Trial Outcomes & Findings for A Study of Abemaciclib in Recurrent Glioblastoma (NCT NCT02981940)
NCT ID: NCT02981940
Last Updated: 2025-09-02
Results Overview
Intratumoral abemaciclib concentration defined as the mean tumor-to-plasma ratio in contrast enhancing tissue. Patients were treated with abemaciclib prior to surgery. Tissue and plasma for analysis of this endpoint were obtained at the time of surgery.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Single time point for each participant for collection of tissue and blood at surgery
Results posted on
2025-09-02
Participant Flow
The trial opened to enrollment on 01/31/17, and the first accrual occurred on 02/09/17. The study permanently closed to accrual on 12/7/22, and the last accrual occurred on 6/18/21. 45 patients were enrolled to the trial with 42 receiving treatment.
Participant milestones
| Measure |
Abemaciclib With Surgery (With Postoperative Abemaciclib)
* Abemaciclib will be administered on a continuous twice daily dosing schedule
* Patients who require re-operation will receive a short preoperative course of Abemaciclib
* Tissue will be used to investigate the ability of Abemaciclib to pass through the blood brain barrier.
* After recovery from surgery, participants will resume Abemaciclib. Each cycle lasts 28 days.
* NOTE: enrollment to this arm is complete
Abemaciclib: Abemaciclib capsule
Surgery: Surgery
|
Abemaciclib Without Surgery
* Abemaciclib will be administered on a continuous twice daily dosing schedule. Each Cycle last 28 days.
* NOTE: enrollment to this arm is complete
Abemaciclib: Abemaciclib capsule
|
Abemaciclib With Surgery (No Postoperative Abemaciclib)
* Abemaciclib will be administered on a continuous twice daily dosing schedule
* Patients who require re-operation will receive a short preoperative course of Abemaciclib
* Tissue will be used to investigate the ability of Abemaciclib to pass through the blood brain barrier.
* After surgery participants will come off study and pursue standard of care treatments at their treating physician's discretion.
Abemaciclib: Abemaciclib capsule
Surgery: Surgery
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
32
|
1
|
|
Overall Study
COMPLETED
|
9
|
31
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Abemaciclib in Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
Abemaciclib With Surgery (With Postoperative Abemaciclib)
n=9 Participants
Abemaciclib will be administered on a continuous twice daily dosing schedule. Patients who require re-operation will receive a short preoperative course of Abemaciclib.
Tissue will be used to investigate the ability of Abemaciclib to pass through the blood brain barrier.
After recovery from surgery, participants will resume Abemaciclib. Each cycle lasts 28 days.
NOTE: enrollment to this arm is complete Abemaciclib: Abemaciclib capsule Surgery: Surgery
|
Abemaciclib Without Surgery
n=32 Participants
Abemaciclib will be administered on a continuous twice daily dosing. schedule. Each Cycle last 28 days.
NOTE: enrollment to this arm is complete Abemaciclib: Abemaciclib capsule
|
Abemaciclib With Surgery (No Postoperative Abemaciclib)
n=1 Participants
Abemaciclib will be administered on a continuous twice daily dosing schedule. Patients who require re-operation will receive a short preoperative course of Abemaciclib.
Tissue will be used to investigate the ability of Abemaciclib to pass through the blood brain barrier.
After surgery participants will come off study and pursue standard of care treatments at their treating physician's discretion.
Abemaciclib: Abemaciclib capsule Surgery: Surgery
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64 years
n=99 Participants
|
60 years
n=107 Participants
|
59 years
n=206 Participants
|
60 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
32 participants
n=107 Participants
|
1 participants
n=206 Participants
|
42 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Single time point for each participant for collection of tissue and blood at surgeryPopulation: This analysis included patients who received abemaciclib prior to surgery, regardless of whether they received postoperative abemaciclib (n=9) or no postoperative abemaciclib (n=1) as per protocol. The surgical cohort of the protocol was amended to end study treatment after surgery.
Intratumoral abemaciclib concentration defined as the mean tumor-to-plasma ratio in contrast enhancing tissue. Patients were treated with abemaciclib prior to surgery. Tissue and plasma for analysis of this endpoint were obtained at the time of surgery.
Outcome measures
| Measure |
Abemaciclib With Surgery (With Postoperative Abemaciclib)
n=9 Participants
Experimental: Abemaciclib with Surgery Abemaciclib will be administered on a continuous twice daily dosing schedule
Patients who require re-operation will receive a short preoperative course of Abemaciclib
Tissue will be used to investigate the ability of Abemaciclib to pass through the blood brain barrier.
After recovery from surgery, participants will resume Abemaciclib.
Each cycle lasts 28 days.
Abemaciclib: Abemaciclib capsule
|
Abemaciclib With Surgery (Without Postoperative Abemaciclib)
n=1 Participants
Participants who require reoperation will be treated with abemaciclib for 10-14 days prior to surgery. Tissue will be used to further investigate the abilities of Abemaciclib. After surgery participants will come off study and pursue standard of care treatments at their treating physician's discretion.
|
|---|---|---|
|
Intratumoral Abemaciclib Concentration
|
145 ng/mL
Interval 10.6 to 616.0
|
10.2 ng/mL
Interval 10.2 to 10.2
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The primary endpoint for the patients treated with abemaciclib in the nonsurgical cohort was PFS6. This Outcome Measure was pre-specified to only assess the "Abemaciclib Without Surgery" Arm/Group.
The primary endpoint for the nonsurgical cohort was six-month progression free survival (PFS6). Progression is defined by Response Assessment in Neuro-Oncology criteria for high-grade glioma (RANO-HGG) as \> 25% increase in sum of the products of perpendicular diameters of enhancing lesions (over best response or baseline if no decrease) on stable or increasing doses of corticosteroids AND/OR one or more of the following: significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids steroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events (radiation therapy, demyelination, ischemic injury, infection, seizures, post-operative changes, or other treatment effects); any new lesion; clear clinical deterioration not attributable to other causes apart from the tumor; or failure to return for evaluation due to death or deteriorating condition.
Outcome measures
| Measure |
Abemaciclib With Surgery (With Postoperative Abemaciclib)
n=31 Participants
Experimental: Abemaciclib with Surgery Abemaciclib will be administered on a continuous twice daily dosing schedule
Patients who require re-operation will receive a short preoperative course of Abemaciclib
Tissue will be used to investigate the ability of Abemaciclib to pass through the blood brain barrier.
After recovery from surgery, participants will resume Abemaciclib.
Each cycle lasts 28 days.
Abemaciclib: Abemaciclib capsule
|
Abemaciclib With Surgery (Without Postoperative Abemaciclib)
Participants who require reoperation will be treated with abemaciclib for 10-14 days prior to surgery. Tissue will be used to further investigate the abilities of Abemaciclib. After surgery participants will come off study and pursue standard of care treatments at their treating physician's discretion.
|
|---|---|---|
|
6-Month Progression Free Survival (PFS6)
|
9.7 Percentage of patients
Interval 2.5 to 22.9
|
—
|
SECONDARY outcome
Timeframe: 2 yearsExpression of levels of phosphorylated retinoblastoma (Rb) to determine if abemaciclib is modulating the intended pathway
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsNumber of participants with treatment-related adverse events as assessed by CTCAE v4.0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsPK measurements expressed as Area under the plasma concentration versus time curve (AUC) of Abemaciclib \[Time Frame C1D1 (pre-treatment), C2D1, C3D1 and C4D1 (each cycle is 28 days)\].
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsPK measurements expressed as Peak Plasma Concentration (Cmax) of Abemaciclib \[Time Frame C1D1 (pre-treatment), C2D1, C3D1 and C4D1 (each cycle is 28 days)\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsThe proportion of participants with measurable disease who experience complete or partial radiographic response determined by the RANO Criteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsThe time from the start of treatment to disease progression or death from any cause
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsTime from start of study treatment to death from any cause
Outcome measures
Outcome data not reported
Adverse Events
Abemaciclib With Surgery
Serious events: 5 serious events
Other events: 5 other events
Deaths: 9 deaths
Abemaciclib Without Surgery
Serious events: 7 serious events
Other events: 21 other events
Deaths: 31 deaths
Cohort 1 Surgery Arm
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Abemaciclib With Surgery
n=9 participants at risk
Abemaciclib will be administered on a continuous twice daily dosing schedule Patients who require re-operation will receive a short preoperative course of Abemaciclib Tissue will be used to investigate the ability of Abemaciclib to pass through the blood brain barrier.
After recovery from surgery, participants will resume Abemaciclib. Each cycle lasts 28 days.
NOTE: enrollment to this arm is complete Abemaciclib: Abemaciclib capsule Surgery: Surgery
|
Abemaciclib Without Surgery
n=32 participants at risk
Abemaciclib will be administered on a continuous twice daily dosing schedule. Each Cycle last 28 days.
NOTE: enrollment to this arm is complete Abemaciclib: Abemaciclib capsule
|
Cohort 1 Surgery Arm
n=1 participants at risk
Participants who require reoperation will be treated with abemaciclib for 10-14 days prior to surgery. Tissue will be used to further investigate the abilities of Abemaciclib. After surgery participants will come off study and pursue standard of care treatments at their treating physician's discretion.
Abemaciclib: Abemaciclib capsule Surgery: Surgery
|
|---|---|---|---|
|
Nervous system disorders
Decreased Motivation, Abulia
|
11.1%
1/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
1/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
General disorders
Gait disturbance
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
3.1%
1/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Surgical and medical procedures
Femur repair
|
11.1%
1/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
11.1%
1/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Nervous system disorders
Seizure
|
22.2%
2/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Infections and infestations
Meningitis
|
11.1%
1/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Nervous system disorders
Brain Abscess
|
11.1%
1/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Infections and infestations
Urinary Tract Infection
|
11.1%
1/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
11.1%
1/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Nervous system disorders
Encephalopathy
|
11.1%
1/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Cardiac disorders
Sinus tachycardia
|
11.1%
1/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Infections and infestations
Positive blood cultures with unknown source
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
100.0%
1/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
3.1%
1/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
6.2%
2/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
3.1%
1/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
6.2%
2/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
6.2%
2/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
3.1%
1/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Renal and urinary disorders
Urinary Urgency
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
6.2%
2/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
6.2%
2/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
3.1%
1/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
General disorders
Death NOS
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
6.2%
2/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Nervous system disorders
Stroke
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
3.1%
1/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
3.1%
1/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
3.1%
1/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
Other adverse events
| Measure |
Abemaciclib With Surgery
n=9 participants at risk
Abemaciclib will be administered on a continuous twice daily dosing schedule Patients who require re-operation will receive a short preoperative course of Abemaciclib Tissue will be used to investigate the ability of Abemaciclib to pass through the blood brain barrier.
After recovery from surgery, participants will resume Abemaciclib. Each cycle lasts 28 days.
NOTE: enrollment to this arm is complete Abemaciclib: Abemaciclib capsule Surgery: Surgery
|
Abemaciclib Without Surgery
n=32 participants at risk
Abemaciclib will be administered on a continuous twice daily dosing schedule. Each Cycle last 28 days.
NOTE: enrollment to this arm is complete Abemaciclib: Abemaciclib capsule
|
Cohort 1 Surgery Arm
n=1 participants at risk
Participants who require reoperation will be treated with abemaciclib for 10-14 days prior to surgery. Tissue will be used to further investigate the abilities of Abemaciclib. After surgery participants will come off study and pursue standard of care treatments at their treating physician's discretion.
Abemaciclib: Abemaciclib capsule Surgery: Surgery
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
3.1%
1/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
3.1%
1/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
100.0%
1/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
3.1%
1/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Investigations
Lipase increased
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
3.1%
1/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Investigations
Lymphocyte count decreased
|
11.1%
1/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
9.4%
3/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
100.0%
1/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Investigations
Neutrophil count decreased
|
22.2%
2/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
15.6%
5/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
6.2%
2/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Investigations
White blood cell decreased
|
22.2%
2/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
18.8%
6/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
1/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/9 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
3.1%
1/32 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
0.00%
0/1 • Adverse Events (AEs) monitored/assessed up to 2 years. AEs are collected from the time of screening through 30 days following end of study treatment and any AEs meeting serious criteria through 90 days following end of study treatment.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place