Trial Outcomes & Findings for Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma (NCT NCT01339052)
NCT ID: NCT01339052
Last Updated: 2019-03-19
Results Overview
pAKT response was determined by pathologist-performed semi-quantitative IHC scoring for pAKT using previously established methods for glioblastoma (GBM) patients. Sample staining scored for intensity on a 0-2+ scale (0 none, 1+ weak positive, 2+ strong positive). Change in pAKT IHC score was the difference in score from baseline to surgery. Participants were classified into 3 groups: a reduction of staining score of one degree or more (considered a response), an increase in score and no change in score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Samples were collected at baseline and at surgery (resected surgical tumor specimen) which occurred after up to 12 days of BKM120 treatment.
Results posted on
2019-03-19
Participant Flow
Patients enrolled from September 2011 through February 2014.
Participant milestones
| Measure |
Cohort 1: Surgical Subjects
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohort 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
50
|
|
Overall Study
Measurable Disease
|
11
|
40
|
|
Overall Study
Evaluable Tumor Sample at Surgery
|
14
|
0
|
|
Overall Study
Evaluable Plasma Sample at Surgery
|
13
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
50
|
Reasons for withdrawal
| Measure |
Cohort 1: Surgical Subjects
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohort 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Disease progression
|
13
|
46
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
Cohort 1: Surgical Subjects
n=15 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohort 2: Non-surgical Subjects
n=50 Participants
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Total
n=65 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
|
13 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 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
|
3 Participants
n=7 Participants
|
3 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
|
12 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
44 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
|
3 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Karnofsky performance status (KPS)
70
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Karnofsky performance status (KPS)
80
|
2 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Karnofsky performance status (KPS)
90
|
10 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Karnofsky performance status (KPS)
100
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Current Tumor Diagnosis
Glioblstoma Multiforme (GBM)
|
15 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Current Tumor Diagnosis
Gliosarcoma
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Initial Tumor Diagnosis
Glioblastoma Multiforme (GBM)
|
13 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Initial Tumor Diagnosis
Anaplastic Astrocytoma (AA) merging w Glioblastoma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Initial Tumor Diagnosis
Gr4 Right Parietal Glioma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Initial Tumor Diagnosis
Astrocytoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Initial Tumor Diagnosis
Anaplastic Astrocytoma (AA)
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Initial Tumor Diagnosis
Gemistocytic Astrocyoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Initial Tumor Diagnosis
Glioma consistent w/ mixed Oligoastrocytoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Initial Tumor Diagnosis
Gliosarcoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Initial Tumor Diagnosis
High grade astrocytoma/glioblastoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Initial Tumor Diagnosis
Oligodendroglioma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
PTEN Status at Registration via Central Path Review
PTEN Negative
|
7 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
PTEN Status at Registration via Central Path Review
Not PTEN Negative
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
PTEN Status at Registration via Central Path Review
PTEN loss by FISH
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
PTEN Status at Registration via Central Path Review
PTEN Mutant
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
PTEN Status at Registration via Central Path Review
Unknown/Pending
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
pAKT StatusStatus at Registration via Central Path Review
pAKT Positive
|
15 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
pAKT StatusStatus at Registration via Central Path Review
pAKT Negative
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
pAKT StatusStatus at Registration via Central Path Review
Unknown/Pending
|
0 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Mutation Status at Registration
PIK3CA mutation
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Mutation Status at Registration
Negative
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Mutation Status at Registration
Unknown/Pending
|
14 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Samples were collected at baseline and at surgery (resected surgical tumor specimen) which occurred after up to 12 days of BKM120 treatment.Population: The analysis dataset is comprised of all treated participants.
pAKT response was determined by pathologist-performed semi-quantitative IHC scoring for pAKT using previously established methods for glioblastoma (GBM) patients. Sample staining scored for intensity on a 0-2+ scale (0 none, 1+ weak positive, 2+ strong positive). Change in pAKT IHC score was the difference in score from baseline to surgery. Participants were classified into 3 groups: a reduction of staining score of one degree or more (considered a response), an increase in score and no change in score.
Outcome measures
| Measure |
Cohort 1: Surgical Subjects
n=15 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Change in pAKT (S473) Immunohistochemistry (IHC) Score From Baseline to Surgery [Cohort 1]
reduced pAKT (S473) IHC Score
|
6 Participants
|
—
|
|
Change in pAKT (S473) Immunohistochemistry (IHC) Score From Baseline to Surgery [Cohort 1]
increased pAKT (S473) IHC Score
|
1 Participants
|
—
|
|
Change in pAKT (S473) Immunohistochemistry (IHC) Score From Baseline to Surgery [Cohort 1]
no change in pAKT (S473) IHC Score
|
7 Participants
|
—
|
|
Change in pAKT (S473) Immunohistochemistry (IHC) Score From Baseline to Surgery [Cohort 1]
Unevaluable
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Participants were assessed radiologically every other cycle on treatment; Relevant for this outcome is up to month 6 evaluation.Population: The analysis dataset is comprised of all treated participants.
PFS6 is the proportion of participants remaining alive and progression-free at 6-months from cycle 1 day 1 of BKM120 treatment. Progressive disease is defined using RANO (Response Assessment in Neuro-Oncology) criteria (Wen et al JCO 2010), which takes modified Macdonald Criteria and adds assessment of non-enhancing lesions. Per RANO, progressive disease (PD) is defined either as \> 25% increase in sum of the products of perpendicular diameters of enhancing lesions on stable or increasing doses of corticosteroids, or one or more of the of the following: 1) Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids steroids not due to co-morbid events; 2) Any new lesion; 3) Clear clinical deterioration not attributable to other causes apart from the tumor; or 4) Failure to return for evaluation due to death or deteriorating condition.
Outcome measures
| Measure |
Cohort 1: Surgical Subjects
n=50 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
6-Month Progression-Free Survival (PFS6) [Cohort 2]
|
0.08 proportion of participants
Interval 0.028 to 0.174
|
—
|
PRIMARY outcome
Timeframe: Samples were collected at surgery (surgical tumor specimen and plasma sample) which occurred after up to 12 days of BKM120 treatment.Population: The analysis dataset is comprised of participants with a paired plasma and brain tumor sample (evaluable). Participants missing a brain tumor sample (n=1) or plasma sample (n=2) are excluded from the calculation.
Levels of BKM120 were determined by liquid chromatography coupled with tandem mass spectrometry. BKM120 tumor-to-plasma ratio at time of surgery was calculated based on these levels.
Outcome measures
| Measure |
Cohort 1: Surgical Subjects
n=13 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
BKM120 Brain-to-Plasma Ratio at Time of Surgery [Cohort 1]
|
1.00 ratio tumor-to-plasma
Interval 0.18 to 8.44
|
—
|
PRIMARY outcome
Timeframe: Samples were collected at surgery (resected surgical tumor specimen) which occurred after up to 12 days of BKM120 treatment.Population: The analysis dataset is comprised of all participants with a resected surgical tumor specimen (evaluable).
Levels of BKM120 were determined by liquid chromatography coupled with tandem mass spectrometry.
Outcome measures
| Measure |
Cohort 1: Surgical Subjects
n=14 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
BKM120 Tumor Tissue Concentration at Time of Surgery [Cohort 1]
|
590 ng/gm
Interval 86.0 to 6947.0
|
—
|
PRIMARY outcome
Timeframe: Samples were collected at surgery which occurred after up to 12 days of BKM120 treatment.Population: The analysis dataset is comprised of all participants with a plasma sample at surgery (evaluable).
Levels of BKM120 were determined by liquid chromatography coupled with tandem mass spectrometry.
Outcome measures
| Measure |
Cohort 1: Surgical Subjects
n=13 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
BKM120 Plasma Concentration at Time of Surgery [Cohort 1]
|
585 ng/mL
Standard Deviation 192
|
—
|
SECONDARY outcome
Timeframe: Samples were collected at baseline (archival tumor specimen) and at surgery (surgical tumor specimen) which occurred after up to 12 days of BTK120 treatment.Population: The analysis dataset is comprised of all participants with a resected surgical tumor specimen (evaluable).
Tumor cell proliferation and tumor cell death was using immunohistochemistry for Ki-67 based on established methods. Percent reduction was based on Ki-67 levels at baseline and at surgery.
Outcome measures
| Measure |
Cohort 1: Surgical Subjects
n=14 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
% Ki-67 Reduction Using Immunohistochemistry (IHC) [Cohort 1]
|
11 % reduction
Interval -81.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Participants were assessed radiologically every other cycle on treatment. Cohort 2 participants were on treatment up to 9.2 months.Population: Only those participants who had measurable disease present at baseline and received at least one dose of therapy are considered evaluable for radiographic response
Radiographic response was based on RANO (Response Assessment in Neuro-Oncology) criteria. Per RANO, complete response (CR): 1) Complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks, 2) No new lesions, 3) All lesions assessed using the same techniques as baseline, 4) No steroid use (or on physiologic replacement doses only), 5) Stable or improved non-enhancing (T2/FLAIR) lesions and 6) Stable or improved clinically; partial response (PR): 1) \>/= 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions (sum LD) sustained for at least 4 weeks and 2) No progression; progressive disease (PD): 1) \> 25% increase sum LD and/or 2) significant increase in T2/FLAIR, 3) any new lesion, 4) clear clinical deterioration; stable disease (SD): none of the above.
Outcome measures
| Measure |
Cohort 1: Surgical Subjects
n=40 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Radiographic Response [Cohort 2]
Not Evaluable
|
2 Participants
|
—
|
|
Radiographic Response [Cohort 2]
Stable Disease
|
16 Participants
|
—
|
|
Radiographic Response [Cohort 2]
Progressive Disease
|
22 Participants
|
—
|
SECONDARY outcome
Timeframe: On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.Population: The analysis dataset is comprised of all treated patients.
Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods. NOTE: This outcome measure was previously titled: "Investigate Pharmacokinetics of BKM120 in This Population by Comparing Maximum Plasma Concentrations (Cmax) From Day 1 to Day 8"
Outcome measures
| Measure |
Cohort 1: Surgical Subjects
n=15 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Maximum Observed Plasma Concentrations (Cmax) of BKM120 Day 1 and Day 8 [Cohort 1]
Day 1
|
471 ng/mL
Standard Deviation 147
|
—
|
|
Maximum Observed Plasma Concentrations (Cmax) of BKM120 Day 1 and Day 8 [Cohort 1]
Day 8
|
820 ng/mL
Standard Deviation 192
|
—
|
SECONDARY outcome
Timeframe: On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.Population: The analysis dataset is comprised of all treated patients.
Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods. The accumulation ratio is day 8/day 1.
Outcome measures
| Measure |
Cohort 1: Surgical Subjects
n=15 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Cmax Accumulation Ratio of BKM120 Day 1 and Day 8 Ratio [Cohort 1]
|
1.88 ratio day 8/day 1
Interval 1.377 to 2.383
|
—
|
SECONDARY outcome
Timeframe: On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.Population: The analysis dataset is comprised of all treated patients.
Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods. NOTE: This outcome measure was previously titled: "Investigate Pharmacokinetics of BKM120 in This Population by Comparing the Drug Exposure Area Under the Curve (AUC0-5h) From Day 1 to Day 8"
Outcome measures
| Measure |
Cohort 1: Surgical Subjects
n=15 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Area Under the Concentration Curve From Time 0 to Last Concentration (AUC0-5h) of BKM120 Day 1 and Day 8 [Cohort 1]
Day 1
|
1.42 ug*h/mL
Standard Deviation 0.50
|
—
|
|
Area Under the Concentration Curve From Time 0 to Last Concentration (AUC0-5h) of BKM120 Day 1 and Day 8 [Cohort 1]
Day 8
|
3.27 ug*h/mL
Standard Deviation 1.43
|
—
|
SECONDARY outcome
Timeframe: On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.Population: The analysis dataset is comprised of all treated patients.
Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods. The accumulation ratio is day 8/day 1.
Outcome measures
| Measure |
Cohort 1: Surgical Subjects
n=15 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
AUC0-5h Accumulation Ratio of BKM120 Day 1 and Day 8 [Cohort 1]
|
2.42 ratio day 8/day 1
Interval 1.694 to 3.146
|
—
|
SECONDARY outcome
Timeframe: On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.Population: The analysis dataset is comprised of all treated patients.
Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods.
