30
|
6.1%
2/33
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
3/30
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.3%
1/30
|
6.1%
2/33
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
2/30
|
6.1%
2/33
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
2/30
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
2/30
|
9.1%
3/33
|
|
Nervous system disorders
Dizziness
|
6.7%
2/30
|
3.0%
1/33
|
|
Nervous system disorders
Dysgeusia
|
13.3%
4/30
|
12.1%
4/33
|
|
Nervous system disorders
Headache
|
13.3%
4/30
|
0.00%
0/33
|
|
Nervous system disorders
Memory impairment
|
6.7%
2/30
|
0.00%
0/33
|
|
Nervous system disorders
Myoclonus
|
6.7%
2/30
|
0.00%
0/33
|
|
Nervous system disorders
Neuropathy peripheral
|
3.3%
1/30
|
6.1%
2/33
|
|
Nervous system disorders
Somnolence
|
3.3%
1/30
|
6.1%
2/33
|
|
Nervous system disorders
Tremor
|
13.3%
4/30
|
3.0%
1/33
|
|
Psychiatric disorders
Anxiety
|
10.0%
3/30
|
24.2%
8/33
|
|
Psychiatric disorders
Confusional state
|
10.0%
3/30
|
3.0%
1/33
|
|
Psychiatric disorders
Depression
|
13.3%
4/30
|
33.3%
11/33
|
|
Psychiatric disorders
Insomnia
|
3.3%
1/30
|
6.1%
2/33
|
|
Psychiatric disorders
Mood altered
|
6.7%
2/30
|
12.1%
4/33
|
|
Renal and urinary disorders
Renal failure acute
|
6.7%
2/30
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
6/30
|
18.2%
6/33
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
6/30
|
21.2%
7/33
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.3%
1/30
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
3/30
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.3%
1/30
|
6.1%
2/33
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/30
|
6.1%
2/33
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.3%
1/30
|
6.1%
2/33
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.3%
4/30
|
15.2%
5/33
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/30
|
9.1%
3/33
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.3%
1/30
|
6.1%
2/33
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
36.7%
11/30
|
12.1%
4/33
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.7%
8/30
|
18.2%
6/33
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
3.3%
1/30
|
6.1%
2/33
|
|
Vascular disorders
Hypertension
|
3.3%
1/30
|
6.1%
2/33
|
|
Vascular disorders
Hypotension
|
0.00%
0/30
|
6.1%
2/33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER