Trial Outcomes & Findings for An Open-Label Phase II Study of Nivolumab or Nivolumab/Ipilimumab in Adult Participants With Progessive/ Recurrent Meningioma (NCT NCT02648997)

Last Updated: 2026-01-26

Results Overview

To evaluate the anti-tumor activity for single-agent nivolumab (cohort 1) or nivolumab plus ipilimumab following radiation therapy (cohort 2) among patients with recurrent/progressive grade I, II or III meningioma.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

6 months

Results posted on

2026-01-26

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 (Original Cohort): Nivolumab Monotherapy Nivolumab monotherapy (240 mg flat dose) on Day 1 of every 2-week cycle	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) Followed by 4 cycles of combination therapy: Nivolumab (1 mg/kg) + Ipilimumab (3 mg/kg) on Day 1 of every 3-week cycle Followed by Nivolumab monotherapy (480 mg flat dose) on Day 1 of every 4-week cycle	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) Followed by 4 cycles of combination therapy: Nivolumab (3 mg/kg) + Ipilimumab (1 mg/kg) on Day 1 of every 3-week cycle Followed by Nivolumab monotherapy (480 mg flat dose) on Day 1 of every 4-week cycle
Overall Study STARTED	25	3	12
Overall Study COMPLETED	25	3	11
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 (Original Cohort): Nivolumab Monotherapy Nivolumab monotherapy (240 mg flat dose) on Day 1 of every 2-week cycle	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) Followed by 4 cycles of combination therapy: Nivolumab (1 mg/kg) + Ipilimumab (3 mg/kg) on Day 1 of every 3-week cycle Followed by Nivolumab monotherapy (480 mg flat dose) on Day 1 of every 4-week cycle	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) Followed by 4 cycles of combination therapy: Nivolumab (3 mg/kg) + Ipilimumab (1 mg/kg) on Day 1 of every 3-week cycle Followed by Nivolumab monotherapy (480 mg flat dose) on Day 1 of every 4-week cycle
Overall Study Still receiving active study tx	0	0	1

Baseline Characteristics

An Open-Label Phase II Study of Nivolumab or Nivolumab/Ipilimumab in Adult Participants With Progessive/ Recurrent Meningioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 (Original Cohort): Nivolumab Monotherapy n=25 Participants Nivolumab monotherapy (240 mg flat dose) on Day 1 of every 2-week cycle	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab n=3 Participants External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) Followed by 4 cycles of combination therapy: Nivolumab (1 mg/kg) + Ipilimumab (3 mg/kg) on Day 1 of every 3-week cycle Followed by Nivolumab monotherapy (480 mg flat dose) on Day 1 of every 4-week cycle	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab n=12 Participants External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) Followed by 4 cycles of combination therapy: Nivolumab (3 mg/kg) + Ipilimumab (1 mg/kg) on Day 1 of every 3-week cycle Followed by Nivolumab monotherapy (480 mg flat dose) on Day 1 of every 4-week cycle	Total n=40 Participants Total of all reporting groups
Age, Customized Age in years · 18-30	1 Participants n=41 Participants	0 Participants n=1581 Participants	1 Participants n=4626 Participants	2 Participants n=72 Participants
Age, Customized Age in years · 31-40	2 Participants n=41 Participants	0 Participants n=1581 Participants	1 Participants n=4626 Participants	3 Participants n=72 Participants
Age, Customized Age in years · 41-50	5 Participants n=41 Participants	1 Participants n=1581 Participants	2 Participants n=4626 Participants	8 Participants n=72 Participants
Age, Customized Age in years · 51-60	6 Participants n=41 Participants	1 Participants n=1581 Participants	3 Participants n=4626 Participants	10 Participants n=72 Participants
Age, Customized Age in years · 61-70	7 Participants n=41 Participants	1 Participants n=1581 Participants	4 Participants n=4626 Participants	12 Participants n=72 Participants
Age, Customized Age in years · 71-80	2 Participants n=41 Participants	0 Participants n=1581 Participants	1 Participants n=4626 Participants	3 Participants n=72 Participants
Age, Customized Age in years · 81-90	2 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	2 Participants n=72 Participants
Sex: Female, Male Female	14 Participants n=41 Participants	1 Participants n=1581 Participants	5 Participants n=4626 Participants	20 Participants n=72 Participants
Sex: Female, Male Male	11 Participants n=41 Participants	2 Participants n=1581 Participants	7 Participants n=4626 Participants	20 Participants n=72 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=72 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=41 Participants	3 Participants n=1581 Participants	12 Participants n=4626 Participants	36 Participants n=72 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	4 Participants n=72 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=72 Participants
Race (NIH/OMB) Asian	1 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	1 Participants n=72 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=72 Participants
Race (NIH/OMB) Black or African American	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=72 Participants
Race (NIH/OMB) White	23 Participants n=41 Participants	3 Participants n=1581 Participants	10 Participants n=4626 Participants	36 Participants n=72 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=72 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=41 Participants	0 Participants n=1581 Participants	2 Participants n=4626 Participants	3 Participants n=72 Participants
Region of Enrollment United States	25 participants n=41 Participants	3 participants n=1581 Participants	12 participants n=4626 Participants	40 participants n=72 Participants
Baseline Karnofsky Performance Status (KPS) 70	8 Participants n=41 Participants	1 Participants n=1581 Participants	2 Participants n=4626 Participants	11 Participants n=72 Participants
Baseline Karnofsky Performance Status (KPS) 80	12 Participants n=41 Participants	0 Participants n=1581 Participants	3 Participants n=4626 Participants	15 Participants n=72 Participants
Baseline Karnofsky Performance Status (KPS) 90	5 Participants n=41 Participants	2 Participants n=1581 Participants	5 Participants n=4626 Participants	12 Participants n=72 Participants
Baseline Karnofsky Performance Status (KPS) 100	0 Participants n=41 Participants	0 Participants n=1581 Participants	1 Participants n=4626 Participants	1 Participants n=72 Participants
Baseline Karnofsky Performance Status (KPS) UNK	0 Participants n=41 Participants	0 Participants n=1581 Participants	1 Participants n=4626 Participants	1 Participants n=72 Participants
WHO Grade of Tumor at Registration WHO Grade 2	18 Participants n=41 Participants	2 Participants n=1581 Participants	7 Participants n=4626 Participants	27 Participants n=72 Participants
WHO Grade of Tumor at Registration WHO Grade 3	7 Participants n=41 Participants	1 Participants n=1581 Participants	4 Participants n=4626 Participants	12 Participants n=72 Participants
WHO Grade of Tumor at Registration Unknown	0 Participants n=41 Participants	0 Participants n=1581 Participants	1 Participants n=4626 Participants	1 Participants n=72 Participants
Current Recurrence # 1st Relapse	1 Participants n=41 Participants	1 Participants n=1581 Participants	6 Participants n=4626 Participants	8 Participants n=72 Participants
Current Recurrence # 2nd Relapse	12 Participants n=41 Participants	2 Participants n=1581 Participants	3 Participants n=4626 Participants	17 Participants n=72 Participants
Current Recurrence # 3rd Relapse	4 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	4 Participants n=72 Participants
Current Recurrence # 4th Relapse	3 Participants n=41 Participants	0 Participants n=1581 Participants	2 Participants n=4626 Participants	5 Participants n=72 Participants
Current Recurrence # Unknown	0 Participants n=41 Participants	0 Participants n=1581 Participants	1 Participants n=4626 Participants	1 Participants n=72 Participants
Current Recurrence # 5th Relapse	2 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	2 Participants n=72 Participants
Current Recurrence # 6th Relapse	3 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	3 Participants n=72 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Subjects who withdrew consent to be followed or otherwise came off-study prior to reaching 6 months progression-free are not considered evaluable for PFS6 and are therefore not included here. This includes 2 COH 1 subjects and 1 COH 2 subject on Dose Level 0A. Another COH 2 subject on Dose Level 0A Withdrew consent to be followed without ever having received any study tx and is also not included in this dataset.

Outcome measures

Outcome measures
Measure	Cohort 1 (Original Cohort): Nivolumab Monotherapy n=23 Participants Nivolumab monotherapy (240 mg flat dose) on Day 1 of every 2-week cycle	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab n=3 Participants External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) Followed by 4 cycles of combination therapy: Nivolumab (1 mg/kg) + Ipilimumab (3 mg/kg) on Day 1 of every 3-week cycle Followed by Nivolumab monotherapy (480 mg flat dose) on Day 1 of every 4-week cycle	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab n=10 Participants External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) Followed by 4 cycles of combination therapy: Nivolumab (3 mg/kg) + Ipilimumab (1 mg/kg) on Day 1 of every 3-week cycle Followed by Nivolumab monotherapy (480 mg flat dose) on Day 1 of every 4-week cycle
Number of Participants Without Disease Progression At Six Months Following Initiation Of Study Therapy	10 Participants	3 Participants	10 Participants

SECONDARY outcome

Timeframe: 2 years

To evaluate additional measures of anti-tumor activity of single-agent nivolumab (cohort 1) and nivolumab plus ipilimumab after radiation therapy (cohort 2) among patients with recurrent/progressive grade I, II or III meningioma

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

1.2.1 To evaluate the safety and tolerability of single-agent nivolumab (cohort 1) and nivolumab plus ipilimumab after radiation therapy (cohort 2) among patients with recurrent/progressive grade I, II or III meningioma

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Using fluorescence activated cell sorting (FACS), the absolute CD4 T cell count will be determined and phenotyping of T effector cells (CD4+CD69+) and T regulatory cells (CD4+CD25+FoxP3+) with determination of absolute number of naive, effector and regulatory T cells as well as percents/ratios of total population will also be determined. Soluble factors such as cytokines, chemokines, soluble receptors and antibodies to tumor antigens will be measured via commercially available multiplex assays and enzyme-linked immunosorbent assays (ELISA)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

To evaluate correlative biomarkers of systemic immune response among patients with recurrent/progressive grade II or III meningioma treated with single-agent nivolumab (cohort 1) and nivolumab plus ipilimumab after radiation therapy (cohort 2)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Evaluation Of Neurologic Function As Measured By The NANO Scale.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Evaluation of change in tumor growth rate as measured by volumetric analysis

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Evaluation of change in tumor growth rate as measured by volumetric analysis

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1 (Original Cohort): Nivolumab Monotherapy

Serious events: 11 serious events

Other events: 25 other events

Deaths: 20 deaths

Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab

Serious events: 7 serious events

Other events: 11 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

David A. Reardon, MD (Clinical Director, Center for Neuro-Oncology)

Dana-Farber Cancer Institute

Phone: 617-632-2166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Cohort 1 (Original Cohort): Nivolumab Monotherapy n=25 participants at risk Nivolumab monotherapy (240 mg flat dose) on Day 1 of every 2-week cycle Note re: Reported # of Participants @ Risk: * Two COH 1 participants are not considered evaluable for 'All-Cause Mortality' because they withdrew consent to be followed. * One additional COH 1 participant is not considered evaluable for 'All-Cause Mortality' because they were lost to follow-up.	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab n=3 participants at risk External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) Followed by 4 cycles of combination therapy: Nivolumab (1 mg/kg) + Ipilimumab (3 mg/kg) on Day 1 of every 3-week cycle Followed by Nivolumab monotherapy (480 mg flat dose) on Day 1 of every 4-week cycle	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab n=11 participants at risk External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) Followed by 4 cycles of combination therapy: Nivolumab (3 mg/kg) + Ipilimumab (1 mg/kg) on Day 1 of every 3-week cycle Followed by Nivolumab monotherapy (480 mg flat dose) on Day 1 of every 4-week cycle Notes re: Reported # of Participants @ Risk: * One COH 2 Dose Level 0A participant withdrew consent to be followed without ever having received any study tx and is therefore not included in the SAE, Other AE, or All-Cause Mortality datasets. * Two additional COH 2 Dose Level 0A participants are not considered evaluable for 'All-Cause Mortality' because they withdrew consent to be followed.
Cardiac disorders Sinus tachycardia	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Ear and labyrinth disorders Vertigo	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Endocrine disorders Adrenal Insufficiancy	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	18.2% 2/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Endocrine disorders Hyperthyroidism	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Endocrine disorders Endocrine disorders, other: Hypophysitis	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Endocrine disorders Endocrine disorders, other: Panhypopituitarism	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Gastrointestinal disorders Colitis	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Gastrointestinal disorders Duodenal ulcer	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Gastrointestinal disorders Dysphagia	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Gastrointestinal disorders Vomiting	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
General disorders Death, NOS	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
General disorders Fatigue	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
General disorders Fever	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
General disorders Gait disturbance	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
General disorders Infusion-related reaction	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
General disorders General disorders and administration site conditions - Other: Decline; PD	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Infections and infestations Lung infection	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Infections and infestations Sepsis	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Infections and infestations Soft tissue infection	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Infections and infestations Urinary tract infection	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Infections and infestations Infections and infestations - Other: Bacteremia	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Infections and infestations Infections and infestations - Other: Pneumonia	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Injury, poisoning and procedural complications Fall	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Investigations Alanine aminotransferase increased	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Investigations Aspartate aminotransferase increased	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Investigations Cardiac troponin T increased	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Investigations Creatinine increased	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Investigations Lipase increased	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Metabolism and nutrition disorders Anorexia	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Nervous system disorders Dysphasia	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Nervous system disorders Edema cerebral	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Nervous system disorders Encephalopathy	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Nervous system disorders Seizure	8.0% 2/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Psychiatric disorders Confusion	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Renal and urinary disorders Renal colic	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Respiratory, thoracic and mediastinal disorders Aspiration	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Surgical and medical procedures Surgical and medical procedures - Other: Bone removal	4.0% 1/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.

Other adverse events
Measure	Cohort 1 (Original Cohort): Nivolumab Monotherapy n=25 participants at risk Nivolumab monotherapy (240 mg flat dose) on Day 1 of every 2-week cycle Note re: Reported # of Participants @ Risk: * Two COH 1 participants are not considered evaluable for 'All-Cause Mortality' because they withdrew consent to be followed. * One additional COH 1 participant is not considered evaluable for 'All-Cause Mortality' because they were lost to follow-up.	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab n=3 participants at risk External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) Followed by 4 cycles of combination therapy: Nivolumab (1 mg/kg) + Ipilimumab (3 mg/kg) on Day 1 of every 3-week cycle Followed by Nivolumab monotherapy (480 mg flat dose) on Day 1 of every 4-week cycle	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab n=11 participants at risk External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) Followed by 4 cycles of combination therapy: Nivolumab (3 mg/kg) + Ipilimumab (1 mg/kg) on Day 1 of every 3-week cycle Followed by Nivolumab monotherapy (480 mg flat dose) on Day 1 of every 4-week cycle Notes re: Reported # of Participants @ Risk: * One COH 2 Dose Level 0A participant withdrew consent to be followed without ever having received any study tx and is therefore not included in the SAE, Other AE, or All-Cause Mortality datasets. * Two additional COH 2 Dose Level 0A participants are not considered evaluable for 'All-Cause Mortality' because they withdrew consent to be followed.
Blood and lymphatic system disorders Anemia	20.0% 5/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	27.3% 3/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Endocrine disorders Hypothyroidism	8.0% 2/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	66.7% 2/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	18.2% 2/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Eye disorders Blurred vision	16.0% 4/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Eye disorders Eye pain	8.0% 2/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Eye disorders Eye disorders - Other, specify: Diplopia	8.0% 2/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Gastrointestinal disorders Constipation	16.0% 4/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	18.2% 2/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Gastrointestinal disorders Diarrhea	24.0% 6/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	45.5% 5/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Gastrointestinal disorders Dry mouth	12.0% 3/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Gastrointestinal disorders Nausea	24.0% 6/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	45.5% 5/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Gastrointestinal disorders Vomiting	12.0% 3/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
General disorders Fatigue	64.0% 16/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	100.0% 3/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	72.7% 8/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
General disorders Fever	8.0% 2/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	100.0% 3/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	27.3% 3/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Infections and infestations Sinusitis	12.0% 3/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Infections and infestations Skin infection	8.0% 2/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Infections and infestations Urinary tract infection	16.0% 4/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Injury, poisoning and procedural complications Fall	24.0% 6/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Investigations Alanine aminotransferase increased	36.0% 9/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	66.7% 2/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	54.5% 6/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Investigations Alkaline phosphatase increased	16.0% 4/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	36.4% 4/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Investigations Aspartate aminotransferase increased	36.0% 9/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	45.5% 5/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Investigations Lipase increased	24.0% 6/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	27.3% 3/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Investigations Neutrophil count decreased	20.0% 5/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	18.2% 2/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Investigations Platelet count decreased	12.0% 3/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Investigations Serum amylase increased	32.0% 8/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	18.2% 2/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Investigations White blood cell decreased	12.0% 3/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	18.2% 2/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Metabolism and nutrition disorders Anorexia	8.0% 2/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	100.0% 3/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	27.3% 3/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Metabolism and nutrition disorders Hypercalcemia	16.0% 4/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Metabolism and nutrition disorders Hyperglycemia	52.0% 13/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	66.7% 2/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	63.6% 7/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Metabolism and nutrition disorders Hypernatremia	12.0% 3/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Metabolism and nutrition disorders Hypoalbuminemia	16.0% 4/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	66.7% 2/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	18.2% 2/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Metabolism and nutrition disorders Hypocalcemia	8.0% 2/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	63.6% 7/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Metabolism and nutrition disorders Hypoglycemia	16.0% 4/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	18.2% 2/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Metabolism and nutrition disorders Hypokalemia	24.0% 6/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	66.7% 2/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	27.3% 3/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Metabolism and nutrition disorders Hypomagnesemia	8.0% 2/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	18.2% 2/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Metabolism and nutrition disorders Hyponatremia	24.0% 6/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	54.5% 6/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Musculoskeletal and connective tissue disorders Arthralgia	12.0% 3/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Musculoskeletal and connective tissue disorders Back pain	8.0% 2/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	9.1% 1/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	8.0% 2/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	18.2% 2/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	8.0% 2/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	8.0% 2/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	33.3% 1/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Musculoskeletal and connective tissue disorders Myalgia	20.0% 5/25 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/3 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.	0.00% 0/11 • AEs are collected and reported from initiation of study medication through 30 days following the last dose of study medication. Any AE meeting Serious criteria (SAE) occurring anytime after a subject's consent through 100 days of the last dose of treatment are reported (or until the start of new anti-cancer treatment, whichever comes first) Adverse Events (AEs) monitored/assessed up to 4 years (as the maximum # of days a patient has been on active study treatment thusfar is 1258 days). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational product; it does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.