Outcome measures
| Measure |
Cohort 1: Surgical Subjects
n=15 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of BKM120 Day 1 and Day 8 [Cohort 1]
Day 1
|
1.5 hours
Interval 1.5 to 5.0
|
—
|
|
Time to Maximum Observed Plasma Concentration (Tmax) of BKM120 Day 1 and Day 8 [Cohort 1]
Day 8
|
1.5 hours
Interval 0.5 to 9.0
|
—
|
SECONDARY outcome
Timeframe: Participants were followed long-term for survival via medical record review. Cohort 2 participants were followed for survival up to 52 months in this study cohort.Population: The analysis dataset is comprised of all treated participants.
Overall survival is defined as the time from date of first dose to death or date last known alive and estimated using Kaplan-Meier (KM) methods.
Outcome measures
| Measure |
Cohort 1: Surgical Subjects
n=50 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS) [Cohort 2]
|
9.8 months
Interval 8.4 to 12.4
|
—
|
SECONDARY outcome
Timeframe: Participants were assessed radiologically every other cycle on treatment and off-treatment via medical record review until death. Cohort 2 participants were followed for progression-free survival up to 12 months in this study cohort.Population: The analysis dataset is comprised of all treated participants.
PFS is defined as the time from first dose to the earliest documentation of disease progression or death. Participants alive without evidence of PD were censored at the date of last disease assessment. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010). See outcome measure #2.
Outcome measures
| Measure |
Cohort 1: Surgical Subjects
n=50 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-Free Survival (PFS) [Cohort 2]
|
1.7 months
Interval 1.4 to 2.7
|
—
|
SECONDARY outcome
Timeframe: Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.Population: The analysis dataset is comprised of all treated patients.
The percentage of patients who experienced any grade 3-5 treatment-related adverse event based on CTCAEv4 as reported on case report forms.
Outcome measures
| Measure |
Cohort 1: Surgical Subjects
n=15 Participants
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
n=50 Participants
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Grade 3-5 Treatment-Related Toxicity Rate
|
40.0 percentage of patients
Interval 19.1 to 64.0
|
32.0 percentage of patients
Interval 21.2 to 44.5
|
Adverse Events
Cohorts 1: Surgical Subjects
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohorts 2: Non-surgical Subjects
Serious events: 12 serious events
Other events: 50 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohorts 1: Surgical Subjects
n=15 participants at risk
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
n=50 participants at risk
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Lipase Increased
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
6.0%
3/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Lymphocyte count decreased
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Platelet count decreased
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Serum amylase increased
|
6.7%
1/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Weight loss
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Seizure
|
6.7%
1/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Spasticity
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
White blood cell decreased
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
Other adverse events
| Measure |
Cohorts 1: Surgical Subjects
n=15 participants at risk
Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
Cohorts 2: Non-surgical Subjects
n=50 participants at risk
Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Ear and labyrinth disorders
Hearing Impaired
|
13.3%
2/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Number of events 4 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
16.0%
8/50 • Number of events 8 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
5/15 • Number of events 8 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
24.0%
12/50 • Number of events 15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
3/15 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
12.0%
6/50 • Number of events 6 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
6/15 • Number of events 6 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
16.0%
8/50 • Number of events 8 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
General disorders
Fatigue
|
73.3%
11/15 • Number of events 23 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
56.0%
28/50 • Number of events 41 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
General disorders
Irritability
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
6.0%
3/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Alanine aminotransferase increased
|
13.3%
2/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
14.0%
7/50 • Number of events 15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
8.0%
4/50 • Number of events 9 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Lipase increased
|
13.3%
2/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
16.0%
8/50 • Number of events 9 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Lymphocyte count decreased
|
13.3%
2/15 • Number of events 5 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Platelet count decreased
|
20.0%
3/15 • Number of events 4 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
14.0%
7/50 • Number of events 15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Serum amylase increased
|
20.0%
3/15 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
10.0%
5/50 • Number of events 8 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
White blood cell decreased
|
13.3%
2/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
10.0%
5/50 • Number of events 5 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Metabolism and nutrition disorders
Anorexia
|
13.3%
2/15 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
6.0%
3/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.0%
6/15 • Number of events 9 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
50.0%
25/50 • Number of events 66 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
13.3%
2/15 • Number of events 7 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Psychiatric disorders
Agitation
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
12.0%
6/50 • Number of events 6 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Psychiatric disorders
Anxiety
|
20.0%
3/15 • Number of events 6 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
22.0%
11/50 • Number of events 18 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Psychiatric disorders
Depression
|
40.0%
6/15 • Number of events 9 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
22.0%
11/50 • Number of events 20 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
10.0%
5/50 • Number of events 6 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
8.0%
4/50 • Number of events 4 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
10.0%
5/50 • Number of events 6 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
26.7%
4/15 • Number of events 9 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
10.0%
5/50 • Number of events 10 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
1/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
8.0%
4/50 • Number of events 6 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
14.0%
7/50 • Number of events 15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Vascular disorders
Thromboembolic event
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
6.0%
3/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Infections and infestations
Conjunctivitis infective
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Infections and infestations
Papulopustular rash
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Alkaline phosphatase increased
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Blood bilirubin increased
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Neutrophil count decreased
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Weight loss
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
6.7%
1/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Rash, unspecified
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify: Significant confluent erythema covering essentia
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Cardiac disorders
Sinus bradycardia
|
13.3%
2/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
6.0%
3/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
6.0%
3/50 • Number of events 4 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
General disorders
Chills
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
6.0%
3/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
6.0%
3/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
1/15 • Number of events 6 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Eye disorders
Blurred vision
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
8.0%
4/50 • Number of events 5 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Eye disorders
Cataract
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Eye disorders
Eye disorders - Other, specify: Left visual field cut/difficulty
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Eye disorders
Eye disorders - Other, specify: Eye Disorder:Dyplopia-Double Vision
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Eye disorders
Eye disorders - Other, specify: Quadranopsia, right
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
General disorders
Edema face
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
General disorders
Pain
|
20.0%
3/15 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Infections and infestations
Infections and infestations - Other, specify: varicella-zoster virus infection
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Infections and infestations
Mucosal infection
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Infections and infestations
Upper respiratory infection
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Injury, poisoning and procedural complications
Fall
|
13.3%
2/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
8.0%
4/50 • Number of events 5 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
2/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.7%
1/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
3/15 • Number of events 4 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
1/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
6.0%
3/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
13.3%
2/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
10.0%
5/50 • Number of events 7 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Ataxia
|
20.0%
3/15 • Number of events 4 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Cognitive disturbance
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
14.0%
7/50 • Number of events 7 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
8.0%
4/50 • Number of events 4 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Dysarthria
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Dysesthesia
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
2.0%
1/50 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Dysphasia
|
13.3%
2/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
18.0%
9/50 • Number of events 10 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
34.0%
17/50 • Number of events 21 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Intracranial hemorrhage
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Memory impairment
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
18.0%
9/50 • Number of events 10 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Nervous system disorders - Other, specify: left tongue deviation
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Neuralgia
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Seizure
|
26.7%
4/15 • Number of events 6 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
22.0%
11/50 • Number of events 14 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Stroke
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Psychiatric disorders
Confusion
|
6.7%
1/15 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
12.0%
6/50 • Number of events 6 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
10.0%
5/50 • Number of events 7 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Psychiatric disorders
Libido decreased
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Renal and urinary disorders
Renal calculi
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
10.0%
5/50 • Number of events 7 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: mild pain at incision site
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Fungal Rash
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
0.00%
0/50 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
8.0%
4/50 • Number of events 4 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
General disorders
Gait disturbance
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
18.0%
9/50 • Number of events 10 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Infections and infestations
Wound infection
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Investigations
Weight gain
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
8.0%
4/50 • Number of events 4 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify: Surgery (post-treatment craniotomy)
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
4.0%
2/50 • Number of events 2 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Aphasia
|
0.00%
0/15 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
6.0%
3/50 • Number of events 3 • Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
The following are considered 'serious' adverse events (SAEs) per protocol: * ALL Grade 5 (fatal) Events * ALL Grade 4 (life threatening or disabling) Events - Unless both Expected AND specifically listed in protocol as not requiring reporting * ANY Grade 2 (moderate) or Grade 3 (severe) Event that is both Unexpected and deemed at least Possibly Related to study intervention Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.
|
Additional Information
Patrick Y. Wen, MD, Director, DFCI Center for Neuro-Oncology
Dana-Farber Cancer Institute
Phone: 617-632-2166
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60